China to Speed Up Approvals Of New Drugs and Medical Devices By Accepting Overseas Trial Data

Share:

china medical device classification

China is looking to speed up approvals for new drugs and devices and plans to accept data from clinical trials carried out overseas, a potential huge benefit  for both international device makers and China’s patients who often face lengthy delays for new products to reach the domestic market.

The move, announced by the cabinet late on October 8th, said foreign trial data can be accepted in a bid to accelerate approvals and help China close an innovation gap with developed markets. As stated in the PRC State Council’s website: “Clinical trial data from overseas centres that complies with Chinese drug and medical device registration requirements can be used to make registration applications in China.”  The move should help speed up approvals in the world’s second largest medical and health market,, where overseas manufacturers have been traditionally facing challenges from Chinese rivals and authorities that are keen to cultivate domestic innovations.

We will be writing more and informing you about the China’s State Council’s official opinions published on October 8th about deepening the reform on China’s the drug and device review and approval process and pushing for more innovations in the medical and health areas.

 


About China Med Device, LLC (CMD) CMD provides turn-key solution for Western medtech companies with regulatory and commercialization services. CMD helps its clients accelerate China entry and growth by offering: market Intelligence and research; CFDA regulatory services (premarket submission, clinical evaluation, clinical trial design & management, post market compliance and legal representation), and other commercial services. If you have an inquiry or feedback regarding our services please email us at info@ChinaMedDevice.com.

Related Posts