The user fee legislation Congress approved June 26 makes quality risk management a GMP requirement, further pressuring pharmaceutical manufacturers to make sure they are protecting their global supply chains. The bill directs FDA to inspect based on risk rather than time or location, and to rely on trusted foreign inspectorates, while adding new user fees for generic drugs that will boost funding for further expansion of the agency’s inspectorate.

Reorganization in January expected to leave CDER’s nine-year-old pharmaceutical quality assessment organization more adaptable to public health emergencies, new pharmaceutical technologies and market dynamics, while further blending approaches to new and generic drug reviews.

Stakeholders propose centralized oversight approaches for managing quality of “like-for-like” fleets of self-contained manufacturing units that could roam the US – or the world. The US FDA shares the industry’s thinking on how best to adapt the site-focused regulatory scheme it enforces to the emerging variety of distributed manufacturing systems.