FDA is announcing the availability of a draft guidance for industry entitled Postapproval Changes to Drug Substances. As part of the reauthorization of the Generic Drug User Fee Amendments (GDUFA II), FDA committed to issuing a guidance on postapproval changes to API DMFs, also known as Type II DMFs, and submission mechanisms for ANDA holders who reference such DMFs. This guidance describes the documentation to be submitted by master file holders or drug substance manufacturers, as appropriate, as well as documentation to be submitted by the approved application holder, along with references to the appropriate pathways for such submissions.
This guidance provides recommendations to holders of approved new drug applications, abbreviated new drug applications, new animal drug applications, abbreviated new animal drug applications, and holders of drug master files and veterinary master files who may want to make a change to the drug substance manufacturing process during the drug product application postapproval period. Specifically, it addresses how the risk of one or more change(s) to the drug substance should be assessed and provides recommendations regarding the documentation needed to support such changes for the drug substance, and where applicable, for the drug product made with modified drug substance.
The guidance covers the following: - facility, scale, and equipment changes associated with all steps of drug substance manufacturing;
- specification changes to starting materials, raw materials, intermediates, and the unfinished and final drug substance;
- synthetic manufacturing process changes;
- changes in the source of drug substance; and
- a change to the container closure system of the drug substance.
To comment on the draft guidance, please visit the public docket, FDA-2018-D-3151. |
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