Measures for the Administration of Drug Registration in China
Measures for the Administration of Drug Registration (2020)
Chapter I General Provisions
Article 1
These Measures are formulated to regulate drug registration activities, ensure the safety, effectiveness, and quality controllability of drugs, in accordance with the Drug Administration Law of the People's Republic of China (“Drug Administration Law”), the Law of the People's Republic of China on Traditional Chinese Medicine, the Vaccine Administration Law of the People's Republic of China (“Vaccine Administration Law”), the Administrative Licensing Law of the People's Republic of China, the Regulations for the Implementation of the Drug Administration Law, and other relevant laws and administrative regulations.
Article 2
These Measures apply to drug research and development, registration, and supervision activities carried out within the territory of the People’s Republic of China for the purpose of marketing drugs.
Article 3
Drug registration refers to the activities in which a drug registration applicant (“applicant”) submits applications for drug clinical trials, marketing authorization, re-registration, or supplementary applications in accordance with statutory procedures and relevant requirements. The drug regulatory authority shall review the safety, effectiveness, and quality controllability based on laws, regulations, and existing scientific knowledge, and decide whether to approve the application.
Upon obtaining the Drug Registration Certificate, the applicant becomes the marketing authorization holder (“holder”).
Article 4
Drug registration shall be managed by classification into traditional Chinese medicine (TCM), chemical drugs, and biological products.
- TCM registration is classified into innovative TCM, improved new TCM, compound preparations of ancient classical TCM formulas, and same-name same-formula drugs.
- Chemical drug registration is classified into innovative chemical drugs, improved new chemical drugs, and generics.
- Biological product registration is classified into innovative biological products, improved new biological products, and marketed biological products (including biosimilars).
Detailed sub-classifications and corresponding application data requirements for TCM, chemical drugs, and biological products shall be formulated and published by the National Medical Products Administration (NMPA) based on product characteristics, innovation level, and review/management needs.
Registration applications for drugs manufactured overseas shall comply with the corresponding detailed classification and application data requirements.
Article 5
The NMPA is responsible for nationwide drug registration management, establishing systems and rules, formulating regulatory norms, organizing drug review and approval according to law, and carrying out relevant supervisory tasks.
The Center for Drug Evaluation (CDE) is responsible for reviewing applications for drug clinical trials, marketing authorizations, supplementary applications, and re-registration of drugs manufactured overseas.
Specialized technical institutions such as the National Institutes for Food and Drug Control (NIFDC), the Pharmacopoeia Commission, the Center for Food and Drug Inspection (CFDI), the Center for Drug Reevaluation, the Administrative Service and Complaint Center, and the Information Center shall undertake tasks including drug testing, approval of generic names, inspection, monitoring and evaluation, certificate issuance, and information system development and management, as required for drug registration.
Article 6
Drug regulatory authorities of provinces, autonomous regions, and municipalities directly under the central government shall be responsible within their jurisdictions for:
1. Accepting, reviewing, and approving re-registration applications for domestically manufactured drugs;
2. Managing post-marketing change filings and reporting;
3. Organizing routine supervision of non-clinical safety evaluation institutions and clinical trial institutions, and investigating violations;
4. Participating in inspections and testing organized by the NMPA;
5. Handling other drug registration matters delegated by the NMPA.
Provincial-level drug regulatory authorities shall establish or designate specialized technical institutions to conduct review, testing, inspection, monitoring, and evaluation necessary for drug regulatory work.
Article 7
Drug registration management shall follow the principles of openness, fairness, and impartiality, be oriented toward clinical value, encourage the research and creation of new drugs, and actively promote the development of generics.
The NMPA shall continue to advance review and approval system reform, optimize procedures, improve efficiency, and establish a drug registration management system led by review, supported by inspection, testing, monitoring, and evaluation.
Chapter II Basic Systems and Requirements
Article 8
Entities engaged in drug research and development and drug registration activities shall comply with relevant laws, regulations, rules, standards, and norms. Where other evaluation methods and technologies are adopted in reference to relevant technical guidelines, their scientific validity and applicability shall be demonstrated. Information throughout the entire process shall be truthful, accurate, complete, and traceable.
Drugs shall comply with national drug standards and the drug quality standards approved by the NMPA. Approved drug quality standards shall constitute the registration standards for the drug. Registration standards shall meet the general technical requirements of the Chinese Pharmacopoeia and shall not be lower than its provisions. Where test items or indicators for the drug to be registered do not apply to the Chinese Pharmacopoeia, the applicant shall provide sufficient supporting data.
Professional technical institutions such as the Center for Drug Evaluation shall formulate technical guidelines and procedures based on scientific progress, industry developments, and drug regulatory needs, and shall make them public.
Article 9
Applicants shall be enterprises or drug R&D institutions capable of assuming corresponding legal liability. Overseas applicants shall designate an enterprise legal person in China to handle related drug registration matters.
Article 10
Before applying for marketing authorization, the applicant shall complete relevant pharmaceutical, pharmacological-toxicological, and clinical trial studies. Non-clinical safety evaluation studies shall be conducted in institutions certified for compliance with Good Laboratory Practice (GLP) for non-clinical studies and shall comply with GLP requirements. Drug clinical trials shall be approved; bioequivalence studies shall be filed for record. Clinical trials shall be conducted in qualified clinical trial institutions in compliance with Good Clinical Practice (GCP).
Applications for drug registration shall be supported by truthful, sufficient, and reliable data, information, and samples to demonstrate safety, efficacy, and quality controllability.
Where overseas research data are used to support drug registration, the source, research institution or laboratory conditions, quality system requirements, and other management conditions shall comply with the International Council for Harmonisation (ICH) principles and meet China’s relevant drug registration requirements.
Article 11
Where changes are made to the items or content stated in the original drug registration approval documents and their attachments, the applicant shall, in accordance with regulations and relevant technical guidelines, conduct sufficient research and verification, fully evaluate the possible impact on the drug’s safety, efficacy, and quality controllability, and submit a supplementary application, filing, or report according to the change procedures.
Article 12
The validity period of the Drug Registration Certificate shall be five years. During the validity period, the holder shall continuously ensure the safety, efficacy, and quality controllability of the marketed drug and shall apply for re-registration six months before expiry.
Article 13
The NMPA shall establish an accelerated marketing authorization system to support innovation oriented toward clinical value. For eligible drug registration applications, applicants may apply for breakthrough therapy designation, conditional approval, priority review and approval, and special review procedures. During drug development and registration, the drug regulatory authorities and their technical institutions shall provide necessary technical guidance, communication, priority resource allocation, shortened review timelines, and other policy and technical support.
Article 14
The NMPA shall establish a linked review and approval system for active pharmaceutical ingredients (APIs), excipients, and packaging materials and containers in direct contact with drugs. When approving a drug preparation, the API shall be reviewed and approved simultaneously, along with relevant excipients and packaging materials/containers. The CDE shall set up a registration platform for APIs, excipients, and packaging materials/containers, publicize the registered information for selection by applicants or holders, and link the review with the preparation’s registration application.
Article 15
Prescription drugs and non-prescription (over-the-counter, OTC) drugs shall be subject to classified registration and conversion management. The CDE shall, based on the characteristics of OTC drugs, formulate and publish technical guidelines and procedures for their marketing authorization. The Center for Drug Reevaluation shall formulate and publish technical requirements and procedures for the post-marketing conversion between prescription and OTC drugs.
Article 16
At key stages before a clinical trial application, during a clinical trial, and before applying for marketing authorization, the applicant may communicate on major issues with the CDE and other technical institutions. During the drug registration process, the CDE and other technical institutions may organize communications with the applicant as needed.
The procedures, requirements, and timelines for communication shall be formulated and published by the respective technical institutions.
Article 17
The CDE and other technical institutions may, as needed, establish expert advisory systems and committees to solicit expert opinions on major issues during review, inspection, testing, and approval of generic names, thereby fully leveraging expert technical support.
Article 18
The NMPA shall establish a catalogue of chemical drugs newly approved for marketing and those passing generic quality and efficacy consistency evaluation, listing the drug name, active ingredients, dosage form, specification, reference preparation status, holder, and other information. The catalogue shall be updated in a timely manner and made public. The CDE shall formulate and publish the procedures and requirements for inclusion in the catalogue.
Article 19
The NMPA shall support the inheritance and innovation of TCM, improve a registration management system and technical evaluation system suited to TCM characteristics, encourage the use of modern science and traditional research methods in TCM development, strengthen TCM quality control, and improve the level of TCM clinical trials.
For TCM registration applications, the applicant shall conduct clinical value and resource assessments, emphasizing clinical value orientation and promoting sustainable resource utilization.
Chapter III Marketing Authorization of Drugs
Section 1 Drug Clinical Trials
Article 20
Drug clinical trials, as referred to in these Measures, are drug studies conducted in humans for the purpose of obtaining marketing authorization to determine the safety and efficacy of the drug.
Article 21
Drug clinical trials are divided into Phase I, Phase II, Phase III, Phase IV trials, and bioequivalence studies. Depending on the characteristics of the drug and the objectives of the study, research may include clinical pharmacology, exploratory clinical trials, confirmatory clinical trials, and post-marketing studies.
Article 22
Drug clinical trials shall be conducted in clinical trial institutions with appropriate qualifications and which are duly filed for record. Vaccine clinical trials shall be conducted or organized by tertiary medical institutions meeting the conditions stipulated by the NMPA and the National Health Commission, or by provincial-level or higher Centers for Disease Control and Prevention.
Article 23
After completing the relevant pharmaceutical, pharmacological-toxicological, and other studies supporting the application for a drug clinical trial, the applicant shall submit the required research data in accordance with application requirements. Upon formal examination, applications meeting the requirements shall be accepted. The CDE shall organize pharmaceutical, medical, and other technical personnel to review accepted applications.
A decision on whether to approve a drug clinical trial shall be made within 60 days from the date of acceptance. If no notification is given within this time, the trial is deemed approved and the applicant may conduct the trial according to the submitted protocol.
Applicants granted approval for a drug clinical trial shall be considered the trial sponsor.
Article 24
Applicants intending to conduct a bioequivalence study shall, as required, complete the filing of the study on the CDE website before commencing the research in accordance with the filed protocol.
Article 25
Drug clinical trials shall be approved by an ethics committee. Management of the drugs used in the trial shall comply with the requirements of Good Clinical Practice.
Article 26
For subsequent phases of a clinical trial already approved, the sponsor shall formulate the corresponding protocol and, after ethics committee approval, submit the protocol and supporting materials to the CDE before implementation.
Article 27
Where it is proposed to add a new indication (or function) or to combine with another drug in an approved clinical trial, the applicant shall submit a new clinical trial application and obtain approval before commencing. The same applies to approved marketed drugs requiring clinical trials to add new indications.
Article 28
Sponsors shall periodically submit Development Safety Update Reports (DSURs) via the CDE website. These shall be submitted annually, within two months after each anniversary of trial approval, unless otherwise required by the CDE. Serious and unexpected adverse reactions and other potential serious safety risks arising during the trial shall be reported promptly in accordance with requirements. Depending on severity, the CDE may require changes to the protocol, informed consent form, investigator’s brochure, or risk control measures, or may suspend or terminate the trial.
Article 29
Where protocol changes, non-clinical or pharmaceutical changes, or new findings arise during a clinical trial, the sponsor shall assess the safety implications for subjects. If no safety impact is anticipated, the change may be implemented and reported in the DSUR. Changes potentially increasing risk require a supplementary application, which the CDE shall decide on within 60 days. Change of sponsor transfers all trial-related rights and obligations to the new sponsor.
Article 30
If safety problems or other risks are identified during a trial, the sponsor shall promptly adjust the protocol, suspend, or terminate the trial and report to the CDE. The CDE may require adjustments, suspension, or termination in cases such as failure of the ethics committee to fulfill duties, inability to ensure subject safety, failure to submit DSURs, failure to address and report adverse reactions, evidence of ineffectiveness, quality issues, fraud, or other violations of Good Clinical Practice. Large-scale unexpected serious adverse reactions or serious quality issues require immediate cessation of the trial.
Article 31
If a clinical trial is suspended by order, the sponsor may resume it only after corrective measures and CDE approval. Suspensions exceeding three years without approved resumption cause automatic invalidation of the trial permit. Terminated trials require a new application for resumption.
Article 32
A clinical trial must commence within three years after approval. If no subject signs informed consent within that period, the permit becomes void and a new application is required.
Article 33
Before commencing a trial, the sponsor shall register the protocol on the trial registry and information disclosure platform. Registration shall be updated during the trial and results registered upon completion. Sponsors are responsible for the truthfulness of registered information.
Section 2 Marketing Authorization
Article 34
After completing all required studies and validations for commercial-scale production and being ready for inspection and testing, the applicant shall submit the marketing authorization application with required materials. Applications passing formal review shall be accepted.
Article 35
For generics, in vitro diagnostic reagents administered as drugs, and other eligible cases where the applicant assesses that clinical trials are unnecessary or infeasible and that the conditions for exemption are met, the applicant may directly apply for marketing authorization. Technical guidelines and requirements for clinical trial exemption shall be formulated and published by the CDE.
Generics shall have the same quality and efficacy as the reference preparation, and the applicant shall reasonably select the reference preparation in accordance with relevant technical guidelines.
Article 36
The following may directly apply for OTC marketing authorization:
1. A drug already marketed domestically with the same active ingredient, indication (or function), dosage form, and specification as an OTC drug;
2. An NMPA-designated OTC drug changing only dosage form or specification without altering indication, dosage, or route of administration;
3. A new compound preparation composed of active ingredients from NMPA-designated OTC drugs;
4. Other situations specified for direct OTC marketing application.
Article 37
If the proposed generic name is not included in the national drug standards or drug registration standards, the applicant shall apply for generic name approval when applying for marketing authorization. After acceptance, the relevant materials shall be forwarded to the Pharmacopoeia Commission for review, and the results returned to the CDE. If already included in standards but name approval is deemed necessary during review, the CDE shall notify the Pharmacopoeia Commission to review and return results to the CDE.
The Pharmacopoeia Commission shall communicate with the applicant during name review and inform the applicant of the decision.
Article 38
The CDE shall organize pharmaceutical, medical, and other technical personnel to review accepted applications. If risk-based triggers arise during review, registration inspections or testing shall be initiated and completed within specified time limits. OTC drugs shall also be sent to the Center for Drug Reevaluation for suitability assessment.
Article 39
If comprehensive review concludes approval, the drug shall be granted marketing authorization and issued a Drug Registration Certificate specifying approval number, holder, manufacturer, and for OTC drugs, the OTC category. Approved manufacturing processes, quality standards, instructions, and labels are attached to the certificate; post-marketing research requirements may also be attached. These details are included in the product dossier and updated as changes occur.
Article 40
If significant changes occur during review that may affect safety, efficacy, or quality controllability, the applicant shall withdraw the application, conduct supplementary studies, and reapply. Changes such as applicant name or address that do not affect technical review shall be promptly reported with supporting documentation.
Section 3 Linked Review and Approval
Article 41
When reviewing a drug preparation registration, the CDE shall conduct linked review of the active pharmaceutical ingredients (APIs), excipients, and packaging materials/containers in direct contact with the drug.
Article 42
Applicants may select registered APIs, excipients, and packaging materials/containers from the public registration platform, or submit relevant research data for unregistered materials together with the preparation application.
Article 43
If supplementary data are needed during linked review, the CDE may request them from either the preparation applicant or the supplier. Based on risk, the CDE may extend inspections to the supplier. APIs used in generics of domestically marketed drugs may be separately reviewed and approved.
Article 44
If linked or separate review is passed, the CDE updates the platform with approved status and publicly discloses relevant information. For APIs, an approval notice is issued with approved manufacturing process, quality standards, and labeling. If not approved, a non-approval notice is issued and the preparation application is rejected.
Section 4 Registration Inspections
Article 45
Registration inspections verify the authenticity and consistency of submitted data, compliance of development, and readiness for commercial manufacturing. They may include extended inspections of API, excipient, and packaging material manufacturers or other contractors.
Article 46
Based on innovation level and inspection history, the CDE decides whether to inspect development sites. If initiated, the CFDI is notified to conduct the inspection and report back for integrated review.
Article 47
Based on product, process, facilities, and inspection history, the CDE decides whether to inspect manufacturing sites. Innovative drugs, improved new drugs, and biologics shall undergo site inspection and pre-marketing GMP inspection. For generics, inspections are risk-based depending on licensing and marketed product history.
Article 48
Within 40 days of acceptance, if inspection is needed, the CDE notifies the CFDI and the applicant. The CFDI completes inspections in principle 40 days before review deadline and reports results. GMP inspections may be conducted simultaneously.
Article 49
If authenticity concerns or credible reports arise during review, the CDE initiates for-cause inspections, and may perform sampling and testing.
Article 50
At the time of marketing authorization application, the applicant and manufacturer shall already hold the required drug manufacturing license.
Section 5 Registration Testing
Article 51
Registration testing includes standard verification and sample testing. Standard verification assesses the scientific soundness of parameters, feasibility of methods, and rationality of quality controls. Sample testing verifies compliance of samples with the declared or CDE-approved standards.
Article 52
Where test items and methods match those in the national drug standards for the same product, only sample testing is required. Otherwise, both standard verification and sample testing are required.
Article 53
The NIFDC or NMPA-designated institutions shall test: innovative drugs; improved new drugs (excluding TCM); biologics, radiopharmaceuticals, and IVDs administered as drugs; and other drugs as specified by the NMPA. For overseas-manufactured drugs, the NIFDC coordinates testing by port drug testing institutions. Other drugs are tested by the applicant’s provincial-level testing institution.
Article 54
Applicants completing pharmaceutical studies and process validation may request registration testing before acceptance of the marketing application. If not, the CDE initiates testing within 40 days after acceptance. Only one pre-acceptance testing request is allowed and must be to a single institution.
Article 55
For domestic drugs, pre-acceptance testing requests go to the provincial drug administration for sampling, sealing, and submission to the testing institution. For overseas drugs, applicants follow specified sampling requirements and submit directly to the NIFDC.
Article 56
If testing is initiated post-acceptance, the CDE notifies the applicant and relevant authorities within 40 days, and applicants submit sealed samples as required. Overseas drugs submit to the NIFDC.
Article 57
Testing institutions review samples and materials within 5 days and decide on acceptance, notifying the CDE. Needed corrections shall be communicated once. In principle, institutions report results at least 40 days before review deadline.
Article 58
If authenticity concerns or credible reports arise during review or inspection, the CDE may initiate sampling and testing, including single-parameter standard verification.
Chapter IV Accelerated Marketing Authorization Procedures
Section 1 Breakthrough Therapy Designation
Article 59
During clinical development, innovative drugs or improved new drugs intended for the prevention or treatment of life-threatening or severely debilitating diseases, for which there are no effective therapies or which show significant clinical advantage over existing treatments based on sufficient evidence, may apply for breakthrough therapy designation.
Article 60
Applicants shall submit a request for breakthrough therapy designation to the CDE. If the conditions are met, the CDE shall include the drug in the breakthrough therapy program after public notice.
Article 61
For clinical trials of drugs under breakthrough therapy designation, the following policy support shall be provided:
1. Applicants may request communication with the CDE at key stages of development, and the CDE shall arrange reviewers for discussion;
2. Applicants may submit interim research data to the CDE, which shall provide feedback on subsequent study plans.
Article 62
If the applicant or the CDE finds that the drug no longer meets the designation criteria, the applicant shall request, or the CDE shall decide, to terminate the breakthrough therapy program and notify the applicant.
Section 2 Conditional Approval
Article 63
During clinical development, drugs in the following categories may apply for conditional approval:
1. Drugs for the treatment of life-threatening diseases with no effective treatment, where clinical trial data already confirm efficacy and predict clinical benefit;
2. Drugs urgently needed for public health, where existing trial data confirm efficacy and predict clinical benefit;
3. Vaccines urgently needed for major public health emergencies or as identified by the National Health Commission, where evaluation shows benefits outweigh risks.
Article 64
Applicants shall communicate with the CDE regarding the conditions for conditional approval and required post-marketing studies, and upon confirmation may submit the marketing application. If approved, the registration certificate shall specify the validity period, post-marketing study requirements, and timelines.
Article 65
If, during review, it is determined that the application no longer meets conditional approval criteria, the CDE shall terminate the procedure and notify the applicant to proceed under normal procedures.
Article 66
Holders of conditionally approved drugs shall implement risk management measures and complete required trials within the specified period, filing the results as a supplementary application. For vaccines with further research requirements, the holder shall complete the studies within the stipulated period.
Article 67
If the holder fails to complete the required studies on time or cannot demonstrate that benefits outweigh risks, the NMPA shall take action up to and including revocation of the registration certificate.
Section 3 Priority Review and Approval
Article 68
The following drugs with significant clinical value may apply for priority review and approval when applying for marketing authorization:
1. Innovative or improved new drugs urgently needed for shortage drugs, major infectious diseases, or rare diseases;
2. New varieties, dosage forms, or specifications of pediatric drugs adapted to children's physiology;
3. Urgently needed vaccines for disease prevention or innovative vaccines;
4. Drugs designated as breakthrough therapies;
5. Conditionally approved drugs;
6. Other cases specified by the NMPA.
Article 69
Applicants shall communicate with the CDE before submission. Upon confirmation, they may apply for priority review at the same time as the marketing application. If conditions are met, the CDE shall include the drug in the program after public notice.
Article 70
Drugs under priority review shall receive the following policy support:
1. Review timeline for marketing authorization shall be 130 days;
2. For urgently needed overseas-marketed rare disease drugs not yet marketed in China, the review timeline shall be 70 days;
3. Priority shall be given to required inspections, testing, and name approval;
4. Upon agreement, supplementary technical materials may be submitted during review.
Article 71
If it is determined during review that the drug no longer meets the criteria, the CDE shall terminate the priority review procedure and proceed with normal review, notifying the applicant.
Section 4 Special Approval
Article 72
In the event of a public health emergency or threat thereof, the NMPA may decide to implement special approval procedures for urgently needed drugs for prevention or control.
Article 73
Special approval applications shall follow the principles of unified command, early intervention, rapid and efficient action, and scientific review. Acceptance, review, inspection, and testing shall be expedited concurrently. Specific conditions, procedures, timelines, and requirements shall follow the provisions for special approval.
Article 74
Drugs under special approval may be limited to specified timeframes and scopes of use according to disease control needs.
Article 75
If it is determined that a drug no longer meets the criteria, the special approval procedure shall be terminated and the applicant notified.
Chapter V Post-Marketing Changes and Re-registration
Section 1 Post-Marketing Research and Changes
Article 76
Holders shall proactively conduct post-marketing research to further confirm the safety, efficacy, and quality controllability of drugs, strengthening ongoing management. Where the registration certificate and its attachments require post-marketing research, the holder shall complete it within the stipulated period and submit a supplementary application, filing, or report as required.
Holders shall continue safety and efficacy research, and based on relevant data, file or apply for revisions to instructions in a timely manner. Regulatory authorities may require revisions based on adverse drug reaction monitoring or post-marketing evaluations.
Article 77
Post-marketing changes are classified by their risk and impact on safety, efficacy, and quality controllability into approval changes, filing changes, and report changes. Holders shall comprehensively assess and verify the impact of changes and conduct necessary studies in accordance with relevant regulations and technical guidelines. The CDE shall formulate and publish the technical guidelines for post-marketing change research.
Article 78
The following changes require a supplementary application and approval before implementation:
1. Major manufacturing process changes;
2. Changes in the instructions affecting efficacy or increasing safety risks;
3. Transfer of the marketing authorization to another holder;
4. Other changes specified by the NMPA as requiring approval.
Article 79
The following changes require filing with the provincial drug administration before implementation:
1. Moderate manufacturing process changes;
2. Changes to packaging label content;
3. Repackaging of the drug;
4. Other filing changes specified by the NMPA.
For overseas-manufactured drugs, such changes shall be filed with the CDE before implementation. The CDE shall issue procedures and requirements for repackaging filings.
Article 80
The following changes shall be reported in the annual report:
1. Minor manufacturing process changes;
2. Other reportable changes specified by the NMPA.
Article 81
Post-marketing supplementary applications requiring inspection or testing shall follow the relevant procedures for registration inspection and testing.
Section 2 Re-registration
Article 82
Holders shall apply for re-registration six months before the expiry of the registration certificate. Domestic holders shall apply to the provincial drug administration; overseas holders shall apply to the CDE.
Article 83
Upon acceptance, the authority shall review the holder’s post-marketing evaluations, adverse reaction monitoring, compliance with approval requirements, and changes to the approved information. If compliant, re-registration is granted and a re-registration approval notice issued. If non-compliant, re-registration is denied and the NMPA shall revoke the certificate.
Article 84
Re-registration shall not be granted where:
1. The application was not submitted before expiry;
2. The holder cannot fulfill obligations to monitor quality, efficacy, and adverse reactions;
3. Required studies were not completed within the stipulated period without reasonable cause;
4. Post-marketing evaluation shows unclear efficacy, significant adverse reactions, or other harm to health;
5. Other circumstances stipulated by laws and regulations.
Certificates not renewed shall be revoked upon expiry.
Chapter VI Acceptance, Withdrawal of Applications, Approval Decisions, and Dispute Resolution
Article 85
Upon receiving a registration application, the authority shall conduct a formal review and decide whether to accept based on:
1. If no license is required by law, a decision of non-acceptance shall be made with reasons;
2. If outside the authority’s jurisdiction, a decision of non-acceptance shall be made and the applicant referred to the correct body;
3. Errors that can be corrected on-site shall be allowed to be corrected, after which the application may be accepted;
4. Incomplete or non-compliant materials shall result in a single notification of all required corrections within five days; failure to supplement within 30 days without justification is deemed withdrawal; if the authority fails to notify within five days, acceptance is automatic;
5. Complete and compliant applications shall be accepted. Required fees must be paid, or the review process will be terminated.
Article 86
If new safety issues are discovered after acceptance, the applicant shall report and supplement materials promptly.
Article 87
If supplementary technical data are required, the CDE shall, in principle, issue a single request listing all issues and allow 80 days for submission. Time for supplementation is excluded from review timelines. Upon receipt, the review period is extended by one-third (or one-quarter for priority reviews). Requests for explanations only require submission within five days. If deficiencies are substantive and uncorrectable, the application will be denied.
Article 88
For clinical trial applications or supplementary applications during a trial, no new technical data may be added during review. If new research is needed, the applicant may withdraw and resubmit.
Article 89
Applicants may withdraw an application after acceptance. Upon withdrawal, related inspections or tests are terminated. If violations such as concealing information or falsification are found, withdrawal is not allowed.
Article 90
If the review conclusion is negative, the CDE shall inform the applicant of reasons, who may file an objection within 15 days. The CDE shall reassess and, if disagreement remains, convene an expert committee within 50 days. Objection periods are excluded from review timelines.
Article 91
Applicants may file complaints about non-compliance by staff during acceptance, review, inspection, testing, or approval.
Article 92
Applications meeting legal requirements shall be approved. Applications shall be denied where:
1. Insufficient data support trial or safety;
2. Major deficiencies in safety, efficacy, or quality;
3. Risks outweigh benefits;
4. Failure to provide supplementary materials in time;
5. Refusal or failure to undergo inspection/testing;
6. Suspected falsification without proof of authenticity;
7. Non-compliance found in inspections/testing;
8. Other legal grounds for denial.
Article 93
Applicants may seek administrative reconsideration or litigation if dissatisfied with an approval decision.
Chapter VII Timelines
Article 94
Timelines specified are the maximum for acceptance, review, inspection, testing, and approval. Priority review timelines follow its specific provisions. Technical institutions shall publish their procedures and timelines.
Article 95
Formal review shall be completed within five days of receipt.
Article 96
Review timelines:
1. Clinical trial and supplementary applications during a trial: 60 days;
2. Marketing authorization: 200 days; priority review: 130 days; urgently needed overseas rare disease drugs: 70 days;
3. API applications for domestic generics: 200 days;
4. Approval changes: 60 days; combined supplementary applications: 80 days; involving trial data or inspections/testing: 200 days;
5. Generic name approval: 30 days;
6. OTC suitability review: 30 days.
Linked reviews follow the preparation’s review timeline.
Article 97
Inspection timelines:
1. The CDE shall notify the inspection body within 40 days of acceptance;
2. Inspections shall be completed 40 days before review deadline.
Article 98
Testing timelines:
1. Sample testing: 60 days; with standard verification: 90 days;
2. Supplementary data during testing: 30 days;
3. Testing completion at least 40 days before review deadline.
Article 99
Re-registration review: 120 days.
Article 100
Administrative decisions: 20 days.
Article 101
Licenses shall be issued within 10 days of decision.
Article 102
Extensions, where necessary, may not exceed half the original period and require approval by the responsible authority, with notification to the applicant.
Article 103
Excluded from timelines: time for applicant to supplement, correct, or verify information; delays due to applicant; suspension periods under law; and time for overseas inspections.
Chapter VIII Supervision and Administration
Article 104
The NMPA supervises technical institutions and provincial drug administrations in their registration-related work.
Article 105
Authorities may inspect drug R&D activities and, if necessary, related product/service providers. Entities must cooperate and not conceal information.
Article 106
The Information Center shall maintain product dossiers, assign codes, and collect all registration-related and post-marketing change data, updating them regularly.
Article 107
Provincial authorities shall oversee GLP and GCP compliance at local institutions. The NMPA may conduct such oversight as needed.
Article 108
The NMPA shall maintain a drug safety credit system, recording licensing, inspections, and violations, disclosing and updating them. Negative records lead to increased inspections and possible joint disciplinary action.
Article 109
The NMPA shall publish the registration approval list, legal basis, requirements, timelines, progress, approval conclusions, and violations found. Instructions (and vaccine labels) of approved drugs shall be made public and updated. Confidential commercial information shall not be disclosed without consent, except as required by law.
Article 110
Certificates shall be revoked where:
1. The holder requests revocation;
2. Re-registration is denied;
3. Licenses are revoked by law;
4. Post-marketing evaluation shows unclear efficacy, significant adverse reactions, or other harm;
5. Vaccine evaluation shows serious adverse events or inferiority to other vaccines;
6. Failure to complete required studies without reason;
7. Other legal grounds.
Chapter IX Legal Liability
Article 111
Submitting false documents, data, materials, or samples, or obtaining approval through deception during registration shall be handled under Article 123 of the Drug Administration Law.
Article 112
False data, materials, or samples, or other fraudulent acts in vaccine trial or registration applications shall be handled under Article 81 of the Vaccine Administration Law.
Article 113
Non-compliance with GLP or GCP by relevant institutions shall be handled under Article 126 of the Drug Administration Law.
Article 114
Conducting a clinical trial without approval shall be handled under Article 125 of the Drug Administration Law; conducting a bioequivalence study without filing shall be handled under Article 127.
Article 115
If a sponsor fails to adjust, suspend, terminate, or report a trial in response to safety issues, it shall be handled under Article 127 of the Drug Administration Law.
Article 116
Violations of Articles 28 and 33 regarding trial registration, DSUR submission, or result registration shall be ordered to correct within a time limit, with fines from RMB 10,000 to 30,000 for failure to correct.
Article 117
Testing institutions issuing false reports shall be handled under Article 138 of the Drug Administration Law.
Article 118
Issuing approval for unqualified clinical trials or drug marketing shall be handled under Article 147 of the Drug Administration Law.
Article 119
Violations by regulatory staff shall be handled under relevant laws and regulations.
Chapter X Supplementary Provisions
Article 120
Registration of narcotics, psychotropics, toxic drugs for medical use, radiopharmaceuticals, and precursor chemicals with special management requirements shall comply with both these Measures and other national provisions.
Article 121
Export vaccines shall meet the standards of the importing country or contractual requirements.
Article 122
For drug-device combination products:
If classified as drugs based on precedent, they shall be registered as drugs;
If classification has not been determined, the applicant shall request determination before applying. If classified as drug-led, registration follows these Measures, with device data reviewed by the Center for Medical Device Evaluation and forwarded to the CDE.
Article 123
Approval number formats:
Domestic: 国药准字H(Z,S)+year+sequence;
Hong Kong, Macao, Taiwan: 国药准字H(Z,S)C+year+sequence;
Foreign: 国药准字H(Z,S)J+year+sequence.
H=chemical, Z=TCM, S=biologics. Approval numbers do not change with post-marketing changes. TCM-specific rules prevail where applicable.
Article 124
Electronic approval documents for drug registration and API approvals have the same legal effect as paper documents.
Article 125
Time periods are calculated in working days.
Article 126
These Measures take effect on July 1, 2020. The 2007 Measures are repealed simultaneously.
The quality of reply f supplementary questions by Chinese authority matters. It is finding for medical device which manufacturer not only corrects, but also learns.
Production in China + approved imported medical device = Fast track at review and approval
The regulation of medical device including IVD is arising. We make it transparent and simple to understand. Share your ideas with top 10 news. We can develop country strategy with you.
Chinese GMP is equivalent to ISO 13485 but with Chinese accent of factory, PTR, quality control and outsouced critical process.
Either for regulatory affairs (registration) in China or beyond, if you have a solid Excel or Word file with tracing items (e.g. PTR), have a free meeting with us. We will make a GRTIS matrix in customer project. You decide the next step and success at Chinese registration
Standards are bridges to conform to essential principle of medical device and to development product. Chinese standards are aligning closer and faster to international standards with national focus.
We explain the possibility of clinical evaluation of highest class III medical device in China.
Learning new country specific regulation in another language is perhaps always a hurdle. Don`t worry. We try to establish a platform where you can learn all regulation by yourself. The registered elearning encloses the video, test, script, meetup with trainer. You will be a giant of regulatory affairs of medical device and In Vitro Diagnostics (IVD) after the course.
Chinese authority expands inspection of medical device, IVD and drug overseas
Let`s approach Taiwan registration of medical device, one of the strongest Asian sales markets.
