CFDA moving to implement greater transparency over drug reviews

As full ICH member CFDA applies international standards

The China Food and Drug Administration (CFDA) is preparing to raise the levels of information disclosure and transparency surrounding drug reviews and approvals. Last week, draft proposals were released seeking public feedback on exactly how information will be disclosed by the Center for Drug Evaluation (CDE) in future.

The proposed measures include requiring the CDE to publish its decisions and reasoning for priority reviews and special approvals. If implemented, the CDE would also be obliged to produce technical review information for all novel drugs and generics within 60 working days of market approval. For generics that have passed quality and efficacy consistency evaluation, details of product specifications, corporate reports, and bioequivalence test data among others will also be released, as well as being listed in the recently released “Listed Drugs Catalogue of China”. The proposals for greater transparency follow the CFDA’s formal admission to full membership of the ICH – the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use – in June last year, part of efforts to upgrade China’s drug review and approval system in line with international norms.

Source: GBI (

Copyright Widler & Schiemann AG 2015. All Rights Reserved. /