【讨论】Post-Approval Changes new FDA Guidance

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The US Food and Drug Administration (FDA) haspublished a new guidance on post-approval changes called "CMC PostapprovalManufacturing Changes To Be Documented in Annual Reports". The aim of thedocument is to clarify which changes need to be reported in annual reports bysponsors of new and generic drug products.
The FDA requires that changes to an approvednew drug application (NDA) or abbreviated new drug application (ANDA) must bereported. 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 arethose with a very little or no potential to affect a product's safety, efficacyor quality. In the new guidance, FDA underlines that changes with little riskto the product should be reported in annual reports (and not insupplements).
To support decision making, the authority hascompiled a new list of changes in the guidance (Appendix A and B). Companiescan reference to see if their post-approval manufacturing changes would beappropriate 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)".