In accordance with the Announcement of the National Medical Products Administration on Matters Related to the Implementation of the Drug Registration Regulation (2020 No. 46), and to facilitate the drafting of supporting regulatory documents and technical guidelines, the Center for Drug Evaluation (CDE), under the deployment of the National Medical Products Administration (NMPA), has formulated the Re-Registration Application Procedures, Dossier Requirements, and Form Review Content for Overseas-Manufactured Drugs (see attachment). This document has been reviewed and approved by the NMPA and is hereby issued, effective from October 1, 2020.

This notice is hereby announced.

Center for Drug Evaluation, National Medical Products Administration