Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
China Implements GMP Appendix for Investigational Products Used in Clinical Trials On July 1, 2022, the Appendix to GMP for Pharmaceuticals: Investigational Products Used in Clinical Trials comes into effect. The Appendix is a supporting document for China's pharmaceutical GMP, which was revised in 2010 and has been effective since 2011.
Jul 01, 2022
China CFDI 2021 Drug Inspection Overview In 2021, China CFDI completed 1,368 drug inspections, including 1,214 drug registration inspections, 101 drug supervision inspections, 6 overseas inspections, and 47 license inspections.
Jun 30, 2022
China Consults on GMP for Pharmaceutical Packaging Materials On June 2, China NMPA released the draft of Good Manufacturing Practice (GMP) of Pharmaceutical Packaging Materials for public comments. The Packaging GMP specifies basic requirements for the manufacture management and quality control of pharmaceutical packaging materials.
Jun 09, 2022
China Specifies GMP Regulations on Investigational Products Used in Clinical Trials On May 27, China NMPA released the Appendix to Good Manufacturing Practice (GMP) for Pharmaceuticals: Investigational Drugs Used in Clinical Trials, which will take effect on July 1, 2022.
Jun 06, 2022
Law & Regulation CDE Guideline Reference Listed Drug (RLD) MAH GMP Marketing Approval Post-market Generic Drug Vaccine GCP COVID-19Monthly Recap: China Pharmaceutical Regulatory Updates | March 2022 Check out the pharmaceutical regulatory updates in China: NMPA releases the 52th list of reference listed drugs; China NMPA consults on drug MAH's inspection regulation...
Apr 08, 2022
China Takes New Measures for GMP & GSP Inspection China has cancelled the GMP and GSP certification since it implemented Drug Administration Law in 2019. Now, the drug manufacturing and supply activities in the country will be inspected according to Administrative Measures on Drug Inspection (Trial).
Jun 15, 2021
China Releases Guidance for Declaration of Chemical Drug Changes On Feb. 10, 2021, China Center for Drug Evaluation issued and started implementing the Guidance for Acceptance and Review of Chemical Drug Changes (Trial). The document addresses supplemental applications that entail the reviews of state-level drug regulatory authorities, including those submitted during clinical trials.
Mar 19, 2021
- China Releases MedDRA Coding Guidance for Adverse Drug Reaction (ADR) Reports
- Generic Drug Application (ANDA) in China
- Monthly Report: New Drug Approvals in China | April 2022
- China Encourages Innovative Drug R&D in Revised Draft of Regulations for Implementing the Drug Administration Law
- Monthly Recap: China Pharmaceutical Regulatory Updates | May 2022