US FDA Advances Regulatory Framework for Continuous Manufacturing and Artificial Intelligence in Drug Manufacturing

The United States Food and Drug Administration (FDA) issued the International Council for Harmonization (ICH) final guidance, “Q13 Continuous Manufacturing of Drug Substances and Drug Products” and a discussion paper for stakeholder comment, “Discussion Paper: Artificial Intelligence in Drug Manufacturing.” These documents represent proactive steps FDA is taking to facilitate the pharmaceutical industry’s adoption of these advanced manufacturing technologies. FDA has long supported advanced manufacturing technologies that might improve process quality and address underlying causes of drug shortages and recalls.

The guidance, which was endorsed by the ICH Assembly as an ICH guideline in November 2022, provides global harmonization for regulatory approaches and encourages broader adoption of continuous manufacturing of drug substances and drug products. The guidance is applicable to products in development (e.g., new drugs, generic drugs, and biological products including biosimilars) and existing products that may transition from batch to continuous manufacturing. This guidance builds on existing ICH quality guidelines, including ICH Q7 through Q12, and replaces the draft guidance of the same name issued in October 2021 and the draft guidance “Quality Considerations for Continuous Manufacturing” issued in February 2019.

FDA has also issued a discussion paper on AI in drug manufacturing to proactively prepare for the implementation of these technologies. The discussion paper does not constitute guidance; instead, its purpose is gathering early feedback from stakeholders to inform future policy development. FDA is seeking input on eight questions in the discussion paper. Public feedback will help inform FDA’s evaluation of the existing regulatory framework as it applies to the use of AI in drug manufacturing and the assurance of quality drugs for U.S. patients. FDA encourages stakeholders to provide comments to the docket (FDA-2023-N-0487) by May 1, 2023.