China’s Quality Regulatory Process Evolving Toward the Western Model

China’s quality regulatory process is evolving toward the Western model as it draws on and incorporates guidance from the EMA, WHO, FDA and ICH.

The CMC and GMP changes are part of a larger healthcare reform effort in China intended to help promote the quality and global marketing of Chinese products and enhance innovation.

Addressing the changing Chinese regulatory landscape, and the CMC component in particular, at the ISPE annual meeting in Orlando, Florida in November, Pfizer Global Regulatory CMC Executive Director Chi-Wan Chen commented that “regulators in China continue to be open minded, which is a very welcome sign.  They are willing to listen to the innovative pharmaceutical industry and adopt international standards, such as ICH.”

Of Chinese origin, Chen was a top FDA CMC regulator – serving as Deputy Director of CDER’s Office of New Drug Quality Assessment (ONDQA) before joining Pfizer in March 2008.

[More on China’s evolving quality regulatory process and Chen’s insights from the ISPE meeting is provided for subscribers here. Non-subscribers may purchase the 8-page story for $95 by contacting Karen Bertani ( To subscribe to IPQ click here.]