In accordance with the "Announcement of the National Medical Products Administration on Matters Concerning the Implementation of the Drug Registration Regulation" (Announcement No. 46 of 2020), and to advance the drafting and formulation of relevant supporting normative documents and technical guidelines, the Center for Drug Evaluation (CDE), under the deployment of the National Medical Products Administration (NMPA), has organized the development of the "Application Procedures, Dossier Requirements, and Formal Review Content for Re-Registration of Overseas-Manufactured Drugs" (see attachment). This document has been reviewed and approved by the NMPA and is hereby issued. It will take effect from October 1, 2020.

Notice is hereby given.

Center for Drug Evaluation, National Medical Products Administration