Newly Revised “Provisions for Drug Registration”

Chapter I General Provisions

Article 1 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 Regulations for the Implementation of the Drug Administration Law of the People's Republic of China and other laws and administrative regulations in order to standardize drug registration activities and ensure the safety, effectiveness and quality control of drugs.

Article 2 These Measures shall apply to drug research, registration and supervision and management activities 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 drug registration applicant (hereinafter referred to as the applicant) submits applications for drug clinical trials, drug marketing authorization, re-registration and supplementary applications in accordance with legal procedures and relevant requirements, and the drug supervision and management department conducts safety, effectiveness and quality controllability reviews based on laws and regulations and existing scientific knowledge, and decides whether to approve its application.

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

Article 4 Drug registration shall be classified and registered according to traditional Chinese medicine, chemical medicine and biological products.

The registration of traditional Chinese medicines is classified according to innovative Chinese medicines, improved new Chinese medicines, traditional Chinese medicine compound preparations with ancient classic prescriptions, and medicines with the same name and prescription, etc.

The registration of chemical medicines is classified according to innovative chemical medicines, improved new chemical medicines, and generic drugs, etc.

The registration of biological products is classified according to innovative biological products, improved new biological products, and marketed biological products (including biosimilars), etc.

The detailed classification of Chinese medicines, chemical medicines, and biological products and the corresponding application dossier requirements shall be organized and formulated by the State Food and Drug Administration based on the product characteristics, degree of innovation, and review and management needs of the registered drugs, and announced to the public.

The registration application for drugs produced overseas shall be implemented in accordance with the detailed classification of drugs and the corresponding application dossier requirements.

Article 5 The State Food and Drug Administration is responsible for the national drug registration management work, and is responsible for establishing a drug registration management work system and system, formulating drug registration management specifications, and organizing drug registration review and approval and related supervision and management work in accordance with the law. The Drug Evaluation Center of the State Drug Administration (hereinafter referred to as the Drug Evaluation Center) is responsible for the review of drug clinical trial applications, drug marketing authorization applications, supplementary applications, and re-registration applications for overseas-produced drugs. The China Food and Drug Inspection Institute (hereinafter referred to as the China Inspection Institute), the State Pharmacopoeia Committee (hereinafter referred to as the Pharmacopoeia Committee), the Food and Drug Review and Inspection Center of the State Drug Administration (hereinafter referred to as the Drug Verification 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, and 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, generic name approval, verification, monitoring and evaluation, certificate delivery, and corresponding information construction and management required for the implementation of drug registration management in accordance with the law.

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

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

(II) Management of filing and reporting of changes after drug marketing;

(III) Organizing routine supervision of drug non-clinical safety evaluation research institutions and drug clinical trial institutions and investigating and handling illegal acts;

(IV) Participating in drug registration verification and testing organized by the State Drug Administration;

(V) Drug registration-related matters entrusted by the State Drug Administration.

The drug professional and technical institutions established or designated by the drug regulatory authorities of provinces, autonomous regions and municipalities directly under the Central Government shall undertake the review, testing, verification, monitoring and evaluation work required for the implementation of drug supervision and management in accordance with the law.

Article 7 Drug registration management shall follow the principles of openness, fairness and justice, be guided by clinical value, encourage the research and creation of new drugs, and actively promote the development of generic drugs.

The State Drug Administration continues to promote the reform of the review and approval system, optimize the review and approval procedures, improve the review and approval efficiency, 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 activities shall comply with relevant laws, regulations, rules, standards and specifications; refer to relevant technical guidelines, and use other evaluation methods and technologies, and prove their scientificity and applicability; the whole process information shall be true, accurate, complete and traceable.

Drugs shall comply with national drug standards and drug quality standards approved by the State Drug Administration. The drug quality standards approved by the State Drug Administration are drug registration standards. Drug registration standards 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 test 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.

Professional and technical institutions such as the Drug Evaluation Center shall formulate technical guidance principles and procedures based on scientific progress, actual industry development and the needs of drug supervision and management, and publish them to the public.

Article 9 Applicants shall be enterprises or drug research and development institutions that can bear corresponding legal responsibilities. Foreign applicants shall designate corporate legal persons in China to handle relevant drug registration matters.

Article 10 Before applying for drug registration, applicants shall complete relevant research work such as pharmacy, pharmacology and toxicology, and drug clinical trials. Non-clinical drug safety evaluation research shall be conducted in institutions that have been certified for the quality management standards for non-clinical drug research, and comply with the quality management standards for non-clinical drug research. Drug clinical trials shall be approved, and bioequivalence tests shall be filed; drug clinical trials shall be conducted in drug clinical trial institutions that meet relevant regulations and comply with the quality management standards for drug clinical trials.

When applying for drug registration, true, sufficient and reliable data, information and samples shall be provided to prove the safety, effectiveness and quality controllability of the drug.

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 Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use and the relevant requirements of drug registration management in my country.

Article 11 Where the matters or contents stated in the original drug registration approval document and its annexes are changed, the applicant shall, in accordance with the provisions and with reference to the relevant technical guidelines, fully study and verify the drug changes, fully assess the possible impact of the changes on the safety, efficacy and quality controllability of the drug, and submit supplementary applications, filings or reports in accordance with the change procedures.

Article 12 The validity period of a drug registration certificate is five years. During the validity period of a drug registration certificate, the holder shall continue to 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 State Drug Administration establishes a drug registration system to accelerate the listing of drugs and 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 the drug development and registration process, the drug supervision and administration departments and their professional technical institutions shall provide necessary technical guidance, communication, priority allocation of resources, shortening of review time limits and other policy and technical support.

Article 14 The State Drug Administration shall establish a system for the joint review and approval of chemical APIs, excipients and packaging materials and containers that directly contact drugs. When approving drug preparations, chemical APIs shall be reviewed and approved together, and related excipients, packaging materials and containers that directly contact drugs shall be reviewed together. The Drug Review Center shall establish an information registration platform for chemical APIs, excipients and packaging materials and containers that directly contact drugs, publicize relevant registration information for selection by relevant applicants or holders, and conduct joint review during the review of relevant drug preparation registration applications.

Article 15 Prescription drugs and over-the-counter drugs shall be subject to classified registration and conversion management. Based on the characteristics of over-the-counter drugs, the Drug Review Center shall formulate relevant technical guidance principles and procedures for the registration of over-the-counter drugs and announce them to the public. The Drug Evaluation Center shall formulate relevant technical requirements and procedures for the conversion of prescription drugs and over-the-counter drugs after they are marketed and announce them to the public.

Article 16 Applicants may communicate with professional and technical institutions such as the Drug Review Center 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, professional and technical institutions such as the Drug Review Center may organize communication with applicants according to work needs.

The procedures, requirements and time limits for communication shall be formulated by professional and technical institutions such as the Drug Review Center in accordance with their functions and announced to the public.

Article 17 Professional and technical institutions such as the Drug Review Center shall establish an expert consultation system and an expert consultation committee according to work needs, listen to expert opinions on major issues during the review, verification, inspection, and generic name approval process, and give full play to the technical support role of experts.

Article 18 The State Drug Administration shall establish a catalog of chemical drugs that are newly approved for marketing and have passed the quality and efficacy consistency evaluation of generic drugs, and shall include relevant information such as drug name, active ingredient, dosage form, specification, whether it is a reference preparation, and holder, and shall be updated in a timely manner and made public. The procedures and requirements for the collection of chemical drug catalogs shall be formulated by the Drug Review Center and announced to the public.

Article 19 The State Drug Administration supports the inheritance and innovation of traditional Chinese medicine, establishes and improves the registration management system and technical evaluation system that conforms to the characteristics of traditional Chinese medicine, encourages the use of modern science and technology and traditional research methods to develop traditional Chinese medicine, strengthens the quality control of traditional Chinese medicine, and improves the level of clinical trials of traditional Chinese medicine.

For the registration application of traditional Chinese medicine, the applicant shall conduct clinical value and resource evaluation, highlight the clinical value orientation, and promote the sustainable use of resources.

Chapter III Drug Registration

Section 1 Drug Clinical Trials

Article 20 The drug clinical trials referred to in these Measures refer to drug research conducted on humans for the purpose of drug registration to determine the safety and effectiveness of drugs.

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 the characteristics of the drug and the purpose of the research, the research content includes clinical pharmacology research, exploratory clinical trials, confirmatory clinical trials and post-marketing research.

Article 22 Drug clinical trials shall be conducted in drug clinical trial institutions that meet the corresponding conditions and are registered in accordance with regulations. Among them, vaccine clinical trials shall be implemented or organized by tertiary medical institutions or provincial-level or higher disease prevention and control institutions that meet the conditions stipulated by the National Medical Products Administration and the National Health Commission.

Article 23 After the applicant completes the pharmaceutical, pharmacological and toxicological research to support the drug clinical trial, if the applicant submits an application for drug clinical trial, the applicant shall submit relevant research materials in accordance with the application materials requirements. After formal review, if the application materials meet the requirements, they shall be accepted. The Drug Review Center shall organize pharmacy, medicine and other technical personnel to review the accepted drug clinical trial applications. The application for drug clinical trial shall be decided within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Drug Review Center; if no notification is made after the deadline, it shall be deemed to be approved, and the applicant may conduct drug clinical trials in accordance with the submitted plan.

The applicant who is approved to conduct drug clinical trials is the drug clinical trial sponsor (hereinafter referred to as the sponsor).

Article 24 If the applicant intends to conduct a bioequivalence test, he shall complete the bioequivalence test filing on the website of the Drug Review Center as required, and carry out relevant research work in accordance with the filed plan.

Article 25 Conducting a clinical trial of a drug shall be subject to the review and approval of the ethics committee.

The management of drugs used in drug clinical trials shall comply with the relevant requirements of the quality management standards for drug clinical trials.

Article 26 Where a drug clinical trial is approved, the sponsor shall formulate a corresponding drug clinical trial plan before conducting subsequent phased drug clinical trials, conduct the clinical trial after review and approval by the ethics committee, and submit the corresponding drug clinical trial plan and supporting materials on the website of the Center for Drug Evaluation.

Article 27 Where a drug approved for clinical trials intends to add indications (or functional indications) or add combination therapy with other drugs, the applicant shall submit a new drug clinical trial application, and may only conduct a new drug clinical trial after approval.

Where a drug approved for marketing needs to conduct a drug clinical trial for an additional indication (or functional indication), a new drug clinical trial application shall be submitted.

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

For suspicious and unexpected serious adverse reactions and other potential serious safety risk information that occur during drug clinical trials, the sponsor shall report to the Drug Review Center in a timely manner in accordance with relevant requirements. According to the severity of the safety risk, the sponsor may be required to take measures to strengthen risk control such as adjusting the drug clinical trial plan, informed consent form, and investigator's manual. If necessary, the sponsor may be required to suspend or terminate the drug clinical trial.

The specific requirements for safety update reports during research and development shall be formulated and announced by the Drug Review Center.

Article 29 During the clinical trial of a drug, if there is a change in the drug clinical trial plan, non-clinical or pharmaceutical changes, or new discoveries, the sponsor shall, in accordance with the regulations, refer to the relevant technical guidelines, and fully evaluate the impact on the safety of the subjects.

If the sponsor assesses that it does not affect the safety of the subjects, it can be directly implemented and reported in the safety update report during research and development. If it may increase the safety risk of the subjects, a supplementary application shall be submitted. The decision on whether to approve the supplementary application shall be made within 60 days from the date of acceptance, and the applicant shall be notified of the approval result through the website of the Drug Review Center; if no notification is made after the deadline, it shall be deemed to be approved.

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

Article 30 If safety problems or other risks are found during the drug clinical trial, the sponsor shall promptly adjust the clinical trial plan, suspend or terminate the clinical trial, and report to the Drug Review Center.

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

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

(II)Failure to effectively ensure the safety of the subjects;

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

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

(V) There is evidence that the research drug is ineffective;

(VI) There are quality problems with the drugs used in clinical trials;

(VII) Fraud in the process of drug clinical trials;

(VIII) Other circumstances that violate the quality management regulations for drug clinical trials.

When a large-scale, unexpected serious adverse reaction occurs in a drug clinical trial, or there is evidence that the drug used in the clinical trial has serious quality problems, the sponsor and the drug clinical trial institution shall immediately stop the drug clinical trial. The drug supervision and administration department may order the adjustment of the clinical trial plan, suspension or termination of the drug clinical trial in accordance with its duties.

Article 31 After the drug clinical trial is ordered to be suspended, if the sponsor intends to continue the drug clinical trial, it shall submit a supplementary application for resumption of the drug clinical trial after completing the rectification, and may continue the drug clinical trial only after review and approval. If the suspension of a drug clinical trial reaches three years and no application for and approval to resume the drug clinical trial is obtained, the drug clinical trial license shall automatically become invalid.

After the termination of the drug clinical trial, if the drug clinical trial is to be continued, a new drug clinical trial application shall be submitted.

Article 32 Drug clinical trials shall be implemented 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 is still required, a new application shall be made.

Article 33 The sponsor shall register the drug clinical trial plan 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 drug clinical trial is completed. 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 disclosure shall be formulated and announced by the Drug Review Center.

Section 2 Drug Marketing Authorization

Article 34 After completing the pharmaceutical, pharmacology and toxicology and drug clinical trials supporting drug registration, determining the quality standards, completing the commercial-scale production process validation, and preparing for drug registration verification and inspection, the applicant shall apply for drug marketing authorization and submit relevant research materials in accordance with the application materials requirements. After a formal review of the application materials, if they meet the requirements, they will be accepted.

Article 35 For generic drugs, in vitro diagnostic reagents managed as drugs, and other eligible situations, if the applicant evaluates that it is unnecessary or impossible to conduct drug clinical trials and meets the conditions for exemption of drug clinical trials, the applicant may directly apply for drug marketing authorization. The technical guidelines and relevant specific requirements for exemption of drug clinical trials shall be formulated and announced by the Drug Review Center.

Generic drugs shall be consistent with the quality and efficacy of reference preparations. Applicants shall select reasonable reference preparations in accordance with relevant technical guidelines.

Article 36 An application for OTC marketing authorization may be directly submitted if any of the following circumstances are met:

(I) An OTC drug with the same active ingredient, indication (or function), dosage form, or specification is already on the market in the country;

(II) An OTC drug determined by the State Drug Administration that changes its dosage form or specification but does not change its indication (or function), dosage, or route of administration;

(III) A new compound preparation composed of the active ingredients of an OTC drug determined by the State Drug Administration;

(IV) Other circumstances where an OTC marketing authorization is directly applied for.

Article 37 If the generic name of the drug to be applied for is not included in the national drug standard or drug registration standard, the applicant shall submit an application for generic name approval at the same time as submitting the application for drug marketing authorization. After the application for drug marketing authorization is accepted, the relevant information on generic name approval shall be transferred to the Pharmacopoeia Commission, which shall be fed back to the Drug Review Center after approval.

If the generic name of the drug to be applied for has been included in the national drug standards or drug registration standards, and the Drug Review Center believes that the generic name of the drug needs to be approved during the review process, it shall notify the Pharmacopoeia Commission to approve the generic name and provide relevant information. The Pharmacopoeia Commission shall provide feedback to the Drug Review Center after approval.

When approving the generic name of the drug, the Pharmacopoeia Commission shall communicate with the applicant and inform the applicant of the approval result.

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

During the review process, drug registration verification and inspection shall be initiated based on risks, and relevant technical institutions shall complete the verification and inspection work within the prescribed time limit.

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

Article 39 If the comprehensive review conclusion 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, a decision of non-approval shall be made. The drug registration certificate shall contain information such as the drug approval number, holder, and manufacturer. The drug registration certificate for over-the-counter drugs shall also indicate the category of over-the-counter drugs.

The approved drug production process, quality standards, instructions and labels shall be sent to the applicant as an attachment to the drug registration certificate, and if necessary, the requirements for post-marketing research of the drug shall also be attached. The above information shall be included in the drug variety file and updated in a timely manner according to the changes after marketing.

After the drug is approved for marketing, the holder shall produce the drug in accordance with the production process and quality standards approved by the State Drug Administration, and shall be refined and implemented in accordance with the requirements of the drug production quality management specification.

Article 40 During the review of the drug marketing authorization application, if there is a major change that may affect the safety, effectiveness and quality controllability of the drug, the applicant shall withdraw the original registration application and re-apply after additional research.

If the applicant's name change, registered address name change, etc. do not involve the content of technical review, the applicant shall promptly notify the Drug Review Center in writing and submit relevant supporting materials.

Section 3 Related Review and Approval

Article 41 When reviewing the registration application for drug preparations, the Drug Review Center shall conduct a related review of the chemical raw materials, excipients, and packaging materials and containers that are in direct contact with drugs used in drug preparations.

The manufacturers of chemical raw materials, excipients, and packaging materials and containers that are in direct contact with drugs shall register product information and research materials on the registration platform for chemical raw materials, excipients, and packaging materials and containers that are in direct contact with drugs in accordance with the requirements of the related review and approval system. The Drug Review Center shall publicize the registration number, product name, company name, production address and other basic information to the public for drug preparation registration applicants to choose.

Article 42 When a drug preparation applicant submits a drug registration application, he or she may directly select the registered chemical raw materials, excipients, and packaging materials and containers that are in direct contact with drugs; if he or she selects unregistered chemical raw materials, excipients, and packaging materials and containers that are in direct contact with drugs, the relevant research materials shall be submitted together with the drug preparation registration application.

Article 43 When reviewing the registration application for drug preparations, the Drug Review Center shall conduct a joint review of the chemical raw materials, excipients, and packaging materials and containers that directly contact drugs used in drug preparations. If additional information is required, the Drug Review Center shall require the drug preparation applicant or the chemical raw materials, excipients, and packaging materials and containers that directly contact drugs to supplement the information in accordance with the supplementary information procedure. Based on the risk, it may propose an extended inspection of the chemical raw materials, excipients, and packaging materials and containers that directly contact drugs.

For the chemical raw materials used in drugs that have been marketed in China, a separate review and approval may be applied for.

Article 44 If the chemical raw materials, excipients, and packaging materials and containers that directly contact drugs have passed the joint review or the separate review and approval, the Drug Review Center shall update the registration status mark on the registration platform for chemical raw materials, excipients, and packaging materials and containers that directly contact drugs, and publicize the relevant information to the public. Among them, chemical raw materials are issued with a chemical raw material approval notice and the approved production process, quality standards and labels at the same time, and the registration number is stated in the chemical raw material approval notice; if it is not approved, a chemical raw material disapproval notice is issued.

If the related review and approval is not passed, the registration status of chemical raw materials, excipients and packaging materials and containers that directly contact drugs will remain unchanged, and the relevant drug preparation application will not be approved.

Section 4 Drug Registration Verification

Article 45 Drug registration verification refers to the verification activities carried out on the development site and production site to verify the authenticity and consistency of the application materials and the conditions for the commercial production of drugs on the market, to check the compliance of drug development and data reliability, etc., and, when necessary, to the extended inspection activities carried out on the chemical raw materials, excipients and packaging materials and containers that directly contact drugs involved in the drug registration application. Manufacturers, suppliers or other entrusted institutions.

The principles, procedures, time limits and requirements for the initiation of drug registration verification shall be formulated and announced by the Drug Review Center; the principles, procedures, time limits and requirements for the implementation of drug registration verification shall be formulated and announced by the Drug Verification Center.

Article 46 The Drug Review Center decides whether to conduct on-site verification of drug registration and development based on risk, according to the degree of drug innovation, the previous verification of drug research institutions, etc.

If the Drug Review Center decides to initiate on-site verification of drug registration and development, it shall notify the Drug Review Center to organize and implement the verification during the review period and inform the applicant at the same time. The Drug Review Center shall complete the on-site verification within the prescribed time limit and feedback the verification situation, verification conclusion and other relevant materials to the Drug Review Center for comprehensive review.

Article 47 The Drug Review Center decides whether to initiate on-site verification of drug registration and production based on risk, according to factors such as the varieties, processes, facilities, and previous verifications applied for registration.

For innovative drugs, improved new drugs, and biological products, on-site verification of drug registration and production and pre-market drug production quality management standard inspections shall be conducted.

For generic drugs, on-site verification of drug registration and production and pre-market drug production quality management standard inspections shall be conducted based on risk, according to whether the drug production license for the corresponding production scope has been obtained and the same dosage form has been marketed.

Article 48 After the drug registration application is accepted, the Drug Review Center shall conduct a preliminary review within 40 days after acceptance. If a drug registration production site inspection is required, the Drug Review Center shall be notified to organize the inspection and provide the relevant materials required for the inspection. At the same time, the applicant and the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government where the applicant or the manufacturer is located shall be informed. In principle, the Drug Review Center shall complete the inspection work 40 days before the expiration of the review period, and feedback the inspection situation, inspection results and other relevant materials to the Drug Review Center.

If a pre-market drug production quality management standard inspection is required, the Drug Review Center shall coordinate the relevant provincial, autonomous region, and municipal drug supervision and administration departments to implement it simultaneously with the drug registration production site inspection. The management requirements for pre-market drug production quality management standard inspection shall be implemented in accordance with the relevant provisions of the Drug Production Supervision and Administration Measures.

The applicant shall accept the inspection within the prescribed time limit.

Article 49 If the Drug Review Center finds that the authenticity of the application materials is in doubt or there are clear clues and reports during the review process, and an on-site inspection and verification is required, it shall initiate a cause-based inspection and conduct sampling inspection if necessary.

Article 50 When applying for a drug marketing authorization, 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 scientific nature of the items set in the drug standards declared by the applicant, the feasibility of the inspection methods, the rationality of the quality control indicators, etc. Sample inspection refers to the laboratory inspection of samples in accordance with the drug quality standards declared by the applicant or approved by the Drug Review Center.

The principles, procedures, time limits and other requirements for the initiation of drug registration inspection shall be formulated and announced by the Drug Review Center. The specific work procedures and requirements for drug registration inspection proposed before the acceptance of drug registration applications, as well as the technical requirements and specifications for drug registration inspection, shall be formulated and announced by the China National Institute for Drug Control.

Article 52 If the inspection items and inspection methods are consistent with those used for the same type of drugs included in the national drug standards, standard review may not be conducted, and only sample inspection shall be conducted. Standard review and sample inspection shall be conducted in other cases.

Article 53 The National Institute for Drug Control or the drug inspection agency designated by the State Drug Administration shall undertake the following drug registration inspections:

(I) Innovative drugs;

(II) Improved new drugs (except traditional Chinese medicines);

(III) Biological products, radioactive drugs and in vitro diagnostic reagents managed in accordance with drugs;

(IV) Other drugs specified by the State Drug Administration.

The drug registration inspection of drugs produced overseas shall be implemented by the port drug inspection agency organized by the National Institute for Drug Control.

The registration inspection of other drugs shall be undertaken by the provincial drug inspection agency where the applicant or the manufacturer is located.

Article 54 After the applicant completes the pharmaceutical-related research supporting the drug's marketing, determines the quality standards, and completes the commercial-scale production process verification, he may apply for drug registration inspection to the National Institute for Drug Control or the drug supervision and administration department of the province, autonomous region, or municipality directly under the Central Government before the drug registration application is accepted; if the applicant fails to apply for drug registration inspection before the drug registration application is accepted, the Drug Review Center shall initiate drug registration inspection within 40 days after the drug registration application is accepted. In principle, the applicant can only apply for drug registration inspection once before the drug registration application is accepted, and shall not apply for drug registration inspection to multiple drug inspection institutions at the same time.

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

Article 55 For the registration application of domestically produced drugs, if the applicant applies for drug registration inspection before the drug registration application is accepted, he shall apply for sampling to the relevant provincial, autonomous regional and municipal drug supervision and administration departments, and the provincial, autonomous regional and municipal drug supervision and administration departments shall organize the sampling and seal it, and the applicant shall send the sampling form, samples, materials required for inspection and standard substances to the corresponding drug inspection institution.

For the registration application of drugs produced abroad, if the applicant applies for drug registration inspection before the drug registration application is accepted, the applicant shall take samples according to the regulations and send the samples, materials required for inspection and standard substances to the China National Institute for Inspection and Quarantine.

Article 56 For the registration application of domestically produced drugs, if the drug registration inspection is required after the drug registration application is accepted, the Drug Review Center shall issue a drug registration inspection notice to the drug inspection agency and the applicant within 40 days after acceptance. The applicant shall apply to the drug supervision and administration department of the relevant province, autonomous region, or municipality directly under the Central Government for sampling.

The drug supervision and administration department of the municipality directly under the Central Government shall organize sampling and seal the application. The applicant shall send the sampling form, samples, materials required for inspection and standard substances to the corresponding drug inspection agency within the prescribed time limit.

For registration applications for drugs produced overseas, if drug registration inspection is required after the application is accepted, the applicant shall take samples according to the prescribed requirements and send the samples, materials required for inspection and standard substances to the China National Institute for Drug Control.

Article 57 The drug inspection agency shall review the samples and materials for inspection submitted by the applicant within five days, make a decision on whether to accept them, and inform the Drug Review Center at the same time. If corrections are required, the applicant shall be informed at one time.

In principle, the drug inspection agency shall feedback the standard review opinion and inspection report to the Drug Review Center forty days before the expiration of the review period.

Article 58 During the review and verification of drugs, if it is found that the authenticity of the application materials is in doubt or there are clear clues reported, or if it is considered necessary to conduct sample inspection, samples may be taken for sample inspection.

During the review process, the Drug Review Center may propose a single review of quality standards based on risks.

Specific news link: Newly revised "Drug Registration Management Measures"