China Issues Fast-Track Registration Procedure For Drugs To Balance Innovation And Risk: SFDA Press Conference
This article was originally published in PharmAsia News
SHANGHAI - China's State FDA issued regulations on a special approval procedure to accelerate the approval process for new drug applications, effective Jan. 7
You may also be interested in...
Pressured by increasing calls from industry, China’s State FDA released a new proposal to expedite new drug reviews, focusing on drugs with high clinical value.
It’s not an anticancer therapy, and it has only Phase II data from overseas, but Takeda has managed to cut the average clinical trial authorization time for Class 1 new drugs in China by two months.
A market access study conducted by IMS and RDPAC sheds lights on regulatory and reimbursement challenges facing MNCs in China.