Register for Upcoming Webinar on DEC. 8 @ 11AM

2023 China NMPA Bluebook is here:

More Coordinated Efforts Between US FDA and China’s CFDA On ICH


More Coordinated Efforts Between US FDA and China’s CFDA On ICH

On August 9, 2017, in an FDAVoice blog post, Theresa M. Mullin, director of FDA’s Office of Strategic Programs at Center for Drug Evaluation & Research, discussed her recent trip to China to meet with CFDA officials. Mullin expressed the agency’s appreciation for China’s recent action to become a member of the International Council for Harmonization (ICH).

During FDA’s meeting with CFDA, they discussed the modernization of regulatory review systems and the importance of international collaboration to ensure consistent standards worldwide. China, like other countries, faces similar challenges to ensuring safe and effective drug products. According to FDA, CFDA has implemented changes to its regulations to align its standards to other global standards in order to address these challenges, including reforming its drug review system and implementing ICH guidelines.

ICH: established in 1990. It has worked to standardize and evaluate drug development practices to ensure the development and manufacture of safe and effective medicines throughout the world. Harmonization of standards will ensure that different markets are held to the same standards throughout the world. CFDA’s membership in ICH will help ensure that goal.

CFDA’s membership in ICH marks a significant milestone in expanding ICH’s impact and promoting global public health,” said Mullin in the blog post. FDA and CFDA will further discuss modernization later in 2017.


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

Have Questions?

Related Services


Recent Events

Related Posts


Get Updated

Receive Updates in Your Inbox