The Food and Drug Administration has proposed on July 14 streamlining regulatory requirements for pharmaceutical companies operating under 'hub-and-spoke' manufacturing models. The agency shared a proposed rule on July 10 designed to create a more efficient registration pathway for distributed manufacturing systems, allowing biopharma companies to register entire networks as single establishments rather than registering each site individually.
Traditionally, FDA-registered establishments are centralized at one location with oversight from an onsite quality unit. In contrast, distributed manufacturing involves a central 'hub' overseeing operations and implementing a unified quality system across multiple 'spoke' units in different locations. Current regulations require both the hub and each spoke to be registered separately, which the FDA said is “unnecessarily burdensome for industry” and could hinder broader adoption of distributed models.
If finalized, the new rule would allow changes such as adding or removing spoke units or relocating mobile production sites to be handled through expedited registration updates. The proposal applies specifically to networks operated as single legal entities with direct authority over their quality systems; it excludes third-party outsourcing arrangements due to concerns about consistent oversight.
The move follows predictions by the National Academies of Sciences, Engineering, and Medicine in 2021 that substantial innovations in integrated and flexible manufacturing were likely within five to ten years but warned that regulatory challenges could slow progress. In 2023, Amgen's manufacturing leaders questioned whether full data requirements at every site were sustainable given distributed models, describing existing rules as “increasingly arduous.”
According to the FDA's vision for its proposed rule, companies would be able to combine data from multiple sites when developing validation strategies for new processes. This approach could reduce required validation activities when expanding networks or deploying mobile units during emergencies—such as BioNTech’s use of modular facilities during the COVID-19 pandemic.
The proposal also addresses foreign manufacturers supplying drugs or ingredients overseas who may not currently register with the FDA. The agency seeks greater oversight by requiring these establishments to register and list their products. Public comments on the proposed rule are open until September 11.
