China Food and Drug Administration, Decision on Revising Matters Relevant to the Administration of the Registration of Imported Pharmaceuticals (Draft for Comments)

国家食品药品监督管理总局关于调整进口药品注册管理有关事项的决定 (征求意见稿)

May 09, 2017 | BY

Susan Mok &clp articles &

Issued: March 17 2017 Main contents: With a view to encouraging the simultaneous conduct of foreign and domestic clinical trials, after approval,…

Promulgated: 2017-03-17

Issued: March 17 2017

Main contents: With a view to encouraging the simultaneous conduct of foreign and domestic clinical trials, after approval, of new foreign pharmaceuticals that have not yet been released into the market, reducing the time interval for such pharmaceuticals to be released into the market in China and abroad and when conducting international multi-center clinical trials of pharmaceuticals in China, the requirement that such pharmaceuticals are to have been registered or entered into Phase II or Phase III trials abroad is abolished, except for vaccine-type pharmaceuticals (Article 1).

Once the international multi-center clinical trials conducted in China are completed, an application for registration and placing the pharmaceutical on the market may be carried out directly (Article 2).

issued:2017-03-17

Issued: March 17 2017

Main contents: With a view to encouraging the simultaneous conduct of foreign and domestic clinical trials, after approval, of new foreign pharmaceuticals that have not yet been released into the market, reducing the time interval for such pharmaceuticals to be released into the market in China and abroad and when conducting international multi-center clinical trials of pharmaceuticals in China, the requirement that such pharmaceuticals are to have been registered or entered into Phase II or Phase III trials abroad is abolished, except for vaccine-type pharmaceuticals (Article 1).

Once the international multi-center clinical trials conducted in China are completed, an application for registration and placing the pharmaceutical on the market may be carried out directly (Article 2).

issued:2017-03-17

This premium content is reserved for
China Law & Practice Subscribers.

  • A database of over 3,000 essential documents including key PRC legislation translated into English
  • A choice of newsletters to alert you to changes affecting your business including sector specific updates
  • Premium access to the mobile optimized site for timely analysis that guides you through China's ever-changing business environment
For enterprise-wide or corporate enquiries, please contact our experienced Sales Professionals at +44 (0)203 868 7546 or [email protected]