Notice from the National Medical Products Administration on optimizing the pilot work of supplementary applications for the evaluation and approval of overseas production drugs.

The State Drug Administration, based on the pilot work of optimizing the application review and approval process for drug supplements, has decided to further optimize the application review and approval process for overseas production drugs. The provincial drug regulatory departments approved by the State Drug Administration for the pilot reform of optimizing the application review and approval process for drug supplements can provide pre-service for major changes in overseas production of chemical drugs by domestic responsible persons in the administrative region before declaration. After the overseas drug marketing license holder completes the study of major changes, the domestic responsible person can apply for pre-service to the pilot unit in the administrative region. For overseas production chemical drug supplement applications that have undergone pre-service, meet the reporting requirements, and do not require initiation of overseas registration verification, the review time limit is shortened from 200 working days to 60 working days.