China Profile Updated
The China profile in ClinRegs has been reviewed and updated with the following information:
- Details from 2024 on the transfer of China’s human genetic resources (HGR) management from the Ministry of Science and Technology (MOST) to the State Council’s National Health Commission (NHC) (See the Regulatory Authority, Clinical Trial Lifecycle, Sponsorship, Informed Consent, and Specimens topics)
- 2024 NHC guidance on applying for an HGR license to conduct research (See the Regulatory Authority topic, Submission Process, Timeline of Review, Definition of Sponsor, and Definition of Specimen)
- Regulations from 2023 on the submission and review of drug clinical trial plans with the National Medical Products Administration (NMPA) (See Scope of Assessment, Submission Process, Submission Content, and Timeline of Review)
- Details on the NMPA’s 2024-2025 pilot program to expedite the review and approval of clinical trials for innovative drugs (See Scope of Assessment)
- Guidance and templates from 2024 for drug clinical trial institutions on filling out its annual NMPA work summary report (See Site/Investigator Selection)
- 2024 NMPA guidelines on decentralized clinical trials using rare disease drugs, including the use of electronic consent (See Risk & Quality Management, Documentation Requirements, Children/Minors, and Mentally Impaired)
- NMPA guidelines from 2024 on evaluating the correlation between adverse events and drugs used in clinical trials (See Safety Reporting)
- Updated guidance from 2023 on establishing ethics committees (ECs) and updated information on China’s National Medical Ethics Expert Committee, provincial medical ethics expert committees (ECs), regional ECs, and institutional ECs (See the Ethics Committee topic)
- 2024 State Council regulations on network security requirements to protect personal data, including processing, data sharing, consent, and security assessments (See Personal Data Protection)
- Cyberspace Administration of China regulations from 2024, which provide exemptions from the security assessment on cross-border transfers of data (See Personal Data Protection)
- 2024 ethics guidelines for human genome editing research (See Scope of Review and Consent for Specimen)
- Guidelines and procedures from 2023 and 2024 to follow during the conduct of clinical trials on a range of risk and quality management topics including gene therapy, risk management, changes to biological products, and decentralized trials (See Risk & Quality Management)
- NMPA’s management measures on supervising and inspecting drug clinical trial institutions (Risk & Quality Management)
- Guidelines from 2024 on identifying sensitive personal information (See Personal Data Protection)
Sources Added During this Update:
(Guidance) Filling in the Annual Work Summary Report of Drug Clinical Trial Institutions (No. 1 of 2024) (NMPA-No1-2024 – Standard Chinese) (English-NMPA-No1-2024 – Google Translation) (January 25, 2024)
National Food and Drug Administration Food and Drug Inspection Center, National Medical Products Administration
(Guidance) Technical Guidelines for the Evaluation of the Relevance of Adverse Events in Drug Clinical Trials (No. 31 of 2024) (NMPA-No31-2024 – Standard Chinese) (English-NMPA-No31-2024 – Google Translation) (June 7, 2024)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for Clinical Trials of Gene Therapy Products for Rare Diseases (GeneCTs-Rare – Standard Chinese) (English-GeneCTs-Rare – Google Translation) (January 18, 2024)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for Pharmaceutical Research and Changes of Biological Products during Clinical Trials (No. 29 of 2024) (NMPA-No29-2024 – Standard Chinese) (English-NMPA-No29-2024 – Google Translation) (June 7, 2024)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Technical Guidelines for Applying Decentralized Clinical Trials in Clinical Development of Rare Disease Drugs (DctrlzCTs-Rare – Standard Chinese) (English-DctrlzCTs-Rare – Google Translation) (May 30, 2024)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Procedures for Safety Information Assessment and Risk Management during Drug Clinical Trials (Risk-Prcdr – Standard Chinese) (English-Risk-Prcdr – Google Translation) (November 3, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Cybersecurity Standard Practice Guidelines - Guidelines for Identifying Sensitive Personal Information (Id-SPI – Standard Chinese) (English-Id-SPI – Google Translation) (Effective September 14, 2024)
China’s Secretariat of the National Cybersecurity Standardization Technical Committee
(Guidance) Ethical Guidelines for Human Genome Editing Research (GeneEdit-Ethics – Standard Chinese) (English-GeneEdit-Ethics – Google Translation) (July 8, 2024)
National Science and Technology Ethics Committee, Central Science and Technology Commission, Party Central Committee
(Notice) Announcement from the National Health Commission Regarding “Regulations of the People's Republic of China on the Administration of Human Genetic Resources (NHC-HGRmgt – Standard Chinese) (April 25, 2024)
National Health Commission
(Notice) Approval of the Pilot Program of Optimizing the Review and Approval of Clinical Trials of Innovative Drugs in Beijing and Shanghai (No. 55 of 2024) (NMPA-No55-2024 – Standard Chinese) (August 2, 2024)
National Medical Products Administration
(Guidance) Human Genetic Resources Service System: Application Guide (HGR-AppGuide – Standard Chinese) (Current as of December 19, 2024)
National Health Commission
(Decree) Decision of the State Council on Amending and Abolishing Some Administrative Regulations (No. 777) (SC-Order777 – Standard Chinese) (Effective May 1, 2024)
State Council
(Notice) Pilot Work Plan for Optimizing the Review and Approval of Clinical Trials of Innovative Drugs (No. 21 of 2024) (NMPA-No21-2024 – Standard Chinese) (July 31, 2024)
National Medical Products Administration
(Regulation) Measures for the Supervision and Inspection of Drug Clinical Trial Institutions (No. 56 of 2023) (NMPA-No56-2023 – Standard Chinese) (English-NMPA-No56-2023 – Google Translate) (Effective March 1, 2024)
National Medical Products Administration
(Regulation) Standards for Submission and Review of Drug Clinical Trial Plans (No. 51 of 2023) (NMPA-No51-2023 – Standard Chinese) (English-NMPA-No51-2023 – Google Translation) (October 12, 2023)
Center for Drug Evaluation, National Medical Products Administration
(Decree) Regulations on Network Data Security Management (No. 790) (DataSec-Regs – Standard Chinese) (Effective January 1, 2025)
State Council
(Regulation) Provisions to Promote and Regulate Cross-border Data Flows (No. 16) (DataTrsfr-Regs – Standard Chinese) (Effective March 22, 2024)
Cyberspace Administration of China
(Webpage) What We Do (CHN-24) (Last Updated September 22, 2018)
National Health Commission
Sources Revised During this Update:
(Guidance) Guidelines for the Establishment of Ethical Review Committees for Clinical Research Involving Humans (2023 Edition) (EC-Guide – Standard Chinese) (English-EC-Guide – Google Translation) (June 6, 2023)
Office of Medical Ethics Expert Committee of the National Health Commission and the Chinese Hospital Association