On August 26th, 2019, China’s top legislature voted to adopt the revision to the drug administration law, which is an update from the version in the year of 2001. In the updated drug law, the concept of marketing authorization holder…
Category: China Pharma RA
ICH Guidelines adopted in China (Continually Updated)
China Drug Regulation Summary
CFDA: Guidelines for Acceptance of Overseas Clinical Trial Data
CFDA Announcement No. 13 in 2018, Issued on Jan. 18, 2018 Outline: To fulfill the clinical need of public for medical devices, improve the innovation of medical device technology, this guideline is made according to the “Opinions on reforming the review…