On Feb. 23, 2020, China's Center of Drug Evaluation (CDE) issued the Work Rules for the Disclosure of New Drugs' Technical Reports (Trial) 1. The document says, from Jun. 1, 2021, CDE will release the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. Innovative new drugs, improved new drugs, and imported original or improved drugs with overseas marketing authorization are the major types covered.
China CDE to Disclose New Drugs' Technical Review Reports
China's Center of Drug Evaluation (CDE) recently announced that it would disclose the technical review reports and package inserts of all new drugs approved since Sept. 1, 2016. The disclosure would also extend to generic drugs and other applications in the future.
You May Also Like
- In Light of the 14th Rare Disease Day, How Is China Doing on Rare Disease Drugs?
- China to Carry out National Insulin Procurement
- Monthly Recap: China Pharmaceutical Regulatory Updates | March 2021
- China's 2021 Two Sessions: What Can We Expect for the Medical and Health Sectors?
- China Launches Medical Device Master File System