The Notice on the Administration of Chemical Active Pharmaceutical Ingredient (API) Registration Renewal applies to APIs that have obtained approval numbers or approval notifications.
For an API manufactured in China, the manufacturer should submit the renewal application to the provincial-level medical products administration.
For an API manufactured outside China, the foreign manufacturer should appoint a corporate entity to act as its local agent in China. The Chinese agent is responsible for submitting the renewal application to the Center for Drug Evaluation (CDE).