SFDA Proposes Further Reforms in China's Drug Approval Process

by Richard Daverman, PhD

March 1, 2013 -- With the goal of encouraging innovation in both new drugs and generics, the SFDA has released new proposed guidelines for its drug review process. The most significant change will be a new emphasis on the clinical need for the drug. Drugs that address an unmet need – whether new or generic – will be given greater priority. In addition, the SFDA proposes greater emphasis on drugs for children and better protection for clinical trial participants. The SFDA aims to speed up approval for the products that meet the most critical needs. More details....