FDA publishes Draft Guidance on CMC Postapproval Changes (Annual Reports)

The US Food and Drug Administration (FDA) issued a draft guidance for industry, CMC Postapproval Manufacturing Changes Reportable in Annual Reports, providing recommendations to drug applicants about the types of changes that may be included in annual reports. Specifically, the guidance describes chemistry, manufacturing, and controls (CMC) postapproval manufacturing changes

Appendix A lists 40 types of CMC postapproval manufacturing changes previously submitted under manufacturing supplements that the FDA has determined to be generally of low risk to product quality (product identity, strength, quality, purity, and potency as they relate to the safety or effectiveness of the product). The changes are divided into six categories:

  • components and composition
  • manufacturing sites
  • manufacturing process
  • specifications
  • container/closure system
  • and miscellaneous changes

The changes listed under these categories are now reportable in Annual Reports. The changes are either additions or revisions to the classification of changes listed in the guidance, Changes to an Approved NDA or ANDA. The guidance states that the changes listed are to be used in the context of the specific product and the circumstances to determine the risk to product quality and whether the proposed change can be reported in an Annual Report.  Based on that evaluation the “NDA or ANDA holder may decide that a change described in Appendix A would more appropriately be submitted as a supplement rather than in an annual report. We [the FDA], therefore, consider this guidance to provide recommendations”.

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