The US Food and Drug Administration (FDA) has proposed a new rule that will simplify the registration step for certain drug manufacturers with multiple facilities.
The new framework, which is yet to be finalised, will allow those with a “hub-and-spoke” model to register as a single facility. This model, which is a common blueprint in the pharma supply chain, involves multiple equivalent manufacturing units at different locations off-shooting from a central hub responsible for quality management. Contract development and manufacturing organisations (CDMOs) use a hub-and-spoke model to increase the efficiency of global supply chain logistics and bypass regional disruptions.
Discover B2B Marketing That Performs
Combine business intelligence and editorial excellence to reach engaged professionals across 36 leading media platforms.
Under current FDA rules, each unit has its own registration requirement – a step that the agency says creates extra administrative burdens. Through the new rule, this will be brought together into one path. A streamlined update process will also allow companies to have units added, relocated, and removed following a notification to the FDA.
Michael Davis, acting director of FDA’s Center for Drug Evaluation and Research (CDER), said: “The FDA is proposing changes to our establishment registration regulations that would reflect how distributed manufacturing actually works — as one single establishment. The proposed changes would make it easier for innovative manufacturers to operate efficiently, and give the FDA a clearer, more accurate picture of how and where drugs are being made.”
The proposed rule would also create new guidelines for establishments making medicines and drug components solely for overseas use. Currently, these facilities do not need to be registered with the FDA – an element the agency says limits its visibility into upstream supply chains. If finalised, the rule would mean these manufacturers must register with the FDA and report on the drugs they produce, improving responses to potential safety concerns and product tracing.
Davis added: “When an active ingredient in a medicine reaches an American patient, the FDA should be able to trace exactly where it came from. Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”
FDA joins manufacturing push
The US pharma landscape under the Trump administration has been characterised by an ongoing trend to reduce reliance on medicine imports. The White House has implemented far-reaching economic policies to bolster domestic manufacturing, innovation, and supply chains to achieve this. The threat of tariffs, for example, led to hundreds of billions of dollars pledged in total by pharma companies to bolster US manufacturing footprints.
The FDA has also been rolling out initiatives to incentivise the construction and registration of new facilities. The FDA launched the PreCheck programme in February 2026, though it was first unveiled in June 2025. Developed in response to an executive order (EO) signed by President Donald Trump, it became the first FDA policy directed at bolstering US pharma manufacturing. Eli Lilly and Regeneron are amongst the first seven companies selected for the pilot.
According to GlobalData analysis, the gap between the use of European and US facilities for manufacturing has widened over recent years. In 2025, 50% of new drugs had dose manufacturing contracts with European-based facilities, almost doubling the region’s share since 2023. By contrast, the proportion for US-based facilities has remained at a static 18% since 2024.
GlobalData is the parent company of Clinical Trials Arena.
