Drug Administration Law of the People's Republic of China

Published:

2015-12-13


(Adopted at the 7th Meeting of the Standing Committee of the Sixth National People's Congress on September 20, 1984, and revised at the 20th Meeting of the Standing Committee of the Ninth National People's Congress on February 28, 2001. According to the Decision on Amending the Marine Environment Protection Law of the People's Republic of China and Other Seven Laws adopted at the 6th Meeting of the Standing Committee of the Twelfth National People's Congress on December 28, 2013 Amendment to the Decision on Amending the Drug Administration Law of the People's Republic of China adopted at the 14th Meeting of the Standing Committee of the Twelfth National People's Congress on April 24, 2015)
Chapter I General Provisions
Article 1 This Law is formulated with a view to strengthening drug supervision and administration, ensuring drug quality, ensuring the safety of drug use, and safeguarding the people's health and legitimate rights and interests in drug use.
Article 2 All units or individuals engaged in the research, production, distribution, use, supervision and control of pharmaceuticals within the territory of the People's Republic of China must abide by this Law.
Article 3 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 encourages the cultivation of traditional Chinese medicinal materials.
Article 4 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 5 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 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 relevant departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the supervision and administration of drugs within their respective functions and responsibilities. The pharmaceutical supervisory and administrative department under the State Council shall cooperate with the competent department for comprehensive economic affairs under the State Council to implement the development plan and industrial policies for the pharmaceutical industry formulated by the State.
Article 6 The drug inspection institutions established or determined by the drug regulatory departments shall undertake the drug inspection work necessary for the implementation of drug approval and drug quality supervision and inspection according to law.
Chapter II Administration of Pharmaceutical Manufacturers
Article 7 The establishment of a pharmaceutical production enterprise must be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located and issued a Pharmaceutical Production License. No drug may be produced without a Drug Production License. The term of validity and the scope of production shall be indicated in the Pharmaceutical Production License, and the license shall be re examined and issued upon expiration. When approving the establishment of a pharmaceutical production enterprise, the pharmaceutical supervisory and administrative department shall, in addition to the conditions prescribed in Article 8 of this Law, comply with the pharmaceutical industry development plan and industrial policy formulated by the State, and prevent duplication of construction.
Article 8 To establish a drug producing enterprise, the following conditions must be met:
(1) Have legally qualified pharmaceutical technicians, engineering technicians and corresponding technical workers;
(2) It has factory buildings, facilities and a hygienic environment suitable for its drug production;
(3) It shall have institutions and personnel capable of conducting quality management and quality inspection on the drugs produced, as well as necessary instruments and equipment;
(4) Have rules and regulations to ensure drug quality.
Article 9 Pharmaceutical producing enterprises must organize production in accordance with the "Standards for the Quality Control of Pharmaceutical Production" formulated by the pharmaceutical supervisory and administrative department under the State Council on the basis of this Law. The pharmaceutical supervisory and administrative department shall, in accordance with the relevant provisions, certify whether the pharmaceutical production enterprises meet the requirements of the Good Manufacturing Practice; A certificate of certification shall be issued to those who pass the certification. The specific measures and steps for the implementation of the "Standards for the Quality Control of Pharmaceutical Production" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.
Article 10 Except for the processing of prepared slices of traditional Chinese medicine, pharmaceuticals must be produced in accordance with the national pharmaceutical standards and the production techniques approved by the pharmaceutical supervisory and administrative department under the State Council, and the production records must be complete and accurate. If a drug producing enterprise changes the production process that affects the quality of drugs, it must report to the original approving department for examination and approval. The prepared slices of traditional Chinese medicine must be prepared in accordance with the national drug standards; In the absence of such provisions in the national drug standards, they must be prepared 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.
Article 11 Raw materials and auxiliary materials needed for the production of pharmaceuticals must meet the requirements for medicinal use.
Article 12 Pharmaceutical producing enterprises must conduct quality inspection on the pharmaceuticals they produce; Those that do not conform to the national drug standards or are not processed in accordance with the processing specifications for prepared slices of traditional Chinese medicine set by the drug regulatory department of the people's government of the province, autonomous region, or municipality directly under the Central Government shall not leave the factory.
Article 13 With the approval of the drug regulatory department of the people's government of a province, autonomous region or municipality directly under the Central Government, a drug producing enterprise may accept the entrustment to produce drugs.
Chapter III Administration of Pharmaceutical Trading Enterprises
Article 14 The establishment of a pharmaceutical wholesale enterprise must be approved by the pharmaceutical supervisory and administrative department of the people's government of the province, autonomous region or municipality directly under the Central Government where the enterprise is located and issued a Pharmaceutical Trade License; The establishment of a drug retail enterprise must be approved by the local drug regulatory department at or above the county level in the place where the enterprise is located and issued a Drug Trade License. Without a Pharmaceutical Trade License, no one may trade in pharmaceuticals. 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 approving the establishment of pharmaceutical trading enterprises, pharmaceutical supervisory and administrative departments shall, in addition to the conditions prescribed in Article 15 of this Law, adhere to the principle of rational distribution and facilitating the purchase of medicines by the masses.
Article 15 To establish a drug handling enterprise, the following conditions must be met:
(1) Have legally qualified pharmaceutical technicians;
(2) Having business premises, equipment, storage facilities and a hygienic environment suitable for the drugs handled;
(3) It has a quality management organization or personnel appropriate to the drugs it trades in;
(4) There are rules and regulations to ensure the quality of the drugs handled.
Article 16 Pharmaceutical trading enterprises must trade in pharmaceuticals in accordance with the "Standards for the Quality Control of Pharmaceutical Trading" formulated by the pharmaceutical supervisory and administrative department under the State Council on the basis of this Law. The pharmaceutical supervisory and administrative department shall, in accordance with the provisions, certify whether the pharmaceutical trading enterprises meet the requirements of the "Standards for the Quality Control of Pharmaceutical Trading"; A certificate of certification shall be issued to those who pass the certification. The specific measures and steps for the implementation of the "Standards for the Quality Control of Pharmaceutical Trading" shall be formulated by the pharmaceutical supervisory and administrative department under the State Council.
Article 17 When purchasing drugs, drug handling enterprises must 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.
Article 18 Pharmaceutical trading enterprises must have true and complete records of the purchase and sale of pharmaceuticals. The purchase and sale records must indicate the generic name, dosage form, specification, batch number, validity period, manufacturer, purchase (sale) unit, purchase (sale) quantity, purchase and sale price, purchase (sale) date of the drugs and other contents specified by the drug regulatory department under the State Council.
Article 19 Pharmaceutical trading enterprises must be accurate in selling pharmaceuticals, and correctly explain the usage, dosage and precautions; Dispensing prescriptions must be checked, and drugs listed in the prescriptions may 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 must indicate the place of origin.
Article 20 Pharmaceutical trading enterprises must formulate and implement a pharmaceutical storage system and take necessary measures to ensure the quality of pharmaceuticals, such as cold storage, prevention of freezing, moisture, prevention of insects and rodents. The inspection system must be implemented for the warehousing and ex warehouse of drugs.
Article 21 Chinese medicinal materials may be sold in urban and rural fairs, unless otherwise stipulated by the State Council. No drugs other than Chinese medicinal materials may be sold in the trade markets of urban and rural fairs, but drug retail enterprises holding Drug Trade Licenses may, within the prescribed scope, set up stores in the trade markets of urban and rural fairs to sell drugs other than Chinese medicinal materials. The specific measures shall be formulated by the State Council.
Chapter IV Administration of Pharmaceuticals in Medical Institutions
Article 22 Medical institutions must be staffed with legally qualified pharmaceutical technicians. Non pharmaceutical technicians shall not directly engage in pharmaceutical technical work.
Article 23 The dispensing of pharmaceutical preparations by a medical institution must be examined and approved by the health administration department of the people's government of the province, autonomous region or municipality directly under the Central Government where it is located, and approved by the drug regulatory department of the people's government of the province, autonomous region or municipality directly under the Central Government, which will issue a Dispensing Permit for Medical Institutions. Without a Dispensing Permit for Medical Organizations, no preparations may be made. The Pharmaceutical Preparation License for Medical Organizations shall indicate the period of validity, and the license shall be re examined and issued upon expiration.
Article 24 Medical institutions must have facilities, management systems, inspection instruments and sanitary conditions that can ensure the quality of pharmaceutical preparations when making pharmaceutical preparations.
Article 25 The pharmaceutical preparations made by medical institutions shall be the varieties that are needed clinically by their own units but are not available on the market, and must 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. The quality of the prepared preparations must be inspected according to regulations; Those qualified shall be used in this medical institution with the doctor's prescription. Under special circumstances, with the approval of the State Council or the pharmaceutical supervisory and administrative 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.
Article 26 When purchasing drugs, medical institutions must 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 27 Pharmacists of medical institutions must check the prescriptions they dispense, and the drugs listed in the prescriptions 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.
Article 28 Medical institutions must formulate and implement a drug storage system and take necessary measures to ensure the quality of drugs, such as cold storage, prevention of freezing, moisture-proof, prevention of insects and rats.
 
 
 
CHAPTER V ADMINISTRATION OF DRUGS
Article 29 To develop a new drug, the drug regulatory department under the State Council must truthfully submit the relevant materials and samples, such as the development method, quality indicators, pharmacological and toxicological test results, in accordance with the provisions of the drug regulatory department under the State Council. The clinical test can be conducted only after the approval of the drug regulatory department under the State Council. Measures for the accreditation of drug clinical trial institutions shall be jointly formulated by the drug regulatory department under the State Council and the health administrative department under the State Council. A new drug that has completed clinical trials and passed the examination and approval shall be approved by the drug regulatory department under the State Council and issued a new drug certificate.
Article 30 Research institutions for non clinical safety evaluation of drugs and clinical trial institutions must implement the quality control standards for non clinical research of drugs and the quality control standards for clinical trial of drugs respectively. The quality control standards for non clinical drug research and clinical drug trials shall be formulated by the departments designated by the State Council.
Article 31 The production of new drugs or drugs with existing national standards must be approved by the drug regulatory department under the State Council, and a drug approval number shall be issued; However, the production of traditional Chinese medicine and prepared slices of traditional Chinese medicine without the administration of approval number is excluded. The catalogue of Chinese medicinal materials and prepared slices of traditional Chinese medicine under the administration of approval number shall be formulated by the drug regulatory department under the State Council in conjunction with the administrative department of traditional Chinese medicine under the State Council. A drug producing enterprise may produce the drug only after obtaining the drug approval number.
Article 32 Drugs must conform to the national drug standards. The provisions of the second paragraph of Article 10 of this Law shall apply to prepared slices of traditional Chinese medicine. 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 shall organize a pharmacopoeia committee to be responsible for the formulation and revision of national drug standards. The drug inspection institutions of the drug regulatory department under the State Council shall be responsible for the standardization of national drug standards and reference materials.
Article 33 The drug regulatory department under the State Council shall organize pharmaceutical, medical and other technical personnel to review new drugs and re evaluate drugs that have been approved for production.
Article 34 Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions must purchase pharmaceuticals from enterprises qualified for pharmaceutical production and trading; However, the purchase of Chinese medicinal materials without the implementation of approval number management is excluded.
Article 35 The State exercises special control over narcotic drugs, psychotropic substances, toxic drugs for medical use and radioactive drugs. The administrative measures shall be formulated by the State Council.
Article 36 The State applies a system for the protection of varieties of traditional Chinese medicines. The specific measures shall be formulated by the State Council.
Article 37 The State applies a classified management system for prescription drugs and non prescription drugs. The specific measures shall be formulated by the State Council.
Article 38 It is prohibited to import drugs with uncertain efficacy, large adverse reactions or other reasons that endanger human health.
Article 39 The import of drugs must be examined by the pharmaceutical supervisory and administrative department under the State Council. The import of drugs may be approved only after the examination confirms that the drugs meet the quality standards and are safe and effective, and a registration certificate for imported drugs shall be issued. A small amount of drugs imported for urgent clinical needs by medical units or for personal use shall go through the import formalities in accordance with the relevant provisions of the State.
[Article 40] Pharmaceuticals must be imported from ports that allow the import of pharmaceuticals, and the pharmaceutical importing enterprises shall register for the record with the pharmaceutical supervisory and administrative department at the place where the port is located. The customs shall release the drug on the strength of the Customs Clearance Form for Imported Drugs issued by the drug regulatory department. Without the Customs Clearance Form for Imported Drugs, the customs shall not release the drugs. The drug regulatory department in the place where the port is located shall notify the drug inspection institution to conduct random inspection of the imported drugs in accordance with the provisions of the drug regulatory department under the State Council, and collect inspection fees in accordance with the provisions of the second paragraph of Article 41 of this Law. 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 41 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 fail to pass the inspection shall not be sold or imported:
(1) Biological products specified by the drug regulatory department under the State Council;
(2) Drugs sold in China for the first time;
(3) Other drugs prescribed by the State Council.
The items and rates of inspection fees for the drugs listed in the preceding paragraph shall be determined and announced by the financial department under the State Council in conjunction with the competent pricing department under the State Council. The measures for collection of inspection fees shall be formulated by the financial department under the State Council in conjunction with the drug regulatory department under the State Council.
Article 42 The drug regulatory department under the State Council shall organize an investigation into the drugs that have been approved for production or import; The approval number or import drug registration certificate shall be revoked for drugs with uncertain efficacy, large adverse reactions or other reasons that endanger human health. A drug whose approval number or import drug registration certificate has been revoked may not be produced, imported, sold or used; Those that have been produced or imported shall be destroyed or disposed of under the supervision of the local drug regulatory department.
Article 43 The State practices a drug reserve system.
When major disasters, epidemics and other emergencies occur in China, the departments designated by the State Council may urgently call up enterprise drugs.
Article 44 The State Council shall have the power to restrict or prohibit the export of pharmaceuticals that are in short supply in China.
Article 45 The import and export of narcotic drugs and psychotropic drugs within the scope prescribed by the State must hold an Import License and an Export License issued by the drug regulatory department under the State Council.
Article 46 Medicinal materials newly discovered or introduced from abroad may be sold only after they have been examined and approved by the drug regulatory department under the State Council.
Article 47 Measures for the control of local folk medicinal materials shall be formulated by the drug regulatory department under the State Council in conjunction with the administrative department of traditional Chinese medicine under the State Council.
Article 48 The production (including preparation, the same below) and sale of counterfeit drugs are prohibited.
Under any of the following circumstances, it is a fake drug:
(1) The ingredients contained in a drug do not conform to those specified in the national drug standards;
(2) Passing a non drug off as a drug or another drug off as such a drug.
Drugs under any of the following circumstances shall be treated as counterfeit drugs:
(1) The drug regulatory department under the State Council prohibits its use;
(2) Production or import without approval, which must be approved in accordance with this Law, or sale without inspection, which must be inspected in accordance with this Law;
(3) Deteriorated;
(4) Contaminated;
(5) Where an API is produced using an API for which an approval number must be obtained in accordance with this Law but no approval number has been obtained;
(6) The indicated indications or functions exceed the specified scope.
Article 49 The production and sale of medicines of inferior quality are prohibited. If the content of the ingredients of a drug does not meet the national drug standards, it is a drug of inferior quality.
Drugs under any of the following circumstances shall be treated as substandard drugs:
(1) The term of validity is not indicated or is changed;
(2) Not indicating or changing the production batch number;
(3) The period of validity has expired;
(4) Packaging materials and containers in direct contact with drugs have not been approved;
(5) Adding colorants, preservatives, spices, flavoring agents and auxiliary materials without authorization;
(6) Other cases that do not meet the drug standards.
Article 50 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.
 
Article 51 Staff members of drug producing enterprises, drug handling enterprises and medical institutions who have direct contact with drugs must 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 VI Administration of Drug Packaging
Article 52 Packaging materials and containers in direct contact with drugs must meet the requirements for medicinal use and meet the standards for safeguarding human health and safety, and shall be examined and approved by the drug regulatory department when examining and approving drugs. Pharmaceutical producing enterprises shall not use unapproved packaging materials and containers that directly contact pharmaceuticals. The unqualified packaging materials and containers that directly contact drugs shall be ordered to stop using by the drug regulatory department.
Article 53 Pharmaceutical packaging must meet the requirements of pharmaceutical quality and be convenient for storage, transportation and medical use. Chinese medicinal materials must be packaged for shipment. On each package, the product name, place of origin, date, transfer unit and the mark of qualified quality must be indicated.
Article 54 Pharmaceutical packages must be printed or pasted with labels and instructions in accordance with regulations.
The general name, ingredients, specifications, manufacturer, approval number, product batch number, production date, expiry date, indications or main functions, usage, dosage, contraindications, adverse reactions and precautions of the drug must be indicated on the label or instructions.
The prescribed marks must be printed on the labels of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, drugs for external use and non prescription drugs.
Chapter VII Administration of Drug Prices and Advertisements
Article 55 For drugs whose prices are regulated by the market according to law, the drug producing enterprises, trading enterprises and medical institutions shall set the prices in accordance with the principles of fairness, reasonableness, honesty and credibility, and consistency between quality and price, so as to provide drugs with reasonable prices to drug users.
Pharmaceutical producing enterprises, trading enterprises and medical institutions shall abide by the provisions of the competent pricing department of the State Council on the control of drug prices, formulate and mark the retail prices of pharmaceuticals, and prohibit profiteering and price fraud that harm the interests of drug users.
Article 56 Pharmaceutical producing enterprises, trading enterprises and medical institutions shall, in accordance with the law, provide the competent pricing department of the government with information on the actual purchase and sale prices and quantities of their pharmaceuticals.
Article 57 A medical institution shall provide the patient with a price list of the drugs used; The designated medical institutions for medical insurance shall also truthfully publish the prices of their commonly used drugs in accordance with the prescribed measures, and strengthen the management of rational drug use. The specific measures shall be formulated by the health administration department under the State Council.
Article 58 Pharmaceutical producing enterprises, trading enterprises and medical institutions are prohibited from secretly giving or receiving rebates or other benefits off the books during the purchase and sale of pharmaceuticals.
Pharmaceutical producing enterprises, trading enterprises or their agents are prohibited from giving money, property or other benefits under any name to the persons in charge of medical institutions, drug purchasers, physicians and other relevant personnel who use their medicines. The responsible person, drug purchaser, physician and other relevant personnel of a medical institution are prohibited from accepting, under any name, money, property or other benefits from a drug producing or trading enterprise or its agent.
Article 59 Drug advertising must 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 the enterprise is located, and an approval number for drug advertising shall be issued; No drug advertisement approval number shall be issued.
Prescription drugs may be introduced in medical and pharmaceutical professional journals jointly designated by the health administration department and the drug regulatory department under the State Council, but they may not be advertised in mass media or in other ways aimed at the public.
Article 60 The contents of a drug advertisement must be true and legal, and shall be subject to the instructions approved by the drug regulatory department under the State Council, and shall not contain false contents.
Drug advertisements shall not contain unscientific assertions or guarantees of efficacy; It is not allowed to use the name and image of state organs, medical research institutions, academic institutions or experts, scholars, doctors or patients as evidence.
Non drug advertisements shall not involve drug publicity.
Article 61 The pharmaceutical supervisory and administrative departments of the people's governments of provinces, autonomous regions and municipalities directly under the Central Government shall inspect the pharmaceutical advertisements approved by them. For advertisements that violate this Law and the Advertising Law of the People's Republic of China, they shall notify the advertising supervisory and administrative organs and put forward suggestions for handling them. The advertising supervisory and administrative organs shall handle them according to law.
Article 62 The provisions of the Price Law of the People's Republic of China and the Advertising Law of the People's Republic of China shall apply to drug prices and advertisements that are not stipulated in this Law.
Chapter VIII Drug Supervision
Article 63 Pharmaceutical supervisory and administrative departments shall have the right to supervise and inspect, in accordance with the provisions of laws and administrative regulations, the development of pharmaceuticals, the production and distribution of pharmaceuticals and the use of pharmaceuticals by medical institutions that have been submitted for approval. The relevant units and individuals shall not refuse to do so or conceal it.
When conducting supervision and inspection, pharmaceutical supervisory and administrative departments must produce supporting documents and keep confidential the technical secrets and business secrets of the inspected person that they know during supervision and inspection.
Article 64 Pharmaceutical supervisory and administrative departments may, according to the needs of supervision and inspection, conduct spot checks on the quality of pharmaceuticals. Sampling inspection shall be carried out in accordance with the regulations and no fees shall be charged. The necessary expenses shall be disbursed in accordance with the provisions of the State Council.
The drug regulatory department may take compulsory administrative measures to seal up or detain the drugs and related materials that have been proved to be likely to endanger human health, and make a decision on administrative disposal within seven days; If a drug needs to be inspected, an administrative decision must be made within 15 days from the date the inspection report is issued.
Article 65 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 must be corrected within the scope of the original announcement.
Article 66 If the party concerned disagrees with the inspection results of the drug inspection institution, it may, within seven days from the date of receiving the inspection results, apply for reinspection to the original drug inspection institution or the drug inspection institution established or designated by the drug regulatory department at the next higher level, or directly apply for reinspection to the drug inspection institution established or designated by the drug regulatory department under the State Council. The drug inspection institution that accepts the reinspection must make a conclusion on the reinspection within the time specified by the drug regulatory department under the State Council.
Article 67 Pharmaceutical supervisory and administrative departments shall, in accordance with the provisions and in accordance with the "Standards for the Quality Control of Pharmaceutical Production" and the "Standards for the Quality Control of Pharmaceutical Trading", carry out follow-up inspections of pharmaceutical manufacturers and pharmaceutical trading enterprises that have passed their certification.
Article 68 The local people's government and the drug regulatory department shall not restrict or exclude the entry into the region of drugs produced by drug producing enterprises outside the region in accordance with the provisions of this Law by means of requesting the implementation of drug inspection, examination and approval, etc.
Article 69 Pharmaceutical supervisory and administrative departments and the pharmaceutical inspection institutions they have set up and the institutions designated to be specialized in pharmaceutical inspection shall not participate in pharmaceutical production and marketing activities, and shall not recommend or supervise the production and sale of pharmaceuticals in their names.
The staff members of drug regulatory departments and the drug inspection institutions they have set up and the institutions designated to be specialized in drug inspection may not participate in drug production and marketing activities.
 
Article 70 The State practices a reporting system for adverse drug reactions. Pharmaceutical producing enterprises, pharmaceutical trading enterprises and medical institutions must constantly inspect the quality, efficacy and reaction of the pharmaceuticals produced, marketed and used by their own units. Any serious adverse reaction that may be related to drug use must be reported to the drug regulatory department and the health administrative department of the local people's government of the province, autonomous region or municipality directly under the Central Government in a timely manner. The specific measures shall be formulated by the drug regulatory department under the State Council in conjunction with the health administration department under the State Council.
With regard to the drugs that have been confirmed to have serious adverse reactions, the drug regulatory department of the State Council or the people's government of the province, autonomous region or municipality directly under the Central Government may take emergency control measures to stop production, sale or 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 71 The drug inspection institutions or personnel of drug producing enterprises, drug handling enterprises and medical institutions shall accept the professional guidance of the drug inspection institutions set up by the local drug regulatory departments.
Chapter IX Legal Liabilities
Article 72 Those who produce or trade in drugs without a Pharmaceutical Production License, Pharmaceutical Trade License or Dispensing License for Medical Organizations shall be banned according to law, the drugs illegally produced and 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 drugs illegally produced and sold (including sold and unsold drugs, the same below) shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 73 Where counterfeit 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 two times but not more than five times the value of the drugs illegally produced or sold shall be imposed concurrently; If there are drug approval documents, they shall be revoked and ordered to stop production or business for rectification; If the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical Trade License or Dispensing License of Medical Organizations shall be revoked; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 74 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 one time but not more than three times the value of the drugs illegally produced or sold shall be imposed concurrently; If the circumstances are serious, the company shall be ordered to suspend production or business for rectification, or the drug approval documents shall be revoked, or the Pharmaceutical Production License, Pharmaceutical Trade License or Dispensing License of Medical Organizations shall be revoked; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 75 The persons directly in charge and other persons directly responsible of the enterprises or other units that are engaged in the production and sale of fake drugs and drugs of inferior quality, if the circumstances are serious, may not engage in drug production or trade for 10 years. The raw and auxiliary materials, packaging materials and production equipment specially used by producers to produce fake and substandard drugs shall be confiscated.
Article 76 If anyone knows or should know that a drug is fake or substandard and provides convenient conditions for its transportation, storage or storage, all the income from its transportation, storage or storage shall be confiscated and a fine of not less than 50% but not more than three times the illegal income shall be imposed; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 77 The notice of punishment for counterfeit or substandard drugs must contain the quality inspection results of the drug inspection institutions; However, the circumstances specified in Subparagraphs (1), (2), (5) and (6) of Paragraph 3 of Article 48 and Paragraph 3 of Article 49 of this Law are excluded.
Article 78 Pharmaceutical producing enterprises, trading enterprises, pharmaceutical non clinical safety evaluation and research institutions, and pharmaceutical clinical testing institutions that fail to implement the "Quality Control Standards of Pharmaceutical Production", "Quality Control Standards of Pharmaceutical Trading", "Quality Control Standards of Pharmaceutical Non clinical Research", and "Quality Control Standards of Pharmaceutical Clinical Testing" as required shall be given a warning and ordered to make corrections within a time limit; If it fails to make corrections within the time limit, it shall be ordered to suspend production or business for rectification, and shall be fined not less than 5000 yuan but not more than 20,000 yuan; If the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical Trade License and the qualification of a drug clinical trial institution shall be revoked.
Article 79 If a pharmaceutical producing enterprise, trading enterprise or medical institution, in violation of the provisions of Article 34 of this Law, purchases pharmaceuticals from an enterprise without a Pharmaceutical Production License or Pharmaceutical Trade License, it shall be ordered to rectify, the pharmaceuticals illegally purchased shall be confiscated, and a fine of not less than two times but not more than five times the value of the pharmaceuticals illegally purchased shall be imposed; The illegal gains, if any, shall be confiscated; If the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical Trade License or the practicing license of a medical institution shall be revoked.
Article 80 Those who import drugs that have obtained drug import registration certificates but fail to register for the record with the drug regulatory department of the place where the port allowing drug import is located according to this Regulation shall be given a warning and ordered to make corrections within a time limit; If it fails to make corrections within the time limit, the registration certificate of imported drugs shall be revoked.
Article 81 Anyone who forges, alters, buys, sells, leases or lends a license or a drug approval certificate shall have his unlawful income confiscated and be concurrently fined not less than one time but not more than three times his unlawful income; If there are no illegal gains, a fine of not less than 20,000 yuan but not more than 100,000 yuan shall be imposed; If the circumstances are serious, the Pharmaceutical Production License, Pharmaceutical Trade License or Dispensing License of Medical Organizations of the seller, lessor or lender shall be revoked or the pharmaceutical approval documents shall be revoked; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 82 If anyone, in violation of the provisions of this Law, provides false certificates, samples of documents or materials or obtains the Pharmaceutical Production License, Pharmaceutical Trade License, Dispensing License for Medical Organizations or pharmaceutical approval documents by other deceptive means, the Pharmaceutical Production License, Pharmaceutical Trade License, Dispensing License for Medical Organizations or pharmaceutical approval documents shall be revoked, The applicant shall not accept the application within five years and shall be fined not less than 10,000 yuan but not more than 30,000 yuan.
Article 83 Where a medical institution sells its preparations on the market, it shall be ordered to rectify, the illegally sold preparations shall be confiscated, and a fine of not less than one time but not more than three times the value of the illegally sold preparations shall be imposed concurrently; The illegal gains, if any, shall be confiscated.
Article 84 If a drug handling enterprise violates the provisions of Article 18 and Article 19 of this Law, it shall be ordered to rectify and given a warning; If the circumstances are serious, the Drug Trade License shall be revoked.
Article 85 Where a drug label does not conform to the provisions of Article 54 of this law, it shall be ordered to rectify and given a warning, except for those that should be treated as fake drugs or medicines of inferior quality according to law; If the circumstances are serious, the approval certificate of the drug shall be revoked.
Article 86 If a drug inspection institution issues a false inspection report, which constitutes a crime, it shall be investigated for criminal responsibility according to law; If the case does not constitute a crime, it shall be ordered to make corrections, given a warning, and the unit shall also be fined not less than 30000 yuan but not more than 50000 yuan; The persons directly in charge and other persons directly responsible shall be demoted, dismissed or dismissed according to law, and shall also be fined not more than 30000 yuan; The illegal gains, if any, shall be confiscated; 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 87 The administrative penalty provided for in Articles 73 to 87 of this Law shall be decided by the drug regulatory department at or above the county level in accordance with the division of duties prescribed by the drug regulatory department under the State Council; The revocation of the Pharmaceutical Production License, Pharmaceutical Trade License, Dispensing License of Medical Organizations, Practicing License of Medical Organizations, or the revocation of pharmaceutical approval documents shall be decided by the original license issuing and approving department.
Article 88 Anyone who violates the provisions of Article 55 and Article 56 of this law on drug price control shall be punished in accordance with the provisions of the Price Law of the People's Republic of China.
Article 89 Where a pharmaceutical producing enterprise, trading enterprise or medical institution secretly gives or accepts rebates or other benefits in the purchase and sale of pharmaceuticals, or if the pharmaceutical producing enterprise, trading enterprise or its agent gives money, property or other benefits to the person in charge of the medical institution using its pharmaceuticals, the pharmaceutical purchaser, the physician and other relevant personnel, the administrative department for industry and commerce shall impose a fine of not less than 10000 yuan but not more than 200000 yuan, The illegal gains, if any, shall be confiscated; If the circumstances are serious, the administrative department for industry and commerce shall revoke the business license of the drug producing enterprise or drug handling enterprise, and notify the drug regulatory department, which shall revoke its Drug Production License or Drug Handling License; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 90 Persons in charge, purchasers and other relevant personnel of pharmaceutical producing enterprises and trading enterprises who receive money, property or other benefits from other producing enterprises, trading enterprises or their agents in the purchase and sale of pharmaceuticals shall be punished according to law, and their illegal gains shall be confiscated; If a crime is constituted, criminal responsibility shall be investigated according to law.
If the responsible person, drug purchaser, physician or other relevant personnel of a medical institution accept money, property or other benefits from a drug producing enterprise, drug handling enterprise or its agent, the administrative department of public health or its own unit shall impose sanctions and confiscate the illegal gains; The administrative department of public health shall revoke the practicing certificate of a medical practitioner who has committed serious illegal acts; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 91 Those who violate the provisions of this law on the administration of drug advertising shall be punished in accordance with the provisions of the Advertising Law of the People's Republic of China, and the drug regulatory department that issued the advertising approval number shall revoke the advertising approval number, and shall not accept the application for approval of the advertisement of the variety within one year; If a crime is constituted, criminal responsibility shall be investigated according to law.
If the drug regulatory department fails to perform its duty of examination on drug advertisements according to law, and the advertisements approved for publication contain false or other contents that violate laws and administrative regulations, the directly responsible person in charge and other directly responsible persons shall be given administrative sanctions according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 92 Pharmaceutical producing enterprises, trading enterprises and medical institutions that violate the provisions of this Law and cause damage to pharmaceutical users shall be liable for compensation according to law.
Article 93 Where a pharmaceutical supervisory and administrative department, in violation of the provisions of this Law, commits one of the following acts, its superior competent authority or supervisory organ shall order it to withdraw the certificate illegally issued, revoke the pharmaceutical approval certificate, and impose administrative sanctions on the directly responsible person in charge and other directly responsible persons according to law; If a crime is constituted, criminal responsibility shall be investigated according to law:
(1) Those who issue certificates to enterprises that do not meet the requirements of the Quality Control Standards for Pharmaceutical Production or the Quality Control Standards for Pharmaceutical Trade, or fail to follow up the inspection of enterprises that have obtained certificates, or fail to order enterprises that do not meet the requirements for certification to make corrections or revoke their certificates according to law;
(2) Issuing a Pharmaceutical Production License, a Pharmaceutical Trade License or a Dispensing Permit for Medical Organizations to a unit that does not meet the statutory requirements;
(3) Issuing an import drug registration certificate to a drug that does not meet the import requirements;
(4) Approving a clinical trial, issuing a new drug certificate, or issuing a drug approval number when the conditions for clinical trial or production are not met.
Article 94 Where a pharmaceutical supervisory and administrative department or a pharmaceutical inspection institution established by it or an institution designated by it to engage in pharmaceutical inspection takes part in pharmaceutical production and trade, its superior organ or supervisory organ shall order it to make corrections, and its illegal income, if any, shall be confiscated; If the circumstances are serious, the persons directly in charge and other persons directly responsible shall be given administrative sanctions according to law.
If a staff member of a pharmaceutical supervisory and administrative department or of a pharmaceutical inspection institution it has set up or of an institution designated by it to be specialized in pharmaceutical inspection participates in pharmaceutical production and trade, he shall be given administrative sanctions according to law.
Article 95 Where a pharmaceutical supervisory and administrative department or the pharmaceutical inspection institution it has set up or appointed illegally collects inspection fees in the course of pharmaceutical supervision and inspection, the relevant government departments shall order the return of the fees, and the persons directly in charge and other persons directly responsible shall be given administrative sanctions according to law. If the circumstances of illegal collection of inspection fees are serious, the inspection qualification of a drug inspection institution shall be revoked.
Article 96 Pharmaceutical supervisory and administrative departments shall perform their duties of supervision and inspection according to law, and supervise enterprises that have obtained Pharmaceutical Production License or Pharmaceutical Trade License to engage in pharmaceutical production and trade in accordance with the provisions of this Law.
Where an enterprise that has obtained a Pharmaceutical Production License or a Pharmaceutical Trade License produces or sells counterfeit drugs or medicines of inferior quality, in addition to the legal liabilities of the enterprise, administrative sanctions shall be imposed on the persons directly in charge and other persons directly responsible of the pharmaceutical supervisory and administrative department who have committed dereliction of duty or dereliction of duty according to law; If a crime is constituted, criminal responsibility shall be investigated according to law.
Article 97 Pharmaceutical supervisory and administrative departments shall order subordinate pharmaceutical supervisory and administrative departments to rectify their administrative acts in violation of this Law within a time limit; If it fails to make corrections within the time limit, it shall have the right to make changes or cancel.
Article 98 If drug regulatory personnel abuse their power, engage in malpractices for personal gain, or neglect their duties, which constitutes a crime, they shall be investigated for criminal responsibility according to law; If the case does not constitute a crime, administrative sanctions shall be imposed according to law.
Article 99 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 X Supplementary Provisions
Article 100 For the purposes of this Law, the following terms mean:
Drugs refer 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, prepared slices of traditional Chinese medicine, proprietary Chinese medicine, chemical raw materials and their preparations, antibiotics, biochemical drugs, radioactive drugs, serum, vaccines, blood products and diagnostic drugs.
Supplementary materials refer to excipients and additives used in the production and dispensing of drugs.
Pharmaceutical producing enterprises refer to enterprises exclusively or partly engaged in the production of pharmaceuticals.
The term "drug handling enterprise" refers to an enterprise exclusively or partly engaged in the handling of drugs.
Article 101 Measures for the control of the planting, collection and breeding of Chinese medicinal materials shall be formulated separately by the State Council.
Article 102 The State exercises special control over the circulation of preventive biological products. The specific measures shall be formulated by the State Council.
Article 103 Specific measures for the implementation of this Law by the Chinese People's Liberation Army shall be formulated by the State Council and the Central Military Commission in accordance with this Law.
Article 104 This Law shall go into effect as of December 1, 2001.

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