The Provisions for Post-approval Changes of Drugs (Interim) stipulates that MAHs are the main body of responsibility for the management of post-approval changes of drugs. MAHs shall establish a post-approval change control system in accordance with the laws and regulations on drug supervision, the Good Manufacturing Practice for Drugs, and other relevant requirements; formulate and implement the principle for internal classification of changes, list of changes, working procedures and risk management requirements of MAH in accordance with the relevant technical guidelines of NMPA and ICH; and determine the change management category after sufficient study, evaluation, and necessary verification with consideration to product characteristics.
- Local Title:药品上市后变更管理办法
- Country/Region:Chinese Mainland
- Competent Authority: National Medical Products Administration (NMPA)
- Status:In force
- Release Date:2021-01-13
- Implementation Date:2021-01-13