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FDA updates 1989 Guidance on Drug Master Files

  • Posted by: inetika
  • Category: GLOBAL NEWS

The 1989 guidance on drug master files (DMFs) is the subject of a revised draft , which deals with submissions of confidential information about facilities, manufacturing, processing, packaging and storing drugs.

FDA states that the update includes new procedures for DMFs referenced in abbreviated new drug applications (ANDAs), more detailed instructions on submitting original DMFs versus amendments, reference to the electronic submission requirements under section 745A of the Federal Food, Drug, and Cosmetic Act (FD&C Act) that apply to certain DMFs, clarification and reorganization of material associated with Type III and Type IV DMFs, and a change in FDA’s contact person for the guidance.
The 22-page draft also discusses the four currently accepted types of DMFs (Type I DMFs were discontinued in 2000):

  • Type II, which is for drug substance, drug substance intermediate and materials used in their preparation or drug product
  • Type III is for packaging material
  • Type IV is for excipient, colorant, flavor, essence or material used in their preparation
  • Type V is for FDA-accepted reference information

The guidance also includes information on the format and delivery of DMFs, submitting original DMFs in eCTD format, submission recommendations by DMF type, and FDA processing and review policies. The agency also touches on the differences between DMFs for BLAs and DMFs for other applications under the FD&C Act.

Copies of the new draft can be accessed from here.

The agency has also further extended the implementation date for Type III DMF submissions in eCTD format to 5 May 2020.