Last week CIRS Head of Regulatory Collaborations and RAPS board member Dr Lawrence Liberti discussed “Challenges and Opportunities for Using Facilitated Regulatory Pathways (FRPs) in Mature and Emerging Markets” as part of a RAPS webcast.
Facilitated Regulatory Pathways (FRPs) comprise a diverse group of regulatory approaches designed to accelerate product development, the submission of marketing authorization applications, and/or regulatory reviews. The goal is to speed access to important new medicines with a positive benefit-risk balance. FRPs used by mature agencies may increase the level of communication between the agency and developer or place a larger emphasis on surrogate endpoints. FRPs found in emerging economies encourage reliance on or recognition of prior decisions from reference authorities to reduce duplicative work.
This webcast highlighted characteristics of FRPs used around the world, how to prepare for their use, and what the future of FRPs may entail.
To view the webcast, click here.
You can also access a previous RAPS webcast featuring Dr Liberti on ‘Aligning Regulatory and Access Expectations: Driving Towards Optimum Outcomes for the Key Stakeholders’ here.