In accordance with the relevant provisions of the Drug Administration Law, to reinforce the management of changes of post-approval drugs, the NMPA organized to formulate of the Provisions for Change Management of Post-approval Drugs (Interim), is hereby promulgated and shall go into effect as of January 12, 2021. The provisions of this present Announcement shall prevail over those previously announced.

Each provincial drug regulatory department shall implement the responsibility for supervision over change management of post-approval drugs at its administrative area, by specifying requirements, formulating working documents, and clarifying time limits. The cooperation between drug registration administration and production supervision should be consolidated for mutual support, to ensure the smooth and orderly implementation of change management of post-approval drugs.