The FDA has issued a proposed rule that would “create a streamlined registration pathway for distributed manufacturing establishments that operate as a single establishment using a ‘hub-and-spoke’ model.”
The rule would also “clarify registration requirements for certain foreign establishments that manufacture drugs, including active pharmaceutical ingredients, that indirectly enter the U.S. drug supply.”
Distributed manufacturing establishments operate using a “’hub-and-spoke’ model, with a central quality oversight hub and multiple equivalent manufacturing units at different locations. Currently, regulations require each manufacturing unit in such a network to register separately, creating unnecessary administrative burdens. Under the proposed rule, distributed manufacturing establishments could register as a single establishment.”
According to the acting director of FDA’s Center for Drug Evaluation and Research, these 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 rule would also “clarify registration and drug listing requirements for certain foreign drug manufacturing establishments.”
The proposed rule, if finalized, is expected to “reduce registration costs for distributed manufacturing companies and generate long-term efficiencies for both industry and the agency.”
