Drug Master File DMF in China was introduced in January 2018 and is very similar to the drug master filing system in the United States.
DMFs in China can be submitted for:
- Active Pharmaceutical Ingredients (APIs)
- Pharmaceutical Excipients
- Pharmaceutical Packaging Materials.
Companies applying for drug marketing authorizations in China will need to reference data from other products used during manufacturing such as Active pharmaceutical ingredients, Excipients, and pharmaceutical Packaging, collectively known in China as AEP. An AEP supplier may choose to protect its proprietary production information by submitting a Drug Master File direct to the regulatory authority responsible for pharmaceuticals in China, the National Medical Products Administration (NMPA).
A China DMF is a confidential and detailed submission of proprietary production and quality data on APIs, excipients, and packaging to the NMPA. The NMPA then stores this information in their database which is accessed by the NMPA as part of the approval of an end product, a drug.
The AEP supplier will receive a China DMF number which it then provides to its customer (the final drug applicant) thereby avoiding passing on confidential information and streamlining the process for the customer. The client then submits the DMF number as part of their drug marketing authorization application in China.
Below we outline the process of submitting drug master files or DMFs in China in four simple steps.
As a foreign manufacturer, your first step is to nominate a local authorized representative known as the NMPA Legal Agent. As your NMPA Legal Agent, Cisema will create an account for you with the NMPA.
The next step is to obtain a pre-DMF number. The pre-DMF number can be obtained in just three (3) working days as not all documents need to be submitted at this stage. The AEP supplier can now give the pre-DMF number to its customers so they can begin the drug authorization approval application using the pre-DMF number. And the AEP supplier continues to prepare its China drug master file application.
The next step is to submit the China DMF application to the NMPA who will then undertake an initial review to ensure all documentation has been provided.
The China DMF application will then be set to status “I” or Inactive. This means the China DMF filing application is ready to be reviewed by the evaluator as part of a drug authorization application.
API, excipient, and packaging material suppliers can submit a China Drug Master File separately from a drug application or they can be submitted as part of a drug application dossier. However, Active Pharmaceutical Ingredient suppliers also have the option to submit a China Drug Master Filing independently.
The next step is the technical review by the NMPA. During approval of the drug, the NMPA may issue a Supplementary Notice for additional information to be submitted. Only once all requirements have been satisfied then the status of the China drug master file is set to “A” or Active. This indicates that the AEP are approved for use in the finished drugs and can be imported into China without restrictions. It can take between 6 and 12 months to obtain approval of a China DMF application. .
