China Profile Updated
The China profile in ClinRegs has been reviewed and updated with the following information:
- New address and contact information for the National Medical Products Administration’s (NMPA’s) Center for Drug Evaluation (CDE) (See Regulatory Authority)
- NMPA handling guidelines on the registration of drug clinical trial institutions and the approval and registration of drug clinical trials (See Scope of Assessment, Submission Process and Submission Content)
- NMPA requirements from 2022 on the electronic submission of drug registration applications (See Submission Process)
- NMPA guideline from 2015 on international multi-center drug clinical trials (See the Clinical Trial Lifecycle topic, Site/Investigator Selection, and Risk & Quality Management)
- Additional NMPA quality management and technical guidelines from 2020, 2021, and 2023 related to clinical trial conduct (See Risk & Quality Management)
- Multi-agency guidance issued in February 2023 on the ethical review of life science and medical research involving humans (See Ethics Committee and the Informed Consent topic)
- Ministry of Science and Technology (MOST) requirements, which took effect in July 2023, on the management of human genetic resources (HGR) (See Regulatory Authority, Scope of Assessment, Submission Process, Timeline of Review, Initiation, Agreements & Registration, Site/Investigator Selection, Definition of Specimen, and Consent for Specimen)
- A June 2023 announcement from MOST on the operation of a new online platform for the management of HGR (Scope of Assessment, Submission Process, and Specimen Import & Export)
- A September 2023 FAQ resource from MOST on HGR applications (See Regulatory Authority)
Sources Added During this Update:
(Guidance) Changes to the Working Procedures During the Review of Drug Registration Applications (Prcdrs-Changes – Standard Chinese) (English-Prcrs-Changes – Google Translation) (November 9, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Interpretation of the Document "Measures for the Ethical Review of Life Science and Medical Research Involving Humans" (Measures-Ethics-Interp – Standard Chinese) (English-Measures-Ethics-Interp – Google Translation) (February 28, 2023)
National Health Commission
(Guidance) Notice on the Requirements for Electronic Submission of Drug Registration Applications (ElectronicApps-Rqts – Standard Chinese) (December 2, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Policy Interpretation of the Detailed Implementation Rules on the Management of Human Genetic Resources (Rules-MgmtHGR-Interp – Standard Chinese) (June 1, 2023)
Ministry of Science and Technology
(Guidance) Technical Guidelines for Clinical Changes in Marketed Chemicals and Biological Products (Chngs-MktChemBio – Standard Chinese) (English-Chngs-MktChemBio – Google Translation) (February 10, 2021)
National Medical Productions Administration
(Guidance) Technical Guidelines for Conditional Approval of Drugs for Marketing (CondtlAppl-Drugs – Standard Chinese) (English-CondtlAppl-Drugs – Google Translation) (November 19, 2020)
National Medical Productions Administration
(Guidance) Technical Guidelines for Patient-Centered Drug Clinical Trial Design (PatientCtr-Design – Standard Chinese) (English-PatientCtr-Design – Google Translation) (July 27, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for Pharmaceutical Change Research of Marketed Biological Products (Chngs-MktBio – Standard Chinese) (English-Chngs-MktBio – Google Translation) (June 25, 2021)
National Medical Productions Administration
(Guidance) Technical Guidelines for Pharmaceutical Change Research of Marketed Chemicals (Chngs-MktChem – Standard Chinese) (English-Chngs-MktChem – Google Translation) (February 10, 2021)
National Medical Productions Administration
(Guidance) Technical Guidelines for the Implementation of Patient-Centered Drug Benefits - Risk Assessment (PatientCtr-Risk – Standard Chinese) (English-PatientCtr-Risk – Google Translation) (July 27, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for the Implementation of Patient-Centered Drug Clinical Trials (PatientCtr-Imp – Standard Chinese) (English-PatientCtr-Imp – Google Translation) (July 27, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Notice) Adjustments to the Human Genetic Resources Management Information System (HGR-InfoSys – Standard Chinese) (September 26, 2023)
Ministry of Science and Technology
(Notice) FAQs on Human Genetic Resources Management (HGR-FAQs – Standard Chinese) (September 12, 2023)
Ministry of Science and Technology
(Regulation) Adjustment of Matters Related to the Management of Human Genetic Resources (HGR-WorkUpdt – Standard Chinese) (June 21, 2023)
Ministry of Science and Technology
(Regulation) Detailed Implementation Rules on the Management of Human Genetic Resources (No. 21) (Rules-MgmtHGR – Standard Chinese) (Effective July 1, 2023)
Ministry of Science and Technology
(Regulation) Ethical Review Measures for Life Sciences and Medical Research Involving Humans (Measures-Ethics – Standard Chinese) (February 18, 2023)
National Health Commission, Ministry of Education, and Ministry of Science and Technology
(Regulation) Guidelines for International Multicenter Drug Clinical Trials (No. 2 of 2015) (NMPA-No2-2015 – Standard Chinese) (March 1, 2015)
National Medical Products Administration
(Regulation) Implementation of Electronic Submission of Drug Registration Applications (NMPA-No110-2022 – Standard Chinese) (November 30, 2022)
National Medical Products Administration
(Regulation) Integrated System Catalog – Management of Human Genetic Resources, License Requirements (HGR-Licenses – Standard Chinese) (Current as of November 29, 2023)
Ministry of Science and Technology
(Webpage) China Human Genetic Resources Management Office (CHN-4 – Standard Chinese) (October 10, 2022)
China National Center for Biotechnology Development, Ministry of Science and Technology
(Webpage) Handling Guideline: Drug Clinical Trial Approval (CHN-14 – Standard Chinese) (Current as of November 29, 2023)
National Medical Products Administration, State Administration for Market Regulation
(Webpage) Handling Guideline: Drug Clinical Trial Institution Registration (CHN-12 – Standard Chinese) (Current as of November 29, 2023)
National Medical Products Administration, State Administration for Market Regulation
(Webpage) Handling Guideline: Drug Clinical Trial Registration (CHN-13 – Standard Chinese) (Current as of November 29, 2023)
National Medical Products Administration, State Administration for Market Regulation
(Webpage) Human Genetic Resources Service System Login (CHN-6 – Standard Chinese) (Current as of November 29, 2023)
Ministry of Science and Technology
(Webpage) Matters Related to the Relocation of the Center for Drug Evaluation Office (CHN-5 – Standard Chinese) (July 31, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Webpage) Ministry of Science and Technology Government Service Platform – User Login (CHN-23 – Standard Chinese) (Current as of November 29, 2023)
Ministry of Science and Technology