On March 17, the China Food and Drug Administration (CFDA) published a draft Decision for Adjusting the Administrative Regime for Import Drug Registrations, soliciting public comments by April 20, 2017.
These measures, if finalized, would bring fundamental changes to the existing import drug registration system of China and significantly accelerate the entrance of foreign innovative drugs to the Chinese market. The highlights are:
- Except for vaccines, the CFDA would no longer require investigational drugs to be approved in another country or to have been in Phase II or Phase III trials elsewhere before an international multi-center trial can be conducted in China for that drug;
- A foreign manufacturer may apply for importation of a chemical drug or a therapeutic biological product before the product has been approved in its home country or region;
- For a foreign drug on which the international multi-center trial has already been conducted in China, the applicant may directly apply for market approval with the CFDA after the multi-center trial is completed; and
- The CFDA would simplify the process of import drug registrations that are based on data from international multi-center trials, and waive the requirements for registration trials on such drugs.
We encourage stakeholders to submit comments and to consider broadly the opportunities these proposed changes will entail.