DMF FILING
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Drug Master File (DMF) in China Introduction

China drug master file (DMF) policy was implemented by China NMPA (formerly CFDA) in July 2019. Under this policy, it is common for drug product applicants to expect their suppliers to obtain China DMF number(s) prior to drug submission, ensuring confidential data review by China CDE without disclosing information to the drug client.

Scope of China DMF
China DMF covers three categories:

  • Active pharmaceutical ingredients (APIs)
  • Excipients
  • Packaging materials

Overlaps in China DMF and US DMF
The China DMF regulatory system shares similarities with the US DMF, EU ASMF, and CEP. However, there are gaps in requirements, including compliance with Chinese Pharmacopoeia (CHP), specific testing data, and others that must be addressed for successful DMF registration in China.

For more on China DMF, click here for our DMF guide.

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