Yes, an approved China DMF (Drug Master File) can be amended or updated. Changes to the DMF must be submitted to the Center for Drug Evaluation (CDE) of the National Medical Products Administration (NMPA) for review and approval. The updated DMF will then be evaluated by the NMPA before it can be implemented. Alternatively, if the changes to the DMF are not significant, they can be reported via the annual report which is due at the end of the first quarter of every year.
