FDA Releases Finalized Guidance on Postapproval CMC Changes

The FDA has finalized guidance on postapproval chemistry, manufacturing and control (CMC) changes developed in collaboration with the International Council for Harmonization.

The harmonized guidance is designed to help drugmakers better manage CMC changes in their quality systems, which could lead to a reduced need for regulatory oversight and to fewer postapproval submissions, the FDA said.

The agency laid out a lengthy list of harmonized regulatory tools and concepts to improve the management of postapproval changes and to enhance transparency between drugmakers and regulators.

For example, the guidance categorizes the CMC change communications expected from marketing authorization holders based on the potential risk and the potential for an adverse effect on product quality. Changes should be ranked from high to low in terms of their potential risk and they will require different actions by drugmakers based on those risks, the agency said.