Shanghai China Old and New Shanghai Tower and Yuyuan Garden

It’s been a little more than a year since China’s FDA (CFDA) announced sweeping policy changes intended to streamline the review of innovative new drugs and rid their system of subpar applicants blocking the progress of true candidates for commercialization. The global pharmaceutical industry raised a collective eyebrow, not sure if the CFDA was truly committed to its new “Fast Track” approval pathway for new drugs.

The CFDA was true to its word. An article published last week (January 4) revealed that the CFDA will conduct clinical trial data inspections on 14 recently received drug registration filings that have completed clinical trials and applied for manufacturing or import. The majority of 14 applications are from multi-national corporations (MNCs), with filings relating to 13 products. The list was released as part of a self-audit process, meaning that applicants who detect data authenticity issues are permitted to withdraw their filing without penalty ahead of inspection.

MNC drug candidates represent have of those on the CFDA’s list:

There are several things worth noting. First, the CFDA is committed to fast-tracking innovative chinese-girl-with-vialdrugs that address diseases or conditions prevalent in China such as Hepatitis C, lung cancer and hypertension/stroke. The list reflects this prioritization.

Second, the CFDA wants China to bring more modern therapeutics to market faster while playing a greater role in clinical trials and eventually the manufacture of MNC drugs in China. It’s encouraging to see half of the fast-tracked drug candidates are from MNCs. With contract manufacturing resources like PaizaBio’s ausia-biotech-hangzhou-campusfill-and-finish operations in Hangzhou, in-country manufacture of MNC drugs is more likely.

Finally, the CFDA is serious about ridding their system of poor drug candidates. In 2016, 80 percent of domestic applicants voluntarily withdrew their applications as part of the self-audit program. This has been more effective than “Draino” for removing blockages that in the past prevented progress. Thankfully, viable drugs from MNCs and domestic companies are a major step closer to final market approval and availability to China’s 1.4 billion potential consumers.

Learn more about CFDA policies and how they impact MNCs from PaizaBio’s China-focused consultancy. Contact David Deere for details.