- Workflow of DMF Filing
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):