Comprehensive coverage on the latest pharmaceutical regulatory update and industry activities in China.
Clinical Real-World Data Pilot Program: Fast-Track Entry Pathway into China It usually takes at least three to five years for innovative new medical products to enter the Chinese market. However, procedure could be much shorter with the application supported by clinical RWD.
Apr 12, 2021
China Announces Technical Requirements for Overseas Approved Chemical Drugs Seeking Domestic Marketing Authorization On Mar. 8, China Center of Drug Evaluation issued the Technical Requirements for CMC Studies and Evaluation of Overseas-approved Chemical Drugs without Domestic Marketing Authorization (Trial).
Mar 09, 2021
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.
Feb 24, 2021
- 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