China Profile Updated
The China profile in ClinRegs has been reviewed and updated with the following information:
- Reforms and requirements from the National Medical Products Administration (NMPA) and the State Council from 2024 and 2025 on improving the drug review and approval system, including application requirements for clinical trials of innovative drugs (See Regulatory Authority, Scope of Assessment, Submission Process, Submission Content, and Timeline of Review)
- NMPA requirements and guidance from 2026 on further optimizing the review and approval of urgently needed drugs marketed overseas (See Scope of Assessment and Timeline of Review)
- National Health Commission (NHC) guidance from 2025 and supplemental information on the management of human genetic resources (See Regulatory Authority, Scope of Assessment, Clinical Trial Lifecyle topic, Personal Data Protection, Definition of Specimen, and Specimen Import & Export)
- References throughout the profile to NMPA’s implementation of the ICH Guidelines for Good Clinical Practice E6(R3) for drug clinical trials
- References to 2025 Center for Drug Evaluation (CDE) guidance on trial design and biosimilars (See Risk & Quality Management)
- CDE informed consent requirements from 2025 for pediatric clinical trial participants (See Children/Minors)
- References to 2025 CDE guidance on vaccine clinical trials and pediatric clinical trials (See Scope of Assessment, Safety Reporting, and Risk & Quality Management)
- Personal data protection requirements from the Cybersecurity Law and references to data protection requirements from the Cyberspace Administration of China and other entities (See Personal Data Protection)
- NMPA requirements from 2025 on format and submissions for drug production licenses (See Manufacturing & Import)
- NHC administrative requirements from 2025 for clinical research initiated by researchers in medical and health institutions (See Initiation, Agreements & Registration)
- Requirements for ethics committees from 2023 regarding the review of scientific and technological activities (See Ethics Committee, Scope of Review, and Oversight of Ethics Committees)
Sources Added During this Update:
(Legislation) Cybersecurity Law of the People's Republic of China (Cyberscrty-Law – Standard Chinese) (English-Cyberscrty-Law – Google Translation) (Effective January 1, 2026)
National People’s Congress
(Guidance) Answers to Questions Related to the Management of Human Genetic Resources (Part 1) (HGR-Answrs-1 – Standard Chinese) (April 1, 2025)
National Health Commission
(Guidance) Answers to Questions Related to the Management of Human Genetic Resources (Part 2) (HGR-Answrs-2 – Standard Chinese) (April 9, 2025)
National Health Commission
(Guidance) Answers to Questions Related to the Management of Human Genetic Resources (Part 3) (HGR-Answrs-3 – Standard Chinese) (April 17, 2025)
National Health Commission
(Guidance) Answers to Questions Related to the Management of Human Genetic Resources (Part 4) (HGR-Answrs-4 – Standard Chinese) (April 25, 2025)
National Health Commission
(Guidance) Answers to Questions Related to the Management of Human Genetic Resources (Part 5) (HGR-Answrs-5 – Standard Chinese) (October 11, 2025)
National Health Commission
(Guidance) Frequently Asked Questions on the Management of Human Genetic Resources (NHC-HGR-FAQs – Standard Chinese) (March 27, 2025)
Department of Science and Education, National Health Commission
(Guidance) Guiding Principles for the Grading of Adverse Events in Vaccine Clinical Trials (CDE-No49-2025 – Standard Chinese) (December 1, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Interpretation on Further Optimizing the Review and Approval of Clinically Urgent Drugs Already Marketed Overseas (NMPA-No3Interp-2026 – Standard Chinese) (English-NMPA-No3Interp-2026 – Google Translation) (January 7, 2026)
National Medical Products Administration, State Administration for Market Regulation
(Guidance) Key Elements and Key Points of Trial Design for the Elderly to Participate in Clinical Trials of Innovative Drugs (CDE-No44-2025 – Standard Chinese) (English-CDE-No44-2025 – Google Translation) (October 23, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Questions and Answers on the Study of Pharmaceutical Similarity of Biosimilars (CDE-No30-2025 – Standard Chinese) (English-CDE-No30-2025 – Google Translation) (July 7, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Scope and Procedures for Filing International Cooperative Clinical Trials Using Human Genetic Resources in China (HGR-IntlCoop – Standard Chinese) (English-HGR-IntlCoop – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Scope and Procedures for Prior Reporting of China’s Human Genetic Resources Information for External Provision or Open Use (HGR-RptOpenUse – Standard Chinese) (English-HGR-RptOpenUse – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Service Guideline: Licensing for the Collection of Human Genetic Resources (HGR-CollLic – Standard Chinese) (English-HGR-CollLic – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Service Guideline: Licensing for the Export of Human Genetic Resources Materials (HGR-ExportLic – Standard Chinese) (English-HGR-ExportLic – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Service Guideline: Licensing for the International Scientific Research Cooperation on Human Genetic Resources (HGR-IntlSciLic – Standard Chinese) (English-HGR-IntlSciLic – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Service Guideline: Licensing for the Preservation of Human Genetic Resources (HGR-PresLic – Standard Chinese) (English-HGR-PresLic – Google Translation) (March 20, 2025)
National Health Commission
(Guidance) Technical Guidelines for Safety Information Evaluation and Reporting of Pediatric Drug Clinical Trials (CDE-No21-2025 – Standard Chinese) (English-CDE-No21-2025 – Google Translation) (May 23, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for Vaccine Clinical Trials (CDE-No16-2025 – Standard Chinese) (English-CDE-No16-2025 – Google Translation) (March 24, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Notice) Announcement on Further Optimizing the Review and Approval of Urgently Needed Overseas-Marketed Drugs (NMPA-No3-2026 – Standard Chinese) (January 7, 2026)
National Medical Products Administration, State Administration for Market Regulation
(Notice) Application of the ICH Guidelines E6(R3): Technical Guidelines for Good Clinical Practice (No. 125 of 2025) (NMPA-No125-2025 – Standard Chinese) (Effective March 31, 2026)
National Medical Products Administration
(Notice) Further Improving the Issuance of Drug Production Licenses (NMPA-No35-2025 – Standard Chinese) (April 7, 2025)
National Medical Products Administration, State Administration for Market Regulation
(Notice) Q&A on Data Export Security Management Policy (QA-DataExprt – Standard Chinese) (October 31, 2025)
Cyberspace Administration of China
(Notice) The Use of New Templates for the "Drug Production License" and the "Radioactive Drug Production License" (NMPA-No63-2025 – Standard Chinese) (English-NMPA-No63-2025 – Google Translation of Appendices) (October 29, 2025)
National Medical Products Administration, State Administration for Market Regulation
(Standard) Data Security Technology—Security Certification Requirements for Cross-border Processing Activity of Personal Information (Standard No. GB/T 46068-2025) (SAMR-Std-PI – Standard Chinese) (Effective March 1, 2026)
State Administration for Market Regulation and National Standardization Administration
(Regulation) Administrative Measures for Researcher-Initiated Clinical Research Conducted by Medical and Health Institutions (Meas-ClinRsrch-Inst – Standard Chinese) (Effective October 1, 2024)
National Health Commission, State Administration of Traditional Chinese Medicine, and the National Bureau of Disease Control and Prevention
(Regulation) Measures for Scientific and Technological Ethics Review (Trial) (Meas-STEthics – Standard Chinese) (Effective December 1, 2023)
Ministry of Science and Technology; Ministry of Education; Ministry of Industry and Information Technology; Ministry of Agriculture and Rural Affairs; National Health Commission; Chinese Academy of Sciences; Chinese Academy of Social Sciences; Chinese Academy of Engineering; China Association for Science and Technology; Science and Technology Commission of the Central Military Commission
(Regulation) Measures for the Authentication of Cross-border Personal Information Export (CAC-No20-2025 – Standard Chinese) (Effective January 1, 2026)
Cyberspace Administration of China and State Administration for Market Regulation
(Regulation) Measures for the Compliance Audit of Personal Information Protection (CAC-No18-2025 – Standard Chinese) (Effective May 1, 2025)
Cyberspace Administration of China
(Regulation) Opinions on Deepening the Reform of Drug and Medical Device Regulation and Promoting the High-quality Development of the Pharmaceutical Industry (No. 53 of 2024) (SC-Opinions-No53 – Standard Chinese) (December 30, 2024)
State Council
(Regulation) Optimizing the Review and Approval of Clinical Trials of Innovative Drugs (No. 86 of 2025) (NMPA-No86-2025 – Standard Chinese) (English-NMPA-No86-2025 – Google Translation of Policy Interpretation) (Effective September 12, 2025)
National Medical Products Administration, State Administration for Market Regulation
(Regulation) Requirements for Application Materials for Clinical Trials of Innovative Drugs and Other Relevant Documents (No. 40 of 2025) (NMPA-No40-2025 – Standard Chinese) (NMPA-No40-2025 – Google Translation of Attachment 1) (September 9, 2025)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Standard Contract Measures for Cross-border Transfer of Personal Information (CAC-No13-2023 – Standard Chinese) (Effective June 1, 2023)
Cyberspace Administration of China with the consent of State Administration for Market Regulation
(Article) China Released New Ethics Rules Requiring a Company's Internal Ethics Committee (CHN-42) (October 16, 2023)
Gu, Aaron; You, Pengfei; Zheng, Cathy; Zhang, Matt; and Yu, Fengqi; Hankun Law Offices
(Article) China’s NHC Issues Updated Guidelines on Human Genetic Resources Management (CHN-32) (April 18, 2025)
Yang, Kexin, Balzano, John, and Post, Julia; Covington & Burling LLP
(Article) Further Deepening the Drug Regulatory Reform to Enhance Efficiency and Safety, Promote Development, Benefit People's Livelihoods (CHN-47 – Standard Chinese) (June 16, 2025)
National Medical Products Administration, State Administration for Market Regulation
(Article) Impact of China’s HGR Rules on Clinical Trials and Scientific Studies Involving China Sites (CHN-36) (December 15, 2023)
Zhou, Lo, Hogan Lovells
(Webpage) CDE - Contact Us (CHN-44 - Standard Chinese) (Current as of March 6, 2026)
Center for Drug Evaluation, National Medical Products Administration
(Webpage) Human Genetic Resource Management (CHN-15 - Standard Chinese) (Current as of March 6, 2026)
National Health Commission
(Webpage) Service Guidelines, Filing, and Prior Reporting Scope and Procedures for Administrative Licensing of Human Genetic Resources (CHN-33 - Standard Chinese) (March 20, 2025)
National Health Commission
Sources Revised During this Update:
(International Guidance) ICH Harmonised Guideline: Guideline for Good Clinical Practice E6(R3) (CHN-37) (Chinese-CHN-37 - Official Translation) (January 6, 2025)
International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use