In order to implement the reform requirements of "streamlining management and serving the government", further optimize the business environment, reduce the burden on enterprises, and promote the electronic declaration of drug registration applications, The National Drug Administration has organized the drafting of the Announcement on the Implementation of Electronic Declaration for Drug Registration Applications (Draft for Soliciting Opinions), as well as the Notice on the Relevant Requirements for Electronic Declaration for Drug Registration Applications (Draft for Soliciting Opinions), the Technical Requirements for Electronic CDs of Application Materials (Draft for Soliciting Opinions), the Structure of Electronic Documents for Drug Registration Applications (Draft for Soliciting Opinions), and the Commitment Letter (Draft for Soliciting Opinions) (see attachment), We are now soliciting opinions from the public.

Please provide relevant feedback to our bureau before November 20, 2022.

Contact number: 010-85242409

Email: zhongwch@cde.org.cn