FDA adopts draft ICH guidance for managing post-approval CMC changes

The United States (US) Food and Drug Administration (FDA) has made available an International Council for Harmonisation (ICH) draft guidance on technical and regulatory considerations for pharmaceutical product lifecycle management. The draft document aims to help facilitate the management of post-approval chemistry, manufacturing and controls (CMC) changes for new and marketed pharmaceutical drug substances and drug products.

Topics in the draft guideline focus on the categorisation of post-approval CMC changes, established conditions, post-approval change management protocols, product lifecycle management, pharmaceutical quality system and change management, the relationship between the regulatory assessment and inspection, and post-approval changes for marketed products. The draft document also includes a decision tree on the established conditions for manufacturing and control, which defines when notification or prior approval is necessary depending on the level of potential risk of a proposed change.

The FDA states that the draft is intended to demonstrate how increased product and process knowledge may contribute to a reduced number of regulatory submissions, which leads to a reduction in unnecessary costs and burdens for manufacturers and regulators. The FDA also states that the guidance helps to encourage continual improvements on products, which may help reduce variability and mitigate some shortages related to manufacturing and quality issues.

To view the ICH draft guidance on technical and regulatory considerations for pharmaceutical product lifecycle management, please click here.