FDA Issues Final Guidance on Post-Approval CMC Changes
The US Food and Drug Administration (FDA) has issued a final guidance on pharmaceutical product lifecycle management in line with a recent guideline from the International Conference on Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), an international non-binding body harmonizing GMP, quality, and clinical practices.
ICH adopted the guideline, Q12, Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management, in November 2019, and the guideline is in process of being adopted by regulatory agencies that are part of the ICH. The FDA has issued a final guidance with the new ICH guideline.
The FDA guidance, Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management Annex, provides a framework to facilitate the management of post-approval chemistry, manufacturing and controls changes in a more predictable and efficient manner. The FDA guidance discusses how to identify the elements in an application that are considered necessary to assure product quality and therefore would require a regulatory submission if changed post-approval.
The guidance is applicable to pharmaceutical drug substances and products (both chemical and biological) that require a marketing authorization and to drug-device and biological product-device combination products that fall under the jurisdiction of the Center for Drug Evaluation and Research or the Center for Biologics Evaluation and Research. Changes needed to comply with new or revised pharmacopoeial monographs are not within the scope of this guidance.
In addition to post-approval changes, the FDA says its final guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight.
Source: US Food and Drug Administration