China’s new drug registration guidelines pave way for the nation’s key role in global trials, but local hurdles hamper seamless roll-out – experts
China’s enactment of new rules to speed up drug and device approvals will free up sponsors to play a greater role in selecting clinical trial sites and open opportunities for CMOs, experts said. Still, even as the move sets the country up to become the main center for clinical trials in Asia, current infrastructural challenges pose considerable hurdles, they added.
With revamped guidelines on clinical site eligibility, drug and trial registration, drug quality and more, as well as with an expanded staff count at the China Food and Drug Administration (CFDA), China is increasingly viable as a region for international site enrollment, experts pointed out. That said, key weaknesses that remain include a shortage of top clinical development talent and poor intellectual property (IP) enforcement, though these issues are being addressed, experts said.
The Chinese State Council released new guidelines on 11 October that it will accept overseas clinical data from drugs and medical devices for registration, on the condition that they were done in multiple locations and meet local requirements.