China Joins ICH Global Harmonization Efforts

On August 9, 2017, in an FDAVoiceblog post, Theresa M. Mullin, director of FDA’s Office of Strategic Programs in the Center for Drug Evaluation and Research, discussed her recent trip to China to meet with China Food and Drug Administration (CFDA) officials. Mullin also 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, the agencies 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, which was established in 1990, 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 continue to discuss modernization later in 2017.

Source: FDA