Measures for the Administration of Drug Registration

Published:

2021-11-26


Measures for the Administration of Drug Registration

Chapter I General Provisions

Article 1 In order to standardize drug registration and ensure the safety, effectiveness and quality of drugs under control, according to the Drug Administration Law of the People's Republic of China (hereinafter referred to as the Drug Administration Law), the Chinese Medicine Law of the People's Republic of China, the Vaccine Administration Law of the People's Republic of China (hereinafter referred to as the Vaccine Administration Law), the Administrative Licensing Law of the People's Republic of China These Measures are formulated in accordance with the Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other laws and administrative regulations.
Article 2 These Measures shall apply to the development, registration, supervision and administration of drugs for the purpose of drug marketing within the territory of the People's Republic of China.
Article 3 Drug registration refers to the activities in which the applicant for drug registration (hereinafter referred to as the applicant) applies for clinical trials, drug marketing license, re registration and other supplementary applications in accordance with legal procedures and relevant requirements, and the drug regulatory department conducts safety, effectiveness and quality controllability reviews based on laws and regulations and existing scientific knowledge, and decides whether to approve the application.
After obtaining the drug registration certificate, the applicant is the holder of the drug marketing license (hereinafter referred to as the holder).
Article 4 The drug registration shall be classified and managed according to the traditional Chinese medicine, chemical medicine and biological products.
Traditional Chinese medicine registration is classified according to traditional Chinese medicine innovation medicine, traditional Chinese medicine improved new medicine, ancient classic famous traditional Chinese medicine compound preparation, and the same name and prescription medicine.
Chemical drug registration is classified according to innovative chemical drugs, improved chemical drugs, generic drugs, etc.
The registration of biological products is classified according to the innovative drugs of biological products, improved new drugs of biological products, and listed biological products (including biological similar drugs).
The detailed classification of traditional Chinese medicine, chemical medicine, biological products and other drugs and the corresponding requirements for application materials shall be formulated by the SDA according to the product characteristics, innovation level and the needs of evaluation management of registered drugs, and shall be published to the public.
The application for registration of drugs produced abroad shall be carried out according to the detailed classification of drugs and the corresponding application materials.
Article 5 The SDA is in charge of the administration of drug registration throughout the country, is responsible for establishing a drug registration administration system and system, formulating drug registration administration standards, and organizing drug registration review and approval and related supervision and administration according to law. The Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for the evaluation of drug clinical trial applications, drug marketing license applications, supplementary applications and overseas drug re registration applications. China Institute for Food and Drug Control (hereinafter referred to as CIFDC), the State Pharmacopoeia Commission (hereinafter referred to as the Pharmacopoeia Commission), the Food and Drug Inspection Center of the State Drug Administration (hereinafter referred to as the Drug Inspection Center), the Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Drug Evaluation Center), the Administrative Affairs Acceptance Service and Complaint Reporting Center of the State Drug Administration The Information Center of the State Drug Administration (hereinafter referred to as the Information Center) and other pharmaceutical professional and technical institutions are responsible for the drug registration inspection, the approval, verification, monitoring and evaluation of generic names, the preparation and delivery of certificates, and the corresponding information construction and management required for the implementation of drug registration management according to law.
Article 6 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall be responsible for the administration of the following drug registration within their respective administrative regions:
(1) Acceptance, examination and approval of applications for re registration of domestically produced drugs;
(2) Management of the filing and reporting of changes after the drug is marketed;
(3) Organize the daily supervision of drug non clinical safety evaluation research institutions and drug clinical trial institutions and investigate and deal with illegal acts;
(4) To participate in the verification and inspection of drug registration organized by the SDA;
(5) Matters related to drug registration entrusted by the SDA.
The pharmaceutical professional and technical institutions set up or designated by the pharmaceutical supervisory and administrative departments of provinces, autonomous regions and municipalities directly under the Central Government shall undertake the work of review, inspection, verification, monitoring and evaluation required for the implementation of pharmaceutical supervision and administration according to law.
Article 7 The administration of drug registration shall follow the principles of openness, fairness and impartiality, be guided by clinical values, encourage research and development of new drugs, and actively promote the development of generic drugs.
The SDA continues to promote the reform of the review and approval system, optimize the review and approval procedures, improve the efficiency of the review and approval, and establish a drug registration management system dominated by review and supported by inspection, verification, monitoring and evaluation.

Chapter II Basic System and Requirements

Article 8 Those engaged in drug development and drug registration shall abide by relevant laws, regulations, rules, standards and norms; If other evaluation methods and technologies are adopted with reference to relevant technical guiding principles, their scientificity and applicability shall be proved; The whole process information shall be true, accurate, complete and traceable.
Drugs shall conform to the national drug standards and the drug quality standards approved by the SDA. The drug quality standards approved by the SDA shall be the drug registration standards. The drug registration standard shall comply with the general technical requirements of the Pharmacopoeia of the People's Republic of China, and shall not be lower than the provisions of the Pharmacopoeia of the People's Republic of China. If the testing items or indicators of the registered varieties are not applicable to the Pharmacopoeia of the People's Republic of China, the applicant shall provide sufficient supporting data.
The Drug Evaluation Center and other professional and technical institutions shall formulate technical guidelines and procedures based on scientific progress, actual industry development and the needs of drug supervision and administration, and publish them to the public.
Article 9 The applicant shall be an enterprise or drug research and development institution that can bear corresponding legal liabilities. The overseas applicant shall designate an enterprise legal person within the territory of China to handle relevant drug registration matters.
Article 10 Before applying for the registration of a drug for marketing, the applicant shall complete the relevant research work in pharmacy, pharmacology and toxicology, and clinical trials of drugs. The non clinical safety evaluation study of drugs shall be carried out in an institution that has been certified by the quality management standards for non clinical drug research, and shall comply with the quality management standards for non clinical drug research. The clinical trial of drugs shall be approved, and the bioequivalence test shall be filed; Drug clinical trials shall be conducted in drug clinical trial institutions that comply with relevant regulations, and shall comply with the quality management specifications for drug clinical trials.
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.
Where overseas research materials and data are used to support drug registration, their sources, research institutions or laboratory conditions, quality system requirements and other management conditions shall comply with the general principles of the International Coordination Conference on Technical Requirements for Registration of Drugs for Human Use and the relevant requirements for drug registration management in China.
Article 11 In case of any change to the matters or contents specified in the original drug registration approval document and its annexes, the applicant shall, in accordance with the provisions and with reference to the relevant technical guidelines, fully study and verify the drug change, fully assess the possible impact of the change on the drug safety, effectiveness and quality controllability, and submit a supplementary application, filing or report in accordance with the change procedures.
Article 12 The valid period of the drug registration certificate is five years. During the valid period of the drug registration certificate, the holder shall continuously guarantee the safety, effectiveness and quality controllability of the listed drugs, and shall apply for drug re registration six months before the expiry of the valid period.
Article 13 The SDA shall establish a system for accelerating the registration of drugs on the market and support drug innovation oriented by clinical value. For qualified drug registration applications, applicants can apply for breakthrough therapeutic drugs, conditional approval, priority review and approval and special approval procedures. In the process of drug development and registration, the drug regulatory department and its professional technical institutions shall provide necessary technical guidance, communication, priority allocation of resources, shortening the review time limit and other policy and technical support.
Article 14 The SDA shall establish an associated review and approval system for chemical APIs, excipients and packaging materials and containers that directly contact drugs. When approving drug preparations, review and approve chemical APIs together, and review related excipients, packaging materials and containers in direct contact with drugs together. The Drug Evaluation Center shall establish a registration platform for chemical APIs, excipients and packaging materials and containers that directly contact drugs, publicize relevant registration information for the selection of relevant applicants or holders, and conduct associated evaluation during the review of relevant drug preparation registration applications.
Article 15 Prescription drugs and non prescription drugs shall be subject to classified registration and conversion management. The Drug Evaluation Center shall, according to the characteristics of OTC drugs, formulate technical guidelines and procedures related to OTC drug marketing registration and publish them to the public. The Drug Evaluation Center shall formulate relevant technical requirements and procedures for post marketing conversion of prescription drugs and over-the-counter drugs and publish them to the public.
Article 16 The applicant may communicate with the Drug Evaluation Center and other professional and technical institutions on major issues before the application for clinical trials, during the clinical trials and before the application for drug marketing license. In the process of drug registration, the Drug Evaluation Center and other professional and technical institutions can organize communication with the applicant according to work needs.
The procedures, requirements and time limit for communication shall be formulated by the Drug Evaluation Center and other professional and technical institutions according to their functions and announced to the public.
Article 17 The Drug Evaluation Center and other professional and technical institutions shall establish an expert consultation system according to work needs, establish an expert advisory committee, listen to experts' opinions on major issues in the process of evaluation, verification, inspection, generic name approval, etc., and give full play to the technical support role of experts.
Article 18 The SDA shall establish a catalog of chemical drugs that have been newly approved for marketing and have passed the evaluation of the consistency of the quality and efficacy of generic drugs, which shall state the name, active ingredients, dosage forms, specifications, whether it is a reference preparation, the holder and other relevant information of the drugs, and shall update and disclose them to the public in a timely manner. The procedures and requirements for the collection of chemical drug catalogues shall be formulated by the Drug Evaluation Center and published to the public.
Article 19 The SDA shall support the inheritance and innovation of traditional Chinese medicine, establish and improve the registration management system and technical evaluation system that conform to the characteristics of traditional Chinese medicine, encourage the use of modern science and technology and traditional research methods to develop traditional Chinese medicine, strengthen the quality control of traditional Chinese medicine, and improve the clinical test level of traditional Chinese medicine.
For the application for registration of traditional Chinese medicine, the applicant shall evaluate the clinical value and resources, highlight the clinical value orientation, and promote the sustainable use of resources.

Chapter III Registration of Drugs on the Market

Section I Clinical trials of drugs
Article 20 The clinical trials of drugs referred to in these Measures refer to the drug studies carried out in human beings for the purpose of drug registration on the market to determine the safety and effectiveness of drugs.
Article 21 Clinical trials of drugs are divided into Phase I clinical trials, Phase II clinical trials, Phase III clinical trials, Phase IV clinical trials and bioequivalence trials. According to drug characteristics and research purposes, the research contents include clinical pharmacological research, exploratory clinical trials, confirmatory clinical trials and post marketing research.
Article 22 Clinical trials of drugs shall be carried out in drug clinical trial institutions that meet the corresponding conditions and are filed according to regulations. Among them, the vaccine clinical trial shall be conducted or organized by a tertiary medical institution or a disease prevention and control institution at or above the provincial level that meets the requirements specified by the SDA and the National Health Commission.
Article 23 Where an applicant applies for a clinical trial of drugs after completing the pharmaceutical, pharmacological and toxicological studies supporting the clinical trial of drugs, the relevant research materials shall be submitted according to the requirements of the application materials. If the application materials meet the requirements after formal examination, it shall be accepted. The Drug Evaluation Center shall organize pharmaceutical, medical and other technical personnel to review the accepted drug clinical trial applications. For the application for drug clinical trial, the applicant shall decide whether to approve the application within 60 days from the date of acceptance, and notify the applicant of the approval result through the website of the Drug Evaluation Center; If no notice is given within the time limit, it shall be deemed as consent, and the applicant may carry out clinical trials of drugs in accordance with the submitted scheme.
The applicant who is approved to carry out drug clinical trials is the sponsor of drug clinical trials (hereinafter referred to as the sponsor).
Article 24 Where the applicant intends to carry out bioequivalence test, it shall carry out relevant research work according to the filing scheme after completing the bioequivalence test filing on the website of the Drug Evaluation Center as required.
Article 25 The development of clinical trials of drugs shall be examined and approved by the Ethics Committee.
The administration of drugs for clinical trials shall conform to the relevant requirements of the quality control norms for clinical trials.
Article 26 Where a drug clinical trial is approved to be carried out, the sponsor shall, before carrying out the subsequent clinical trials of drugs by stages, formulate a corresponding drug clinical trial plan, which shall be carried out after being examined and approved by the Ethics Committee, and submit the corresponding drug clinical trial plan and supporting materials on the website of the Drug Evaluation Center.
Article 27 Where a drug approved for clinical drug trials intends to increase its indications (or main functions) or increase its use of drugs in combination with other drugs, the applicant shall apply for a new clinical drug trial, and the new clinical drug trials may be carried out only after approval.
Where clinical trials of drugs are required to be carried out to increase the indications (or main functions) of drugs approved for marketing, an application for new clinical trials of drugs shall be submitted.
Article 28 The sponsor shall regularly submit the safety update report during the R&D period on the website of the Drug Evaluation Center. The safety update report during the research and development period shall be submitted once a year, and within two months after each full year after the approval of the drug clinical trial. The Drug Evaluation Center may require the sponsor to adjust the reporting cycle according to the review.
For suspicious and unexpected serious adverse reactions and other potential serious safety risk information during the drug clinical trial, the sponsor shall timely report to the Drug Evaluation Center according to relevant requirements. According to the severity of the safety risk, the sponsor can be required to take measures to strengthen risk control, such as adjusting the drug clinical trial plan, informed consent, and the investigator's manual. When necessary, the sponsor can be required to suspend or terminate the drug clinical trial.
The specific requirements for the safety update report during the R&D period shall be formulated and published by the Drug Evaluation Center.
Article 29 During the clinical trial of drugs, if there are changes in the clinical trial plan, non clinical or pharmaceutical changes or new discoveries, the sponsor shall fully assess the impact on the safety of the subjects in accordance with the provisions and with reference to the relevant technical guidelines.
If the sponsor considers that the safety of the subject will not be affected, it can be directly implemented and reported in the safety update report during the research and development period. If it may increase the safety risk of the subject, a supplementary application shall be submitted. The supplementary application shall be approved or not within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Drug Evaluation Center; If no notice is given within the time limit, it shall be deemed as consent.
If the sponsor is changed, the changed sponsor shall assume the relevant responsibilities and obligations of the drug clinical trial.
Article 30 If safety problems or other risks are found during a drug clinical trial, the sponsor shall timely adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the Drug Evaluation Center.
Under any of the following circumstances, the sponsor may be required to adjust the drug clinical trial plan, suspend or terminate the drug clinical trial:
(1) The Ethics Committee fails to perform its duties;
(2) The safety of the subject cannot be effectively guaranteed;
(3) The sponsor fails to submit the security update report during the R&D period as required;
(4) The sponsor fails to timely handle and report suspicious and unexpected serious adverse reactions;
(5) There is evidence proving that the study drug is invalid;
(6) The drugs used in clinical trials have quality problems;
(7) Practicing fraud in the course of drug clinical trial;
(8) Other violations of the quality management specifications for drug clinical trials.
When a wide range of unexpected serious adverse reactions occur in the clinical trial of drugs, or there is evidence proving that there are serious quality problems with the drugs used in the clinical trial, the sponsor and the drug clinical trial institution shall immediately stop the clinical trial of drugs. The drug regulatory department may, in accordance with its duties, order adjustment of the clinical trial plan, suspension or termination of the clinical trial of drugs.
Article 31 Where the sponsor intends to continue the clinical trial of drugs after the suspension of the clinical trial of drugs has been ordered, he/she shall submit a supplementary application for resuming the clinical trial of drugs after completing the rectification, and the clinical trial of drugs may continue only after examination and approval. If the drug clinical trial has been suspended for more than three years and the drug clinical trial has not been applied for and approved to resume, the drug clinical trial license will automatically become invalid.
After the termination of the drug clinical trial, if it is planned to continue the drug clinical trial, it shall re apply for the drug clinical trial.
Article 32 Clinical trials of drugs shall be conducted within three years after approval. If no informed consent is signed by the subject within three years from the date of approval of the drug clinical trial application, the drug clinical trial license will automatically become invalid. If it is still necessary to conduct a clinical trial of drugs, a new application shall be made.
Article 33 The sponsor shall register the drug clinical trial scheme and other information on the drug clinical trial registration and information publicity platform before conducting the drug clinical trial. During the drug clinical trial, the sponsor shall continuously update the registration information and register the drug clinical trial results and other information after the completion of the drug clinical trial. The registration information is publicized on the platform, and the sponsor is responsible for the authenticity of the drug clinical trial registration information.
The specific requirements for drug clinical trial registration and information publicity shall be formulated and published by the Drug Evaluation Center.
Section 2 Drug Marketing License
Article 34 After the applicant has completed the research on pharmacy, pharmacology and toxicology and clinical trials of drugs supporting the drug registration, determined the quality standards, completed the verification of the commercial scale production process, and prepared to accept the verification and inspection of drug registration, he/she shall file an application for drug marketing license, and submit the relevant research materials according to the requirements of the application materials. After formal examination of the application materials, if they meet the requirements, they shall be accepted.
Article 35 For generic drugs, in vitro diagnostic reagents under drug administration and other conditions that meet the requirements, if the applicant considers that it is unnecessary or impossible to carry out clinical trials of drugs and meets the conditions for exemption of clinical trials of drugs after evaluation, the applicant may directly file an application for drug marketing license. The technical guidelines and relevant specific requirements for clinical trials of drugs exempted shall be formulated and published by the Drug Evaluation Center.
The quality and efficacy of generic drugs shall be consistent with that of reference preparations. The applicant shall select a reasonable reference preparation with reference to the relevant technical guidelines.
Article 36 Under any of the following circumstances, the applicant may directly file an application for OTC drug marketing license:
(1) The OTC drugs with the same active ingredients, indications (or main functions), dosage forms and specifications have been marketed in China;
(2) The OTC drugs determined by the SDA change the dosage form or specification, but do not change the indications (or main functions), dosage and route of administration;
(3) A new compound preparation composed of the active ingredients of the over-the-counter drugs determined by the SDA;
(4) Other situations of direct application for OTC drug marketing license.
Article 37 Where the generic name of the drug to be used in the declaration of a drug is not included in the national drug standard or drug registration standard, the applicant shall submit an application for approval of the generic name at the same time as the application for drug marketing license. After the application for drug marketing license is accepted, the relevant information on the approval of generic name shall be transferred to the Pharmacopoeia Committee, which shall feed it back to the Drug Evaluation Center after approval.
The generic name of the drug to be used in the application for the drug has been listed in the national drug standard or drug registration standard. If the Drug Evaluation Center deems it necessary to approve the generic name of the drug during the evaluation, it shall notify the Pharmacopoeia Committee to approve the generic name and provide relevant information. After the approval of the Pharmacopoeia Committee, it shall feed back to the Drug Evaluation Center.
When approving the generic name of a drug, the Pharmacopoeia Committee shall communicate with the applicant and inform the applicant of the approval result.
Article 38 The Drug Evaluation Center shall organize pharmaceutical, medical and other technical personnel to review the accepted drug marketing license applications as required.
During the review, the drug registration verification and inspection shall be started based on risks, and the relevant technical institutions shall complete the verification and inspection within the specified time limit.
The Drug Evaluation Center shall conduct a comprehensive evaluation on the safety, effectiveness and quality controllability of drugs according to the drug registration application materials, verification results, inspection results, etc. The OTC drugs shall also be transferred to the Drug Evaluation Center for OTC drug suitability review.
Article 39 If the conclusion of the comprehensive review is passed, the drug shall be approved for marketing and a drug registration certificate shall be issued. If the comprehensive review conclusion is not passed, the decision of disapproval shall be made. The drug registration certificate shall contain the drug approval number, holder, manufacturer and other information. The drug registration certificate of OTC drugs shall also indicate the category of OTC drugs.
The approved drug production process, quality standards, instructions and labels shall be sent to the applicant together as an annex to the drug registration certificate, and when necessary, the post marketing research requirements shall also be attached. The above information shall be included in the drug variety archives and updated in a timely manner according to the post marketing changes.
After a drug is approved for marketing, the holder shall produce the drug in accordance with the production process and quality standards approved by the SDA, and shall refine and implement the drug in accordance with the requirements of the Good Manufacturing Practice.
Article 40 In case of any major change that may affect the drug safety, effectiveness and quality controllability during the review of the drug marketing license application, the applicant shall withdraw the original registration application and re apply after supplementary research.
If the change of the name of the applicant or the change of the name of the registered address does not involve the content of the technical review, the applicant shall promptly notify the Drug Evaluation Center in writing and submit the relevant supporting materials.
Section III Related review and approval
Article 41 When reviewing the application for registration of drug preparations, the Drug Evaluation Center shall conduct a related evaluation on the chemical raw materials, excipients and packaging materials and containers directly in contact with drugs selected for drug preparations.
Manufacturers of chemical APIs, excipients and packaging materials and containers that directly contact drugs shall register product information and research data on the registration platform of chemical APIs, excipients and packaging materials and containers that directly contact drugs in accordance with the requirements of the related review and approval system. The Drug Evaluation Center shall publicize the registration number, product name, enterprise name, production address and other basic information to the public for the selection of drug preparation registration applicants.
Article 42 When applying for drug registration, the applicant for pharmaceutical preparations may directly select the registered chemical raw materials, excipients and packaging materials and containers that directly contact the drugs; If unregistered chemical APIs, excipients and packaging materials and containers that directly contact drugs are selected, relevant research materials shall be reported together with the drug preparation registration application.
Article 43 When reviewing the application for registration of drug preparations, the Drug Evaluation Center shall conduct a related review of the chemical raw materials, excipients and packaging materials and containers directly in contact with drugs selected for drug preparations. If additional information is required, the applicant of drug preparations or the registration enterprise of chemical raw materials, excipients and packaging materials and containers directly in contact with drugs shall be required to provide additional information according to the procedures for additional information, It can be put forward to carry out extended inspection on chemical raw materials, excipients and packaging materials and container enterprises that directly contact drugs based on risks.
Those who copy the chemical raw materials used in the domestic marketed drugs may apply for separate review and approval.
Article 44 If chemical APIs, excipients and packaging materials and containers that directly contact drugs pass the associated review or separate review and approval, the Drug Evaluation Center shall update the registration status logo on the registration platform of chemical APIs, excipients and packaging materials and containers that directly contact drugs and publicize relevant information to the public. Among them, the chemical API approval notice and the approved production process, quality standards and labels shall be issued at the same time, and the registration number shall be indicated in the chemical API approval notice; If approval is not granted, a notice of disapproval shall be issued for chemical APIs.
In case of failure to pass the related review and approval, the registration status of chemical APIs, excipients, packaging materials and container products that directly contact drugs will remain unchanged, and the application for related drug preparations will not be approved.
Section 4 Verification of Drug Registration
Article 45 Drug registration verification refers to the verification activities carried out on the development site and production site in order to verify the authenticity and consistency of the application materials and the conditions for the commercial production of drugs on the market, check the compliance of drug development and the reliability of data, as well as, when necessary, the chemical raw materials, auxiliary materials, packaging materials and container manufacturers that directly contact drugs involved in the drug registration application Extended inspection activities carried out by suppliers or other entrusted institutions.
The principles, procedures, time limits and requirements for starting drug registration verification shall be formulated and published by the Drug Evaluation Center; The principles, procedures, time limits and requirements for the implementation of drug registration verification shall be formulated and published by the Drug Verification Center.
Article 46 The Drug Evaluation Center shall decide whether to carry out on-site inspection of drug registration and development based on risks according to the degree of drug innovation and the previous inspection of drug research institutions.

If the Drug Evaluation Center decides to start the on-site verification of drug registration and development, it shall notify the Drug Evaluation Center to organize and implement the verification during the evaluation, and inform the applicant at the same time. The Drug Inspection Center shall complete the on-site inspection within the specified time limit and feed back the inspection results, inspection conclusions and other relevant materials to the Drug Inspection Center for comprehensive evaluation.
Article 47 The Drug Evaluation Center shall decide whether to start the on-site inspection of drug registration based on risks according to the varieties, processes, facilities, previous inspections and other factors applied for registration.
For innovative drugs, improved new drugs and biological products, on-site verification of drug registration and inspection of drug production quality management specifications before marketing shall be carried out.
For generic drugs, the on-site inspection of drug registration and the inspection of pre marketing drug production quality management specifications shall be carried out based on risks according to whether the drug production license of the corresponding production scope has been obtained and whether the same dosage form has been marketed.
Article 48 After the acceptance of a drug registration application, the Drug Evaluation Center shall conduct a preliminary examination within 40 days after the acceptance. If on-site inspection of drug registration production is required, the Drug Evaluation Center shall be notified to organize the inspection, provide the relevant materials required for the inspection, and inform the applicant and the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government where the applicant or the manufacturer is located. In principle, the Drug Inspection Center shall complete the inspection 40 days before the expiration of the evaluation time limit, and feed back the inspection results and other relevant materials to the Drug Inspection Center.
If it is necessary to conduct pre marketing inspection on drug production quality management specifications, the Drug Inspection Center shall coordinate the drug regulatory departments of relevant provinces, autonomous regions and municipalities directly under the Central Government to carry out the on-site inspection of drug registration production simultaneously. The administrative requirements for the pre marketing inspection of the pharmaceutical production quality control specifications shall be implemented in accordance with the relevant provisions of the Measures for the Supervision and Administration of Pharmaceutical Production.
The applicant shall accept the verification within the specified time limit.
Article 49 In the process of evaluation, if the Drug Evaluation Center finds that the authenticity of the application materials is in doubt or there are clear clues to report, which need to be checked on the spot, it shall start the inspection for reasons and conduct sampling inspection when necessary.
Article 50 When applying for a drug marketing license, the applicant and the manufacturer shall have obtained the corresponding drug production license.
Section 5 Drug Registration Inspection
Article 51 Drug registration inspection includes standard review and sample inspection. Standard review refers to the laboratory evaluation of the scientificity of the items set in the drug standards applied by the applicant, the feasibility of the inspection methods, and the rationality of the quality control indicators. Sample inspection refers to the laboratory inspection of samples according to the drug quality standards declared by the applicant or approved by the Drug Evaluation Center.
The principles, procedures, time limits and other requirements for starting drug registration and inspection shall be formulated and announced by the Drug Evaluation Center. Prior to the acceptance of drug registration applications, the specific working procedures and requirements for drug registration inspection, as well as technical requirements and specifications for drug registration inspection, shall be formulated and published by the CIIC.
Article 52 If the inspection items and methods used for the drugs of the same variety are consistent with those contained in the national drug standards, only sample inspection may be conducted instead of standard review. In other cases, standard review and sample inspection shall be conducted.
Article 53 The CIIC or the drug inspection institution designated by the SDA shall undertake the following drug registration inspection:
(1) Innovative medicine;
(2) Improved new drugs (except traditional Chinese medicine);
(3) Biological products, radioactive drugs and in vitro diagnostic reagents under drug control;
(4) Other drugs prescribed by the SDA.
The registration and inspection of drugs produced abroad shall be carried out by the port drug inspection institutions organized by the CIIC.
The registration inspection of other drugs shall be undertaken by the applicant or the provincial drug inspection institution where the manufacturer is located.
Article 54 After the applicant has completed the pharmaceutical related research to support the drug market, determined the quality standards, and completed the verification of the commercial scale production process, he/she may submit the drug registration inspection to the Chinese Academy of Inspection or the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government before accepting the drug registration application; If the applicant fails to submit the drug registration inspection before the acceptance of the drug registration application, the Drug Evaluation Center shall start the drug registration inspection within 40 days after the acceptance of the drug registration application. In principle, the applicant can only submit a drug registration inspection once before the acceptance of the drug registration application, and may not submit a drug registration inspection to multiple drug inspection institutions at the same time.
The drug registration and inspection materials submitted by the applicant shall be consistent with the corresponding contents of the drug registration and application materials, and the drug inspection organization, samples and materials shall not be changed during the drug registration and inspection process.
Article 55 For the application for the registration of domestically produced drugs, if the applicant submits the drug registration inspection before the acceptance of the drug registration application, it shall apply to the drug regulatory department of the relevant province, autonomous region, or municipality directly under the Central Government for sampling. The drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall organize the sampling and seal it. The applicant shall send the sampling form, samples, data required for inspection, and reference materials to the corresponding drug inspection agency.
For the application for the registration of drugs produced abroad, if the applicant submits the drug registration inspection before the acceptance of the drug registration application, the applicant shall take samples according to the requirements of the regulations, and send the samples, materials required for inspection and reference materials to the CIIC.
Article 56 For the application for the registration of domestically produced drugs, if the drug registration inspection is required after the acceptance of the drug registration application, the Drug Evaluation Center shall issue a notice of drug registration inspection to the drug inspection institution and the applicant within 40 days after the acceptance. The applicant shall apply to the drug regulatory department of the relevant province, autonomous region or municipality directly under the Central Government for sampling. The drug regulatory department of the province, autonomous region or municipality directly under the Central Government shall organize the sampling and seal it. The applicant shall send the sampling form, samples, data required for inspection and reference materials to the corresponding drug inspection institution within the specified time limit.
For the registration application of drugs produced abroad, if the drug registration inspection is required after the acceptance of the drug registration application, the applicant shall take samples according to the requirements of the regulations, and send the samples, materials required for inspection and reference materials to the CIIC.
Article 57 The drug inspection institution shall, within five days, examine the samples and materials for inspection submitted by the applicant, decide whether to accept them, and notify the Drug Evaluation Center at the same time. If it is necessary to make corrections, the applicant shall be informed at one time.
In principle, drug inspection institutions shall feed back the standard review opinions and inspection reports to the Drug Evaluation Center 40 days before the expiration of the evaluation time limit.
Article 58 In the process of drug review and verification, if it is found that there is doubt about the authenticity of the application materials or there are clear clues to report, or it is deemed necessary to conduct sample inspection, samples may be taken for sample inspection.
During the review, the Drug Evaluation Center may propose a single review of the quality standard based on risk.

Chapter IV Procedures for Accelerating the Registration of Drugs on the Market

Section I Breakthrough Therapeutic Drug Procedures
Article 59 During the clinical trial of drugs, the applicant may apply for the application of breakthrough therapeutic drug procedures for innovative drugs or improved new drugs that are used to prevent and treat diseases that seriously endanger life or seriously affect the quality of life, and that have no effective means of prevention and treatment or have sufficient evidence to show obvious clinical advantages compared with existing means of treatment.
Article 60 Where an applicant applies for the application of breakthrough therapeutic drug procedures, the applicant shall submit an application to the Drug Evaluation Center. If the conditions are met, the Drug Evaluation Center shall incorporate the breakthrough treatment drug procedure after the procedure is publicized.
Article 61 The following policy supports shall be given to clinical trials of drugs that are included in breakthrough therapeutic drug procedures:
(1) The applicant can submit an application for communication to the Drug Evaluation Center at the critical stage of the drug clinical trial, and the Drug Evaluation Center will arrange reviewers for communication;
(2) The applicant may submit the staged research materials to the Drug Evaluation Center, which will, based on the existing research materials, make comments or suggestions on the next research scheme and feed back to the applicant.
Article 62 For the clinical trial of drugs included in the breakthrough therapeutic drug procedure, if the applicant finds that the conditions for inclusion are no longer met, he/she shall timely propose to the Drug Evaluation Center to terminate the breakthrough therapeutic drug procedure. If the Drug Evaluation Center finds that it no longer meets the requirements for inclusion, it shall terminate the breakthrough therapeutic drug procedure for this variety in a timely manner and notify the applicant.
Section II Conditional Approval Procedures
Article 63 During the clinical trial of drugs, drugs meeting the following conditions may apply for conditional approval:
(1) Drugs that are used to treat diseases seriously endangering life and for which there is no effective treatment method, and the clinical trial of drugs has already confirmed the efficacy and can predict its clinical value;
(2) Drugs urgently needed in public health, and the existing data of drug clinical trials show the efficacy and can predict its clinical value;
(3) Vaccines urgently needed in response to major public health emergencies or other vaccines recognized as urgently needed by the National Health Commission, whose benefits outweigh the risks after assessment.
Article 64 Where an application for conditional approval is filed, the applicant shall communicate with the Drug Evaluation Center about the conditions for conditional approval of listing and the research work to be completed after listing, and submit the application for drug marketing license after the communication, communication and confirmation.
If the requirements for conditional approval are met after review, the drug registration certificate shall state the period of validity of the drug registration certificate for conditional approval, the research work to be completed after marketing, the time limit for completion and other related matters.
Article 65 In the process of evaluation, if it is found that the drug registration application included in the conditional approval procedure cannot meet the conditions for conditional approval, the Drug Evaluation Center shall terminate the conditional approval procedure for the variety and inform the applicant to study the application according to the normal procedure.
Article 66 With regard to the drugs approved with conditions, the holders shall take corresponding risk management measures after the drugs are marketed, complete the clinical trials of drugs and other relevant studies as required within the prescribed time limit, and report by means of supplementary applications.
If further research is required when approving the application for vaccine registration, the vaccine holder shall complete the research within the specified time limit.
Article 67 If the holder of a conditionally approved drug fails to complete the research as required within the time limit or cannot prove that the benefits outweigh the risks, the SDA shall deal with it according to law until the drug registration certificate is cancelled.
Section III Priority Review and Approval Procedures
Article 68 When applying for drug marketing license, the following drugs with obvious clinical value can be applied for the application of priority review and approval procedure:
(1) Shortage drugs urgently needed clinically, innovative drugs and improved new drugs for the prevention and treatment of major infectious diseases and rare diseases;
(2) New varieties, dosage forms and specifications of medicines for children that meet the physiological characteristics of children;
(3) Vaccines and innovative vaccines urgently needed for disease prevention and control;
(4) Drugs included in breakthrough therapeutic drug procedures;
(5) Drugs that meet the conditions for approval;
(6) Other situations where the State Drug Administration stipulates that the review and approval shall be given priority.
Article 69 Before applying for drug marketing license, the applicant shall communicate with the Drug Evaluation Center. After confirmation of the communication, the applicant shall apply to the Drug Evaluation Center for priority review and approval at the same time of applying for drug marketing license. If the conditions are met, the Drug Evaluation Center shall be included in the priority evaluation and approval procedure after being publicized according to the procedure.
Article 70 The following policy supports shall be given to drug marketing license applications that are included in the priority review and approval procedures:
(1) The time limit for review of drug marketing license application is 130 days;
(2) For the rare disease drugs that are urgently needed clinically and have been listed abroad but not listed in China, the review time limit is 70 days;
(3) Priority shall be given to those who need to check, inspect and approve the generic names of drugs;
(4) After communication and confirmation, technical data can be supplemented and submitted.
Article 71 In the process of review, if it is found that the drug registration application included in the priority review and approval procedure cannot meet the requirements for priority review and approval, the Drug Evaluation Center shall terminate the priority review and approval procedure for this variety, review according to the normal review procedure, and inform the applicant.
Section 4 Special Examination and Approval Procedures
Article 72 When a public health emergency threatens to occur and after the occurrence of a public health emergency, the SDA may, according to law, decide to give special approval to the preventive and therapeutic drugs needed for public health emergencies.
Article 73 The SDA shall, in accordance with the principles of unified command, early intervention, rapid and efficient, and scientific approval, organize to accelerate and simultaneously carry out the acceptance, review, verification, and inspection of drug registration applications subject to special approval. The circumstances, procedures, time limit, requirements, etc. of the special approval shall be implemented in accordance with the provisions of the special drug approval procedures.
Article 74 The use of drugs included in the special examination and approval procedures may be limited to a certain period and scope according to the specific needs of disease prevention and control.
Article 75 If it is found that the drugs included in the special approval procedure no longer meet the requirements for inclusion, the special approval procedure for the drugs shall be terminated and the applicant notified.

Chapter V Change and Re registration of Drugs after Marketing

Section 1 Post marketing research and change of drugs
Article 76 The holders shall take the initiative to 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.
If the drug registration certificate and its annexes require the holder to carry out relevant research after the drug is marketed, the holder shall complete the supplementary application, filing or report as required within the specified time limit.
After a drug is approved for marketing, the holder shall continue to carry out research on the drug safety and effectiveness, file a record in a timely manner according to relevant data or submit a supplementary application for revising the instructions, and constantly update and improve the instructions and labels. The drug regulatory department may, according to its duties, require the holder to revise the instructions and labels according to the adverse drug reaction monitoring and post marketing evaluation results of drugs.
Article 77 Changes after the drugs are marketed shall be classified into approval changes, record changes and report changes according to their risks and impact on the drug safety, effectiveness and quality controllability.
The holder shall, in accordance with the relevant provisions and referring to the relevant technical guidelines, comprehensively assess and verify the impact of the changes on the drug safety, effectiveness and quality controllability, and carry out the corresponding research work.
The technical guidelines for post marketing change research of drugs shall be formulated by the Drug Evaluation Center and published to the public.
Article 78 The holder shall file a supplementary application for the following changes, which shall be implemented after approval:
(1) Major changes during drug production;
(2) Changes in other contents of the drug package insert that involve effectiveness and increase safety risks;
(3) The holder transfers the drug marketing license;
(4) Other changes required to be approved by the SDA.
Article 79 The holder of the following changes shall report to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government for the record before the implementation of the change:
(1) Moderate changes during drug production;
(2) Change of drug packaging label content;
(3) Drug subpackaging;
(4) Other changes required to be filed by the SDA.
If the above changes occur to the drugs produced abroad, they shall be reported to the Drug Evaluation Center for filing before the implementation of the changes.
The procedures and requirements for drug subpackaging filing shall be formulated and issued by the Drug Evaluation Center.
Article 80 Holders shall report the following changes in their annual reports:
(1) Minor changes during drug production;
(2) Other changes required to be reported by the SDA.
Article 81 Where a supplementary application submitted after a drug is marketed needs to be checked and inspected, it shall be conducted with reference to the procedures for drug registration check and inspection in these Measures.
Section 2 Re registration of drugs
Article 82 The holder shall apply for re registration six months before the expiry of the drug registration certificate. The holder shall submit an application for re registration of domestically produced drugs to the drug regulatory department of the province, autonomous region or municipality directly under the Central Government where the holder is located, and the holder shall submit an application for re registration of overseas produced drugs to the Drug Evaluation Center.
Article 83 After the acceptance of the application for drug re registration, the drug regulatory department or drug evaluation center of the province, autonomous region, or municipality directly under the Central Government shall review the post marketing evaluation and adverse reaction monitoring of the drug holders in accordance with the drug approval documents and the requirements of the drug regulatory department, as well as the changes in the information contained in the drug approval documents. If they meet the requirements, they shall be re registered, To issue a drug re registration approval notice. Those that do not meet the requirements shall not be re registered and shall be reported to the SDA for cancellation of the drug registration certificate.
Article 84 Under any of the following circumstances, re registration shall not be allowed:
(1) Failure to apply for re registration at the expiration of the validity period;
(2) The holder of the drug registration certificate is unable to perform the responsibility of continuously investigating the drug quality, efficacy and adverse reactions within the validity period of the drug registration certificate;
(3) Failing to complete the drug approval documents and the research work required by the drug regulatory department within the specified time limit without reasonable reasons;
(4) According to the post marketing evaluation, the efficacy is uncertain, adverse reactions are large, or human health is endangered for other reasons;
(5) Other circumstances under which re registration is not allowed as prescribed by laws and administrative regulations.
For drugs that are not allowed to be re registered, the drug registration certificate shall be cancelled upon expiration.

Chapter VI Acceptance, Withdrawal of Applications, Examination and Approval Decisions and Dispute Resolution

Article 85 After receiving the application for drug registration, the drug regulatory department shall conduct a formal examination and decide whether to accept it or not according to the following circumstances:
(1) If an application item does not need to obtain an administrative license according to law, a decision of rejection shall be made immediately, and the reasons shall be explained.
(2) If the application matters do not fall within the scope of the authority of the department according to law, the department shall immediately make a decision not to accept the application and inform the applicant to apply to the relevant administrative organ.
(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them on the spot; If the corrected application materials are complete and conform to the legal form, it shall be accepted.
(4) If the application materials are incomplete or do not conform to the legal form, the applicant shall be informed of all the contents that need to be supplemented or corrected on the spot or within five days. If the application materials need to be returned together with the notification according to regulations, they shall be returned. The applicant shall complete the supplement and correction within 30 days. If the applicant fails to make corrections within the time limit without justifiable reasons, it shall be deemed to have abandoned the application and no decision on rejection is needed. If the applicant is not notified to make corrections within the time limit, the application shall be deemed accepted as of the date of receipt of the application materials.
(5) If the application items fall within the scope of the authority of the department, the application materials are complete and conform to the legal form, or the applicant submits all the supplemented and corrected materials as required, the drug registration application shall be accepted.
After the acceptance of the drug registration application, if the applicant needs to pay the fee, the applicant shall pay the fee as required. If the applicant fails to pay the fee within the prescribed time limit, the drug registration review and approval shall be terminated.
Article 86 After the acceptance of the drug registration application, if there is any new discovery of drug safety, the applicant shall timely report and supplement the relevant materials.
Article 87 After the acceptance of the drug registration application, if the applicant needs to supplement new technical materials on the basis of the original application materials, the Drug Evaluation Center shall, in principle, propose a request for supplementary materials, list all the problems, and notify the applicant in writing to supplement the materials within 80 days. The applicant shall submit all the supplementary materials at one time as required, and the time for supplementary materials shall not be included in the drug evaluation time limit. The Drug Evaluation Center will start the evaluation after receiving all the applicant's supplementary information, and the evaluation time limit will be extended by one third; If the priority review approval procedure is applicable, the review time limit shall be extended by one quarter.
If the applicant is not required to supplement new technical materials, but only needs to explain the original application materials, the Drug Evaluation Center shall notify the applicant to submit relevant explanations as required within five days.
If the Drug Evaluation Center considers that there are substantive defects that cannot be corrected, it will no longer require the applicant to supplement information. Make a decision not to approve based on the existing declaration materials.
Article 88 No new technical data shall be added to an application for a drug clinical trial or a supplementary application during a drug clinical trial during the evaluation period; If it is necessary to carry out new research, the applicant may reapply after withdrawal.
Article 89 After the application for drug registration is accepted, the applicant may withdraw the application. If the applicant agrees to withdraw the application, the Drug Evaluation Center or the drug regulatory department of the province, autonomous region, or municipality directly under the Central Government shall terminate the registration procedure and notify the drug registration verification, inspection, and other technical institutions. If it is found in the process of review, verification and inspection that illegal acts such as concealing the truth or providing false information are suspected, it shall be handled according to law, and the applicant shall not withdraw the drug registration application.
Article 90 During the drug registration period, if the evaluation conclusion is not passed, the Drug Evaluation Center shall inform the applicant of the reason for the failure, and the applicant may raise an objection to the Drug Evaluation Center within 15 days. The Drug Evaluation Center shall conduct a comprehensive evaluation based on the applicant's objections and feed back to the applicant.
If the applicant still disagrees with the results of the comprehensive evaluation, the Drug Evaluation Center shall organize an expert advisory committee to make an argument within 50 days according to the provisions, and form a final evaluation conclusion based on the results of the expert's argument.
The applicant's objection and expert argumentation time are not included in the review time limit.
Article 91 During the period of drug registration, if the applicant believes that the staff members have violated the regulations or committed irregularities in the work of drug registration acceptance, review, verification, inspection, approval, etc., the applicant may file a complaint and report it to the unit to which he belongs or to a higher authority.
Article 92 Where an application for drug registration meets the statutory requirements, it shall be approved.
An application for drug registration shall not be approved under any of the following circumstances:
(1) The research materials applied for in the drug clinical trial are insufficient to support the drug clinical trial or cannot guarantee the safety of the subject;
(2) The application materials show that there are major defects in the safety, effectiveness, quality controllability, etc. of the applied drug;
(3) The application materials cannot prove the safety, effectiveness and quality controllability of the drug, or the risk of the drug is considered to be greater than the benefit after evaluation;
(4) The applicant fails to supplement the materials within the specified time limit;
(5) The applicant refuses to accept or fails to accept the verification and inspection of drug registration within the prescribed time limit without justifiable reasons;
(6) In the process of drug registration, the applicant believes that the application materials are untrue and the applicant cannot prove their authenticity;
(7) The results of on-site drug registration verification or sample inspection do not meet the requirements;
(8) Other circumstances that shall not be approved as stipulated by laws and regulations.
Article 93 After the examination and approval of a drug registration application is completed, if the applicant disagrees with the administrative licensing decision, he or she may file an administrative reconsideration or an administrative lawsuit according to law.

Chapter VII Working Time Limit

Article 94 The time limit stipulated in these Measures is the longest time for acceptance, review, verification, inspection, approval, etc. of drug registration. The working time limit related to the priority review and approval procedure shall be implemented according to the relevant provisions on priority review and approval.
The Drug Evaluation Center and other professional and technical institutions shall clearly define their own work procedures and time limits and publicize them to the public.
Article 95 After receiving an application for drug registration, the drug regulatory department shall conduct a formal examination and make a decision on acceptance, supplementation or rejection within five days.
Article 96 The time limit for drug registration review shall be implemented in accordance with the following provisions:
(1) The time limit for review and approval of drug clinical trial application and supplementary application during drug clinical trial is 60 days;
(2) The time limit for the review of drug marketing license application is 200 days, including 130 days for the review of priority review and approval procedures, and 70 days for the review of priority review and approval procedures for drugs for rare diseases that are urgently needed overseas;
(3) The review time limit for separately applying for copying chemical APIs that have been listed in China is 200 days;
(4) The time limit for the review of the supplementary application for approval type changes is 60 days, and for the consolidated declaration of supplementary applications, the time limit for the review is 80 days, including 200 days for the review involving the review of clinical trial research data and the verification and inspection of drug registration;
(5) The time limit for approval of generic drug names is 30 days;
(6) The time limit for OTC drug suitability review is 30 days.
The time limit for related review is consistent with that for related drug preparations.
Article 97 The time limit for drug registration verification shall be implemented in accordance with the following provisions:
(1) The Drug Evaluation Center shall notify the Drug Evaluation Center to start the inspection within 40 days after the acceptance of the drug registration application, and notify the applicant at the same time;
(2) In principle, the Drug Inspection Center shall complete the on-site inspection of drug registration production 40 days before the expiration of the evaluation time limit, and feed back the inspection results and other relevant materials to the Drug Inspection Center.
Article 98 The time limit for drug registration inspection shall be implemented in accordance with the following provisions:
(1) The time limit for sample inspection is 60 days, and the time limit for sample inspection and standard review simultaneously is 90 days;
(2) The time limit for supplementary materials during drug registration and inspection is 30 days;
(3) In principle, the drug inspection institution shall complete the work related to drug registration inspection 40 days before the expiration of the evaluation time limit, and feed back the drug standard review opinions and inspection reports to the Drug Evaluation Center.
Article 99 The time limit for examination and approval of drug re registration is 120 days.
Article 100 The decision on administrative examination and approval shall be made within 20 days.
Article 101 The drug regulatory department shall issue and serve the relevant administrative license within 10 days from the date of making the decision on the approval of drug registration.
Article 102 If it is really necessary to extend the time limit due to special circumstances such as variety characteristics, review, verification and inspection, the extended time limit shall not exceed half of the original time limit. After the approval of the person in charge of the relevant technical agency for drug review, verification and inspection, the technical agency extending the time limit shall notify the applicant in writing and notify other relevant technical agencies.
Article 103 The following time shall not be included in the relevant working time limit:
(1) The time taken by the applicant to supplement information, rectify after verification, and check production process, quality standards and instructions as required;
(2) The time for inspection, examination, expert consultation, etc. is delayed due to the applicant's reasons;
(3) If the review and approval procedure is suspended according to the provisions of laws and regulations, the time occupied during the suspension of the review and approval procedure;
(4) If overseas verification is started, the time taken for overseas verification.

Chapter VIII Supervision and Administration

Article 104 The SDA shall be responsible for the supervision, administration, assessment, evaluation and guidance of the work related to drug registration and administration undertaken by the drug evaluation center and other relevant professional and technical institutions and the drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government.
Article 105 Pharmaceutical supervisory and administrative departments shall, in accordance with the provisions of laws and regulations, supervise and inspect pharmaceutical research and development activities, and may, when necessary, conduct extended inspections of the units and individuals that provide products or services for pharmaceutical research and development. The relevant units and individuals shall cooperate and shall not refuse or conceal such inspections.
Article 106 The Information Center is responsible for establishing drug variety archives, implementing coding management on drugs, collecting information such as drug registration application, safety related reports during clinical trials, review, verification, inspection, approval, and approval, filing, and reports of changes after drug marketing, and continuously updating them. The information center shall formulate and publish the relevant systems for the management of drug variety archives and codes.
Article 107 The drug regulatory departments of provinces, autonomous regions and municipalities directly under the Central Government shall organize daily supervision and inspection of the compliance of drug non clinical safety evaluation research institutions and drug clinical trial institutions within their respective jurisdictions with the quality control standards for drug non clinical research and drug clinical trial, and supervise their continued compliance with statutory requirements. The SDA shall, as required, supervise and inspect research institutions such as drug non clinical safety evaluation research institutions and drug clinical trial institutions.
Article 108 The SDA shall establish a drug safety credit management system, and the Drug Verification Center shall be responsible for establishing drug safety credit files of drug non clinical safety evaluation and research institutions and drug clinical testing institutions, recording the licensing, daily supervision and inspection results, investigation and punishment of illegal acts, etc., and shall publish them to the public according to law and update them in a timely manner. The drug regulatory department shall increase the frequency of supervision and inspection for those with bad credit records, and may implement joint punishment in accordance with national regulations. The relevant systems for drug safety credit files of drug non clinical safety evaluation research institutions and drug clinical testing institutions shall be formulated and published by the Drug Verification Center.
Article 109 The SDA shall, in accordance with the law, publish to the public the list of matters to be examined and approved for drug registration, the legal basis, the requirements for examination and approval and the time limit for handling the matter, disclose to the applicant the progress of drug registration, disclose to the public the conclusions and basis of the review of the approval of listed drugs, as well as the violations found in the supervision and inspection, and accept social supervision.
The instructions of drugs approved for marketing shall be made public to the public and updated in a timely manner. Among them, the vaccine should also disclose the label content and update it in a timely manner.
Without the consent of the applicant, the drug regulatory department, professional and technical institutions and their staff, personnel participating in expert review, etc. shall not disclose the trade secrets, undisclosed information or confidential business information submitted by the applicant, except as otherwise provided by law or involving national security and major social and public interests.
Article 110 Under any of the following circumstances, the SDA shall cancel the drug registration certificate and publish it:
(1) The holder proposes to cancel the drug registration certificate;
(2) Refusing to re register in accordance with these Measures;
(3) The holder's drug registration certificate, drug production license and other administrative licenses are revoked or revoked according to law;
(4) According to the provisions of Article 83 of the Drug Administration Law, the curative effect is uncertain, adverse reactions are large, or human health is endangered for other reasons;
(5) According to the provisions of Article 61 of the Vaccine Administration Law, the post marketing evaluation shows that the abnormal reaction of vaccination is serious or endangers human health for other reasons;
(6) According to the provisions of Article 62 of the Vaccine Administration Law, the product design, production process, safety, effectiveness or quality controllability of the vaccine variety is found to be significantly inferior to other vaccine varieties for the prevention and control of the same disease after the evaluation after the marketing;
(7) Violating the provisions of laws and administrative regulations, failing to complete the corresponding research work within the specified time limit according to the requirements of the drug approval documents or the requirements of the drug regulatory department without reasonable reasons;
(8) Other circumstances under which the drug registration certificate should be cancelled according to law.

Chapter IX Legal Liabilities

Article 111 In the process of drug registration, anyone who provides false certificates, data, materials, samples or uses other means to defraud a clinical trial license or a drug registration license shall be dealt with in accordance with Article 123 of the Drug Administration Law.
Article 112 Those who apply for clinical trial or registration of vaccines and provide false data, materials, samples or commit other deceptive acts shall be dealt with in accordance with Article 81 of the Vaccine Administration Law.
Article 113 In the process of drug registration, if a drug non clinical safety evaluation research institution or drug clinical trial institution fails to comply with the quality control standards for drug non clinical research and drug clinical trial, it shall be handled in accordance with Article 126 of the Drug Administration Law.
Article 114 Those who carry out clinical trials of drugs without approval shall be dealt with in accordance with Article 125 of the Drug Administration Law; If the bioequivalence test is not filed, it shall be handled in accordance with Article 127 of the Drug Administration Law.
Article 115 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 SDA, the matter shall be handled in accordance with Article 127 of the Drug Administration Law.
Article 116 If the applicant violates the provisions of Article 28 and Article 33 of these Measures and has any of the following circumstances, he/she shall be ordered to make corrections within a time limit; If it fails to make corrections within the time limit, it shall be fined not less than 10000 yuan but not more than 30000 yuan:
(1) The drug clinical trial was not registered on the drug clinical trial registration and information publicity platform as required before the drug clinical trial was carried out;
(2) Failure to submit safety update report during R&D as required;
(3) The clinical trial results and other information were not registered after the completion of the drug clinical trial.
Article 117 Where a drug inspection institution issues a false inspection report when undertaking the inspection work required for drug registration, it shall be handled in accordance with Article 138 of the Drug Administration Law.
Article 118 If a drug registration certificate is issued for a drug that does not meet the requirements but is approved for clinical trials, it shall be handled in accordance with Article 147 of the Drug Administration Law.
Article 119 Any drug regulatory department or its staff member who violates laws and regulations in the process of drug registration and administration shall be dealt with in accordance with relevant laws and regulations.

Chapter X Supplementary Provisions

Article 120 The application for registration of narcotic drugs, psychotropic drugs, toxic drugs for medical use, radioactive drugs, pharmaceutical precursor chemicals and other drugs with special regulations shall comply with other relevant national regulations in addition to the provisions of these Measures.
Article 121 The standards for exporting vaccines shall meet the standards of the importing country (region) or the requirements of the contract.
Article 122 For the combined pharmaceutical and mechanical products to be applied for registration, if the same kind of products have been defined as drugs by their attributes, the application shall be made according to the drugs; If the product attribute has not been defined, the applicant shall apply to the SDA for defining the product attribute before applying for registration. If the attribute is defined as drug, it shall be registered according to the procedures specified in these Measures. The research data belonging to the medical device part shall be submitted to the drug evaluation center for comprehensive evaluation after the evaluation conclusion is made by the medical device technical evaluation center of the SDA.
Article 123 The format of the approval number for domestic drug production is: GYZZ H (Z, S)+four digit year number+four digit serial number. The format of the approval number for the production of drugs in Hong Kong, Macao and Taiwan is: Guoyao Zhunzi H (Z, S) C+four digit year number+four digit serial number.
The format of approval number of overseas drugs is: Guoyao Zhunzi H (Z, S) J+four digit year number+four digit serial number.
Among them, H represents chemical medicine, Z represents traditional Chinese medicine, and S represents biological products.
The drug approval number shall not be changed due to the change of the registration items after the listing.
If there are other provisions on traditional Chinese medicine, such provisions shall prevail.
Article 124 The electronic document of the drug registration approval certificate and the electronic document of the approval document of the API prepared by the drug regulatory department have the same legal effect as the paper document.
Article 125 The time limit stipulated in these Measures shall be calculated in working days.
Article 126 These Measures shall come into force as of July 1, 2020. The Measures for the Administration of Drug Registration promulgated by the former Order No. 28 of the State Food and Drug Administration on July 10, 2007 shall be repealed at the same time.

 

 

 

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