CROs conducting bioequivalence and bioavailability (BE/BA) studies for generics firms will have to log details of their sites with the US FDA under new ‘self-identification’ rules.
The requirement – part of the generic drug user fee act (GDUFA) that was passed into US law in July – is the first time sites providing the BE/BA data used in ANDAs have had to notify the FDA of their activities. Previously the agency only needed such submissions from API and finished dosage manufacturing facilities and packaging plants.
Food and Drug Administration (FDA) spokesman Christopher Kelly confirmed this, telling Outsourcing-pharma.com that: “It's a new requirement that BA/BE sites register via self-identification; however, this is different from register and listings.”
He explained that, unlike sites that are required to register under section 510 of the Federal Food, Drug, and Cosmetic Act or section 351 of the Public Health Service Act, under GDUFA BE/BA sites will need to ‘self-identify’ and log their details via an online database the FDA is developing.
Kelly added that: “These [BE/BA] sites are also exempt from facility and user fees.”
The FDA estimates that the ‘self identification’ process – which uses the same submission formatting and standards currently emploed by the existing Drug Registration and Listing System (eDRLS) - will take around two and a half hours per BE/BA facility.
But what does the services industry think? Outsourcing-pharma.com contacted bioRASi, a Florida, US-based contract research Organisation (CRO) that provides BE/BA services for pharmas putting together ANDAs, for its take on the new requirement.
Regulatory services director Stephanie Finnegan told us that: “Self-identification and registration is an excellent forum to demonstrate to the FDA that we in pharmaceutical development are capable of, and in fact, pleased to police ourselves and to comply with regulations,” describing the FDA as the most important client in drug development.
Finnegan also said that the registration process is straightforward and even suggested it may be completed more quickly than the agency estimates.
“We do not think that the registration requirements are onerous at all, and in fact, it will probably not take as long to register as is suggested."
She added that: “Any time that we, as a group, can foster the rapid development and approval of generic drugs and also underscore our commitment to quality and compliance to the Agency, that is a worthy accomplishment.”