CFDA proposes major modernizations

In four new draft regulations, China FDA proposed reforms that would bring many of the agency's policies closer in line with Western standards. The proposals include strengthened IP protections and an expedited review process for clinical trial applications (CTAs). CFDA recommended that stakeholders email comments on the proposals by May 25. The final deadline is June 10.

In proposals in one document, CFDA would require meetings before sponsors begin Phase I or Phase III clinical studies. If the agency takes no action within 60 days of a submission, a sponsor would be allowed to proceed with a trial. In the U.S., a sponsor may begin trials if FDA does not raise an objection to its IND within 30 days...