China Profile Updated
The China profile in ClinRegs has been reviewed and updated with the following information:
- New guidelines for protocol changes during drug clinical trials (See Scope of Review, Submission Process, and Risk & Quality Management)
- Several new quality management and technical guidelines to use during the conduct of a clinical trial (See Risk & Quality Management)
- New regulations on the security assessment of data exports (See Personal Data Protection)
- A new appendix to good manufacturing practice guidance for drugs (See Manufacturing & Import, Quality Requirements, Labeling, and Product Management)
- A new online platform for drug import license procedures (See Manufacturing & Import)
Sources Added During this Update:
(Regulation) Guidelines for Drug Clinical Trial Data Management and Statistical Analysis Plan (No. 63 of 2021) (NMPA-No63-2021 – Standard Chinese) (Effective December 27, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Guidelines for Pharmacovigilance Testing (No. 22 of 2022) (NMPA-No22-2022 – Standard Chinese) (Effective April 15, 2022)
National Medical Products Administration
(Regulation) Guidelines for the Application of Patient-Reported Outcomes in Drug Clinical Development (No. 62 of 2021) (NMPA-No62-2021 – Standard Chinese) (Effective December 27, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Guiding Principles for Statistics of Centralized Monitoring of Drug Clinical Trials (No. 11 of 2022) (NMPA-No11-2022 – Standard Chinese) (Effective January 18, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Guiding Principles for Writing the Clinical Risk Management Plan (No. 68 of 2021) (NMPA-No68-2021 – Standard Chinese) (Effective December 27, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Launching of Electronic Payment Certificates for Registration Fees for Drugs and Medical Device Products (No. 37 of 2022) (NMPA-No37-2022 – Standard Chinese) (Effective August 22, 2022)
National Medical Products Administration
(Regulation) Measures for the Security Assessment of Data Exports (No. 11) (CAC-No11-2022 – Standard Chinese) (Effective September 1, 2022)
Cyberspace Administration of China
(Regulation) Opinions on Strengthening the Ethical Governance of Science and Technology (SC-EthicalGov – Standard Chinese) (March 20, 2022)
State Council
(Regulation) Technical Guidelines for Clinical Pharmacological Research of Biosimilars (No. 17 of 2022) (NMPA-No17-2022 – Standard Chinese) (Effective February 8, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Clinical Research and Development of Drugs for Rare Diseases (No. 71 of 2021) (NMPA-No71-2021 – Standard Chinese) (Effective December 31, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Clinical Trials of Topically Administered Locally Effective Drugs (No. 32 of 2022) (NMPA-No32-2022 – Standard Chinese) (Effective May 26, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Pharmaceutical Research and Evaluation of Immune Cell Therapy Products (No. 30 of 2022) (NMPA-No30-2022 – Standard Chinese) (Effective May 26, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Pharmaceutical Research and Evaluation of In Vivo Gene Therapy Products (No. 31 of 2022) (NMPA-No31-2022 – Standard Chinese) (Effective May 26, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Pharmaceutical Research and Evaluation of In Vitro Genetic Modification Systems (No. 29 of 2022) (NMPA-No29-2022 – Standard Chinese) (Effective May 26, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for the Pharmaceutical Research and Evaluation of Specific Human Immunoglobulins (No. 27 of 2022) (NMPA-No27-2022 – Standard Chinese) (Effective May 20, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Protocol Changes During Drug Clinical Trials (No. 34 of 2022) (NMPA-No34-2022 – Standard Chinese) (Effective June 23, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for the Study of Human Bioavailability and Bioequivalence of Innovative Drugs (No. 4 of 2022) (NMPA-No4-2022 – Standard Chinese) (Effective January 4, 2022)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Writing Safety Reference Information in the Investigator's Manual (No. 60 of 2021) (NMPA-No60-2021 – Standard Chinese) (Effective December 23, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Guidelines for Comprehensive Analysis of The Effectiveness of Clinical Studies of Drugs (No. 59 of 2021) (NMPA-No59-2021 – Standard Chinese) (Effective December 23, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Regulation) Technical Guidelines for Long-term Follow-up Clinical Research of Gene Therapy Products (No. 50 of 2021) (NMPA-No50-2021 – Standard Chinese) (Effective December 1, 2021)
Center for Drug Evaluation, National Medical Products Administration
(Guidance) Amendments to Good Management Practice for Drug Business (No. 28) (NMPA-No28-2016) – Standard Chinese) (July 13, 2016)
National Medical Products Administration, State Administration for Market Regulation
(Guidance) Good Management Practice for Drug Business (No. 13) (NMPA-No13-2015 – Standard Chinese) (Effective May 18, 2015)
National Medical Products Administration, State Administration for Market Regulation
(Guidance) Good Manufacturing Practice for Drugs (2010 Revision) (NMPA-GMP) (Effective March 1, 2011)
National Medical Products Administration, State Administration for Market Regulation
(Guidance) Appendix to Good Manufacturing Practice for Drugs (2010 Revision) (No. 43 of 2022) (NMPA-No43-2022 – Standard Chinese) (Effective July 1, 2022)
National Medical Products Administration, State Administration for Market Regulation
(Webpage) China International Trade Single Window (CHN-2) (Current as of November 18, 2022)
General Administration of Customs of China
(Webpage) China: CFDA New Drug Import License Procedure (CHN-28) (January 15, 2020)
Marken, A UPS Company
(Webpage) Commercialization of Healthcare in China: Overview (CHN-29) (December 1, 2021)
Zhou, Alan Zhou, et al., Global Law Office
(Webpage) Contact Us (CHN-31) (Current as of November 18, 2022)
National Medical Products Administration, State Administration for Market Regulation
Sources Revised During this Update:
(Article) The Life Sciences Law Review: China (CHN-22) (February 23, 2022)
Balzano, John C., Covington & Burling LLP