New fees, tests and document requirements for DMF registration of APIs

There has been a recent and important change regarding the DMF (Drug Master File) registration of APIs (Active Pharmaceutical Ingredients) in China.

The NMPA (National Medical Products Administration, formerly CFDA) notice was published on 17th January 2020. A new online application system was implemented on 17th January 2020. It includes a new registration form.

There is the possibility that the NMPA introduced these changes in order to charge API DMF separately from final pharmaceutical products. An official application fee of RMB 367,600.00 was introduced. No official announcement containing detailed payment instructions, such as price and payment target, have yet been issued.

The process of API DMF is shown simplified below:
• Application for DMF number
• Preparation of all required technical documents
• Submission of the complete application dossier to CDE (Center for Drug Evaluation)
• CDE’s approval and online status “I”, which is made visible online.

The process for the “Bundle Technical Review” is shown simplified below:
• Payment of application fee for API (new requirement)
• Performance of registration test for API in China (new requirement)
• Receipt of test report, which is directly transferred from the test laboratory to the CDE
• Start of “Bundle Technical Review” together with the final pharmaceutical product
• Receipt of supplementary notice
• Preparation and submission of supplementary dossier
• CDE’s final approval and online status “A”