July 10 (Reuters) – The U.S. FDA on Friday proposed a rule to streamline registration requirements for certain drug manufacturers that operate through a central hub and multiple production facilities, as part of its efforts to improve supply-chain transparency.
Here are some details:
• If finalized, the rule would allow manufacturers using a “hub-and-spoke” model to register as a single facility.
• In such a model, multiple sites produce the same drug under a single quality management system, allowing centralized oversight of production across different locations.
• Under current regulations, each manufacturing unit in such a network must register separately with the U.S. Food and Drug Administration.
• The agency said the proposed rule would allow such manufacturing establishments to register as a single establishment, while enabling units to be added, relocated or removed through a streamlined update process.
• Companies would be required to notify the FDA before relocating a manufacturing unit.
• The proposal would also clarify registration and drug-listing requirements for certain foreign facilities, including those that make active pharmaceutical ingredients.
• The FDA said some foreign establishments that manufacture drugs or drug components solely for distribution to other foreign facilities may not currently be registered with the agency, limiting its visibility into upstream supply chains.
• Under the proposed rule, those facilities would be more clearly required to register with the FDA and report the drugs they produce, improving the agency’s ability to trace products and respond to potential safety concerns.
• If finalized, the rule is expected to reduce registration costs and generate long-term efficiencies for both the industry and the agency, the FDA said.
(Reporting by Siddhi Mahatole in Bengaluru; Editing by Shilpi Majumdar)
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