A Little Late, But CMC Annual Reportable Postapproval Changes Guidance Hits the Street

The good news is that there is some regulatory relief for the down-regulation of some changes from supplements to Annual Report notifications; the bad news is that the industry will likely spend as much time figuring out the Guidance and trying to position changes such that they can reasonably be read to be covered by the document as trying to get a Regulatory Project Manager on the phone at OGD.

The revised 13 page document covers changes to both NDAs and ANDAs and provides a general background section and the standard disclaimers found in all FDA guidance documents, but the real meat is found in Appendix A and Appendix B, which describe the types of changes that can now be submitting in the Annual Report.   Appendix A contains those types of changes that can be submitted in the Annual Report if the change has minimal potential to have an adverse effect on product quality (this is where the rubber meets the road and where firms are likely to be maybe too creative in their views of the impact of change- so be careful). Appendix B restates the annual reportable changes found in the various Scale-up and Post-approval Changes (SUPAC) Guidances.

FDA reminds the industry to continue to pay attention to the older “Changes to an Approved NDA and ANDA” Guidance and also notes that data supporting the change should be adequately presented to support the applicant’s determination that the change did not require the submission of a supplement.

The new Guidance covers changes to components and composition, manufacturing sites, manufacturing process, batch size and equipment changes, specifications, changes in container closures, and labeling changes associated with other related changes (e.g., how supplied or description changes).  The complete guidance document can be found here. Please be careful in your interpretation of the various provisions of this Guidance and remember the decision to submit a change in the Annual Report must take into consideration the potential for impacting the product quality and not the ultimate finding that it did not.

For questions related to this guidance or for help in its interpretation please contact Joan Janulis at j.janulislachmanconsultants.com or one of the Lachman Regulatory team.