Date: Thursday, November 5th, 2015
Time: 8AM PST | 11AM EST | 4PM GMT
The Chinese government (State Council) announced on Aug. 18th, 2015 to implement comprehensive reforms to China FDA (CFDA) review and approval system for drugs and medical devices. These reforms are aimed to achieve 5 goals: (1) enhance quality of review and approval, (2) eliminate backlog of regulatory applications, (3) improve quality of generic drugs, (4) encourage research and development of innovative new drugs, and (5) increase transparency of regulatory review and approval. Twelve tasks and multiple measures were announced which are highlighted by lifting drug review and approval standards including definition of a new drug, moving forward with quality equivalence assessment for generic drugs, accelerating review and approval of innovative new drugs, conducting pilot practice of drug marketing authorization holder (MAH) system, reinforcing responsibilities/liabilities of applicants, and improving review and approval of drug clinical trial applications. These reforms will have a profound impact on the entire health care industry in China, affecting both Chinese and foreign companies pursuing development and registration of drugs and medical devices in China. This webinar is designed to go through these reforms with our ex-China audience, analyzing and discussing potential implications and business impact to foreign companies, in order to help our clients to develop up-to-date and optimized business strategy and plan under the new regulatory environment in China.
Hua Mu, M.D., Ph.D.
Senior Vice President and Global Head of Product Development Service & Partnership
Download Dr. Mu’s Bio Here