Drug Administration Law of the People's Republic of China

Published:

2021-11-26


Drug Administration Law of the People's Republic of China

(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and revised for the first time at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001) The first amendment was made in accordance with the Decision on Amending the Pharmaceutical Administration Law of the People's Republic of China adopted at the 14th Meeting of the Standing Committee of the 12th National People's Congress on April 24, 2015. The second amendment was made at the 12th Meeting of the Standing Committee of the 13th National People's Congress on August 26, 2019.)

catalogue
Chapter I General Provisions
Chapter II Drug Development and Registration
Chapter III Holders of Drug Marketing License
Chapter IV Pharmaceutical Production
Chapter V Pharmaceutical Trading
CHAPTER VI ADMINISTRATION OF PHARMACEUTICAL AFFAIRS IN MEDICAL INSTITUTIONS
Chapter VII Post marketing Administration of Drugs
Chapter VIII Drug Prices and Advertising
Chapter IX Drug Reserve and Supply
Chapter X Supervision and Administration
Chapter XI Legal Liabilities
Chapter XII Supplementary Provisions

Chapter I General Provisions

Article 1 This Law is formulated with a view to strengthening drug control, ensuring drug quality, safeguarding the safety of drug use and the legitimate rights and interests of the public, and protecting and promoting public health.
Article 2 This Law applies to the development, production, distribution, use, supervision and administration of pharmaceuticals within the territory of the People's Republic of China.
The term "drugs" as used in this Law refers to substances used for the prevention, treatment and diagnosis of human diseases, for the purpose of regulating human physiological functions and for which indications or main functions, usage and dosage are prescribed, including traditional Chinese medicine, chemical drugs and biological products.
Article 3 The administration of drugs should focus on the people's health, adhere to the principles of risk management, full process control and social co governance, establish a scientific and strict supervision and management system, comprehensively improve the quality of drugs, and ensure the safety, effectiveness and accessibility of drugs.
Article 4 The State shall develop modern medicine and traditional medicine and give full play to their roles in prevention, medical treatment and health care.
The State protects the resources of wild medicinal materials and varieties of traditional Chinese medicines, and encourages the cultivation of genuine Chinese medicinal materials.
Article 5 The State encourages the research and development of new drugs and protects the legitimate rights and interests of citizens, legal persons and other organizations in the research and development of new drugs.
Article 6 The State adopts a system of drug marketing license holders for drug administration. The holder of the drug marketing license is legally responsible for the safety, effectiveness and quality controllability of the drug in the whole process of drug development, production, marketing and use.
Article 7 Anyone engaged in the development, production, marketing and use of drugs shall abide by laws, regulations, rules, standards and norms, and ensure that the information in the whole process is true, accurate, complete and traceable.
Article 8 The drug regulatory department under the State Council shall be in charge of drug supervision and administration throughout the country. The relevant departments under the State Council shall be responsible for the supervision and administration of pharmaceuticals within their respective functions and responsibilities. The drug regulatory department under the State Council shall cooperate with the relevant departments under the State Council to implement the national drug industry development plan and industrial policies.
The drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government are responsible for drug supervision and administration within their respective administrative areas. The departments responsible for drug supervision and administration under the people's governments of cities divided into districts and counties (hereinafter referred to as drug supervision and administration departments) are responsible for drug supervision and administration within their respective administrative areas. The relevant departments of the local people's governments at or above the county level shall be responsible for drug related supervision and administration within their respective functions and responsibilities.
Article 9 The local people's governments at or above the county level shall be responsible for the drug supervision and administration within their respective administrative areas, uniformly lead, organize and coordinate the drug supervision and administration and the response to drug safety emergencies within their respective administrative areas, and establish and improve the drug supervision and administration mechanism and information sharing mechanism.
Article 10 People's governments at or above the county level shall incorporate drug safety work into their national economic and social development plans, include drug safety work funds into their government budgets, strengthen drug supervision and management capacity building, and provide guarantee for drug safety work.
Article 11 The pharmaceutical professional technical institutions set up or designated by the pharmaceutical supervisory and administrative departments shall be responsible for the review, inspection, verification, monitoring and evaluation required for the implementation of pharmaceutical supervision and administration according to law.
Article 12 The State shall establish a sound drug traceability system. The drug regulatory department under the State Council shall formulate unified standards and specifications for drug traceability, promote the exchange and sharing of drug traceability information, and achieve drug traceability.
The State establishes a pharmacovigilance system to monitor, identify, evaluate and control adverse drug reactions and other harmful reactions related to drug use.
Article 13 People's governments at all levels and their relevant departments, pharmaceutical industry associations, etc. shall strengthen the publicity and education of drug safety, and carry out the popularization of laws and regulations on drug safety.
The news media shall carry out public publicity of drug safety laws and regulations and other knowledge, and supervise drug violations by public opinion. The publicity and report on drugs shall be comprehensive, scientific, objective and fair.
Article 14 Pharmaceutical industry associations shall strengthen self-discipline in the industry, establish and improve industry norms, promote the construction of industry integrity system, guide and urge members to carry out pharmaceutical production and marketing activities according to law.
Article 15 The people's governments at or above the county level and their relevant departments shall, in accordance with the relevant regulations of the State, commend and reward the units and individuals that have made outstanding contributions to the development, production, distribution, use, supervision and administration of drugs.

Chapter II Drug Development and Registration

Article 16 The State supports the innovation of drugs that are guided by clinical value and have definite or special curative effects on human diseases, encourages the development of new drugs that have new therapeutic mechanisms, treat diseases seriously endangering life or rare diseases, and have multiple targeted and systematic regulatory and intervention functions on human beings, so as to promote the progress of drug technology.
The State encourages the use of modern science and technology and traditional Chinese medicine research methods to carry out scientific and technological research and drug development of traditional Chinese medicine, establish and improve a technical evaluation system consistent with the characteristics of traditional Chinese medicine, and promote the inheritance and innovation of traditional Chinese medicine.
The State shall take effective measures to encourage the development and innovation of medicines for children, support the development of new varieties, dosage forms and specifications of medicines for children that meet the physiological characteristics of children, and give priority to the review and approval of medicines for children.
Article 17 Those engaged in drug research and development shall abide by the quality control standards for non clinical research and clinical trials of drugs, and ensure that the whole process of drug development continues to meet the statutory requirements.
The drug regulatory department under the State Council shall, together with the relevant departments under the State Council, formulate the quality control standards for non clinical drug research and the quality control standards for clinical drug trials.
Article 18 Non clinical drug research shall be carried out in accordance with the relevant provisions of the State, with personnel, sites, equipment, instruments and management systems appropriate to the research project, and to ensure the authenticity of relevant data, materials and samples.
Article 19 To carry out clinical trials of drugs, relevant data, materials and samples, such as research methods, quality indicators, pharmacological and toxicological test results, shall be truthfully submitted in accordance with the provisions of the drug regulatory department under the State Council, and shall be approved by the drug regulatory department under the State Council. The drug regulatory department under the State Council shall decide whether to approve and notify the applicant of the clinical trial within 60 working days from the date of accepting the application for clinical trial. If the applicant fails to do so within the time limit, it shall be deemed to have consented. The bioequivalence test shall be reported to the drug regulatory department under the State Council for the record.
Clinical trials of drugs shall be conducted in clinical trial institutions with appropriate conditions. Drug clinical trial institutions shall be put on record, and the specific measures shall be jointly formulated by the drug regulatory department under the State Council and the competent health department under the State Council.
Article 20 The clinical trial of drugs shall be carried out in accordance with ethical principles, and a clinical trial plan shall be formulated, which shall be examined and approved by the Ethics Committee.
The Ethics Committee shall establish an ethical review system to ensure that the ethical review process is independent, objective and fair, supervise and standardize the development of drug clinical trials, protect the legitimate rights and interests of subjects, and safeguard social and public interests.
Article 21 To carry out a clinical trial of drugs, it is necessary to truthfully explain and explain the purpose, risks and other details of the clinical trial to the subject or his guardian, obtain an informed consent signed voluntarily by the subject or his guardian, and take effective measures to protect the legitimate rights and interests of the subject.
Article 22 If safety problems or other risks are found during the clinical trial of drugs, the sponsor of the clinical trial shall timely adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the drug regulatory department under the State Council. When necessary, the drug regulatory department under the State Council may order adjustment of the clinical trial plan, suspension or termination of the clinical trial.
Article 23 For drugs that are being used in clinical trials to treat diseases that seriously endanger lives and have no effective means of treatment, if they may benefit from medical observation and conform to ethical principles, they can be used for other patients with the same condition in the institutions conducting clinical trials after examination and informed consent.
Article 24 Pharmaceuticals listed in China shall be approved by the drug regulatory department under the State Council and obtain a drug registration certificate; However, the traditional Chinese medicines and prepared slices of traditional Chinese medicines that have not been examined and approved are excluded. The catalogue of Chinese medicinal materials and prepared slices of traditional Chinese medicine under examination and approval administration shall be formulated by the drug regulatory department under the State Council in conjunction with the department in charge of traditional Chinese medicine under the State Council.
When applying for drug registration, true, sufficient and reliable data, materials and samples shall be provided to prove the safety, effectiveness and quality controllability of drugs.
Article 25 With respect to the drugs applied for registration, the drug regulatory department under the State Council shall organize pharmaceutical, medical and other technical personnel to review the safety, effectiveness and quality controllability of the drugs, as well as the applicant's quality management, risk prevention and control, liability compensation and other capabilities; If the conditions are met, a drug registration certificate shall be issued.
When approving drugs, the drug regulatory department under the State Council shall review and approve chemical APIs, relevant auxiliary materials, packaging materials and containers in direct contact with drugs, and quality standards, production processes, labels and instructions of drugs.
The auxiliary materials referred to in this Law refer to excipients and additives used in the production and dispensing of pharmaceuticals.
Article 26 For the treatment of diseases seriously endangering life and for which there is no effective means of treatment, as well as drugs urgently needed in public health, if the clinical trial of drugs has data showing the efficacy and can predict its clinical value, it may be approved with conditions, and the relevant matters shall be clearly stated in the drug registration certificate.
Article 27 The drug regulatory department under the State Council shall improve the drug review and approval system, strengthen capacity building, establish and improve communication, expert consultation and other mechanisms, optimize the review and approval process, and improve the efficiency of review and approval.
The conclusion and basis of the review of drugs approved for marketing shall be made public according to law and subject to social supervision. The business secrets learned in the review and approval shall be kept confidential.
Article 28 Drugs shall conform to the national drug standards. If the drug quality standards approved by the drug regulatory department under the State Council are higher than the national drug standards, the approved drug quality standards shall prevail; If there is no national drug standard, it shall meet the approved drug quality standard.
The Pharmacopoeia of the People's Republic of China and drug standards promulgated by the drug regulatory department under the State Council are the national drug standards.
The drug regulatory department under the State Council, together with the competent health department under the State Council, shall organize a pharmacopoeia committee to be responsible for the formulation and revision of the national drug standards.
The drug inspection institutions set up or designated by the drug regulatory department under the State Council shall be responsible for the standardization of national drug standards and reference materials.
Article 29 The names of drugs listed in the national drug standards are the generic names of drugs. If it has been used as a generic name of a drug, the name shall not be used as a drug trademark.

  Chapter III Holders of Drug Marketing License

Article 30 The holder of the drug marketing license refers to the enterprise or drug research and development institution that has obtained the drug registration certificate.
The holder of a drug marketing license shall, in accordance with the provisions of this Law, be responsible for the non clinical research, clinical trials, production and marketing, post marketing research, adverse reaction monitoring, reporting and handling of drugs. Other units and individuals engaged in drug research, production, marketing, storage, transportation, use and other activities shall bear corresponding responsibilities according to law.
The legal representative and principal responsible person of the holder of the drug marketing license shall be fully responsible for the drug quality.
Article 31 A holder of a drug marketing license shall establish a drug quality assurance system and assign special personnel to be independently responsible for drug quality control.
The holder of the drug marketing license shall regularly review the quality management system of the entrusted drug manufacturing enterprise and drug handling enterprise, and supervise that they continue to have the quality assurance and control capabilities.
Article 32 The holder of a drug marketing license may produce drugs on his own or entrust a drug producing enterprise to produce drugs.
Where a holder of a drug marketing license manufactures drugs on his own, he shall obtain a drug production license in accordance with the provisions of this Law; Where production is entrusted, qualified pharmaceutical manufacturers shall be entrusted. The holder of the drug marketing license and the entrusted production enterprise shall sign the entrustment agreement and the quality agreement, and strictly perform the obligations agreed in the agreement.
The pharmaceutical supervisory and administrative department under the State Council shall formulate guidelines for quality agreements for entrusted drug production, and guide and supervise the holders of drug marketing licenses and entrusted manufacturing enterprises in fulfilling their obligations of drug quality assurance.
Blood products, anesthetic drugs, psychotropic drugs, toxic drugs for medical use, and pharmaceutical precursor chemicals shall not be commissioned for production; However, unless otherwise stipulated by the drug regulatory department under the State Council.
Article 33 The holder of the drug marketing license shall establish the drug marketing release procedures, examine the drugs released from the factory by the drug manufacturing enterprise, and release them only after the signature of the quality authorized person. Those failing to meet the national drug standards shall not be released.
Article 34 The holder of the drug marketing license may sell the drugs for which the drug registration certificate has been obtained by himself or entrust the drug handling enterprise to sell them. A holder of a drug marketing license who engages in drug retail activities shall obtain a drug trading license.
A holder of a drug marketing license who sells drugs on his own shall meet the requirements specified in Article 52 of this Law; In case of entrusted sales, qualified drug handling enterprises shall be entrusted. The holder of the drug marketing license and the entrusted enterprise shall sign an entrustment agreement and strictly perform their obligations under the agreement.
Article 35 Where a holder of a drug marketing license, a drug producing enterprise or a drug handling enterprise entrusts the storage and transportation of drugs, it shall evaluate the quality assurance ability and risk management ability of the entrusted party, sign an entrustment agreement with the entrusted party, stipulate the drug quality responsibility, operating procedures, etc., and supervise the entrusted party.
Article 36 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall establish and implement a drug traceability system, provide traceability information in accordance with regulations, and ensure the traceability of drugs.
Article 37 Holders of drug marketing licenses shall establish an annual reporting system, and report the production and sales of drugs, post marketing research, risk management, etc. to the drug regulatory departments of the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government in accordance with regulations.
Article 38 If the holder of the drug marketing license is an overseas enterprise, the enterprise legal person designated by the holder in China shall perform the obligations of the holder of the drug marketing license and bear joint and several liabilities with the holder of the drug marketing license.
Article 39 The manufacturer of prepared slices of traditional Chinese medicine shall perform the relevant obligations of the holder of the drug marketing license, implement the whole process management of the production and sales of prepared slices of traditional Chinese medicine, establish a traceability system for prepared slices of traditional Chinese medicine, and ensure the safety, effectiveness and traceability of prepared slices of traditional Chinese medicine.
Article 40 With the approval of the drug regulatory department under the State Council, the holder of the drug marketing license may transfer the drug marketing license. The transferee shall have the capability of quality management, risk prevention and control and liability compensation to ensure the safety, effectiveness and quality controllability of the drug, and perform the obligations of the drug marketing license holder.

Chapter IV Pharmaceutical Production

Article 41 To engage in drug production activities, approval must be obtained from the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located and a drug production license must be obtained. No drug may be produced without a drug production license.
A drug production license shall indicate the period of validity and the scope of production, and the license shall be re examined and re issued upon expiration.
Article 42 To engage in drug production activities, the following conditions shall be met:
(1) There are legally qualified pharmaceutical technicians, engineering technicians and corresponding technical workers;
(2) There are factory buildings, facilities and sanitary environment suitable for drug production;
(3) There are institutions, personnel and necessary instruments and equipment capable of conducting quality management and quality inspection on the drugs produced;
(4) There are rules and regulations to ensure the quality of drugs, and they meet the requirements of the pharmaceutical production quality control standards formulated by the pharmaceutical supervisory and administrative department under the State Council in accordance with this Law.
Article 43 Those engaged in pharmaceutical production shall abide by the quality control standards for pharmaceutical production, establish and improve the quality control system for pharmaceutical production, and ensure that the whole process of pharmaceutical production continues to meet the statutory requirements.
The legal representative and principal person in charge of the pharmaceutical production enterprise shall be fully responsible for the pharmaceutical production activities of the enterprise.
Article 44 Pharmaceuticals shall be produced in accordance with the national pharmaceutical standards and the production processes approved by the pharmaceutical supervisory and administrative departments. Production and inspection records shall be complete and accurate and shall not be fabricated.
The prepared slices of traditional Chinese medicine shall be prepared in accordance with the national drug standards; In the absence of such provisions in the national drug standards, the processing shall be carried out in accordance with the processing specifications formulated by the drug regulatory departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government. The processing specifications formulated by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall be reported to the drug regulatory department under the State Council for the record. Those that do not meet the national drug standards or are not processed in accordance with the processing specifications formulated by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government may not leave the factory or be sold.
Article 45 The raw materials and auxiliary materials needed for the production of pharmaceuticals shall meet the pharmaceutical requirements and the relevant requirements of the pharmaceutical production quality control standards.
In the production of drugs, the suppliers of raw materials and auxiliary materials shall be examined in accordance with regulations to ensure that the raw materials and auxiliary materials purchased and used meet the requirements of the preceding paragraph.
Article 46 Packaging materials and containers in direct contact with pharmaceuticals shall meet the requirements for medicinal use and meet the standards for safeguarding human health and safety.
The unqualified packaging materials and containers that directly contact drugs shall be ordered to stop using by the drug regulatory department.
Article 47 Pharmaceutical producing enterprises shall conduct quality inspection of pharmaceuticals. Those failing to meet the national drug standards shall not leave the factory.
Drug producing enterprises shall establish procedures for the release of drugs from the factory and specify the standards and conditions for the release from the factory. Those meeting the standards and conditions can be released only after being signed by the quality authorized person.
Article 48 Pharmaceutical packaging shall meet the requirements of pharmaceutical quality and facilitate storage, transportation and medical use.
Chinese medicinal materials shall be packaged for shipment. On each package, the product name, place of origin, date and supplier shall be indicated, and the mark of qualified quality shall be attached.
Article 49 Pharmaceutical packages shall be printed or affixed with labels and instructions in accordance with regulations.
The label or instruction manual shall indicate the generic name, ingredients, specifications, the holder of the marketing license and its address, the manufacturer and its address, the approval number, the product batch number, the date of production, the period of validity, the indications or functions, the usage, dosage, contraindications, adverse reactions and precautions of the drug. The words in the labels and instructions shall be clear, and the production date, expiry date and other matters shall be clearly marked for easy identification.
The labels and instructions of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and non prescription drugs shall bear the prescribed marks.
Article 50 The holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions who work in direct contact with drugs shall undergo annual health examination. Those who suffer from infectious diseases or other diseases that may contaminate drugs may not engage in work that directly contacts drugs.

Chapter V Pharmaceutical Trading

Article 51 To engage in drug wholesale activities, the approval of the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government where the enterprise is located shall be obtained and a drug handling license shall be obtained. To engage in drug retail activities, the approval of the drug regulatory department of the local people's government at or above the county level shall be obtained and a drug trading license shall be obtained. Without a drug trading license, no drug may be traded.
The term of validity and scope of business shall be indicated in the drug trade license, and the license shall be re issued upon expiration.
When implementing the drug trade license, the drug regulatory department shall follow the principle of facilitating the purchase of drugs by the masses in addition to the conditions specified in Article 52 of this Law.
Article 52 Pharmaceutical trading activities shall meet the following requirements:
(1) There are legally certified pharmacists or other pharmaceutical technicians;
(2) Having business premises, equipment, storage facilities and a hygienic environment suitable for the drugs handled;
(3) There is a quality management organization or personnel appropriate to the drugs handled;
(4) There are rules and regulations to ensure the quality of drugs, and they meet the requirements of the quality control standards for drug handling formulated by the drug regulatory department under the State Council in accordance with this Law.
Article 53 Pharmaceutical trading activities shall comply with the quality control standards for pharmaceutical trading, establish and improve the quality control system for pharmaceutical trading, and ensure that the whole process of pharmaceutical trading continues to meet the statutory requirements.
The State encourages and guides drug retail chain operation. The headquarters of enterprises engaged in drug retail chain business activities shall establish a unified quality management system and perform management responsibilities for the business activities of their retail enterprises.
The legal representative and principal responsible person of the drug handling enterprise shall be fully responsible for the drug handling activities of the enterprise.
Article 54 The State applies a classified management system for prescription drugs and non prescription drugs. The specific measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
Article 55 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall purchase drugs from holders of drug marketing licenses or enterprises qualified for drug production and trading; However, the purchase of Chinese medicinal materials without examination and approval is excluded.
Article 56 When purchasing drugs, drug handling enterprises shall establish and implement a system for inspection and acceptance of purchased drugs, and verify the drug certificates and other marks; Those that do not meet the specified requirements shall not be purchased or sold.
Article 57 Pharmaceutical trading enterprises shall have authentic and complete records of the purchase and sale of pharmaceuticals. The purchase and sale records shall indicate the generic name, dosage form, specification, product batch number, validity period, marketing license holder, manufacturer, purchase and sale unit, purchase and sale quantity, purchase and sale price, purchase and sale date of the drug, and other contents specified by the drug regulatory department under the State Council.
Article 58 When retailing drugs, drug handling enterprises shall be accurate and correct, and shall correctly explain the usage, dosage and precautions; The dispensing prescription shall be checked, and the drugs listed in the prescription shall not be changed or substituted without authorization. The prescription with incompatibility or excessive dosage shall be refused to be dispensed; If necessary, the prescription can be dispensed only after it is corrected or re signed by the prescribing physician.
Pharmaceutical trading enterprises selling Chinese medicinal materials shall indicate the place of origin.
Pharmacists or other pharmaceutical technicians who have been legally certified shall be responsible for drug management, prescription verification and dispensing, and guidance for rational use of drugs in their enterprises.
Article 59 Pharmaceutical trading enterprises shall formulate and implement a pharmaceutical storage system, and take necessary measures to ensure the quality of pharmaceuticals, such as cold storage, frost prevention, moisture-proof, pest prevention and rat prevention.
An inspection system shall be implemented for the warehousing and ex warehousing of drugs.
Article 60 Chinese medicinal materials may be sold in urban and rural fairs, unless otherwise stipulated by the State Council.
Article 61 Holders of drug marketing licenses and drug handling enterprises that sell drugs through the Internet shall abide by the relevant provisions of this Law on drug handling. The specific administrative measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
Vaccines, blood products, narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs under special state control may not be sold on the Internet.
Article 62 The third-party platform provider of drug online trading shall, in accordance with the provisions of the drug regulatory department under the State Council, file a record with the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located.
The third-party platform provider shall, in accordance with the law, review the qualification of the drug marketing license holders and drug trading enterprises that apply to enter the platform for operation, ensure that they meet the statutory requirements, and manage the drug trading activities that occur on the platform.
If the third-party platform provider finds that the holder of the drug marketing license or the drug handling enterprise that enters the platform for trading has violated the provisions of this Law, it shall stop it in a timely manner and immediately report it to the drug regulatory department of the local people's government at the county level; If a serious illegal act is found, the provision of online trading platform services shall be stopped immediately.
Article 63 Medicinal materials newly discovered or introduced from abroad may be sold only after being approved by the drug regulatory department under the State Council.
Article 64 Pharmaceuticals shall be imported from ports that allow the import of pharmaceuticals, and the pharmaceutical importing enterprises shall file a record with the pharmaceutical supervisory and administrative department at the place where the port is located. The customs shall go through the customs formalities on the strength of the customs clearance form for imported drugs issued by the drug regulatory department. If there is no customs clearance form for imported drugs, the customs shall not release them.
The drug regulatory department in the place where the port is located shall notify the drug inspection institution to conduct random inspection of imported drugs in accordance with the provisions of the drug regulatory department under the State Council.
The port for drug import shall be proposed by the drug regulatory department under the State Council jointly with the General Administration of Customs and submitted to the State Council for approval.
Article 65 Where a medical institution urgently needs to import a small amount of drugs for clinical purposes, it may do so with the approval of the drug regulatory department under the State Council or the people's government of a province, autonomous region or municipality directly under the Central Government authorized by the State Council. Imported drugs shall be used for specific medical purposes in designated medical institutions.
A small amount of drugs brought into China for personal use shall be handled in accordance with the relevant provisions of the State.
Article 66 The import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the State shall hold the import license and export license issued by the drug regulatory department under the State Council.
Article 67 It is prohibited to import drugs with uncertain efficacy, large adverse reactions or other reasons that endanger human health.
Article 68 The pharmaceutical supervisory and administrative department under the State Council shall appoint a pharmaceutical inspection institution to inspect the following pharmaceuticals before they are sold or imported:; Those that have not been inspected or failed to pass the inspection shall not be sold or imported:
(1) Drugs sold in China for the first time;
(2) Biological products specified by the drug regulatory department under the State Council;
(3) Other drugs prescribed by the State Council.

CHAPTER VI ADMINISTRATION OF PHARMACEUTICAL AFFAIRS IN MEDICAL INSTITUTIONS

Article 69 A medical institution shall be staffed with legally qualified pharmacists or other pharmaceutical technicians to be responsible for the drug administration, prescription verification and dispensing, rational drug use guidance, etc. of the unit. Non pharmaceutical technicians shall not directly engage in pharmaceutical technical work.
Article 70 When purchasing drugs, medical institutions shall establish and implement a system for inspection and acceptance of purchased drugs, and verify the drug certificates and other marks; Those that do not meet the specified requirements shall not be purchased or used.
Article 71 A medical institution shall have a place, equipment, storage facilities and a hygienic environment suitable for the drugs it uses, formulate and implement a drug storage system, and take necessary measures such as cold storage, antifreeze, moisture-proof, pest prevention and rat prevention to ensure the quality of drugs.
Article 72 Medical institutions shall adhere to the principle of safe, effective, economical and reasonable drug use, follow the guiding principles for clinical application of drugs, clinical diagnosis and treatment guidelines, drug instructions and other rational drug use, and examine the appropriateness of doctors' prescriptions and medical orders for drug use.
Drug users other than medical institutions shall abide by the provisions of this Law on the use of drugs by medical institutions.
Article 73 Pharmacists or other pharmaceutical technicians who have been legally certified as qualified shall check the prescriptions they dispense, and shall not alter or substitute the drugs listed in the prescriptions without authorization. The prescription with incompatibility or excessive dosage shall be refused to be dispensed; If necessary, the prescription can be dispensed only after it is corrected or re signed by the prescribing physician.
Article 74 A medical institution shall obtain a pharmaceutical preparation license from the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located before making pharmaceutical preparations. No pharmaceutical preparations may be made without a pharmaceutical preparation license of a medical institution.
The pharmaceutical preparation license of a medical institution shall indicate the period of validity, and the license shall be re examined and issued upon expiration.
Article 75 When making preparations, medical institutions shall have facilities, management systems, inspection instruments and a hygienic environment that can ensure the quality of preparations.
Medical institutions shall make preparations in accordance with the approved process, and the raw materials, auxiliary materials and packaging materials needed shall meet the pharmaceutical requirements.
Article 76 The pharmaceutical preparations made by medical institutions shall be the varieties that are clinically needed by their units but not available on the market, and shall be approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government where they are located; However, unless the law provides otherwise for the preparation of traditional Chinese medicine preparations.
The quality of the preparations made by medical institutions shall be inspected in accordance with regulations; Those qualified shall be used in the unit according to the doctor's prescription. With the approval of the drug regulatory department under the State Council or the drug regulatory department of the people's government of a province, autonomous region, or municipality directly under the Central Government, preparations made by medical institutions may be used among designated medical institutions.
Preparations made by medical institutions shall not be sold on the market.

Chapter VII Post marketing Administration of Drugs

Article 77 The holder of a drug marketing license shall formulate a post marketing risk management plan for drugs, actively carry out post marketing research on drugs, further verify the safety, effectiveness and quality controllability of drugs, and strengthen the continuous management of drugs already on the market.
Article 78 With regard to the drugs approved with conditions, the holders of the drug marketing license shall take corresponding risk management measures and complete relevant research as required within the specified time limit; If the drug regulatory department under the State Council fails to complete the research as required within the time limit or fails to prove that the benefits outweigh the risks, it shall handle the matter according to law until the drug registration certificate is cancelled.
Article 79 Changes made in the course of drug production shall be managed by category according to their risks and effects on drug safety, effectiveness and quality controllability. If it is a major change, it shall be approved by the drug regulatory department under the State Council. Other changes shall be filed or reported in accordance with the provisions of the drug regulatory department under the State Council.
The holder of the drug marketing license shall, in accordance with the provisions of the drug regulatory department under the State Council, comprehensively assess and verify the impact of the changes on the drug safety, effectiveness and quality controllability.
Article 80 The holder of the drug marketing license shall carry out post marketing ADR monitoring, actively collect, track and analyze the information on suspected ADRs, and take risk control measures for drugs with identified risks in a timely manner.
Article 81 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall regularly inspect the quality, efficacy and adverse reactions of the drugs produced, handled and used by their own units. If any suspected adverse reaction is found, it shall be reported to the drug regulatory department and the competent health department in a timely manner. The specific measures shall be formulated by the drug regulatory department under the State Council in conjunction with the competent health department under the State Council.
For drugs that have been confirmed to have serious adverse reactions, the drug regulatory department under the State Council or the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government shall, according to the actual situation, take emergency control measures such as stopping production, sales and use, and shall organize an appraisal within five days, and make an administrative decision within fifteen days from the date of the conclusion of the appraisal.
Article 82 Where a drug has quality problems or other potential safety hazards, the holder of the drug marketing license shall immediately stop selling the drug, inform the relevant drug handling enterprises and medical institutions to stop selling and using the drug, recall the sold drug, make public the recall information in a timely manner, and immediately stop production when necessary, and report the recall and handling of the drug to the provinces, autonomous regions Report by the drug regulatory department and the competent health department of the people's government of the municipality directly under the Central Government. Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall cooperate.
If the holder of the drug marketing license should recall the drugs but fails to recall them according to law, the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall order him to recall them.
Article 83 The holder of the drug marketing license shall regularly conduct post marketing evaluation on the safety, effectiveness and quality controllability of the listed drugs. When necessary, the drug regulatory department under the State Council may order the holders of drug marketing licenses to carry out post marketing evaluations or directly organize post marketing evaluations.
The drug registration certificate shall be cancelled for drugs whose efficacy is uncertain, whose adverse reactions are large, or which endanger human health for other reasons.
Drugs whose drug registration certificates have been cancelled shall not be produced, imported, sold or used.
The drugs whose drug registration certificates have been cancelled or whose validity period has expired shall be destroyed under the supervision of the drug regulatory department or other harmless treatment measures shall be taken according to law.

Chapter VIII Drug Prices and Advertising

Article 84 The State shall improve the drug procurement management system, monitor drug prices, conduct cost price investigations, strengthen drug price supervision and inspection, investigate and deal with drug price violations such as price monopoly and price gouging according to law, and maintain drug price order.
Article 85 For drugs whose prices are regulated by the market according to law, the holders of the drug marketing license, drug producing enterprises, drug handling enterprises and medical institutions shall set the prices in accordance with the principles of fairness, reasonableness, honesty and good faith, and consistency between quality and price, so as to provide the drug users with drugs with reasonable prices.
Pharmaceutical marketing license holders, pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall abide by the provisions of the pharmaceutical pricing department under the State Council on the administration of pharmaceutical prices, formulate and indicate the retail prices of pharmaceuticals, and prohibit such acts as profiteering, price monopoly and price fraud.
Article 86 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions shall, in accordance with the law, provide the competent drug pricing authorities with information on the actual purchase and sale prices and quantities of their drugs.
Article 87 Medical institutions shall provide patients with a price list of the drugs they use, truthfully publish the prices of their commonly used drugs according to regulations, and strengthen the administration of rational drug use. The specific measures shall be formulated by the competent health department under the State Council.
Article 88 Holders of drug marketing licenses, drug producing enterprises, drug handling enterprises and medical institutions are prohibited from giving or receiving rebates or other illegitimate interests in the purchase and sale of drugs.
It is prohibited for holders of drug marketing licenses, drug producing enterprises, drug handling enterprises or agents to give money, property or other illegitimate interests in any name to the responsible persons, drug purchasers, physicians, pharmacists and other relevant personnel of the medical institutions that use their drugs. Responsible persons, drug purchasers, physicians, pharmacists and other relevant personnel of medical institutions are prohibited from accepting money, property or other illegitimate benefits from the holders of drug marketing licenses, drug producing enterprises, drug handling enterprises or agents in any name.
Article 89 An advertisement for a drug shall be approved by the advertising examination organ designated by the people's government of the province, autonomous region or municipality directly under the Central Government where the advertiser is located; Those without approval shall not be published.
Article 90 The contents of a drug advertisement shall be true and legal, and shall be subject to the drug directions approved by the drug regulatory department under the State Council, and shall not contain false contents.
Drug advertisements shall not contain assertions or guarantees of efficacy or safety; It is not allowed to use the name or image of state organs, scientific research institutions, academic institutions, trade associations or experts, scholars, doctors, pharmacists, patients, etc. to make recommendations or certificates.
Non drug advertisements shall not involve drug publicity.
Article 91 Where there are no provisions on drug prices and advertisements in this Law, the provisions of the Price Law of the People's Republic of China, the Anti monopoly Law of the People's Republic of China, the Anti Unfair Competition Law of the People's Republic of China, the Advertising Law of the People's Republic of China, etc. shall apply.

Chapter IX Drug Reserve and Supply

Article 92 The State implements a drug reserve system and establishes drug reserves at the central and local levels.
In the event of a major disaster, epidemic situation or other emergencies, drugs may be urgently used in accordance with the provisions of the Emergency Response Law of the People's Republic of China.
Article 93 The State implements the system of essential drugs, selects an appropriate number of essential drugs, strengthens the organization of production and storage, improves the supply capacity of essential drugs, and meets the demand for basic drugs for disease prevention and control.
Article 94 The State shall establish a drug supply and demand monitoring system, timely collect, summarize and analyze the information on the supply and demand of drugs in short supply, give early warning to drugs in short supply, and take countermeasures.
Article 95 The State implements a system for the control of the list of drugs in short supply. The specific measures shall be formulated by the competent health department under the State Council in conjunction with the drug regulatory department under the State Council and other departments.
If the holder of a drug marketing license stops producing drugs in short supply, he shall report to the drug regulatory department under the State Council or the drug regulatory department under the people's government of the province, autonomous region or municipality directly under the Central Government in accordance with regulations.
Article 96 The State encourages the development and production of medicines in short supply, and gives priority to the examination and approval of medicines in short supply urgently needed in clinical use and new medicines for the prevention and treatment of major infectious diseases, rare diseases and other diseases.
Article 97 The State Council may restrict or prohibit the export of drugs in short supply. When necessary, the relevant departments of the State Council may take measures such as organizing production, price intervention and expanding imports to ensure the supply of drugs.
Holders of drug marketing licenses, drug producing enterprises and drug handling enterprises shall guarantee the production and supply of drugs in accordance with the relevant provisions.

Chapter X Supervision and Administration

Article 98 The production (including preparation, the same below), sale and use of fake medicines and medicines of inferior quality are prohibited.
Under any of the following circumstances, it is a fake drug:
(1) The ingredients contained in the drug do not conform to the ingredients specified in the national drug standards;
(2) To pass a non drug off as a drug or another drug off as such a drug;
(3) Deteriorated drugs;
(4) The indications or functions indicated on the drug are beyond the prescribed scope.
Under any of the following circumstances, a drug is inferior:
(1) The content of drug ingredients does not meet the national drug standards;
(2) Contaminated drugs;
(3) Drugs with no indication or change of expiry date;
(4) Drugs without marked or changed product batch number;
(5) Drugs that have expired;
(6) Drugs that add preservatives and auxiliary materials without authorization;
(7) Other drugs that do not meet the drug standards.
It is prohibited to produce or import drugs without obtaining drug approval documents; It is prohibited to use APIs, packaging materials and containers that have not been reviewed and approved in accordance with regulations to produce drugs.
Article 99 Pharmaceutical supervisory and administrative departments shall, in accordance with the provisions of laws and regulations, supervise and inspect the development, production and distribution of pharmaceuticals and the use of pharmaceuticals by pharmaceutical using entities. When necessary, they may conduct extended inspections of the entities and individuals that provide products or services for the development, production, distribution and use of pharmaceuticals. The relevant entities and individuals shall cooperate, and shall not refuse or conceal them.
Drug regulatory departments shall focus on the supervision and inspection of high-risk drugs.
If there is evidence to prove that there may be potential safety hazards, the drug regulatory department shall, according to the supervision and inspection, take such measures as admonition, interview, rectification within a time limit, suspension of production, sales, use and import, and timely publish the inspection and handling results.
When conducting supervision and inspection, pharmaceutical supervisory and administrative departments shall produce supporting documents, and shall keep confidential the trade secrets they have learned during supervision and inspection.
Article 100 Pharmaceutical supervisory and administrative departments may, according to the needs of supervision and administration, conduct spot checks on the quality of pharmaceuticals. The sampling inspection shall be carried out according to the regulations, and no fees shall be charged; Samples shall be purchased. The necessary expenses shall be disbursed in accordance with the provisions of the State Council.
The drug regulatory department may seal up and detain the drugs and related materials that have evidence to prove that they may endanger human health, and make an administrative decision within seven days; If a drug needs to be inspected, an administrative decision shall be made within 15 days after the inspection report is issued.
Article 101 The drug regulatory departments under the State Council and the people's governments of provinces, autonomous regions, and municipalities directly under the Central Government shall regularly publish the results of the random inspection of drug quality; If the announcement is inappropriate, it shall be corrected within the scope of the original announcement.
Article 102 If the party concerned disagrees with the results of drug inspection, it may, within seven days of receiving the results of drug inspection, apply for re inspection to the original drug inspection institution or the drug inspection institution set up or designated by the drug regulatory department at the next higher level, or directly apply for re inspection to the drug inspection institution set up or designated by the drug regulatory department of the State Council. The drug inspection institution that accepts the reinspection shall make a conclusion on the reinspection within the time specified by the drug regulatory department under the State Council.
Article 103 Pharmaceutical supervisory and administrative departments shall inspect the compliance of holders of pharmaceutical marketing licenses, pharmaceutical producing enterprises, pharmaceutical trading enterprises, pharmaceutical non clinical safety evaluation and research institutions, pharmaceutical clinical testing institutions, etc. with pharmaceutical production quality control standards, pharmaceutical trading quality control standards, pharmaceutical non clinical research quality control standards, pharmaceutical clinical testing quality control standards, etc, Supervise its continuous compliance with statutory requirements.
Article 104 The State shall establish a professional and specialized team of drug inspectors. Inspectors shall be familiar with drug laws and regulations and have professional knowledge of drugs.
Article 105 Pharmaceutical supervisory and administrative departments shall establish pharmaceutical safety credit files for holders of drug marketing licenses, pharmaceutical producing enterprises, pharmaceutical trading enterprises, pharmaceutical non clinical safety evaluation and research institutions, pharmaceutical clinical testing institutions and medical institutions, record the issuance of licenses, the results of daily supervision and inspection, the investigation and punishment of illegal acts, etc., and publish them to the public according to law and update them in a timely manner; For those with bad credit records, the frequency of supervision and inspection shall be increased, and joint punishment may be implemented according to national regulations.
Article 106 A drug regulatory department shall publish its e-mail address and telephone number, accept inquiries, complaints and reports, and promptly reply, verify and handle them according to law. If the report is verified to be true, the reporter shall be rewarded in accordance with the relevant provisions.
The drug regulatory department shall keep confidential the information of the informer and protect the legitimate rights and interests of the informer. If an informer reports to his unit, the unit may not retaliate against the informer by rescinding or changing the labor contract or by other means.
Article 107 The State practices a unified system for the publication of drug safety information. The drug regulatory department under the State Council shall uniformly publish the overall situation of the country's drug safety, warning information on drug safety risks, information on major drug safety incidents and their investigation and handling, and other information that the State Council determines needs to be uniformly published. Drug safety risk warning information, major drug safety incidents and their investigation and handling information may also be published by the drug regulatory department of the people's government of the relevant province, autonomous region, or municipality directly under the Central Government if their impact is limited to specific areas. The above information shall not be released without authorization.
The publication of drug safety information shall be timely, accurate and comprehensive, with necessary explanations to avoid misleading.
No unit or individual may fabricate or disseminate false drug safety information.
Article 108 People's governments at or above the county level shall formulate emergency plans for drug safety incidents. Pharmaceutical marketing license holders, pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions shall formulate their own disposal plans for pharmaceutical safety incidents, and organize training and emergency drills.
In the event of a drug safety incident, the people's government at or above the county level shall immediately organize and carry out response work in accordance with the emergency plan; The relevant units shall immediately take effective measures to deal with the situation and prevent the harm from spreading.
Article 109 If a drug regulatory department fails to discover the systemic risks of drug safety in a timely manner, or to eliminate the hidden dangers of drug safety in a timely manner within the area under its supervision and administration, the people's government at the same level or the drug regulatory department of the people's government at a higher level shall interview its principal responsible person.
If the local people's government fails to perform its drug safety duties and fails to eliminate major regional drug safety hazards in a timely manner, the people's government at a higher level or the drug regulatory department of the people's government at a higher level shall interview its main responsible person.
The departments and local people's governments interviewed shall immediately take measures to rectify the drug supervision and administration.
The interview and rectification shall be included in the review and assessment records of the drug supervision and administration work of the relevant departments and local people's governments.
Article 110 The local people's governments and their drug regulatory departments shall not restrict or exclude the entry of drugs produced by holders of drug marketing licenses or drug producing enterprises in other regions by means of requiring drug inspection, examination and approval.
Article 111 Pharmaceutical supervisory and administrative departments and their established or designated pharmaceutical professional technical institutions shall not participate in pharmaceutical production and marketing activities, and shall not recommend or supervise the production and sale of pharmaceuticals in their names.
Staff members of drug regulatory departments and their established or designated drug specialized technical institutions may not participate in drug production and marketing activities.
Article 112 Where the State Council has other special regulations on the administration of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals, etc., such regulations shall prevail.
Article 113 Where a drug regulatory department discovers that an illegal drug act is suspected of committing a crime, it shall promptly transfer the case to the public security organ.
For those who do not need to be investigated for criminal responsibility or exempted from criminal punishment according to law, but should be investigated for administrative responsibility, the public security organ, the People's Procuratorate or the People's Court shall promptly transfer the case to the drug regulatory department.
If the public security organ, the People's Procuratorate, the People's Court consult with the drug regulatory department, the competent ecological environment department and other departments to provide assistance such as inspection conclusions, determination opinions and harmless treatment of the drugs involved, the relevant departments shall provide timely assistance.

Chapter XI Legal Liabilities

Article 114 Anyone who violates the provisions of this Law and constitutes a crime shall be investigated for criminal responsibility according to law.
Article 115 Anyone who produces or sells drugs without obtaining a drug production license, a drug handling license or a pharmaceutical preparation license of a medical institution shall be ordered to close down, the drugs illegally produced or sold and the illegal income therefrom shall be confiscated, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold (including drugs already sold or unsold, the same below) shall be imposed; If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan.
Article 116 Where counterfeit drugs are produced or sold, the drugs illegally produced or sold and the illegal income therefrom shall be confiscated, the production or business suspension shall be ordered for rectification, the drug approval documents shall be revoked, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced or sold shall be imposed; If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan; If the circumstances are serious, the drug production license, drug handling license or pharmaceutical preparation license of a medical institution shall be revoked, and the corresponding application shall not be accepted within 10 years; If the holder of the drug marketing license is an overseas enterprise, the drug import shall be prohibited within ten years.
Article 117 Where inferior drugs are produced or sold, the drugs illegally produced or sold and the illegal income therefrom shall be confiscated, and a fine of not less than 10 times but not more than 20 times the value of the drugs illegally produced or sold shall also be imposed; If the value of drugs illegally produced or wholesale is less than 100,000 yuan, it shall be calculated as 100,000 yuan; if the value of drugs illegally retailed is less than 10,000 yuan, it shall be calculated as 10,000 yuan; If the circumstances are serious, the company shall be ordered to suspend production and business for rectification or even revoke the drug approval certificate, drug production license, drug trade license or pharmaceutical preparation license of medical institutions.
If the prepared slices of traditional Chinese medicine produced or sold do not meet the drug standards and do not affect the safety and effectiveness, they shall be ordered to make corrections within a time limit and given a warning; A fine of not less than 100000 yuan but not more than 500000 yuan may be imposed.
Article 118 If anyone produces or sells fake medicines or medicines of inferior quality and the circumstances are serious, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be confiscated of the income they have earned from their own units during the period when the violation occurred, and a fine of not less than 30 percent but not more than three times the income they have received shall be imposed, and they shall be prohibited from engaging in drug production and marketing activities for life, The public security organ may also impose a detention of not less than five days but not more than 15 days.
The raw materials, auxiliary materials, packaging materials and production equipment specially used by producers to produce fake and substandard drugs shall be confiscated.
Article 119 Any drug using unit that uses fake drugs or drugs of inferior quality shall be punished in accordance with the provisions on the sale of fake drugs or the retail sale of drugs of inferior quality; If the circumstances are serious, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons who have medical and health personnel practice certificates shall also have their practice certificates revoked.
Article 120 If anyone knows or should know that a drug is fake, inferior or a drug specified in Items 1 to 5 of the first paragraph of Article 124 of this Law, and provides convenient conditions for its storage and transportation, all the storage and transportation income shall be confiscated, and a fine of not less than one time but not more than five times the illegal income shall also be imposed; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal income shall also be imposed; If the illegal income is less than 50,000 yuan, it shall be calculated as 50,000 yuan.
Article 121 The decision on punishment for counterfeit or substandard drugs shall, in accordance with law, state the conclusion of the quality inspection conducted by the drug inspection institution.
Article 122 Anyone who forges, alters, leases, lends, or illegally trades in or sells licenses or drug approval documents shall have his unlawful income confiscated and be concurrently fined not less than one time but not more than five times his unlawful income; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the illegal gains shall be imposed concurrently, the drug production license, drug trading license, pharmaceutical preparation license of medical institutions or the drug approval certificate shall be revoked, and the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20,000 yuan but not more than 200,000 yuan, and drug production and trading activities shall be prohibited for 10 years, The public security organ may also impose a detention of not less than five days but not more than 15 days; If the illegal income is less than 100000 yuan, it shall be calculated as 100000 yuan.
Article 123 Where a person provides false certificates, data, materials or samples or uses other means to defraud a clinical trial license, drug production license, drug trade license, pharmaceutical preparation license of a medical institution or drug registration license, the relevant license shall be revoked, and he shall not be subject to the corresponding application within 10 years, and shall also be fined not less than 500,000 yuan but not more than 5 million yuan; If the circumstances are serious, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan, and shall be prohibited from engaging in drug production and marketing activities for ten years, and may be detained by the public security organ for not less than five days but not more than 15 days.
Article 124 If anyone, in violation of the provisions of this Law, commits one of the following acts, the drugs illegally produced, imported or sold, the illegal gains and the raw materials, auxiliary materials, packaging materials and production equipment specially used for illegal production shall be confiscated, the production and business suspension shall be ordered for rectification, and a fine of not less than 15 times but not more than 30 times the value of the drugs illegally produced, imported or sold shall be imposed concurrently; If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan; If the circumstances are serious, the drug approval certificate shall be revoked, or even the drug production license, drug handling license or pharmaceutical preparation license of a medical institution shall be revoked. The legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be confiscated of the income obtained from the unit during the period when the illegal act occurred, and a fine of not less than 30 percent but not more than three times the income obtained shall be imposed, It is forbidden to engage in drug production and marketing activities for ten years or even for life, and may be detained by the public security organ for not less than five days but not more than 15 days:
(1) Production and import of drugs without obtaining drug approval documents;
(2) Produce and import drugs using the drug approval certificate obtained by deception;
(3) The use of APIs that have not been reviewed and approved for drug production;
(4) Sales of drugs that should be inspected but have not been inspected;
(5) Production and sales of drugs prohibited by the drug regulatory department under the State Council;
(6) Compile production and inspection records;
(7) Make major changes in the drug production process without approval.
Whoever sells the drugs specified in Items 1 to 3 of the preceding paragraph, or any drug user uses the drugs specified in Items 1 to 5 of the preceding paragraph, shall be punished in accordance with the provisions of the preceding paragraph; If the circumstances are serious, the legal representative, principal responsible person, directly responsible person in charge and other responsible persons of the drug using unit who have medical and health personnel practice certificates shall also have their practice certificates revoked.
If a small amount of drugs that have been legally listed abroad are imported without approval, and the circumstances are relatively minor, they may be mitigated or exempted from punishment according to law.
Article 125 Whoever, in violation of the provisions of this Law, commits one of the following acts shall have his unlawfully produced and sold drugs, his unlawful income, and his packaging materials and containers confiscated, be ordered to suspend production and business for rectifications, and be concurrently fined not less than 500000 yuan but not more than 5 million yuan; If the circumstances are serious, the drug approval certificate, drug production license and drug trading license shall be revoked, and the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan, and the drug production and trading activities shall be banned for ten years or even for life:
(1) Conducting drug clinical trials without approval;
(2) Use packaging materials or containers that have not been reviewed and are in direct contact with drugs to produce drugs, or sell such drugs;
(3) Use unapproved labels and instructions.
Article 126 Unless otherwise provided for in this Law, holders of drug marketing licenses, drug producing enterprises, drug handling enterprises, drug non clinical safety evaluation and research institutions, and drug clinical testing institutions that fail to comply with the quality control standards for drug production, drug handling, drug non clinical research, and drug clinical testing shall be ordered to make corrections within a time limit, Give warning; If it fails to make corrections within the time limit, it shall be fined not less than 100000 yuan but not more than 500000 yuan; If the circumstances are serious, a fine of not less than 500000 yuan but not more than 2 million yuan shall be imposed, the company shall be ordered to suspend production and business for rectification or even revoke the drug approval certificate, drug production license, drug distribution license, etc. The drug non clinical safety evaluation and research institutions, drug clinical trial institutions, etc. shall not carry out drug non clinical safety evaluation and research, drug clinical trials within five years The directly responsible person in charge and other responsible persons shall confiscate the income they have earned from their own units during the period when the violation occurred, impose a fine of not less than 10 percent but not more than 50 percent of the income they have earned, and prohibit drug production and marketing for ten years or even for life.
Article 127 Whoever, in violation of the provisions of this Law, commits one of the following acts shall be ordered to make corrections within a time limit and given a warning; If it fails to make corrections within the time limit, it shall be fined not less than 100000 yuan but not more than 500000 yuan:
(1) The bioequivalence test was not filed;
(2) During the clinical trial of drugs, if safety problems or other risks are found, the clinical trial sponsor fails to timely adjust the clinical trial plan, suspend or terminate the clinical trial, or fails to report to the drug regulatory department under the State Council;
(3) Failure to establish and implement a drug traceability system as required;
(4) Failing to submit the annual report as required;
(5) Failing to record or report changes in the drug production process as required;
(6) No post marketing risk management plan has been formulated;
(7) Failure to carry out post marketing research or post marketing evaluation of drugs in accordance with regulations.
Article 128 Except for those who should be punished according to law for fake drugs and medicines of inferior quality, if the drug package does not have a label or an instruction manual printed or affixed according to the regulations, or if the label or instruction manual does not indicate relevant information or have a prescribed mark printed according to the regulations, it shall be ordered to correct and given a warning; If the circumstances are serious, the drug registration certificate shall be revoked.
Article 129 Anyone who, in violation of the provisions of this Law, fails to purchase drugs from the holder of the drug marketing license, the drug producing enterprise, the drug handling enterprise or the medical institution, shall be ordered to make corrections, the drugs illegally purchased and the illegal income shall be confiscated, and a fine of not less than two times but not more than ten times the value of the drugs illegally purchased shall be imposed; If the circumstances are serious, a fine of not less than 10 times but not more than 30 times the value of the goods shall also be imposed, and the drug approval certificate, drug production license, drug handling license or medical institution practice license shall be revoked; If the value of goods is less than 50000 yuan, it shall be calculated as 50000 yuan.
Article 130 If a drug handling enterprise, in violation of the provisions of this Law, fails to keep records on the purchase and sale of drugs in accordance with the provisions, or fails to correctly explain the usage, dosage and other matters of the retail drugs, or fails to dispense prescriptions in accordance with the provisions, it shall be ordered to make corrections and be given a warning; If the circumstances are serious, the drug handling license shall be revoked.
Article 131 If a third-party platform provider for drug online trading violates the provisions of this Law by failing to perform its obligations of qualification examination, report, or stop providing online trading platform services, it shall be ordered to make corrections, its illegal gains shall be confiscated, and a fine of not less than 200000 yuan but not more than 2 million yuan shall be imposed; If the circumstances are serious, it shall be ordered to suspend business for rectification, and a fine of not less than 2 million yuan but not more than 5 million yuan shall be imposed.
Article 132 Those who import drugs with drug registration certificates but fail to file for the record with the drug regulatory department of the place where the port where the drugs are allowed to be imported according to regulations shall be ordered to make corrections within a time limit and given a warning; If it fails to make corrections within the time limit, the drug registration certificate shall be revoked.
Article 133 If a medical institution, in violation of the provisions of this Law, sells its preparations on the market, it shall be ordered to make corrections, the preparations illegally sold and the illegal income shall be confiscated, and a fine of not less than two times but not more than five times the value of the preparations illegally sold shall be imposed concurrently; If the circumstances are serious, a fine of not less than five times but not more than fifteen times the value of the goods shall also be imposed; If the value of goods is less than 50000 yuan, it shall be calculated as 50000 yuan.
Article 134 Where a holder of a drug marketing license fails to monitor adverse drug reactions or report suspected adverse drug reactions in accordance with the provisions, he shall be ordered to make corrections within a time limit and given a warning; If it fails to make corrections within the time limit, it shall be ordered to suspend production and business for rectification, and shall be fined not less than 100000 yuan but not more than one million yuan.
If a drug handling enterprise fails to report the suspected adverse drug reactions as required, it shall be ordered to rectify within a time limit and given a warning; If it fails to make corrections within the time limit, it shall be ordered to suspend production and business for rectification, and shall be fined not less than 50000 yuan but not more than 500000 yuan.
If a medical institution fails to report the suspected adverse drug reactions according to the provisions, it shall be ordered to make corrections within a time limit and given a warning; If it fails to make corrections within the time limit, it shall be fined not less than 50000 yuan but not more than 500000 yuan.
Article 135 If the holder of the drug marketing license refuses to recall the drug after being ordered to do so by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, he shall be fined not less than five times but not more than ten times the value of the drug to be recalled; If the value of goods is less than 100000 yuan, it shall be calculated as 100000 yuan; If the circumstances are serious, the drug approval certificate, drug production license and drug distribution license shall be revoked, and the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be fined not less than 20000 yuan but not more than 200000 yuan. If a drug producing enterprise, drug handling enterprise or medical institution refuses to cooperate with the recall, it shall be fined not less than 100000 yuan but not more than 500000 yuan.
Article 136 Where the holder of the drug marketing license is an overseas enterprise, and the designated enterprise legal person in China fails to perform the relevant obligations in accordance with the provisions of this Law, the provisions of this Law on the legal liability of the holder of the drug marketing license shall apply.
Article 137 Whoever commits any of the following acts shall be given a heavier punishment within the range of punishment prescribed in this Law:
(1) To pass off narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, and drug precursor chemicals as other drugs, or pass off other drugs as the above-mentioned drugs;
(2) Produce and sell fake and substandard drugs mainly used by pregnant women and children;
(3) The biological products produced and sold belong to fake medicines and inferior medicines;
(4) Production and sales of counterfeit and substandard drugs, resulting in personal injury consequences;
(5) Produce and sell counterfeit and substandard drugs, and commit again after handling;
(6) Refusing or evading supervision and inspection, forging, destroying or concealing relevant evidence materials, or using sealed up or detained articles without authorization.
Article 138 Where a drug inspection institution issues a false inspection report, it shall be ordered to make corrections, given a warning, and fined not less than 200000 yuan but not more than 1 million yuan; The persons directly in charge and other persons directly responsible shall be demoted, dismissed or dismissed according to law, their illegal gains shall be confiscated and they shall be fined not more than 50000 yuan; If the circumstances are serious, the inspection qualification shall be revoked. If the inspection results issued by a drug inspection institution are untrue and cause losses, it shall bear the corresponding liability for compensation.
Article 139 The administrative penalty provided for in Articles 115 to 138 of this Law shall be decided by the drug regulatory department of the people's government at or above the county level according to the division of responsibilities; The revocation of a license or the revocation of a license shall be decided by the department that originally approved or issued the license.
Article 140 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution employs personnel in violation of the provisions of this Law, the drug regulatory department or the competent health department shall order him to dismiss and impose a fine of not less than 50000 yuan but not more than 200000 yuan.
Article 141 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution gives or accepts rebates or other illegitimate interests in the purchase and sale of drugs, the holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or an agent shall give to the person in charge of the medical institution that uses its drugs, drug purchasers, physicians Where the property or other illegitimate interests of pharmacists and other relevant personnel are involved, the market supervision and administration department shall confiscate the illegal gains and impose a fine of not less than 300000 yuan but not more than 3 million yuan; If the circumstances are serious, the holder of the drug marketing license, the business license of the drug producing enterprise or the drug handling enterprise shall be revoked, and the drug regulatory department shall revoke the drug approval certificate, the drug production license or the drug handling license.
Where a holder of a drug marketing license, a drug producing enterprise or a drug trading enterprise offers bribes to state functionaries in the course of drug development, production or trading, the legal representative, the principal responsible person, the directly responsible person in charge and other responsible persons shall be prohibited from engaging in drug production and trading activities for life.
Article 142 Where a holder of a drug marketing license, a person in charge of a drug producing enterprise, a drug handling enterprise, a purchaser or other relevant personnel accepts money, property or other illegitimate benefits from another holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or an agent in the purchase and sale of drugs, the illegal gains shall be confiscated and a punishment shall be imposed according to law; If the circumstances are serious, drug production and marketing activities shall be prohibited for five years.
If the responsible person, drug purchaser, physician, pharmacist and other relevant personnel of a medical institution receive property or other illegitimate benefits from the holder of the drug marketing license, drug producing enterprise, drug handling enterprise or agent, the competent health department or this unit shall impose sanctions and confiscate the illegal income; If the circumstances are serious, his practice certificate shall also be revoked.
Article 143 If anyone, in violation of the provisions of this Law, fabricates or disseminates false drug safety information, which constitutes an act against the administration of public security, the public security organ shall impose a public security administration penalty according to law.
Article 144 Where a holder of a drug marketing license, a drug producing enterprise, a drug handling enterprise or a medical institution violates the provisions of this Law and causes damage to the drug users, it shall be liable for compensation according to law.
If the damage is caused by the quality problem of a drug, the victim may request compensation from the holder of the drug marketing license or the drug manufacturing enterprise, or request compensation from the drug trading enterprise or medical institution. If a claim for compensation is received from the victim, the first responsibility system shall be implemented and compensation shall be made first; After the compensation is made in advance, the claim may be made according to law.
Where fake medicines or medicines of inferior quality are produced or are still sold or used while clearly knowing that they are fake medicines or medicines of inferior quality, the victim or his close relatives may, in addition to claiming compensation for the losses, claim compensation of ten times the price or three times the losses; If the amount of additional compensation is less than 1000 yuan, it shall be 1000 yuan.
Article 145 Where a pharmaceutical supervisory and administrative department or a pharmaceutical professional technical institution set up or designated by it participates in pharmaceutical production and trade, the competent authority at a higher level shall order it to make corrections and confiscate its illegal income; If the circumstances are serious, the persons directly in charge and other persons directly responsible shall be given sanctions according to law.
Any staff member of a pharmaceutical supervisory and administrative department or of a pharmaceutical professional technical institution set up or designated by the department shall be punished according to law if he participates in pharmaceutical production and marketing activities.
Article 146 Where a drug regulatory department or a drug inspection institution set up or designated by it illegally collects inspection fees during drug supervision and inspection, the relevant government departments shall order it to return the fees, and the directly responsible person in charge and other directly responsible persons shall be punished according to law; If the circumstances are serious, the inspection qualification shall be revoked.
Article 147 If a pharmaceutical supervisory and administrative department, in violation of the provisions of this Law, commits any of the following acts, it shall revoke the relevant license, and the directly responsible person in charge and other directly responsible persons shall be punished according to law:
(1) Approval of clinical trial of drugs if the conditions are not met;
(2) Issue drug registration certificates to unqualified drugs;
(3) A pharmaceutical production license, a pharmaceutical trading license or a pharmaceutical preparation license for a medical institution shall be issued to a unit that does not meet the requirements.Article 148 Where a local people's government at or above the county level, in violation of the provisions of this Law, commits one of the following acts, the persons who are directly in charge and the other persons who are directly responsible shall be given the sanction of recording a demerit or a major demerit; If the circumstances are serious, they shall be demoted, dismissed or dismissed:
(1) Concealed, false, delayed or omitted drug safety incidents;
(2) Failing to eliminate major regional potential drug safety hazards in a timely manner, resulting in particularly serious drug safety incidents within the administrative region, or continuous major drug safety incidents;
(3) Inadequate performance of duties, causing serious adverse effects or heavy losses.
Article 149 If a drug regulatory department, in violation of the provisions of this Law, commits one of the following acts, the directly responsible person in charge and other directly responsible persons shall be given a sanction of recording a demerit or a major demerit; If the circumstances are relatively serious, they shall be demoted or dismissed from their posts; If the circumstances are serious, they shall be dismissed:
(1) Concealed, false, delayed or omitted drug safety incidents;
(2) Failing to promptly investigate and deal with the drug safety violations found;
(3) Failing to discover the systemic risks of drug safety in a timely manner, or failing to eliminate the hidden dangers of drug safety in the supervision and management area in a timely manner, causing serious impact;
(4) Other persons who fail to perform their duties of drug supervision and administration, causing serious adverse effects or heavy losses.
Article 150 Pharmaceutical supervisory and administrative personnel who abuse their power, engage in malpractices for personal gain or neglect their duties shall be punished according to law.
In case of dereliction of duty or dereliction of duty in investigating and dealing with illegal acts of counterfeit or substandard drugs, the persons directly in charge of the drug regulatory department and other persons directly responsible shall be given heavier sanctions according to law.
Article 151 The value of goods specified in this Chapter shall be calculated on the basis of the marked price of drugs illegally produced or sold; If there is no marked price, it shall be calculated according to the market price of similar drugs.

Chapter XII Supplementary Provisions

Article 152 The cultivation, collection and breeding of Chinese medicinal materials shall be administered in accordance with the provisions of relevant laws and regulations.
Article 153 Measures for the control of local folk medicinal materials shall be formulated by the drug regulatory department under the State Council jointly with the department in charge of traditional Chinese medicine under the State Council.
Article 154 Specific measures for the implementation of this Law by the Chinese People's Liberation Army and the Chinese People's Armed Police Force shall be formulated by the State Council and the Central Military Commission in accordance with this Law.
Article 155 This Law shall go into effect as of December 1, 2019.

 

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