CHINA DRUG MASTER FILE WHITEPAPER

Cisema’s China Drug Master File Whitepaper provides key information about Drug Master Files (DMF) for Active Pharmaceutical Ingredients, Excipients and Packaging for drugs in mainland China.

The whitepaper addresses:

  • The regulatory framework, including the various Chinese authorities responsible for DMFs
  • The Process of preparing and submitting a Drug Master File in China for Active Pharmaceutical Ingredients, Excipients and Packaging
  • Post-Market Responsibilities
China Drug Master File whitepaper

What is a Drug Master File?

In China, as in other jurisdictions such as the United States or Europe, Drug Master Files (DMFs) provide detailed and confidential information about the manufacturing, processing, packaging, and storage of drug substances, excipients, and packaging materials.

DMFs allow suppliers of Active Pharmaceutical Ingredients (API), Excipients or Pharmaceutical Packaging (collectively known as AEP) to submit detailed information about their products and processes to the regulatory authorities without disclosing proprietary information to their customers, the drug Marketing Authorization Holder (MAH).

The National Medical Products Administration (NMPA) (formerly known as the China Food and Drug Administration or CFDA) is the regulatory authority responsible for the review and approval of Drug Master Files in China.

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How does a DMF work?

Manufacturers of APIs, Excipients and Pharmaceutical Packaging submit applications for their respective Drug Master File directly to the NMPA. The application dossier includes detailed information on:

  • manufacturing processes
  • quality control measures
  • compliance with Chinese regulatory standards.

We provide lists of the various documentation required in our DMF Whitepaper (complete the form to request a copy).

The information that is disclosed in the DMF application can only be accessed by the NMPA. Moreover, this information cannot be accessed publicly and is not shared with the drug manufacturer. In this way, it helps protect proprietary and intellectual property by allowing manufacturers to provide necessary information to regulators without revealing sensitive data to competitors or customers.

The NMPA will then review the Drug Master Filing application to ensure it meets all regulatory requirements at which stage it will be granted an “Inactive” status. A full technical review takes place once a drug marketing authorization application is submitted. Once the drug is finally approved, the status of the Active Pharmaceutical Ingredients (API), Excipients or Pharmaceutical Packaging DMF applications changes to “Active”.

To learn more about the specific Drug Master Filing process in China, request our dedicated DMF Approval in China Whitepaper by submitting the request form which can be found on this page.

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