TGA is proceeding to update its Advertising regulations. The next step is a public consultation ending 27 April 2018. We look at the specific changes and their impact.
On December 28, CFDA released the draft regulations for inspection of overseas drug and medical device manufacturers. Domestically CFDA has been stepping up inspection efforts for several years, including unannounced and random audits. Now CFDA inspection is going global. We take a look at the proposed inspection program.
China’s CFDA released draft regulation changes in October with far reaching proposals including faster Clinical trial approvals and abolition of Type Testing. At the same time CFDA is getting tougher in postmarket supervision. This could all be law by Chinese new Year.
CFDA held a press conference in September to announce the implementation of the updated Devices classification catalogue, which takes effect next August. It’s a very substantial overhaul and some manufacturers will find themselves needing to re-register at higher classification. Is your device reclassified?
The annual TGA Sponsor Information day provides a focused full day program on Australian regulatory requirements. here from TGA officials and leading industry experts on how it all works. Still time to register….
Presentations from CFDA leadership at the CIMDR meeting in Hangzhou point to continuing reform in Type Testing requirements, clinical trials supervision, device classifications and review processes. We take a look at the key messages from CFDA on China’s regulatory reform program.