Drug Registration Management Measures

Measures for the Administration of Drug Registration

Chapter One   General   Provisions

　　Article 1: To regulate drug registration activities, ensure the safety, efficacy, and quality control of drugs, these measures are formulated in accordance with the "Drug Administration Law of the People's Republic of China" (hereinafter referred to as the "Drug Administration Law"), the "Traditional 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", the "Implementation Regulations of the Drug Administration Law of the People's Republic of China" and other laws and administrative regulations.

　　Article 2: These measures apply to drug research, registration, and supervision activities within the territory of the People's Republic of China aimed at drug marketing.

　　Article 3: Drug registration refers to the activities where drug registration applicants (hereinafter referred to as applicants) submit applications for drug clinical trials, drug marketing authorization, re-registration, and supplementary applications according to legal procedures and relevant requirements, and the drug regulatory authorities review safety, efficacy, and quality control based on laws, regulations, and current scientific knowledge to decide whether to approve the applications.

　　After obtaining the drug registration certificate, the applicant becomes the drug marketing authorization holder (hereinafter referred to as the holder).

　　Article 4: Drug registration is managed by classification into traditional Chinese medicine, chemical drugs, and biological products.

　　Traditional Chinese medicine registration is classified into innovative traditional Chinese medicines, improved new traditional Chinese medicines, compound preparations of ancient classic prescriptions, and drugs with the same name and formula.

　　Chemical drug registration is classified into innovative chemical drugs, improved new chemical drugs, and generic drugs.

　　Biological product registration is classified into innovative biological products, improved new biological products, and marketed biological products (including biosimilars).

　　The detailed classification of traditional Chinese medicines, chemical drugs, biological products, and the corresponding application material requirements are organized and formulated by the National Medical Products Administration based on the product characteristics, degree of innovation, and review management needs of registered drugs, and are publicly announced.

　　Registration applications for drugs produced overseas shall be implemented according to the detailed classification of drugs and corresponding application material requirements.

　　Article 5: The National Medical Products Administration is responsible for the national drug registration management, establishing the drug registration management system and regulations, formulating drug registration management standards, and organizing drug registration review, approval, and related supervision work according to law. The Center for Drug Evaluation of the National Medical Products Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for reviewing applications for drug clinical trials, drug marketing authorization, supplementary applications, and re-registration of drugs produced overseas. Professional technical institutions such as the National Institutes for Food and Drug Control (hereinafter referred to as NIFDC), the Pharmacopoeia Commission of China (hereinafter referred to as the Pharmacopoeia Commission), the Food and Drug Inspection and Examination Center of the National Medical Products Administration (hereinafter referred to as the Drug Inspection Center), the Drug Evaluation Center of the National Medical Products Administration, the Administrative Matters Acceptance Service and Complaint Reporting Center of the National Medical Products Administration, and the Information Center of the National Medical Products Administration (hereinafter referred to as the Information Center) undertake drug registration inspection, generic name approval, verification, monitoring and evaluation, certificate issuance and delivery, and related informatization construction and management required by law.

　　Article 6: The drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government are responsible for the following drug registration-related management work within their administrative regions:

　　(1) Acceptance, review, and approval of re-registration applications for domestically produced drugs;

　　(2) Management of filing and reporting matters for post-marketing changes of drugs;

　　(3) Organizing daily supervision and investigation of illegal activities of drug non-clinical safety evaluation research institutions and drug clinical trial institutions;

　　(4) Participating in drug registration verification, inspection, and other work organized by the National Medical Products Administration;

　　(5) Drug registration-related matters entrusted by the National Medical Products Administration.

　　Professional technical institutions set up or designated by the drug regulatory departments of provinces, autonomous regions, and municipalities directly under the Central Government undertake review, inspection, verification, monitoring, and evaluation work required by law for drug supervision and management.

　　Article 7: Drug registration management follows the principles of openness, fairness, and impartiality, is guided by clinical value, encourages research and development of new drugs, and actively promotes the development of generic drugs.

　　The National Medical Products Administration continuously promotes reform of the review and approval system, optimizes review and approval procedures, improves review and approval efficiency, and establishes a drug registration management system led by review and supported by inspection, verification, monitoring, and evaluation.

Chapter Two   Basic Systems and Requirements

　　Article 8: Those engaged in drug research and drug registration activities shall comply with relevant laws, regulations, rules, standards, and norms; if other evaluation methods and technologies are used by referring to relevant technical guidelines, their scientificity and applicability shall be demonstrated; the authenticity, accuracy, completeness, and traceability of information throughout the process shall be ensured.

　　Drugs shall comply with national drug standards and drug quality standards approved by the National Medical Products Administration. The drug quality standards approved by the National Medical Products Administration shall be the drug registration standards. Drug registration standards shall meet 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. If the testing items or indicators of the registered variety do not apply to the Pharmacopoeia, the applicant shall provide sufficient supporting data.

　　The Drug Evaluation Center and other professional technical institutions shall formulate technical guidelines and procedures based on scientific progress, actual industry development, and drug supervision and management needs, and publicly announce them.

　　Article 9: Applicants shall be enterprises or drug research institutions capable of bearing corresponding legal responsibilities. Overseas applicants shall designate a corporate legal person within China to handle related drug registration matters.

　　Article 10: Before applying for drug marketing registration, applicants shall complete relevant research work such as pharmaceutical, pharmacological toxicology, and drug clinical trials. Drug non-clinical safety evaluation research shall be conducted in institutions certified by the Good Laboratory Practice for Non-clinical Laboratory Studies and comply with the Good Laboratory Practice for Non-clinical Laboratory Studies. Drug clinical trials shall be approved, with bioequivalence trials filed; drug clinical trials shall be conducted in drug clinical trial institutions that meet relevant regulations and comply with Good Clinical Practice.

　　Applications for drug registration shall provide true, sufficient, and reliable data, materials, and samples to prove the safety, efficacy, and quality control of the drug.

　　When using overseas research data and materials to support drug registration, their sources, research institutions or laboratory conditions, quality system requirements, and other management conditions shall comply with the common principles of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use and meet the relevant requirements of China's drug registration management.

　　Article 11 When changing the matters or content specified in the original drug registration approval documents and their attachments, the applicant shall, in accordance with regulations and referring to relevant technical guidelines, conduct sufficient research and verification on the drug changes, fully assess the potential impact of the changes on the drug's safety, efficacy, and quality controllability, and submit supplementary applications, filings, or reports according to the change procedures.

　　Article 12 The validity period of the drug registration certificate is five years. During the validity period, the holder shall continuously ensure the safety, efficacy, and quality controllability of the marketed drug and apply for drug re-registration six months before the expiration of the validity period.

　　Article 13 The National Medical Products Administration establishes an accelerated drug market registration system to support drug innovation guided by clinical value. For eligible drug registration applications, applicants may apply for breakthrough therapy drugs, conditional approval, priority review and approval, and special approval procedures. During drug development and registration, the drug regulatory authorities and their professional technical institutions provide necessary technical guidance, communication, priority resource allocation, shortened review timelines, and other policy and technical support.

　　Article 14 The National Medical Products Administration establishes a linked review and approval system for chemical raw materials, excipients, and packaging materials and containers that directly contact drugs. When approving drug formulations, chemical raw materials are reviewed and approved together, and related excipients, packaging materials, and containers that directly contact drugs are reviewed together. The Drug Evaluation Center establishes an information registration platform for chemical raw materials, excipients, and packaging materials and containers that directly contact drugs, publicly discloses related registration information for applicants or holders to choose from, and conducts linked reviews during the review of related drug formulation registration applications.

　　Article 15 Prescription drugs and over-the-counter drugs implement classified registration and conversion management. The Drug Evaluation Center formulates relevant technical guidelines and procedures for the market registration of over-the-counter drugs based on their characteristics and publicly announces them. The Drug Evaluation Center formulates technical requirements and procedures related to the post-market conversion of prescription and over-the-counter drugs and publicly announces them.

　　Article 16 Applicants may communicate with the Drug Evaluation Center and other professional technical institutions on major issues at key stages such as before applying for drug clinical trials, during drug clinical trials, and before applying for drug marketing authorization. During the drug registration process, the Drug Evaluation Center and other professional technical institutions may organize communication with applicants as needed.

　　The procedures, requirements, and time limits for communication are formulated separately by the Drug Evaluation Center and other professional technical institutions according to their functions and publicly announced.

　　Article 17 The Drug Evaluation Center and other professional technical institutions establish an expert consultation system as needed, form expert advisory committees, and seek expert opinions on major issues during review, verification, inspection, and generic name approval processes to fully utilize experts' technical support.

　　Article 18 The National Medical Products Administration establishes a catalog collection of newly approved chemical drugs for marketing and those passing generic drug quality and efficacy consistency evaluation, listing drug names, active ingredients, dosage forms, specifications, whether they are reference preparations, holders, and other related information, updating it promptly and publicly disclosing it. The procedures and requirements for collecting the chemical drug catalog are formulated by the Drug Evaluation Center and publicly announced.

　　Article 19 The National Medical Products Administration supports the inheritance and innovation of traditional Chinese medicine, establishes and improves registration management systems and technical evaluation systems that conform to the characteristics of traditional Chinese medicine, encourages the use of modern scientific technology and traditional research methods to develop traditional Chinese medicine, strengthens quality control of traditional Chinese medicine, and improves the level of clinical trials of traditional Chinese medicine.

　　For traditional Chinese medicine registration applications, applicants shall conduct clinical value and resource assessments, emphasizing clinical value orientation and promoting sustainable resource utilization.

Chapter 3   Drug Market Registration

　　Section 1 Drug Clinical Trials

　　Article 20 Drug clinical trials referred to in these measures mean drug research conducted on humans to determine drug safety and efficacy for the purpose of drug market registration.

　　Article 21 Drug clinical trials 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 objectives, the research content includes clinical pharmacology studies, exploratory clinical trials, confirmatory clinical trials, and post-marketing studies.

　　Article 22 Drug clinical trials shall be conducted in drug clinical trial institutions that meet corresponding conditions and are filed according to regulations. Vaccine clinical trials shall be conducted or organized by tertiary medical institutions or provincial-level and above disease prevention and control institutions that meet the conditions stipulated by the National Medical Products Administration and the National Health Commission.

　　Article 23 After completing pharmaceutical, pharmacological, toxicological, and other studies supporting drug clinical trials, applicants shall submit relevant research data according to the application data requirements when applying for drug clinical trials. After formal review, if the application data meet the requirements, acceptance shall be granted. The Drug Evaluation Center shall organize pharmaceutical, medical, and other technical personnel to review accepted drug clinical trial applications. Decisions on whether to approve the conduct of drug clinical trials shall be made within 60 days from acceptance and notified to applicants via the Drug Evaluation Center website; if no notification is given after the deadline, approval is deemed granted, and applicants may conduct drug clinical trials according to the submitted plan.

　　Applicants approved to conduct drug clinical trials are referred to as drug clinical trial sponsors (hereinafter referred to as sponsors).

　　Article 24 Applicants intending to conduct bioequivalence trials shall complete bioequivalence trial filing on the Drug Evaluation Center website as required and conduct related research according to the filed plan.

　　Article 25 Drug clinical trials shall be approved by an ethics committee.

　　The management of drugs used in drug clinical trials shall comply with the relevant requirements of the Good Clinical Practice for Drug Trials.

　　Article 26 For approved drug clinical trials, sponsors shall formulate corresponding drug clinical trial protocols before conducting subsequent phased drug clinical trials, conduct them after ethics committee approval, and submit corresponding drug clinical trial protocols and supporting materials on the Drug Evaluation Center website.

　　Article 27 For approved drug clinical trials, if the drug intends to add indications (or functional main treatments) or add combination use with other drugs, applicants shall submit new drug clinical trial applications and may only conduct new drug clinical trials after approval.

　　For approved marketed drugs, if adding indications (or functional main treatments) requires conducting drug clinical trials, new drug clinical trial applications shall be submitted.

　　Article 28 Sponsors shall regularly submit safety update reports during the research and development period on the Drug Evaluation Center website. Safety update reports during the research and development period shall be submitted once a year, within two months after each full year following the approval of the drug clinical trial. The Drug Evaluation Center may require sponsors to adjust the reporting cycle based on review circumstances.

　　For suspected and unexpected serious adverse reactions and other potential serious safety risk information occurring during drug clinical trials, the sponsor shall report to the Center for Drug Evaluation in a timely manner according to relevant requirements. Depending on the severity of the safety risk, the sponsor may be required to take measures to strengthen risk control by adjusting the drug clinical trial protocol, informed consent form, investigator's brochure, etc. If necessary, the sponsor may be required to suspend or terminate the drug clinical trial.

　　The specific requirements for safety update reports during the research and development period shall be formulated and published by the Center for Drug Evaluation.

　　Article 29 During the drug clinical trial, if there are changes to the drug clinical trial protocol, non-clinical or pharmaceutical changes, or new findings, the sponsor shall fully assess the impact on the safety of subjects in accordance with regulations and relevant technical guidelines.

　　If the sponsor's assessment concludes that there is no impact on the safety of subjects, the changes may be implemented directly and reported in the safety update report during the research and development period. If the changes may increase the safety risk to subjects, a supplementary application shall be submitted. The supplementary application shall be decided within sixty days from the date of acceptance, and the approval result shall be notified to the applicant through the Center for Drug Evaluation's website; if no notification is given after the deadline, it shall be deemed approved.

　　If the sponsor changes, the changed sponsor shall bear the relevant responsibilities and obligations of the drug clinical trial.

　　Article 30 During the drug clinical trial, if safety issues or other risks are found, the sponsor shall promptly adjust the clinical trial protocol, suspend or terminate the clinical trial, and report to the Center for Drug Evaluation.

　　In any of the following circumstances, the sponsor may be required to adjust the drug clinical trial protocol, suspend or terminate the drug clinical trial:

　　(1) The ethics committee fails to perform its duties;

　　(2) Unable to effectively ensure the safety of subjects;

　　(3) The sponsor fails to submit safety update reports during the research and development period as required;

　　(4) The sponsor fails to promptly handle and report suspected and unexpected serious adverse reactions;

　　(5) There is evidence proving the investigational drug is ineffective;

　　(6) Quality problems occur with the clinical trial drug;

　　(7) Fraud occurs during the drug clinical trial process;

　　(8) Other violations of drug clinical trial quality management standards.

　　If widespread, unexpected serious adverse reactions occur during the drug clinical trial, or there is evidence proving serious quality problems with the clinical trial drug, the sponsor and the drug clinical trial institution shall immediately stop the drug clinical trial. The drug regulatory authority may, according to its duties, order adjustments to the clinical trial protocol, suspension, or termination of the drug clinical trial.

　　Article 31 After a drug clinical trial is ordered to be suspended, if the sponsor intends to continue the drug clinical trial, a supplementary application for resuming the drug clinical trial shall be submitted after completing rectification. The drug clinical trial may continue only after review and approval. If the drug clinical trial suspension lasts for three years without application and approval for resumption, the drug clinical trial license shall automatically become invalid.

　　After the drug clinical trial is terminated, if the sponsor intends to continue the drug clinical trial, a new drug clinical trial application shall be submitted.

　　Article 32 Drug clinical trials shall be conducted within three years after approval. If no subject signs the informed consent form within three years from the date of approval of the drug clinical trial application, the drug clinical trial license shall automatically become invalid. If the drug clinical trial still needs to be conducted, a new application shall be submitted.

　　Article 33 The sponsor shall register the drug clinical trial protocol and other information on the drug clinical trial registration and information disclosure 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 trial ends. The registration information shall be disclosed 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 disclosure shall be formulated and published by the Center for Drug Evaluation.

　　Section 2 Drug Marketing Authorization

　　Article 34 After completing research supporting drug marketing registration such as pharmaceutical, pharmacological toxicology, and drug clinical trials, determining quality standards, completing commercial-scale production process validation, and preparing for drug registration inspection, the applicant shall submit a drug marketing authorization application and submit relevant research data according to the application requirements. After formal review of the application materials, if the requirements are met, the application shall be accepted.

　　Article 35 For generic drugs, in vitro diagnostic reagents managed as drugs, and other eligible cases, if the applicant assesses that drug clinical trials are unnecessary or cannot be conducted and meets the conditions for exemption from drug clinical trials, the applicant may directly submit a drug marketing authorization application. The technical guidelines and specific requirements for exemption from drug clinical trials shall be formulated and published by the Center for Drug Evaluation.

　　Generic drugs shall be consistent with the reference preparations in quality and efficacy. The applicant shall select reasonable reference preparations with reference to relevant technical guidelines.

　　Article 36 If any of the following conditions are met, a non-prescription drug marketing authorization application may be submitted directly:

　　(1) A non-prescription drug with the same active ingredient, indication (or main function), dosage form, and specification is already marketed domestically;

　　(2) A non-prescription drug whose dosage form or specification has been changed as determined by the National Medical Products Administration, but without changing the indication (or main function), dosage, or route of administration;

　　(3) A new compound preparation using active ingredients of non-prescription drugs as determined by the National Medical Products Administration;

　　(4) Other situations where a non-prescription drug marketing authorization application is directly submitted.

　　Article 37 If the proposed drug generic name for the application is not included in the national drug standards or drug registration standards, the applicant shall submit a generic name approval application simultaneously when submitting the drug marketing authorization application. After acceptance of the drug marketing authorization application, the generic name approval related materials shall be transferred to the Pharmacopoeia Commission, and after approval, feedback shall be given to the Center for Drug Evaluation.

　　If the proposed drug generic name for the application is included in the national drug standards or drug registration standards, and the Center for Drug Evaluation deems it necessary to approve the drug generic name during the review process, it shall notify the Pharmacopoeia Commission to approve the generic name and provide relevant materials. After approval, feedback shall be given to the Center for Drug Evaluation.

　　When the Pharmacopoeia Committee approves the generic name of a drug, it should communicate well with the applicant and inform the applicant of the approval result.

　　Article 38: The Drug Evaluation Center shall organize pharmacists, medical personnel, and other technical staff to review the accepted drug marketing authorization applications as required.

　　During the review process, if drug registration verification and inspection are initiated based on risk, the relevant technical institutions shall complete the verification and inspection within the prescribed time limit.

　　The Drug Evaluation Center shall conduct a comprehensive review of the drug's safety, efficacy, and quality controllability based on the drug registration application materials, verification results, inspection results, etc. For over-the-counter drugs, the review shall also be forwarded to the Drug Evaluation Center for suitability review of over-the-counter drugs.

　　Article 39: If the comprehensive review conclusion is approved, the drug shall be approved for marketing and a drug registration certificate shall be issued. If the comprehensive review conclusion is not approved, a decision of disapproval shall be made. The drug registration certificate shall specify the drug approval number, holder, manufacturer, and other information. For over-the-counter drugs, the drug registration certificate shall also indicate the category of the over-the-counter drug.

　　The approved drug production process, quality standards, instructions, and labels shall be issued to the applicant as attachments to the drug registration certificate. If necessary, post-marketing study requirements shall also be attached. The above information shall be included in the drug variety file and updated in a timely manner according to post-marketing changes.

　　After the drug is approved for marketing, the holder shall produce the drug according to the production process and quality standards approved by the National Medical Products Administration and refine and implement according to the requirements of the Good Manufacturing Practice for Drugs.

　　Article 40: During the review period of the drug marketing authorization application, if major changes occur that may affect the drug's safety, efficacy, and quality controllability, the applicant shall withdraw the original registration application, supplement the research, and reapply.

　　Changes in the applicant's name, registered address, and other changes not involving technical review content shall be promptly notified in writing to the Drug Evaluation Center and relevant supporting documents shall be submitted.

　　Section 3 Related Review and Approval

　　Article 41: When reviewing drug formulation registration applications, the Drug Evaluation Center shall conduct related reviews on the chemical raw materials, excipients, and packaging materials and containers that directly contact the drug used in the drug formulation.

　　Manufacturers of chemical raw materials, excipients, and packaging materials and containers that directly contact drugs shall register product information and research data on the registration platform for chemical raw materials, excipients, and packaging materials and containers according to the related review and approval system requirements. The Drug Evaluation Center shall publicly disclose basic information such as registration number, product name, company name, and production address to the public for drug formulation registration applicants to choose from.

　　Article 42: Drug formulation applicants may directly select registered chemical raw materials, excipients, and packaging materials and containers that directly contact drugs when submitting drug registration applications; if unregistered chemical raw materials, excipients, and packaging materials and containers that directly contact drugs are selected, relevant research data shall be submitted together with the drug formulation registration application.

　　Article 43: When reviewing drug formulation registration applications, the Drug Evaluation Center shall conduct related reviews on the chemical raw materials, excipients, and packaging materials and containers that directly contact drugs used in the drug formulation. If supplementary materials are required, the drug formulation applicant or the registration enterprise of the chemical raw materials, excipients, and packaging materials and containers shall supplement the materials according to the supplementary materials procedure requirements. Based on risk, extended inspections may be proposed for the enterprises of chemical raw materials, excipients, and packaging materials and containers that directly contact drugs.

　　For generic drugs using chemical raw materials of domestically marketed drugs, separate review and approval may be applied for.

　　Article 44: For chemical raw materials, excipients, and packaging materials and containers that directly contact drugs that pass related review and approval or separate review and approval, the Drug Evaluation Center shall update the registration status on the registration platform for chemical raw materials, excipients, and packaging materials and containers and publicly disclose relevant information. Among them, chemical raw materials shall be issued a chemical raw material approval notice along with the approved production process, quality standards, and labels. The chemical raw material approval notice shall specify the registration number; if not approved, a chemical raw material disapproval notice shall be issued.

　　For those that do not pass related review and approval, the registration status of chemical raw materials, excipients, and packaging materials and containers shall remain unchanged, and the related drug formulation applications shall not be approved.

　　Section 4 Drug Registration Verification

　　Article 45: Drug registration verification refers to verification activities conducted on the research and production sites to verify the authenticity and consistency of the submitted materials and the commercial production conditions of the drug, checking the compliance of drug development, data reliability, etc., and, when necessary, extended inspections on the manufacturers, suppliers, or other entrusted institutions of chemical raw materials, excipients, and packaging materials and containers involved in the drug registration application.

　　The principles, procedures, time limits, and requirements for initiating drug registration verification shall be formulated and published by the Drug Evaluation Center; the principles, procedures, time limits, and requirements for implementing drug registration verification shall be formulated and published by the Drug Verification Center.

　　Article 46: The Drug Evaluation Center shall decide whether to conduct on-site drug registration research verification based on the degree of drug innovation, previous verification status of the drug research institution, and other risk-based factors.

　　When the Drug Evaluation Center decides to initiate on-site drug registration research verification, it shall notify the Drug Verification Center to organize the verification during the review period and inform the applicant. The Drug Verification Center shall complete the on-site verification within the prescribed time limit and feedback the verification status, conclusions, and related materials to the Drug Evaluation Center for comprehensive review.

　　Article 47: The Drug Evaluation Center shall decide whether to initiate on-site drug registration production verification based on the registered variety, process, facilities, previous verification status, and other risk-based factors.

　　For innovative drugs, improved new drugs, and biological products, on-site drug registration production verification and pre-marketing Good Manufacturing Practice inspections shall be conducted.

　　For generic drugs, based on whether the corresponding drug production license for the production scope has been obtained and whether the same dosage form variety has been marketed, risk-based drug registration production verification and pre-marketing Good Manufacturing Practice inspections shall be conducted.

　　Article 48: After accepting the drug registration application, the Drug Evaluation Center shall conduct a preliminary review within 40 days of acceptance. If on-site drug registration production verification is required, the Drug Verification Center shall be notified to organize the verification, provide relevant materials needed for verification, and inform the applicant as well as the drug regulatory authorities of the applicant or manufacturer’s province, autonomous region, or municipality. In principle, the Drug Verification Center shall complete the verification work 40 days before the review deadline and feedback the verification status, results, and related materials to the Drug Evaluation Center.

　　For pre-market Good Manufacturing Practice (GMP) inspections of drugs, the Drug Verification Center coordinates with the drug supervision and administration departments of relevant provinces, autonomous regions, and municipalities directly under the central government to conduct on-site verification simultaneously with drug registration production inspections. The management requirements for pre-market GMP inspections shall be implemented in accordance with the relevant provisions of the Drug Production Supervision and Administration Measures.

　　Applicants shall accept the verification within the prescribed time limit.

　　Article 49: During the review process, if the Drug Evaluation Center finds doubts about the authenticity of the submitted materials or receives clear clues or reports, and on-site inspection and verification are needed, a cause-based inspection shall be initiated, and sampling inspection shall be conducted if necessary.

　　Article 50: When applying for drug marketing authorization, the applicant and the manufacturing enterprise shall have obtained the corresponding drug manufacturing license.

　　Section 5 Drug Registration Inspection

　　Article 51: Drug registration inspection includes standard re-verification and sample inspection. Standard re-verification refers to laboratory evaluation of the scientific validity of the items set in the drug standards declared by the applicant, the feasibility of the testing methods, and the rationality of quality control indicators. Sample inspection refers to laboratory testing of samples according to the drug quality standards declared by the applicant or determined by the Drug Evaluation Center.

　　The principles, procedures, time limits, and other requirements for initiating drug registration inspection shall be organized, formulated, and published by the Drug Evaluation Center. The specific work procedures and requirements for drug registration inspection and the technical requirements and standards for drug registration inspection proposed before the acceptance of drug registration applications shall be formulated and published by the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 52: If the inspection items and methods used for the same variety of drugs included in the national drug standards are consistent, standard re-verification may be waived, and only sample inspection is required. In other cases, both standard re-verification and sample inspection shall be conducted.

　　Article 53: The National Institute for the Control of Pharmaceutical and Biological Products or drug inspection institutions designated by the National Medical Products Administration shall undertake the following drug registration inspections:

　　(1) Innovative drugs;

　　(2) Improved new drugs (excluding traditional Chinese medicine);

　　(3) Biological products, radioactive drugs, and in vitro diagnostic reagents managed as drugs;

　　(4) Other drugs stipulated by the National Medical Products Administration.

　　Drug registration inspection for drugs produced overseas shall be organized and implemented by the National Institute for the Control of Pharmaceutical and Biological Products through port drug inspection institutions.

　　Registration inspection for other drugs shall be undertaken by the provincial drug inspection institutions where the applicant or manufacturing enterprise is located.

　　Article 54: After the applicant completes pharmaceutical-related research supporting drug marketing, determines quality standards, and completes commercial-scale production process validation, they may apply for drug registration inspection to the National Institute for the Control of Pharmaceutical and Biological Products or the drug supervision and administration departments of provinces, autonomous regions, or municipalities directly under the central government before the acceptance of the drug registration application; if the applicant does not apply for drug registration inspection before acceptance, the Drug Evaluation Center shall initiate drug registration inspection within 40 days after acceptance. In principle, the applicant may only apply once for drug registration inspection before acceptance and shall not apply to multiple drug inspection institutions simultaneously.

The drug registration inspection materials submitted by the applicant shall be consistent with the corresponding content of the drug registration application materials, and changes to the drug inspection institution, samples, or materials during the drug registration inspection process are not allowed.

　　Article 55: For registration applications of domestically produced drugs, if the applicant applies for drug registration inspection before acceptance, they shall apply for sampling to the drug supervision and administration departments of relevant provinces, autonomous regions, or municipalities directly under the central government. These departments shall organize sampling and sealing, and the applicant shall deliver the sampling form, samples, inspection materials, and reference substances to the corresponding drug inspection institution.

　　For registration applications of drugs produced overseas, if the applicant applies for drug registration inspection before acceptance, the applicant shall sample according to regulations and deliver the samples, inspection materials, and reference substances to the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 56: For registration applications of domestically produced drugs, if drug registration inspection is required after acceptance, the Drug Evaluation Center shall issue a drug registration inspection notice to the drug inspection institution and the applicant within 40 days after acceptance. The applicant shall apply for sampling to the drug supervision and administration departments of relevant provinces, autonomous regions, or municipalities directly under the central government, which shall organize sampling and sealing. The applicant shall deliver the sampling form, samples, inspection materials, and reference substances to the corresponding drug inspection institution within the prescribed time limit.

　　For registration applications of drugs produced overseas, if drug registration inspection is required after acceptance, the applicant shall sample according to regulations and deliver the samples, inspection materials, and reference substances to the National Institute for the Control of Pharmaceutical and Biological Products.

　　Article 57: The drug inspection institution shall review the samples and materials submitted by the applicant within five days, decide whether to accept them, and notify the Drug Evaluation Center. If corrections are needed, the applicant shall be informed once.

　　In principle, the drug inspection institution shall provide the standard re-verification opinions and inspection reports to the Drug Evaluation Center 40 days before the review deadline.

　　Article 58: During drug evaluation and verification, if doubts about the authenticity of the submitted materials arise, or clear clues or reports are received, or if sample inspection is deemed necessary, samples may be taken for inspection.

　　During the review process, the Drug Evaluation Center may propose re-verification of individual quality standards based on risk.

Chapter 4   Accelerated Drug Marketing Registration Procedures

　　Section 1 Breakthrough Therapy Drug Procedure

　　Article 59: During clinical trials, innovative drugs or improved new drugs used to prevent or treat diseases that seriously threaten life or severely affect quality of life, and for which there are no effective prevention or treatment methods or sufficient evidence shows significant clinical advantages compared to existing treatments, may apply for the breakthrough therapy drug procedure.

　　Article 60: To apply for the breakthrough therapy drug procedure, the applicant shall submit an application to the Drug Evaluation Center. If the conditions are met, the Drug Evaluation Center shall publicly announce and include the drug in the breakthrough therapy drug procedure.

　　Article 61: For clinical trials included in the breakthrough therapy drug procedure, the following policy supports are provided:

　　(1) The applicant may apply for communication with the Drug Evaluation Center at key stages of clinical trials, and the Drug Evaluation Center shall arrange reviewers for communication;

　　(2) The applicant may submit interim research data to the Drug Evaluation Center, which shall provide opinions or suggestions on the next research plan based on existing data and feedback to the applicant.

　　Article 62: For drugs included in the breakthrough therapy drug program clinical trials, if the applicant finds that the inclusion criteria are no longer met, they shall promptly apply to the Drug Evaluation Center to terminate the breakthrough therapy drug program. If the Drug Evaluation Center finds that the inclusion criteria are no longer met, it shall promptly terminate the breakthrough therapy drug program for the drug and notify the applicant.

　　Section 2: Conditional Approval Procedure

　　Article 63: During drug clinical trials, drugs meeting the following conditions may apply for conditional approval:

　　(1) Drugs for treating diseases that seriously threaten life and have no effective treatment methods, with clinical trial data confirming efficacy and predicting clinical value;

　　(2) Drugs urgently needed for public health, with clinical trial data showing efficacy and predicting clinical value;

　　(3) Vaccines urgently needed to respond to major public health emergencies or other vaccines recognized as urgently needed by the National Health Commission, with benefits assessed to outweigh risks.

　　Article 64: For applying for conditional approval, the applicant shall communicate with the Drug Evaluation Center regarding the conditions for conditional approval and the research work to be continued after marketing. After confirmation through communication, the applicant shall submit the drug marketing authorization application.

　　Upon review, if the conditional approval requirements are met, the drug registration certificate shall specify the validity period of the conditional approval, the research work to be continued after marketing, completion deadlines, and other related matters.

　　Article 65: During the review process, if it is found that the drug registration application included in the conditional approval procedure does not meet the conditional approval conditions, the Drug Evaluation Center shall terminate the conditional approval procedure for the drug and notify the applicant to apply through the normal procedure.

　　Article 66: For conditionally approved drugs, the holder shall take corresponding risk management measures after the drug is marketed and complete relevant studies such as clinical trials within the prescribed time as required, and apply through a supplementary application.

　　For vaccines approved with further research requirements, the vaccine holder shall complete the research within the prescribed time.

　　Article 67: For conditionally approved drugs, if the holder fails to complete the research as required within the time limit or cannot prove that the benefits outweigh the risks, the National Medical Products Administration shall handle it according to law, up to and including revoking the drug registration certificate.

　　Section 3: Priority Review and Approval Procedure

　　Article 68: When applying for drug marketing authorization, drugs with obvious clinical value may apply for priority review and approval procedures:

　　(1) Clinically urgently needed shortage drugs, 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 pediatric drugs that meet children's physiological characteristics;

　　(3) Vaccines urgently needed for disease prevention and control and innovative vaccines;

　　(4) Drugs included in the breakthrough therapy drug program;

　　(5) Drugs meeting the conditional approval criteria;

　　(6) Other circumstances for priority review and approval as stipulated by the National Medical Products Administration.

　　Article 69: Before submitting a drug marketing authorization application, the applicant shall communicate with the Drug Evaluation Center. After confirmation through communication, the applicant shall submit the priority review and approval application to the Drug Evaluation Center simultaneously with the drug marketing authorization application. If conditions are met, the Drug Evaluation Center shall publicize according to procedures and include the drug in the priority review and approval procedure.

　　Article 70: For drug marketing authorization applications included in the priority review and approval procedure, the following policy supports are provided:

　　(1) The review period for drug marketing authorization applications is 130 days;

　　(2) For clinically urgently needed rare disease drugs already marketed abroad but not yet marketed domestically, the review period is 70 days;

　　(3) Priority arrangement is given for the verification, inspection, and approval of drug generic names;

　　(4) After confirmation through communication, supplementary technical data may be submitted.

　　Article 71: During the review process, if it is found that the drug registration application included in the priority review and approval procedure does not meet the priority review and approval conditions, the Drug Evaluation Center shall terminate the priority review and approval procedure for the drug, review it according to the normal procedure, and notify the applicant.

　　Section 4: Special Approval Procedure

　　Article 72: When threatened by or after the occurrence of a public health emergency, the National Medical Products Administration may lawfully decide to implement special approval for emergency prevention and treatment drugs needed for the public health emergency.

　　Article 73: For drug registration applications under special approval, the National Medical Products Administration shall organize accelerated and simultaneous acceptance, review, verification, and inspection of drug registration according to the principles of unified command, early intervention, rapid efficiency, and scientific approval. The circumstances, procedures, time limits, and requirements for special approval shall be implemented according to the special drug approval procedures.

　　Article 74: For drugs included in the special approval procedure, their use may be limited within a certain period and scope according to specific needs for disease prevention and control.

　　Article 75: For drugs included in the special approval procedure, if it is found that they no longer meet the inclusion criteria, the special approval procedure for the drug shall be terminated and the applicant notified.

Chapter 5   Post-Marketing Changes and Re-Registration of Drugs

　　Section 1: Post-Marketing Research and Changes of Drugs

　　Article 76: The holder shall proactively conduct post-marketing research on the drug to further confirm the safety, efficacy, and quality controllability of the drug, and strengthen continuous management of marketed drugs.

　　If the drug registration certificate and its attachments require the holder to conduct related research work after marketing, the holder shall complete it within the prescribed time and submit supplementary applications, filings, or reports as required.

　　After drug approval and marketing, the holder shall continuously conduct safety and efficacy studies, timely file or submit supplementary applications for label revisions based on relevant data, and continuously update and improve the label and packaging. The drug regulatory authority may, according to its duties and based on adverse drug reaction monitoring and post-marketing evaluation results, require the holder to revise the label and packaging.

　　Article 77 Changes after drug marketing shall be managed by classification according to the risk and impact on drug safety, efficacy, and quality controllability, divided into approval changes, filing changes, and reporting changes.

　　The holder shall, in accordance with relevant regulations and referring to relevant technical guidelines, comprehensively assess and verify the impact of the changes on drug safety, efficacy, and quality controllability, and conduct corresponding research work.

　　The technical guidelines for post-marketing drug change research shall be formulated by the Drug Evaluation Center and announced to the public.

　　Article 78 For the following changes, the holder shall submit a supplementary application and implement after approval:

　　(1) Major changes in the drug production process;

　　(2) Changes involving efficacy content in the drug instructions and other content that increases safety risks;

　　(3) Transfer of the drug marketing authorization by the holder;

　　(4) Other changes requiring approval as stipulated by the National Medical Products Administration.

　　Article 79 For the following changes, the holder shall file with the provincial, autonomous region, or municipality drug supervision department before implementation:

　　(1) Moderate changes in the drug production process;

　　(2) Changes in drug packaging label content;

　　(3) Drug repackaging;

　　(4) Other changes requiring filing as stipulated by the National Medical Products Administration.

　　For drugs produced overseas undergoing the above changes, filing shall be made with the Drug Evaluation Center before implementation.

　　The procedures and requirements for drug repackaging filing shall be formulated and issued by the Drug Evaluation Center.

　　Article 80 For the following changes, the holder shall report in the annual report:

　　(1) Minor changes in the drug production process;

　　(2) Other changes requiring reporting as stipulated by the National Medical Products Administration.

　　Article 81 Supplementary applications submitted after drug marketing that require verification and inspection shall be handled in accordance with the relevant drug registration verification and inspection procedures of this method.

　　Section 2 Drug Re-registration

　　Article 82 The holder shall apply for re-registration six months before the expiration of the drug registration certificate. Applications for re-registration of domestically produced drugs shall be submitted by the holder to the drug supervision department of the province, autonomous region, or municipality where they are located; applications for re-registration of overseas produced drugs shall be submitted to the Drug Evaluation Center by the holder.

　　Article 83 After accepting the drug re-registration application, the provincial, autonomous region, or municipality drug supervision department or the Drug Evaluation Center shall review the holder's post-marketing evaluation and adverse reaction monitoring, the implementation of related work according to the drug approval documents and drug supervision department requirements, and changes in information stated in the drug approval documents. If compliant, re-registration shall be granted and a drug re-registration approval notice issued. If not compliant, re-registration shall be denied and the drug registration certificate shall be revoked upon request to the National Medical Products Administration.

　　Article 84 Re-registration shall be denied under any of the following circumstances:

　　(1) Failure to apply for re-registration before the expiration of validity;

　　(2) The holder cannot fulfill the responsibility of continuous monitoring of drug quality, efficacy, and adverse reactions during the validity period of the drug registration certificate;

　　(3) Failure to complete the research work required by the drug approval documents and drug supervision department within the prescribed time limit without reasonable cause;

　　(4) Post-marketing evaluation shows uncertain efficacy, significant adverse reactions, or other reasons harmful to human health;

　　(5) Other circumstances stipulated by laws and administrative regulations where re-registration is not granted.

　　For drugs denied re-registration, the drug registration certificate shall be revoked upon expiration.

Chapter 6   Acceptance, Withdrawal of Application, Approval Decision, and Dispute Resolution

　　Article 85 After receiving a drug registration application, the drug supervision department shall conduct a formal review and decide whether to accept the application based on the following situations:

　　(1) If the application matter does not require administrative licensing according to law, a decision of non-acceptance shall be made immediately with reasons explained.

　　(2) If the application matter is not within the department's authority according to law, a decision of non-acceptance shall be made immediately and the applicant informed to apply to the relevant administrative authority.

　　(3) If there are errors in the application materials that can be corrected on the spot, the applicant shall be allowed to correct them immediately; if the corrected materials are complete and comply with legal form, the application shall be accepted.

　　(4) If the application materials are incomplete or do not comply with legal form, the applicant shall be informed on the spot or within five days of all required corrections. If materials need to be returned at the time of notification, they shall be returned. The applicant shall complete the corrections within thirty days. If the applicant fails to correct without valid reason, it shall be deemed as abandonment of the application without a non-acceptance decision. If the applicant is not notified of corrections within the time limit, the application shall be deemed accepted from the date of receipt of the materials.

　　(5) If the application matter is within the department's authority, and the materials are complete and comply with legal form, or the applicant submits all required supplementary materials as requested, the drug registration application shall be accepted.

　　After acceptance of the drug registration application, if fees are required, the applicant shall pay according to regulations. If the applicant fails to pay within the prescribed time, the drug registration review and approval shall be terminated.

　　Article 86 After acceptance of the drug registration application, if new drug safety findings arise, the applicant shall promptly report and supplement relevant materials.

　　Article 87 After acceptance of the drug registration application, if the applicant needs to supplement new technical data based on the original application materials, the Drug Evaluation Center shall, in principle, request supplementary data once, listing all issues and notifying the applicant in writing to submit the supplementary materials within eighty days. The applicant shall submit all supplementary materials at once as required. The time for supplementary materials shall not be included in the drug evaluation time limit. After receiving all supplementary materials, the Drug Evaluation Center shall start the evaluation, extending the evaluation time by one-third; for priority review and approval procedures, the evaluation time is extended by one-quarter.

　　If the applicant does not need to supplement new technical data but only needs to provide explanations for the original application materials, the Drug Evaluation Center shall notify the applicant to submit the relevant explanations within five days as required.

　　If the Drug Evaluation Center finds substantial defects that cannot be remedied, it will no longer require the applicant to supplement materials. A decision of disapproval will be made based on the existing application materials.

　　Article 88: During the review of drug clinical trial applications and supplementary applications during drug clinical trials, no new technical data may be added; if new research is needed, the applicant may withdraw and resubmit the application.

　　Article 89: After acceptance of a drug registration application, the applicant may request withdrawal. Upon agreeing to the withdrawal, the Drug Evaluation Center or the provincial, autonomous region, or municipality drug regulatory department shall terminate the registration process and notify the drug registration verification, inspection, and other technical institutions. If during review, verification, or inspection, illegal acts such as concealing the truth or providing false information are suspected, they shall be handled according to law, and the applicant may not withdraw the drug registration application.

　　Article 90: During drug registration, if the review conclusion is disapproval, the Drug Evaluation Center shall inform the applicant of the reasons for disapproval. The applicant may raise objections to the Drug Evaluation Center within fifteen days. The Drug Evaluation Center shall conduct a comprehensive evaluation considering the applicant's objections and provide feedback.

　　If the applicant still has objections to the comprehensive evaluation results, the Drug Evaluation Center shall organize an expert advisory committee for demonstration within fifty days as prescribed and form the final review conclusion based on the expert demonstration results.

　　The time for applicant objections and expert demonstrations shall not be included in the review time limit.

　　Article 91: During drug registration, if the applicant believes that staff have violated regulations or behaved improperly in drug registration acceptance, review, verification, inspection, approval, etc., they may file complaints or reports to their unit or higher authorities.

　　Article 92: Drug registration applications that meet legal requirements shall be approved.

　　Drug registration applications shall not be approved under any of the following circumstances:

　　(1) The research data for the drug clinical trial application is insufficient to support conducting the trial or cannot ensure the safety of subjects;

　　(2) The submitted materials show significant defects in the safety, efficacy, or quality controllability of the applied drug;

　　(3) The submitted materials cannot prove the safety, efficacy, or quality controllability of the drug, or evaluation considers the drug's risks outweigh the benefits;

　　(4) The applicant fails to supplement materials within the prescribed time limit;

　　(5) The applicant refuses or without valid reason fails to accept drug registration verification or inspection within the prescribed time limit;

　　(6) During drug registration, if the submitted materials are deemed untruthful and the applicant cannot prove their authenticity;

　　(7) The results of on-site drug registration verification or sample inspection do not meet regulations;

　　(8) Other circumstances where approval is not allowed as stipulated by laws and regulations.

　　Article 93: After the drug registration application approval is completed, if the applicant has objections to the administrative licensing decision, they may file for administrative reconsideration or administrative litigation according to law.

Chapter 7   Work Time Limits

　　Article 94: The time limits stipulated in these measures are the maximum durations for acceptance, review, verification, inspection, approval, and other drug registration work. Time limits related to priority review and approval procedures shall be implemented according to relevant priority review and approval regulations.

　　The Drug Evaluation Center and other professional technical institutions shall clarify their work procedures and time limits and make them public.

　　Article 95: After receiving a drug registration application, the drug regulatory department shall conduct a formal review and make a decision on acceptance, correction, or non-acceptance within five days.

　　Article 96: The time limits for drug registration review shall be implemented as follows:

　　(1) The review and approval time limit for drug clinical trial applications and supplementary applications during clinical trials is sixty days;

　　(2) The review time limit for drug marketing authorization applications is two hundred days, of which the priority review and approval procedure time limit is one hundred thirty days, and the priority review and approval procedure for clinically urgently needed rare disease drugs already marketed abroad is seventy days;

　　(3) The review time limit for standalone applications for generic chemical raw materials already marketed domestically is two hundred days;

　　(4) The review time limit for supplementary applications for approval-type changes is sixty days; if the supplementary application combines multiple items, the review time limit is eighty days, and if it involves clinical trial data review or drug registration verification and inspection, the review time limit is two hundred days;

　　(5) The approval time limit for drug generic names is thirty days;

　　(6) The suitability review time limit for over-the-counter drugs is thirty days.

　　The review time limit for related reviews shall be consistent with the review time limit of the related drug formulation.

　　Article 97: The time limits for drug registration verification shall be implemented as follows:

　　(1) The Drug Evaluation Center shall notify the Drug Verification Center to initiate verification within forty days after accepting the drug registration application and simultaneously notify the applicant;

　　(2) The Drug Verification Center shall, in principle, complete the on-site drug registration production verification forty days before the review time limit expires and provide verification status, results, and related materials to the Drug Evaluation Center.

　　Article 98: The time limits for drug registration inspection shall be implemented as follows:

　　(1) The sample inspection time limit is sixty days; if sample inspection and standard re-verification are conducted simultaneously, the time limit is ninety days;

　　(2) The time limit for supplementing materials during drug registration inspection is thirty days;

　　(3) The drug inspection institution shall, in principle, complete related drug registration inspection work forty days before the review time limit expires and provide drug standard re-verification opinions and inspection reports to the Drug Evaluation Center.

　　Article 99: The review and approval time limit for drug re-registration is one hundred twenty days.

　　Article 100: Administrative approval decisions shall be made within twenty days.

　　Article 101: The drug regulatory department shall issue and deliver the relevant administrative license documents within ten days from the date of making the drug registration approval decision.

　　Article 102: When special circumstances arise due to the characteristics of the variety and the work of review, verification, inspection, etc., and it is necessary to extend the time limit, the extension shall not exceed half of the original time limit. After approval by the head of the relevant technical institution for drug review, verification, inspection, etc., the technical institution extending the time limit shall notify the applicant in writing and inform other relevant technical institutions.

　　Article 103: The following times shall not be included in the relevant work time limits:

　　(1) The time occupied by the applicant supplementing materials, rectifying after verification, and verifying production processes, quality standards, and instructions as required;

　　(2) The time delayed due to the applicant's reasons for verification, inspection, convening expert consultation meetings, etc.;

　　(3) The time occupied during the suspension of the review and approval procedure in accordance with laws and regulations;

　　(4) The time occupied by initiating overseas verification;

Chapter 8   Supervision and Administration

　　Article 104: The National Medical Products Administration is responsible for the supervision, assessment, evaluation, and guidance of the drug review center and other related professional technical institutions, as well as the drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government that undertake drug registration management-related work.

　　Article 105: Drug supervision and administration departments shall supervise and inspect drug research and development activities in accordance with laws and regulations. When necessary, they may extend inspections to units and individuals providing products or services for drug research and development. Relevant units and individuals shall cooperate and shall not refuse or conceal information.

　　Article 106: The Information Center is responsible for establishing drug variety archives, implementing coding management of drugs, collecting information on drug registration applications, safety-related reports during clinical trials, review, verification, inspection, approval, as well as approval, filing, and reporting of post-marketing changes, and continuously updating this information. The relevant systems for drug variety archives and coding management shall be formulated and published by the Information Center.

　　Article 107: The drug supervision and administration departments of provinces, autonomous regions, and municipalities directly under the central government shall organize routine supervision and inspection of drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc., within their jurisdictions to ensure compliance with the Good Laboratory Practice for Non-clinical Laboratory Studies and Good Clinical Practice for Clinical Trials. The National Medical Products Administration shall conduct supervision and inspection of such research institutions as needed.

　　Article 108: The National Medical Products Administration establishes a drug safety credit management system. The Drug Verification Center is responsible for establishing drug safety credit files for drug non-clinical safety evaluation research institutions and drug clinical trial institutions, recording license issuance, routine supervision and inspection results, violations, and other situations, publicly disclosing them according to law, and updating them in a timely manner. Drug supervision and administration departments shall increase the frequency of supervision and inspection for those with poor credit records and may implement joint disciplinary actions according to national regulations. The relevant systems for drug safety credit files of drug non-clinical safety evaluation research institutions and drug clinical trial institutions shall be formulated and published by the Drug Verification Center.

　　Article 109: The National Medical Products Administration shall publicly disclose the list of drug registration approval matters, legal basis, approval requirements, and processing time limits to the public, disclose the progress of drug registration to applicants, publicly disclose the review conclusions and basis of approved marketed drugs, as well as illegal and irregular acts found during supervision and inspection, and accept public supervision.

　　The instructions for approved marketed drugs shall be publicly disclosed and updated in a timely manner. Among them, vaccines shall also disclose label content and update it promptly.

　　Without the applicant's consent, drug supervision and administration departments, professional technical institutions and their staff, and personnel involved in expert review shall not disclose the applicant's submitted trade secrets, undisclosed information, or confidential business information, except as otherwise provided by law or involving national security or major social public interests.

　　Article 110: The National Medical Products Administration shall cancel the drug registration certificate and announce it in the following circumstances:

　　(1) The holder voluntarily requests the cancellation of the drug registration certificate;

　　(2) Re-registration is not granted according to these measures;

　　(3) The holder's drug registration certificate, drug production license, and other administrative licenses are legally revoked or canceled;

　　(4) According to Article 83 of the Drug Administration Law, the drug is ineffective, has significant adverse reactions, or endangers human health for other reasons;

　　(5) According to Article 61 of the Vaccine Administration Law, after post-marketing evaluation, the vaccine causes severe abnormal vaccination reactions or endangers human health for other reasons;

　　(6) According to Article 62 of the Vaccine Administration Law, after post-marketing evaluation, the vaccine's product design, production process, safety, efficacy, or quality controllability is significantly inferior to other vaccines preventing and controlling the same disease;

　　(7) Violating laws and administrative regulations, failing to complete corresponding research work within the prescribed time limit as required by the drug approval documents or drug supervision and administration departments without reasonable cause;

　　(8) Other circumstances where the drug registration certificate shall be canceled according to law.

Chapter 9   Legal Liability

　　Article 111: During the drug registration process, providing false certificates, data, materials, samples, or using other means to fraudulently obtain clinical trial permits or drug registration permits shall be handled in accordance with Article 123 of the Drug Administration Law.

　　Article 112: Providing false data, materials, samples, or other deceptive acts in applying for vaccine clinical trials or registration shall be handled in accordance with Article 81 of the Vaccine Administration Law.

　　Article 113: During the drug registration process, drug non-clinical safety evaluation research institutions, drug clinical trial institutions, etc., that fail to comply with the Good Laboratory Practice for Non-clinical Laboratory Studies, Good Clinical Practice for Clinical Trials, and other regulations shall be handled in accordance with Article 126 of the Drug Administration Law.

　　Article 114: Conducting drug clinical trials without approval shall be handled in accordance with Article 125 of the Drug Administration Law; conducting bioequivalence trials without filing shall be handled in accordance with Article 127 of the Drug Administration Law.

　　Article 115: During drug clinical trials, if safety issues or other risks are found and the clinical trial sponsor fails to timely adjust the clinical trial protocol, suspend or terminate the clinical trial, or fails to report to the National Medical Products Administration, it shall be handled in accordance with Article 127 of the Drug Administration Law.

　　Article 116: Violating the provisions of Articles 28 and 33 of these measures, if the sponsor has any of the following circumstances, they shall be ordered to make corrections within a time limit; if they fail to correct within the time limit, a fine of not less than 10,000 yuan but not more than 30,000 yuan shall be imposed:

　　(1) Failure to register on the Drug Clinical Trial Registration and Information Disclosure Platform as required before conducting drug clinical trials;

　　(2) Failure to submit safety update reports during the research and development period as required;

　　(3) Failure to register clinical trial results and other information after the completion of drug clinical trials.

　　Article 117: If a drug testing institution issues a false test report while undertaking testing work required for drug registration, it shall be dealt with in accordance with Article 138 of the Drug Administration Law.

　　Article 118: Approving drug clinical trials that do not meet the conditions or issuing drug registration certificates for drugs that do not meet the conditions shall be handled in accordance with Article 147 of the Drug Administration Law.

　　Article 119: If the drug supervision and administration department and its staff have illegal or irregular conduct during the drug registration management process, they shall be dealt with according to relevant laws and regulations.

Chapter 10   Appendix   Provisions

　　Article 120: For registration applications of narcotic drugs, psychotropic drugs, toxic medical drugs, radioactive drugs, precursor chemicals for drugs, and other drugs subject to special management regulations, in addition to handling according to the provisions of these Measures, they shall also comply with other relevant national regulations.

　　Article 121: The standards for exported vaccines shall comply with the standards of the importing country (region) or contractual requirements.

　　Article 122: For drug-device combination products intended for registration, if similar products have been classified as drugs by attribute determination, they shall be declared as drugs; if not yet classified by attribute, the applicant shall apply to the National Medical Products Administration for product attribute determination before registration. If the attribute is determined to be mainly drugs, registration shall be conducted according to the procedures stipulated in these Measures. Research data related to the medical device part shall be reviewed by the Medical Device Technical Review Center of the National Medical Products Administration, and then transferred to the Drug Review Center for comprehensive review.

　　Article 123: The format of the drug approval number for domestically produced drugs is: National Medicine Standard H (Z, S) + four-digit year + four-digit serial number. The format for drugs produced in Hong Kong, Macau, and Taiwan regions is: National Medicine Standard H (Z, S) C + four-digit year + four-digit serial number.

　　The format for drug approval numbers for drugs produced overseas is: National Medicine Standard H (Z, S) J + four-digit year + four-digit serial number.

　　Where H represents chemical drugs, Z represents traditional Chinese medicine, and S represents biological products.

　　The drug approval number shall not change due to changes in registration matters after marketing.

　　For traditional Chinese medicine, other provisions shall apply.

　　Article 124: Electronic documents of drug registration approval certificates and active pharmaceutical ingredient approval documents produced by the drug supervision and administration department have the same legal effect as paper documents.

　　Article 125: The time limits stipulated in these Measures are calculated in working days.

　　Article 126: These Measures shall come into force on July 1, 2020. The "Drug Registration Management Measures" promulgated by the former State Food and Drug Administration Order No. 28 on July 10, 2007, shall be repealed simultaneously.