Post-Approval Changes: new FDA Guidance

The US Food and Drug Administration (FDA) has published a new guidance on post-approval changes called "CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports". The aim of the document is to clarify which changes need to be reported in annual reports by sponsors of new and generic drug products.

The FDA requires that changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA) must be reported. There are three ways to do this:

  • in advance (Prior Approval Supplement)
  • at the time of the change or right before (Changes Being Effected-0 Day or CBE-30)
  • on an annual basis (Annual Report).

The changes reported on an annual basis are those with a very little or no potential to affect a product's safety, efficacy or quality. In the new guidance, FDA underlines that changes with little risk to the product should be reported in annual reports (and  not in supplements).

To support decision making, the authority has compiled a new list of changes in the guidance (Appendix A and B). Companies can reference to see if their post-approval manufacturing changes would be appropriate to report in an annual report:

  • Appendix A "lists examples of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that we have determined generally to be of low risk to product quality".
  • Appendix B "provides examples of minor changes to be documented in an annual report that were previously published in FDA's Scale-up and Postapproval Changes (SUPAC) guidances and other postapproval change CMC guidances (see Section V. Resources for a list of those guidances)".

Source: FDA Guidance for Industry: CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports

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