Regulatory Focus™ > News Articles > FDA Unveils New Guidance on Reporting Post-Approval Changes

FDA Unveils New Guidance on Reporting Post-Approval Changes

Posted 04 March 2014 | By

A new guidance finalized by the US Food and Drug Administration (FDA) is meant to clarify which events and changes sponsors of new and generic drug products need to report in their annual reports to FDA.

Under FDA regulations, changes to an approved new drug application (NDA) or abbreviated new drug application (ANDA) must be reported to regulators. Depending on the impact, reports of the change must either be approved in advance (Prior Approval Supplement), reported at the time of the change (Changes Being Effected-0 Day) or right before (CBE-30), or on an annual basis.

Those reported in an annual report are those that have the least potential to affect a product's safety, efficacy or quality. As FDA explains in its new guidance, CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports, many changes reported to FDA are of little risk to the product, and therefore would be better suited to annual reports-not supplements.

As such, FDA has compiled a new list of changes (Appendix A and B in the guidance) that companies can reference to see if their post-approval manufacturing changes would be appropriate to report in an annual report.

"We expect NDA and ANDA holders to evaluate the specific change that they are planning to make in the context of their particular circumstances to determine whether the proposed change would present a minimal potential to have an adverse effect on product quality," FDA writes. "When a risk-based evaluation shows that the proposed change would have a minimal potential to have an adverse effect on product quality, the change can be documented in the next annual report."

The new guidance supersedes change reporting recommendations in all other guidance documents, FDA said.

The guidance also covers the basics of the changes that must be recorded in the annual report, including a list of the changes, a summary of tests confirming the (non)impact of the changes, a description of the changes, and references to products affected.

 

CMC Postapproval Manufacturing Changes To Be Documented in Annual Reports

Federal Register


Tags: CMC

Regulatory Focus newsletters

All the biggest regulatory news and happenings.

Subscribe