New harmonised guidance for post-approval changes released by FDA

The US Food and Drug Administration (FDA) has released its final guidance for industry with new International Council for Harmonisation (ICH) guidelines, providing a more predictable and efficient framework for the management of post-approval chemistry, manufacturing and controls changes.

According to the FDA, the recommendations discuss 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.

Dr Michael Kopcha, director of the FDA’s Office of Pharmaceutical Quality, commented: “The FDA is continually working to promote drug innovation and improvement, strengthen quality assurance, safety and supply of drug products and enable more efficient use of industry and regulatory resources. Through the harmonisation of requirements for drug lifecycle management, manufacturers and the FDA can meet these goals in less time through effective management of post-approval changes.”

The agency also suggested that the guidance has the potential to help facilitate innovations in manufacturing through a flexible, risk-based approach to regulatory oversight. It stated that encouraging continual product improvement can help reduce product variability and prevent and mitigate shortages related to manufacturing and quality issues.

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 authorisation, as well as drug-device and biological product-device combination products that fall under the jurisdiction of the Center for Drug Evaluation and Research (CDER) or the Center for Biologics Evaluation and Research (CBER).

Dr Kopcha concluded: “Effective implementation of this guidance will provide an opportunity for the FDA to focus attention and resources on higher risk post-approval changes, incentivising manufacturers with additional flexibilities to continually improve their manufacturing processes, which can reduce the likelihood of quality-related supply disruptions and related drug shortages.”