News
Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Hot topic
REGULATION
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
REGULATION
Law & Regulation
Guideline
Reference Listed Drug (RLD)
MAH
GMP
Marketing Approval
Post-market
Generic Drug
Vaccine
GCP
COVID-19
Monthly 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
REGULATION
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
Most Popular
- Monthly Report: New Drug Approvals in China | February 2024
- Monthly Recap: China Pharmaceutical Regulatory Updates | February 2024
- 2023 China CDE Drug Evaluation Report
- [Updated] China Expedites Process for Transferring Overseas Drug Manufacturing Sites to China
- Monthly Report: New Drug Approvals in China | March 2024