《药品注册管理办法》英文版，来啦！

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Provisi** of Drug Registration

（The measure of Drug Registration is approved by State Administration for Market Regulation in Order No.27 on January 22，2020）

Chapter 1：General Principles

Article 1：For the purposes of standardizing drug regulation behaviors and ensuring the safety，effectiveness and quality control of the drugs, the provisi** is enacted according to 《The Drug Administration Law of People’s Republic of China》（hereinafter called“ The Drug Administration”），《Law of the people’s Republic of China on Traditional Chinese Medicine》，《Vaccine Administration Law of the People’s Republic of China》（hereinafter called “Vaccine Administration Law”），《Law of the People’s Republic of China on Administrative Permission》，《Regulati** for Implementation of the Drug Administration》and other laws and administrative regulati**.

Article 2: The provisi** is applicable to the activities of drug research，registration and supervision and administration for the purposes of launching the drug within the territory of the People’s Republic of China.

Article 3: Drug Registration refers to the applicants of Drug Registration（hereinafter called “Applicant”）submitting the files of drug clinical trials，drug marketing authorization，re-registration and supplementary applicati** according to the legal procedures and related requirements. The administration decides whether to approve such the application according to review the safety, effectiveness and quality control based on laws and regulati** and existing scientific cognition.

The applicant is Marketing Authorization Holder（hereinafter called “MAH”）after achieving the marketed drug license.

Article 4：Drug registration is divided into Traditional Chinese Medicine，Chemical Medicine and Biological products for classified management

Traditional Chinese medicine registration is classified according to innovative traditional Chinese medicine, Modified traditional Chinese Medicine, compound prei** of traditional Chinese medicine of ancient classical preion, same preion of same name。

Chemical drug registration is classified according to innovative chemical drugs，modified chemical drugs and generic drugs

The registration of Biological products is classified according to innovative biological products, modified biological products and marketed biological products（including Biosimilars）

Detailed classification and corresponding requirements of application files of Traditional Medicine，chemical drug and biological products will be organized and drafted and then be announced to public based on product features，degree of innovation，review management of the drug by National Medical Products Administration（NMPA）

The application of the drugs manufactured overseas should be executed according to the detailed classification and corresponding requirements of the application files

Article 5：National Medical Products Administration is in charge of national drug registration, resp**ible for establishing system and institution of drug registration, drafting standard of drug registration management, organizing the activities of evaluation and approval of drug registration and relevant supervision and administration in accordance of law. Center for Drug Evaluation (herein after called CDE), NMPA is resp**ible for evaluating the applicati** of drug clinical trials，drug marketing authorization, supplementary applicati** and re-registration of drugs manufactured overseas. National Institutes for Food and Drug Control(hereinafter called NIFDC),Chinese Pharmacopoeia Commission(hereinafter called CPC),Center for Food and Drug Inspection of NMPA(hereinafter called CFDI), Center for Drug Reevaluation, NMPA(hereinafter called CDR), Center for Administrative Affairs Acceptance and Complaint Reports, NMPA(hereinafter called NMPAAACR), Center for Information, NMPA(hereinafter called NMPAIC) and other professional and technical instituti** are in charge of promoting the implementation of drug quality control, approval of common name, inspection, monitoring and evaluation, system permit and certification, corresponding information c**truction and management, etc.

Article 6: Regulatory authorities of each province, autonomous region and province-level municipality are in charge of the following relevant activities of drug registration within respective administrative regi**, including:

(1) Accept，review and approve the re-registration of the domestic drugs.

(2) Manage filings of modificati** and reporting matters of post-marketing drugs

(3) Organize the daily surveillance and investigating and handing illegal acts of non-clinical drug safety evaluation research institute and clinical trial institution.

(4) Participate in the verification and inspection organized by NMPA

(5) Relevant affairs of drug registration entrusted by NMPA

Drug administration of each province, autonomous region and province-level municipality is resp**ible for the implementation of review，inspection，verification，monitoring and evaluation through the management of drug supervision with internally established institution or appointed drug professional and technical institution.

Article 7: Drug registration should comply with the principle of openness, fairness and equity. Take the clinical value as guide, encourage research and develop new drugs and actively promote the development of generic drug.

NMPA keeps expanding trials of comprehensive reforms in evaluation and approval system, optimize the procedures of evaluation and approval, raise the efficacy of evaluation and approval, take the evaluation as leading factor, provide inspection, verification, monitoring and evaluation as support for building the system.

Charpter2: Basic system and requirements

Article 8: Engaging in drug research and drug registration should comply with laws, regulati**, rules, regulatory documents, standards and specificati**. C**ulting relevant technical guidelines and using other evaluation method and techniques should be proved to be scientific and applicable. The information through the whole process should be guaranteed to be true, accurate, complete and traceable.

Drug should comply with the national drug standards and the drug quality standards authorized by NMPA. The drug quality standards approved by NMPA are called durg registration standards. Drug registration standards should fit in with general technical requirements in Pharmacopoeia of the People’s Republic of China which should not be less than the provision of the Pharmacopoeia. The applicant should provide sufficient supportive data when the inspection items or testing (detection) index do not apply to the Pharmacopoeia.

CDE and other professional technique instituti** should develop the principle of technical guidance and procedure on the basis of scientific development, industry development reality and requirements in drug supervision (administration).

Article 9: The applicant should be the enterprises to bear legal liability (resp**ibility) or the drug research institution. Foreign enterprise should appoint domestic business corporation to handle the drug registration items.

Article10: The applicant should finish the pharmaceutical research，pharmacology and toxicology study，drug clinical trials，etc. Applicant should carry out the non-clinical safety evaluation in the instituti** achieved certificate of Good Laboratory Practice (GLP) and comply with GLP. Drug clinical trials should be approved, among them bioequivalence test should set up a file. Applicant should carry out the drug clinical trials in the clinical trial institution in accordance with relevant regulation and comply with Good Clinical Practice (GCP).

True, sufficient and reliable data, materials and samples should be provided when applying drug registration for proving the safety, effectiveness and quality-control of the drug.

Article11: When using outside research materials and data for supporting drug registration, the source, research institution or laboratory conditi**, quality requirements and other management should be in line with generally accepted practices asked by International Conference on harmonization and meet the requirements by national drug registration When changing items or other contents in the former drug approval certificates and their attachments, applicant should carry out full（sufficient，plenitude） research and verification of the change，and then make a full assessment on the effects on safety，effectiveness and quality-control of the drug, what’s more， making supplementary application，record filings or report in line with variation procedure.

Article 12: Drug registration certificate is valid for 5 years，MAH should keep guaranteeing the safety，effectiveness and quality-control of the drug within their terms of validity and apply re-registration 6 months ago before the term of validity.

Article 13：NMPA establishes systems for accelerating the marketing registration to support clinical-value-oriented drug innovation. Applicant can apply for Breakthrough Therapy，Conditional Ratification（Approval），Priority Review and Special Examination and Approval of drugs which meets the requirement for drug registration. Through the research and registration, regulatory authorities and their professional and technical instituti** should give essential technical guidance，communication，priority resources，shorter review span（time） and other policy and technique support.

Article 14: NMPA establishes Associated Evaluation and Approval System of Chemical APIs, excipients, packaging materials and containers which come into direct contact with drugs. When reviewing the pharmaceutical preparati**，the chemical APIs should be reviewed at the same time along with associated excipients，packaging materials and containers which come into direct contact with drugs. CED establishes information registration platform of chemical APIs, excipients, packaging materials and containers which come into direct contact with drugs. The associated registration should be made public for applicant and MAH，and associated review and approval will be carried out in the registration of the pharmaceutical registration.

Article 15: Carry out classification registration and transformational management for Preion Drug and Non-preion (Over-the-counter，OTC) drug. CDE will establish the corresponding principle of technical guidance and procedure for marketing registration of OTC drugs according to the OTC drug characteristics and the make public. Drug evaluation center establishes corresponding technique requirements and procedure on transformation of preion drug and OTC drugs and make public.

Article 16：The applicant can communicate with CDE and other professional technical institute on important issues at any time，such as before applying for the clinical trials，during the clinical trials and before applying for the drug marketing authorization. CDE and other professional technical institutes can communicate with the applicant as what work demands.

CDE and other professional technical institutes ，according to their duties，establish the procedure，requirement and schedule of the communication respectively.

Article 17: CDE and other professional technical institutes introduce expert c**ulting system and establish expert advisory committee as what work demands. Giving full play to the role of technology supporting specialists, refer to expert advice on important issues during the process of review，verification，inspection and approval of common name.

Article 18: NMPA establish the catalogue of chemical medicines recording newly approved drugs and generic drugs which have passed quality and effectiveness c**istency evaluation. The catalogue record the drug name, API, dosage form, specificati**, whether reference preion or not, MAH and so forth, timely updated and made public. The CDE establishes the procedure and requirement of catalogue of chemical medicines and make public

Article19: NMPA supports the preservation and innovative development of traditional Chinese medicine（herein after called TCM），establish and improve the registration system and technique evaluation system combined with TCM, and encourage the use of modern scientific technology and traditional methods to research and develop TCM. Strengthen the quality control of TCM and improve the clinical trials of TCM.

Applicant should evaluate clinical value and resource when applying for registration of TCM, steering for clinical value and promote sustainable utilization of resources.

Chapter 3：Drug registration for approval

Section 1: Drug clinical trials

Article 20：The clinical trials mentioned in this law mean that the drug research is aimed to ascertain the safety and effectiveness in human body for the purpose of marketing registration.

Article 21：Clinical trials are divided into Phase I，Phase II，Phase III and Phase IV and bioequivalence trials. Research contents include pharmacological research, exploratory clinical trial, confirmatory clinical trial, post-marketing clinical study according to characteristics of the drug and purpose of the research.

Article 22: The clinical trials should be conducted in the clinical trial institutes satisfying corresponding conditi** and recorded according to regulati**. Among them, Vaccine clinical trials should be conducted or organized in the third-class hospital meeting the conditi** set by NMPA and National Health Commission or institute at or provincial level for Disease control and prevention.

Article 23：Applicant should submit relevant research materials according to the requirements of application dossiers for the application of clinical trials after finishing the pharmaceutical and pharmacological research which support the clinical trials. The application dossiers according with the requirements will be accepted after the verification of the forms. CDE should organize pharmaceutical，medical and other talents to review accepted clinical trial application, deciding whether they agree with the application of clinical trial within 60 days from the acceptance of the application and confirm with the applicant of the results of review in website of CDE. Failure to confirm shall be deemed to be an approval and the applicant can conduct clinical trials according to submitted proposal. The applicants who obtain permission to conduct clinical trials are called sp**or of the drug clinical trials (hereinafter called Sp**or).

Article 24: Applicant who is planning to conduct bioequivalence test should put on record(file) of bioequivalence in the website of CDE and conduct relevant research according to the file.

Article 25: To conduct drug clinical trials should be examined and approved by the Ethic Committee.

The drugs used in the drug clinical trial should comply with the Criteri** for the Quality Control of Clinical Trial of drugs.

Article 26: When approved of conducting drug clinical trials and before starting staged clinical trials，corresponding plan for drug clinical trials should be drawn up and conducted after approval of the Ethic Committee，in addition applicant should file relevant plan of clinical trials and supportive data in the website of CDE.

Article 27：The drugs which get the approval of conducting clinical trials are planning to develop new indication( or functi**) and combinati** with other drugs，the applicant should submit new application of drug clinical trials and conduct the new clinical trials after the approval.

The clinical trials need to be conducted when planning to develop new indicati** of the marketed drugs, and also the application of new clinical trial should be submitted.

Article 28: The sp**or should submit the regular safety updated report during the research on the website of CDE. The safety report should be submitted once a year during the research or within 2 months for every extra year after getting the clinical approval. CDE can ask sp**or to adjust reporting period.

Sp**or should report suspicious and unexpected serious adverse effects and other potential serous safety risk information to CDE according to the requirements in time. Based on the severity of safety risk, CDE can ask sp**ors to adjust clinical trial, informed c**ent and investigator’s brochure，etc. ,to strengthen the measures to control the risk. What’s more，CDE can ask sp**ors to suspend or terminate the drug clinical trial.

CDE is resp**ible for the the formulation and publication of detail requirement of the safety updated report during the research.

Article 29: Sp**ors should evaluate the effects on the safety of subject according to the regulati** and referring to corresponding technical guidelines when the change of clinical trial plan happen, non-clinical or pharmaceutical changes happen or other new findings appear.

Sp**or can implement the clinical trial directly and mention in the safety updated report during the research. The sp**ors should submit supplementary application if the risk of safety increases. CDE should decide whether they agree with the supplementary application within 60 days from the acceptance of application and inform the applicant on the website of CDE. Failure to confirm should be deemed to an approval.

The modified sp**or will bear the obligati** and resp**ibilities of drug clinical trials if the change of sp**ors happen.

Article 30：Sp**or should adjust clinical trial plan，suspend or terminate clinical trials and report to CDE when finding the safety probems or other risks during the clinical trial.

The sp**ors should be asked to adjust clinical trial, suspend or terminate clinical trials under any of the following circumstances:

(1) Ethic committee does not perform their duties.

(2) The safety of the subjects can’t be guaranteed.

(3) The sp**ors do not submit the safety updated report during the research.

(4) The sp**ors do not deal with and report the suspicious and unexpected serious adverse reaction.

(5) There is evidence that the drug is ineffective

(6) There are quality problems in clinical trial drugs

(7) There is some trickery during the drug clinical trials

(8) There are other situati** violating Criteri** for Quality Control of Clinical Trial of Drugs

When large-scale, unexpected serious adverse reacti** appears or there is proof that serious quality problems were found in the drugs used in the clinical trials, sp**ors and drug clinical institution should terminate the trials immediately. Medical products administrati** should demand to adjust clinical trial plans，suspend or terminate clinical trials.

Article 31: Sp**ors who are planning to continue to conduct clinical trials after the suspension should finish rectification and submit supplementary application for restoring clinical trials. The clinical trials can be restored after examination and approval. If the suspension times of the clinical trial exceed 3 years and the sp**ors do not submit and get approval of restore clinical trials, the permit of clinical trials expire voluntarily.

If the sp**ors plan to continue to conduct the clinical trials after the termination, they should submit clinical trial application again.

Article 32: Drug clinical trials should be conducted within 3 years after approval. If there are no subjects signing informed c**ent within 3 years after approval of clinical trial application，the permit of clinical trials expire voluntarily. The sp**ors should apply again if they want to continue the clinical trial.

Article 33: Sp**ors should register the information of clinical trial protocol on WWW.CHINADRUGTRIALS.ORG.CN before conducting the clinical trials. Sp**ors should continue to update registered information during the clinical trial and register results at the end of clinical trial. Sp**ors are resp**ible for the authenticity of registered information on the website.

The CDE is resp**ible for the formulation and publicity of detailed requirements of registered information and information publicity of clinical trials.

Section 2: Marketing Authorization

Article 34：Applicants can submit the application of marketing authorization and submit relevant research data according to requirements of application dossiers when they have finished the pharmaceutical and pharmacological research and drug clinical trials，identified quality specification，finished the verification of manufacture process in a commercial scale and prepared for the drug registration verification and inspection. If the application dossiers pass the formal examination，they will be accepted.

Article 35: The applicant can submit drug marketing authorization if the generic drugs, in vitro diagnostic reagents administered in the ways like drugs and other conditi** have been estimated without the need or accomplishment of clinical trials and comply with the conditi** of waiver of clinical trials. CDE is resp**ible for formulation and publicity of the technological guidance and detail requires for waiver of clinical trials.

Generic drugs should be c**istent with reference preparati** in quality and efficacy. The applicants should choose reasonable reference preparati** according to relevant technological guidance.

Article 36: The applicant can submit the application of over-the-counter drug marketing authorization under any of the following circumstances.

(1) The over-the-counter drugs with the same active ingredients, indicati**(or functi**), dosage forms and strength have been already marketed at home

(2) The over-the-counter drugs are identified with the change of dosage forms or strength but with the same indication (or function), dosage and administration by NMPA.

(3) The new compound preparation c**isted of the active ingredients in over-the-counter drugs identified by NMPA

(4) Including other conditi** that applying over-the-counter drugs directly.

Article 37: If the drug generic name intending to used in the drug registration which are not included in national drug standard or drug registration specification，the applicants should submit verification application of the generic name when submit the application of the marketing authorization. When the application of the marketing authorization is accepted, the relevant dossiers for verifying the generic name should be transferred to National Pharmacopeia Committee and the committee resp**es to CDE after verification

IF the generic name intending to be used in the drug registration has already been included in the national drug standard or drug registration specificati** but the generic name is c**idered to need verification drug the process of review by CDE，the pharmacopeia committee will be informed of verifying generic name and providing relevant dossiers and resp**es to CDE after verification.

The pharmacopeia should communicate with applicant when verifying the generic name and inform the applicant the verified results.

Article 38: CDE should organize pharmaceutical, medical and other technician to evaluate the accepted application of drug marketing authorization according to the requirements.

CDE will initiate the verification and inspection action based on risk during the evaluation and relevant technical institutes should finish the verification and inspection within the time limit.

CDE will give comprehensive evaluation on the safety, efficacy and quality control based on the drug registration, results of verification and inspection and etc. The over-the-counter drugs should be transferred to drug evaluation center for the verification of suitability of over-the-counter drugs.

Article 39: If the conclusion of the comprehensive review is unanimous，the drug marketing authorization will be approved and a drug registration certificate will be sent. If the conclusion is Not Passed, the decision Not Approved will be made. Drug registration certificate will record the Registered Document of Approval, holder, manufacturer and other information. The certificate of over-the-counter drugs should give clear indication of categories.

The manufacture process, quality specification, instruction and labels verified will be attachment to the drug registration certificate and sent to the applicant. The requirements of post-marketing research can be attached when necessary. The above information will be included in the files of the drug and updated immediately based on the change after marketing.

The MAH should manufacture drugs according to the verified manufacture process and quality specificati** by NMPA after the marketing authorization and refine and implement the acti** according to the requirements of Criteri** for Quality Control of Drug manufacturing。

Article 40: If some possible changes which may affect safety, effectiveness and quality control of drug happen during the review of application of marketing authorization, the applicant should recall the original application and conduct supplementary research and apply again.

If the name of the applicant and name of registration address change, or some things not included in the context of technology review change, the applicant should give CDE a written notification and provide relevant accountability information.

Section 3: Bundling Review and Approval

Article 41: Bundling review of chemical APIs, excipients and packaging materials and containers contacting directly with the drug will be made when CDE is reviewing the application of pharmaceutical compositi**.

The enterprises manufacturing chemical APIs，excipients，packaging materials and containers contacting directly with drugs should register the product information and research dossiers on the publicity system website for chemical APIs，excipients and packaging materials. CDE should make publicity the registered number，product names，enterprise names，production address and other basic information for applicant of pharmaceutical preparation to choose.

Article 42: The applicant of pharmaceutical preparation can choose registered chemical APIs, excipients, packaging materials and containers contacting directly with drug when applying for the drug registration. If choosing the chemical APIs, excipients, packaging materials and containers contacting directly with drug without registration, the relevant research data should be declared at the same time when sending registration application of pharmaceutical preparati**.

Article 43: CDE carries on bundling review of chemical APIs，excipients，packaging materials and containers contacting directly with the drug which chosen in the pharmaceutical preparati** when reviewing the application of pharmaceutical preparation. If supplementary data are needed, the applicant of pharmaceutical preparation or the enterprise of who manufacturing the chemical APIs, excipients and packaging materials and containers contacting directly with drug should submit supplementary data according to the requirements and procedures of supplementary dossiers. CDE can carry on extension inspection of enterprises of who manufacturing the chemical APIs, excipients and packaging materials and containers contacting directly with drugs based on risks.

Independent review and approval can be applied when imitating the chemical APIs used in launched drugs.

Article 44: When the chemical APIs, excipients, packaging materials and containers contacting directly with drugs pass the bundling review or independent review and approval, CDE should update registration status indicator on the website of registration platform of chemical API, excipients, packaging materials and containers contacting with drug, and make publicity the relevant information. Among them, notice of approval and verified manufacturing process, quality standard and label should be sent when the chemical APIs are approved，the notice of approval should record the registered number clearly. If not approved，notice of disapproval should be sent.

If bundling review and approval don’t pass，registration status of chemical APIs，excipients，packaging materials and containers will remain unchanged and relevant application pharmaceutical preparation will not be approved.

Section 4: Drug registration inspection

Article 45：Drug registration inspection refers to inspection activities conducted in development site and production field to verify the authenticity and c**istency of application dossiers and manufacturing conditi** for commercial production after launch, and inspect compliance and data reliability of development, and carry on extension inspection on manufacturer, provider of chemical APIs, excipients and packaging materials and containers contacting directly with drugs or other trustees.

The principle, procedure, time limit and requirement of starting drug registration inspection will be formulated and made public by CDE. The principle, procedure, time limit and requirement of implementing drug registration inspection will be formulated and made public by center for food and drug inspection.

Article 46: CDE decides whether to carry on development site inspection for drug registration based on risk of degree of innovation of the drug and the previous inspected situation of the research institute.

When CDE decides to initiate research site inspection，it will inform the center for food and drug inspection (CDI) of organizing and conducting inspection during the review and informs the applicant. The CDI should finish on-site inspection within the stipulated time and feedback the inspection situation and inspection conclusi** and other relevant materials to CDE for comprehensive review.

Article 47：CDE decides whether to initiate the drug registration on-site inspection based on the risk of registered varieties，process, instruments, previous accepted inspection situation and so forth.

The drug registration on-site production inspection and inspection of criterion for quality control of pre-marketing manufacturing drugs should be carried on for innovative drugs, modified drugs and biologics.

The drug registration on-site inspection and inspection of criterion for quality control of pre-marketing manufacturing drugs should be carried on based on risks whether the enterprise has achieved relevant manufacturing scope of drug production license and there have been launched drugs with the same category of dosage forms for generic drugs.

Article 48: CDE should conduct a preliminary censoring within 40 days after the acceptance of drug registration. If drug registration on-site inspection needed, CDE will inform the CDI of organizing the inspection and provide relevant materials needed in the inspection，and inform the applicant or the medical products administration of province, autonomous region, province-level municipality where production enterprise locates in. CDE should finish the inspection in principle 40 days before expiration of time limit of review and feedback the inspection situation and inspection results and other relevant materials to CDE.

If inspection of criterion for quality control of the pre-marketing drug manufacturing needed, CDI will coordinate relevant medical products administration of province, autonomous region， province-level municipality to implement the drug registration production on-site synchronization inspection. The administration of criterion for quality control of drug production should comply with relevant regulati** of the measures for the supervision and administration of drug production

The applicant should accept inspection within the stipulated time.

Article 49：CDE should initiate cause inspecti** and carry on sampling inspection when necessary if there are application dossiers of doubtful authenticity or tip-off with clear clues during the review when on-site inspection is needed.

Article 50: Applicant and production enterprise should achieve relevant drug production license when applying for drug marketing license.

Section 5: Drug registration inspection

Article 51: Drug registration inspection includes specification verification and sample inspection. Specification verification refers to conducting laboratory evaluation for scientificity of project setting，feasibility of testing methods，rationality of quality control index of the applicant’s drug specification. Sample inspection refers to conducting laboratory inspection of sample according to the quality specification which the applicant submitted or CDE has already checked and ratified.

Principle，procedure，time limit of initiating the drug registration inspection should be formulated and made public by CDE. Specific work procedure and requirement before the acceptance of drug application and requirement and regulation of drug registration inspection technology should be formulated and made public by National Institutes for Food and Drug Control.

Article 52: If the inspection items and testing methods used in the same category of drug recorded in the national drug specification，specification verification will not be needed and only sample inspection will be needed. Any other circumstances should have specification verification and sample inspection.

Article 53: National institutes for food and drug control or the drug inspection institutes appointed by NMPA will take the following the drug registration inspection：

（1） Innovative drugs

（2） Modified new drugs（except TCM）

（3）Biologics，radiopharmaceuticals and in vitro diagnostic reagents managed in accordance with drugs.

（4） Other drugs regulated by NMPA.

The registration inspection of the drugs produced abroad will be implemented by port drug inspection office organized by National Institutes for food and drug control.

The province-level drug inspection institute where the applicant or production enterprises located will take the registration inspection of other drugs

Article 54: If the applicant has finished the pharmaceutical relevant research，established quality specification and finished the process validation in commercial scale, the applicant can submit drug registration inspection application to National Institutes for food and drug control or drug administration of province, autonomous region and province-level municipality before the acceptance of drug registration application. If the applicant does not submit the registration inspection application before the acceptance of drug registration application, CDE will initiate registration inspection within 40 days after the acceptance of drug registration application. In principle, the applicant can submit only one registration inspection before the acceptance of registration application. Submitting registration inspection to multiple inspection institutes will not be permitted.

The submitted drug registration inspection dossiers should comply with the corresponding context in drug registration application dossiers. Changing the drug inspection institutes, sample and dossiers during the process of registration inspection will not be permitted.

Article 55: In the case of domestic drug registration application, the applicant should submit sampling application to drug administration of corresponding province, autonomous region and province-level municipality before the acceptance of drug registration application. Drug administration of province, autonomous region and province-level municipality should plan to sample and put seal and label. The sampling sheet, sample, dossiers needed in inspection, and reference materials should be sent to corresponding drug inspection institutes.

In the case of registration application of drugs manufactured overseas, applicant should submit drug registration inspection application, extract samples, and send samples, dossiers needing in inspection and reference materials to National Institutes for food and drug control.

Article 56: In the case of domestic drug registration application, if drug registration inspection is needed after acceptance of registration application, CDE will inform the inspection institute and applicant of drug registration inspection within 40 days after the acceptance. The applicant submits sampling application to drug administration of corresponding province, autonomous region and province-level municipality. Drug administration of province，autonomous region and province-level municipality should extract sample，put seal and label. The applicant should send sampling sheet, sample, dossiers needed in the inspection and reference materials to corresponding inspection institutes within the prescribed time limit.

If registration inspection is needed during the registration application of drugs manufactured overseas，applicant should sample，send sample，dossiers needed in the inspection and reference materials according to the requirements to National Institutes for food and drug control.

Article 57: Drug inspection institutes should verify the submitted sample for test by the applicant and dossiers within 5 days , and decide whether to accept them, and inform CDE at the same time. If amendment needed, inform the applicant in one time.

Drug inspection institutes should feedback the opinion of specification validation and inspection report to CDE within 40 days before expiration of review time limit in principle.

Article 58: If there are dossiers of doubtful authenticity or tip-off with clear clues during the review and verification，or in the other cases that sample inspection is needed， CDE can extract samples and take sampling inspection.

CDE can take individual verification of quality specification based on risks during the review.

Chapter 4: Expedited Programs for drug marketing

Section1：Breakthrough Therapy Designation

Article 59: The applicant can apply for Breakthrough Therapy Designation during the clinical trial if the innovative drug or modified drug can be used in these diseases which threat to life seriously or influence quality of life strongly and there is lack of effective method of prevention and treatment. What’s more，there are obvious clinical advantages with the innovative drugs or modified drugs compared with existing treatment approach.

Article 60: The applicant can apply to CDE for Breakthrough Therapy Designation. If qualified, the drug will be taken in Breakthrough Therapy Designation and made public by CDE.

Article 61：The following supportive policy will be given to the clinical trial of drug taken in Breakthrough Therapy Designation.

(1) Applicant can submit communication application to CDE during the critical stage of clinical trial. CDE should arrange reviewers for the communication.

(2) Applicant can submit interim research data to CDE. CDE should present opini** or suggesti** on the next stage research protocol based on the existing research dossiers and feedback to the applicant.

Article 62: If applicant finds that the clinical trial of drug taken in the Breakthrough Therapy Designation is not suitable for the inclusion criterion, the applicant should submit to terminate the Breakthrough Therapy Designation in time. If CDE finds that drug is not suitable for the inclusion criterion, CDE will terminate the Breakthrough Therapy Designation in time and informs the applicant.

Section2：Conditional Approval Designation

Article 63：Conditional approval can be applied during the clinical trial according to the following circumstances.

(1) The drug is indicated for these diseases which threat to life seriously and there are not existing curative methods. The drug clinical trials have proved its effectiveness and its predicted clinical values.

(2) The drug is needed urgently in the public health sanitation and the clinical trials have proved its effectiveness and its predicted values

(3) The vaccine is needed urgently in the vital emergent incidents in public health or thought as other urgently needed vaccines by National Health Commission. The profit of the vaccine is greater than the risk after evaluation.

Article 64: When applying for the conditional approval, the applicant should communicate with CDE about the conditi** of the conditional approval and completion of the following research after launch.

If the drug is in accordance with the conditional approval after review, the expiry date of the conditional approval, the following research work after launch and the planned c**ummation time will be included in the approval certificate.

Article 65: If CDE finds that the drug is not in accordance with the conditional approval, CDE will terminate the conditional approval designation and inform the applicant of research and application in the common procedure.

Article 66: MAH should take corresponding risk management measures for the conditional approval drug and finish the clinical trials within stipulated time and apply in complementary application

MAH of vaccine should finish the research within stipulated time for the further research requirement after the registration application of the vaccine.

Article 67: If the MAH of the conditional approval drug does not finish the research according to the requirement within the stipulated time or prove that the profit is greater than risk, NMPA will decide according to law until they logout the drug registration certificate.

Section 3: Priority Review Designation

Article 68: Priority review designation can be applied during the marketing application if the drug has the obvious clinical values in any following circumstances.

(1) Innovative drug and modified drug include shortage drug in urgent need, the drug for major infectious diseases prevention and cure, rare disease drug.

(2) New categories, dosage forms and strength in accordance with children’s physiological characteristics.

(3) Urgent need vaccine and innovative vaccine for prevention and control of disease

(4) The drug under breakthrough therapy designation.

(5) The drug under conditional approval designation

(6) Other priority review cases stipulated by NMPA

Article 69：The applicant should communicate with CDE before applying for drug marketing license. If getting confirmation after communication, the applicant can submit priority review application at the time of submitting the marketing license.

Article 70: Give the following supportive policies for the marketing license of the drug under priority review designation.

(1) The limited time of review for drug marketing license is 130 days

(2) The limited time of rare disease drugs in urgent need which has already launched abroad is 70 days

(3) If verification, inspection, examination and approval of drug general name are needed, the application will be given priority to.

(4) The supplementary technology dossiers can be submitted after communication and confirmation.

Article 71: If the drug registration application included in the priority review designation does not satisfy the conditi** of priority review, CDE will terminate the priority review designation and conduct review in regular review designation, and inform the applicant.

Section 4: Special Review and Approval Procedure

Article 72: If emergent events of public health are threatening to people or the emergent events of public health have already happened, NMPA can take special review and approval procedure in the drugs for prevention and treatment in the emergent events of public health according to law.

Article 73: For the drug registration application of special review and approval, NMPA organizes, expedites and conducts the registration acceptance, review, verification and inspection at the same time in the principle of ‘unity of command, earlier intervention，high-speed and high-efficiency，scientific review and approval’. The conditi**, procedures, limited time and requirements of the special review and approval should be in accordance with regulati** of special review and approval designation.

Article 74: The use of the drugs in the special review and approval will be restricted in special limited time and scope for the special requirements of prevention of the disease.

Article 75: If the drug included in the special review and approval procedure does not comply with the conditi**, the special review and approval will be terminated and the applicant will be informed.

Chapter 5: Change and Reregistration of drug after marketing

Section1: Investigation and change after drug marketing

Article 76：MAH should conduct post-marketing investigation for further corroboration of the safety，effectiveness and quality control of the drug and take persistent management of the marketing drugs

CDE will ask MAH to conduct post-marketing investigation in the drug certificate and its attachment and MAH should finish the investigation within the stipulated time and submit the supplementary application，record or report.

MAH should carry on persistent investigation of the safety and effectiveness of the drug and record in time or submit supplementary application of revising instruction based on the relevant data to continue to update the instruction and label. Drug administration will ask MAH to revise the instruction and label according to their duties based on the drug adverse reaction monitoring and post-marketing evaluation.

Article 77: Sort management will be done in the change of post-marketing drug according to the effects of change on the risk of the safety，effectiveness and quality control and severity of the effects. The changes will be classified into review and approval, file and record, and report.

MAH should take comprehensive evaluation and corroboration of effects of the changes on the safety, effectiveness and quality control according to relevant regulati** and referring to relevant technology guidance principle, and take corresponding investigation.

The technology guidance principle of post-marketing drug investigation will be formulated and made public by CDE.

Article 78: MAH should submit the supplementary application in the following changes and carry on implement after approval.

(1) Significant changes in the drug manufacturing process

(2) The changes involving efficacy and increasing safety risk in the drug instruction

(3) MAH transfers the marketing license

(4) The other changes required to be reviewed and approved by NMPA

Article 79：MAH should record and file to the local drug administration of province，autonomous region and province-level municipality before carrying on implement of changes in the following circumstances

(1) Moderate change in the drug manufacturing process

(2) The change of packaging label

(3) The sub-packaging of drug

(4) The other changes required to record and file stipulated by NMPA

If there are aforementioned changes in the drugs manufactured overseas，record and file to CDE before implement

The CDE will formulate and make public the procedure and requirements of drug sub-packaging

Article 80：MAH should mention in the annual report in the following changes

（1） Microscopic changes in the manufacturing process

（2） The other changes required to report stipulated by NMPA

Article 81：If verification and inspection is needed in the supplementary application after marketing，refer to the relevant articles about drug registration verification and inspection procedure

Section 2: Drug Re-registration

Article 82: MAH should submit the drug re-registration 6 months before the expiry date of the drug registration certificate. MAH of the drugs manufactured at home should submit the re-registration application to the local drug administration of province, autonomous region and province-level municipality. MAH of the drugs manufactured abroad should submit application to CDE.

Article 83: After acceptance of the re-registration, the drug administration of province, autonomous region and province-level municipality or CDE will review the post-marketing evaluation, adverse reaction monitoring, the relevant work implemented according to drug approval document and requirements of drug administration, information change recorded in the drug approval certificate. If complying with rule, grant the re-registration and send the re-registration approval certificate. If not, do not grant the re-registration and feedback to NMPA for cancelation of the drug registration certificate.

Article 84：Do not grant the re-registration in the following circumstances

（1） Do not submit the re-registration application before the expiry date

（2） MAH does not take the resp**ibility for persistent evaluation on drug quality，effectiveness and adverse reaction

（3） Do not finish the investigation work according to the drug approval documents and requirements of drug administration within the stipulated time

（4） The drug belongs to uncertainty of curative effect，severity of adverse reaction or life-threatening categories after post-marketing evaluation.

（5） The situation “not granting re-registration” stipulated by the laws and regulati**.

Cancel the drug registration certificate after the expiry date for the drugs which do not pass the re-registration application.

Chapter 6: Acceptance, withdrawal, review and approval decision,

dispute resolution

Article 85: The drug administration will carry on formality examination after the acceptance of drug registration application and decide whether to accept based on the following circumstance.

(1) Application items do not need administrative license according to the laws. It should make the decision of inadmissibility and notify the applicant with the reas**.

(2) If application articles legally do not belong to authorized scope of this department，it should issue a rejection notice and inform the applicants of applying for relevant administration organs.

(3) If the error of application dossiers can be retrieved then and there，the applicants should be allowed to retrieve the errors on the spot. If the application materials are complete after correction and in accordance with the legal form, the application should be accepted.

(4) If the application materials are not complete or in accordance with the legal form, the applicant should be informed of the all contexts of the deficiency at one time there and then or within five days. If the application materials are required to return according to the regulation at the time of inform, the application materials should be returned. The applicant should finish the deficiency materials within 30 days. If the applicant’s deficiency correction is overdue without a justifiable reason, the application is deemed to be abandoned and there is no need to make the decision of inadmissibility. If the applicant is not informed of the deficiency within the time, the application is deemed to be accepted since the day of accepting the materials.

(5) If the application articles belong to the authorized scope of the department, and the application materials are complete and in accordance with the legal , or the applicant complete the deficiency according to the requirements, the drug registration application should be accepted.

The applicant should pay the fees according to the rules if the drug registration application need the fees after the acceptance. If the applicant does not pay the fees within the stipulated time, the review and approval of the drug registration will be terminated.

Article 86: If there are new findings of the safety of the drugs after the acceptance of the registration application, the applicant should report in time and submit the relevant materials

Article 87: If the applicant should submit the new technique materials based on the original applicant materials after the acceptance of registration application, CDE should put forward the requirement of complementary materials at one time in principle and make clear all the questi** and give a written notification to the applicant for submitting the complementary materials within 80 days. The applicant should submit the whole complementary materials at one time according to the requirements, the time of preparing the complementary materials will not be included in the time of review and approval. CDE will restart the review after accepting the whole complementary materials，and one-third of the time limit of review will be extended. If the application is suitable for priority review procedure, one-fourth of the time limit will be extended.

If there is no need for the applicant to submit the new complementary materials and there is just need to give explanation to the original application, CDE will inform the applicant of submitting the explanation statement.

If the CDE thinks that there is substantial weakness and it can not be corrected, there will be no need for the applicant to submit the complementary materials. CDE will make the decision of inadmissibility based on the previous application materials.

Article 88：The new complementary technical materials can not be submitted during the review in the complementary application of clinical trials and in the clinical trials. The applicant can resubmit the new application after the withdrawal if new researches need to be done.

Article 89: The applicant can withdraw the application after the acceptance of the drug registration application. CDE or drug administration of province, autonomous region, province municipality should terminate the registration procedure and inform the institute of registration verification and inspection after the agreement of withdrawal. If illegal acti** of suspected of withholding the truth or providing false information happen during the review，verification and inspection，deal with application according to the law and the applicant will not be allowed to withdraw the registration application.

Article 90: CDE should inform the applicant the reason if the conclusion of the review is “Not passed” during the drug registration and the applicant can submit objecti** to CDE within 15 days. CDE will carry on comprehensive evaluation on the objecti** and feedback to the applicant

If the applicant still has the objecti** on the results of comprehensive assessment， CDE will organize the expert committee to dem**trate or prove and draw the final review conclusion based on the results of the dem**tration of the experts.

The time of the applicant objection and expert dem**tration will not be included in the time of review.

Article 91: Applicant believes that the staff violate the regulation or has irregular acti** during the drug registration acceptance, review, verification, inspection, approval in the drug registration. He or she can complain and report to the unit they belong to or by higher authorities.

Article 92: If the drug registration application meets the law and requirements，give the approval.

If drug registration has cases under any of the following circumstances, do not give the approval.

(1) The research data in the drug clinical application can not support for carrying out the clinical trials or guarantee the safety of subjects

(2) The application materials shows that there are higher defects in the safety，effectiveness，quality control

(3) The application data can not prove the safety，effectiveness and quality control of the drug or the risks of the drug outweigh the benefits

(4) The applicants do not submit the complementary data in the stipulated time

(5) The applicants refuse to accept the verification and inspection of the drug registration or to accept the verification and inspection without a justifiable reason in the stipulated time.

(6) Inauthenticity is c**idered in the drug registration and the applicant can not prove its authenticity.

(7) The results of the development site inspection or sample inspection do not meet the regulati**

(8) Other cases that the laws and regulati** c**idered not approval

Article 93: If the applicant has objecti** to the administrative permission decision after the review and approval of the drug registration, he or she can apply for administrative rec**ideration or bring an administrative lawsuit in accordance with law.

Chapter 7: Specific time period

Article 94: The prescribed time period in the provisi** refers to the longest time of acceptance, review, verification, inspection and approval. The time period of Priority Review procedure is carried out in accordance with the relevant regulation.

CDE and other specific professional institute should make their own unit’s procedures and time period clear and make them public.

Article 95: Drug regulatory department should carry out formality examination after acceptance of the drug registration application and make the decision of acceptance, amendment or not acceptance within 5 days.

Article 96: The time period of drug registration review and approval should carried out in accordance of the following regulati**.

(1) The time period of the review and approval for drug clinical trial and the supplementary application during drug clinical trials is 60 days

(2) The time period of review and approval for the drug marketing license application is 200 days and the time period of Priority Review and Approval is 130 days. The time period of review and approval for the rare disease drugs which have already launched abroad is 70 days.

(3) The time period of review and approval for the generic drugs which have already launched in home is 200 days.

(4) The time period of supplementary application of the change of review and approval is 60 days. The time period of supplementary application together with application items is 80 days，if the verification of clinical investigation data and verification and inspection of drug registration is 200 days.

(5) The time period of approval of common name is 30 days

(6) The time period of suitability review of OTC drugs is 30 days

The time period of bundling review and approval is the same as relevant drug pharmaceuticals.

Article 97: The time period of drug registration verification is carried out under the following regulati**

(1) CDE should inform the CDI to initiate verification and inform the applicant at the same time within 40 days after the acceptance of drug registration application.

(2) CDE should in principle finish the drug registration site inspection and feedback the inspection conditi** and results to CDE 40 days before the expiration of the time period of review and approval.

Article 98: The time period of the drug registration inspection is carried out under the following regulati**.

(1) The time period of sample inspection is 60 days, the time period of sample inspection together with specification review is 90 days.

(2) The time period of submitting supplementary data during the drug registration inspection is 30 days.

(3) The drug inspection institute should in principle finish the relevant inspection work before the expiration of review and approval

Article 99: The time period of the review and approval of drug reregistration is 120 days

Article 100：The decision of administrative review and approval should made within 20 days.

Article 101: Drug regulatory department should issue and deliver the relevant administrative permission certificate within 10 days after the decision of review and approval.

Article 102: If there is need for extension of time period because of the product character or in the special cases of review，verification and inspection, the extended time period can not be longer than 1/2 of the original time period. After the approval of person in charge of the review, verification and inspection, a written notification should be sent to the applicant by the technology institute of time period extension and the other relevant technology institutes should be informed as well.

Article 103: The time period can not be included in the relevant time period under the following cases.

(1) The time period taken by the applicant for preparing the supplementary data, rectifying after the inspection, and checking the manufacture process, quality specification and instruments.

(2) The time period taken up for postponing the verification，inspection and holding the expert c**ulting conference by the applicant.

(3) The time period taken up for terminating the review and approval procedure in the case of terminating review and procedure in according to the laws and rules

(4) The time period taken up for the overseas verification

Chapter 8: Supervision and Control

Article 104: NMPA takes the resp**ibility for the supervision and control, assessment, evaluation and guidance of the relevant work in drug registration taken by CDE and other professional technology institutes, drug administration department of province, autonomous region and province-level municipality

Article 105: Drug administration department should carry out the supervision inspection on the drug research and manufacture activities according to requirements of laws and regulati**. When necessary, it can carry out extended inspection on the unit and person who provide the product or service. The relevant unit and person should cooperate and shouldn’t reject and conceal.

Article 106: Information center is in charge of establishing the drug variety files and implementing code management, collecting drug registration application, relevant reports, reviews, inspecti**, approvals during the clinical trials and the approval, record and report of change after the launch, and keep renewing. The relevant principles of the drug category files and code management are formulated by information center and made publicly.

Article 107: The drug administration of province, autonomous region, province-level municipality should implement daily supervision inspection on compliance with the Criteri** for the Quality Control of non-clinical clinical trial and Criteri** for the Quality Control of Clinical Trial and supervise them for continuous compliance with statutory requirement. NMPA can implement supervision and inspection on the drug non-clinical safety assessment institute and clinical trial institute.

Article 108: NMPA establishes the drug safety credit management system. Drug inspection center is in charge of establishing the drug safety credit files of non-clinical safety assessment research institute and drug clinical trial institutes, recording license issue, daily supervision and inspection results, investigation and punishment of illegal acts, updating in time and making them publicly. Drug administration department can increase the frequency of supervision and inspection on the ones who have poor credit record and implement joint punishment on them. The drug safety credit file system of drug non-clinical safety assessment research institute and drug clinical trial institute will be formulated by drug inspection center and made publicly.

Article 109: NMPA make publicly the item list of registration review and approval，legal basis，requirements of review and approval，and handling time period. NMPA should make the registration progress known to the applicant and make publicly the review conclusion and basis of the approved drugs, and illegal and irregularity action during the supervision and inspection. NMPA c**ciously accept social supervision.

The instructi** of the approved drugs should be made publicly and updated in time. Among them, the label content of the vaccine should be made publicly and updated in time.

The drug administration department, professional technology institutes and their working personnel, the specialists who participated in review should not conceal the commercial secrets, undisclosed information or confidential business information submitted by the applicant ,except as otherwise stipulated by law or involving national security and major social and public interests.

Article 110: NMPA should cancel the drug registration certificate and make publicly under the following cases

（1） Holders themselves put forward cancellation of drug registration certificate.

（2） The re-registration should not be given according to the regulati**

（3） Holders’ drug registration certificate，drug production certificate and other administrative license were canceled or revoked according to laws

（4） According to the Article 83 in Pharmaceutical Administration Law, the drugs’ curative effects are not accurate，adverse reacti** are serious or the drugs give threatens to body health for other reas**

（5） According to the Article 61 in Vaccine Management Law，the vaccines’ adverse events following immunization are serious after post-marketing evaluation or the vaccines give threatens to health for other reas**

（6） According to the Article 62 in Vaccine Management Law, after the post-marketing the vaccine’s product design, manufacture process, safety and effectiveness or quality-control is obviously inferior to other vaccines whose functi** of prevention and control of the same disease

（7） The applicants do not finish relevant investigation work without appropriate reas** within the stipulated time period under the requirements of drug certificate files or the administration department

（8） The other conditi** in which the drug certificate should be canceled according to laws

Chapter 9: Legal resp**ibility

Article 111: When finding that the false certificate, data, materials, samples are provided or the other methods used for getting clinical trial permit or drug registration by cheating or fraud ，handle according to Article 123 in Drug Administration Laws

Article 112：When finding that the submitted false data, materials, samples in the vaccine clinical application and registration or other cheating acts，handle according to Article 81 in Vaccine Management Laws

Article 113：If the drug safety assessment research institutes and drug clinical trial institutes do not obey the Criteri** for the Quality Control of non-Clinical and Clinical Trial of drugs during the drug registration，handle according to Article 126 in Drug Administration Laws.

Article 114: If finding that carrying out drug clinical trials without approval, handle according to Article 125 in Drug Administration Laws. If finding that carrying out bioequivalence trials without file and record, handle according to Article 127 in Drug Administration Laws.

Article 115: If finding that there are safety problems or other risks during the clinical trials and the sp**or of the clinical trials do not adjust the clinical trial protocols in time , suspend or terminate the clinical trials ,or report to NMPA, handle in Article 127 in Drug Administration Laws.

Article 116: If finding the violation of Article 28 and 33 in this provision and sp**ors have acti** under the following circumstances, they should be ordered to make correcti**. If they do not make correcti** within the time limit , a fine of more than 10,000 yuan and less than 30,000 yuan will be given.

(1) Do not register the information of clinical trial protocol on WWW.CHINADRUGTRIALS.ORG.CN before conducting the clinical trials.

(2) Do not submit the regular safety updated report during the research on the website of CDE

(3) Do not register the information of results after the end of clinical trials.

Article 117: If finding that the drug inspecti** provide the false inspection report during taking the inspection works needed in the registration, handle according to Article 138 in the Drug Administration Laws.

Article 118: If the approval of conducting clinical trials is given without meeting the criteri** or the drug registration certificate is issued without meeting the criteri**, handle according to 147 in the Drug Administration Laws

Article 119：If finding that the drug administrative departments and their personnels have illegal acts during the process of drug registrati**，handle according to relevant laws and regulati**.

Chapter 10: Supplementary Provisi**

Article 120: The registration of narcotic drugs, psychotropic drugs, toxic drugs for medical use and precursor chemicals and other drugs under special management should comply with other regulati** except the regulati** in this provision.

Article 121: The standards of vaccines exported should comply with the standards of importing countries(districts) or the requirements of contract.

Article 122: In the case of application of drug-medical device combination products, if the character of same kind of product has been designed as drug, the application should submitted as drugs. If the character has not been designed, applicant should apply the character designation to NMPA before submitting registration. If the character designation is drug, conduct registration in the procedure of the provision. Among them , the research dossiers of medical devices should reviewed and concluded by Center For Medical Device Evaluation, NMPA and then transferred to CDE for comprehensive review.

Article 123: The approval number format of the drugs manufactured at home is Sate Medical Permitment H（Z，S）+ four-digit number of the year number+ four-digit number of the sequence number. The approval number format of the drugs manufactured in HongKong, Macau and Taiwan is State Medical Permitment H(Z,S)C+ four-digit number of the year number+ four-digit number of the sequence number.

The approval number format of the drugs manufactured overseas is State Medical Permitment H(Z,S)J+ four-digit number of the year number+ four-digit number of the sequence number. Among them H represents chemical drugs, Z represents traditional Chinese medicines, S represents Biological prodcuts

The approval number will not alter because of the change of registration items after launch.

If there are other provisi**, the traditional Chinese Medcine should be followed

Article 124: The electronic records of the drug registration approval certificate and active pharmaceutical ingredient approval certificate has the equal legal effect as the paper document

Article 125: The time period regulated in this provision is in working days.

Article 126: This provision will be conducted from 1st July, 2020. The original Provision of Drug Registration issued 10th July，2007 by NMPA will be abandoned at the same time.

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