USFDA Proposes New Rule to Streamline Drug Manufacturing Facility Registration
Bengaluru: The U.S. FDA has proposed a rule to streamline registration for certain distributed drug manufacturing sites and clarify reporting requirements for some foreign production facilities, as part of its efforts to improve supply-chain transparency.
If finalized, the rule, proposed on Friday, would allow manufacturers using a "hub-and-spoke" model to register as a single facility. In such a model, a central site oversees quality operations across multiple units producing the same products at 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 distributed 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.
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 for distributed manufacturing companies and generate long-term efficiencies for both the industry and the agency, the FDA said.
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.
