FDA Finalizes Guidance with Internationally Harmonized Recommendations to Further Support Safe, High-Quality Human Drug Products

The U.S. Food and Drug Administration is announcing the availability of a final guidance for industry, “Q12 Technical and Regulatory Considerations for Pharmaceutical Product Lifecycle Management.” This guidance, which was adopted as an ICH Guideline in November 2019, provides a framework to facilitate the management of post-approval chemistry, manufacturing and controls changes in a more predictable and efficient manner. The 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 postapproval.

In addition to post-approval changes, the guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight. Encouraging continual product improvement can help reduce product variability and prevent and mitigate shortages related to manufacturing and quality issues. In addition to benefitting industry and regulators, the approach discussed in the guidance will help to assure that patients have access to high quality therapies.

The FDA publishes ICH guidelines as FDA guidances. This 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 pharmacopeial monographs are not within the scope of this guidance.