According to the regulatory requirements for DMF filing in China, such as the Drug Administration Law of the People’s Republic of China (2019 Revision) and the Provisions for Drug Registration (2020 SAMR Decree No. 27), an overseas manufacturer of an Active Pharmaceutical Ingredient (API), a pharmaceutical excipient or packaging material shall apply for marketing authorization in China through DMF filing for the product. After submitting an application for DMF filing to Center for Drug Evaluation (CDE), CDE will arrange a technical review for the product in combination with its related finished dosage from (Drug-related Associated Review). For every accepted application, a filing number will be issued by CDE and the general product information will be published online.
To be further clarified, we summarized the workflow of China DMF filing below (Fig. 1):
After preparing a DMF dossier for product filing in China, the applicant could submit the application on CDE’s platform. CDE will check the dossier completeness and accept the application when no deficiency is identified. After dossier acceptance, an inactive filing number will be issued by CDE with status “I” (inactive). According to the requirements of Drug-related Associated review, manufacturer of the finished dosage form shall also submit drug registration for review. For a high-risk API, pharmaceutical excipient or packaging material, National Medical Products Administration (NMPA) will conduct for-cause on-site inspection in the process of research, development, manufacture, distribution and use of product during the review. The product will be comprehensively reviewed based on the DMF dossier, the result of site inspection and sample testing. For a positive result, the filing number will be activated with status “A” (active) and the product is approved for China marketing authorization.
