What is DMF retirement?

DMF retirement” refers to the process by which a Drug Master File (DMF) is officially closed or deactivated by the regulatory authority (e.g., the FDA in the U.S.). This retirement can happen voluntarily by the DMF holder or sometimes by the regulatory authority, often due to inactivity or non-compliance. DMFs are critical for storing detailed proprietary information about an Active Pharmaceutical Ingredient (API), drug formulation, manufacturing process, quality controls, and packaging materials that are used in the production of a drug product. When a DMF is retired, it means that it is no longer considered active and cannot be used in new submissions for drug applications.

Reasons for DMF Retirement

DMFs can be retired for several reasons:

• Voluntary Retirement by DMF Holder: The DMF holder (typically the manufacturer) might choose to retire the DMF if the product is no longer in demand, if manufacturing has ceased, or if the information within the DMF is outdated.
• Inactivity or Non-Compliance: If the DMF has not been updated or referenced for an extended period, the regulatory agency may consider it inactive and initiate retirement. A lack of timely annual updates or necessary amendments might also trigger retirement.
• Regulatory Decision: Sometimes, the regulatory authority itself decides to retire a DMF if there are repeated compliance issues, non-adherence to required quality standards, or serious safety concerns.

DMF Retirement Process

The regulatory agency usually requires that the DMF holder submit a formal request or notification indicating their intention to retire the DMF. In some cases, the agency might notify the holder if it is retiring the DMF for compliance or other reasons.

Once the DMF retirement request is accepted, the agency removes the DMF from its list of active files. This means that the DMF will no longer appear as an option for reference in new drug applications or supplements.