CDE: opinions on reference to ICH m3 guiding principles in the evaluation of new drug research

Source: CDE 2016-8-4 at present, China's existing guiding principle system basically covers all aspects of non clinical safety research, providing an important reference for new drug research and evaluation However, in the process of new drug development, the relevant contents of the phased requirements are scattered in the guiding principles, without forming a system; there are also some guiding principles that have not been revised according to the recent progress, which can not adapt well to the current evaluation of new drug research in China, and is not conducive to international standards ICH m3 "guidelines for non clinical safety research supporting clinical trials and marketing of drugs" has been released and implemented in 2009 This guideline harmonizes and unifies the phased requirements of ICH three parties for non clinical safety research needed to support clinical trials and market applications, conforms to the general rules of new drug research evaluation, and is also suitable for research evaluation of new drugs in China In order to implement the relevant spirit of the opinions of the State Council on the reform of the review and approval system for pharmaceutical and medical devices (GF [2015] No 44), before the release of the relevant guiding principles in China, the phased requirements of ICH m3 guiding principles can be referred to in the new drug research evaluation to provide corresponding non clinical research support for the proposed clinical trial and listing application Drug review center 2016 August 1, 2006