Did you know?

ChinaBio® Group is a consulting and advisory firm helping life science companies and investors achieve success in China. ChinaBio works with U.S., European and APAC companies and investors seeking partnerships, acquisitions, novel technologies and funding in China.  

Learn more >>

Free Newsletter

Have the latest stories on China's life science industry delivered to your inbox daily or weekly - free!

  Email address:
   

China's FDA Issues Proposals to Speed Drug Approvals, Improve IP

publication date: May 15, 2017
Last week, the CFDA began circulating draft proposals for broad-based reforms that will bring China's drug regulatory system closer to western procedures. Among other changes, the CFDA plans to begin approving INDs automatically if the agency doesn't issue a ruling within two months -- a much shorter timeline than the current practice. It will also allow conditional access to better treatments for rare diseases after Phase I trials. The agency loosened its controls over China clinical trial sites and improved IP protection of novel drugs. And the National Reimbursable Drug List will be updated continuously (the February update was the first in eight years).

Share this with colleagues:  


This article is available for purchase - please click here for details.

Sorry this page is available to subscribers only.
If you're not a subscriber why not subscribe today?

If you are already a subscriber, please login.

If you believe you should have received this message in error, please contact us.


 

To gain access to the members only content click here to subscribe.

You will be given immediate access to premium content on the site.

Upcoming event
ChinaBio Partnering Forum 2019
Shanghai , China
May 8-9, 2019
 
ChinaBio® News

Greg Scott BIO-Europe Interview
Greg Scott Interviewed at BIO-Europe Spring

How to bring your China assets to China in 8 minutes


Greg Scott Mendelspod Interview
"Mr. Bio in China."
Mendelspod Interview

Multinational pharma held to a higher standard in China

ChinaBio® Events