Proposal aims to modernise registration for distributed drug manufacturers, strengthening real-time transparency across the pharmaceutical supply chain.
The US Food and Drug Administration is proposing a new, streamlined drug manufacturing registration pathway to improve its visibility into upstream supply chains.
If finalised, under the proposed rule, distributed manufacturing establishments could register as a single establishment, rather than the current siloed model where each manufacturing unit is required to register separately.
FDA anticipates that having a central quality oversight hub and multiple equivalent manufacturing units at different locations will lower registration costs for these companies. Additionally, that it would improve efficiency in the long-term and enable the agency to be better equipped to detect and respond to potential safety concerns.
Notably, manufacturing units could be added, relocated or removed. Companies would be required to provide advanced notice of relocation of a unit, closing a gap in the FDA’s real-time oversight.
The ‘hub-and-spoke’ model would make it clearer that certain foreign establishments must register with the FDA and report on the drugs they produce. This includes active pharmaceutical ingredients (APIs), that indirectly enter the US drug supply chain.
Dr Michael Davis, PhD, Acting Director of FDA’s Center for Drug Evaluation and Research, 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. Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve.”
Closing this registration gap for foreign establishments is a concrete step toward increasing the supply chain transparency that patients deserve”
Dr Michael Davis, PhD, Acting Director of FDA’s Center for Drug Evaluation and Research
This move is part of the agency’s efforts to improve reliable access to medicines by strengthening pharmaceutical manufacturing and aligning regulatory frameworks.
In May, the FDA also made progress to improve its efficacy by piloting one-day inspectional assessments. The initiative is aimed at increasing the number of facilities the agency can assess, without compromising regulatory rigour.
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