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Posted 17 March 2022 | By Joanne S. Eglovitch 

FDA, EMA tout benefits of parallel scientific advice program

3085 Regulators described how the parallel scientific advice (PSA) program offered by the US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) saves sponsors time and resources by bringing both health authorities to the table to hammer out solutions to complex scientific issues arising from their drug development packages at a 16 March webinar held by FDA’s Small Business and Industry Assistance (SBIA) program.
 
The goal of the PSA program is to “provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and biologics),” according to a July 2021 principles document on the program.
 
Officials said the best candidates for the joint review program are for those drugs which are either innovative, address an unmet medical need, or treat a rare disease.
 
Thorsten Vetter, EMA senior scientific advisor, illustrated the benefits of the program in a case study involving the development of a drug to treat inflammatory bowel disease in the pediatric population. The sponsor was unable to recruit enough subjects for a Phase 3 study and wanted advice on how to proceed with a study design.
 
Vetter said through the joint review, the sponsor was able to get alignment on a complex pediatric study design for a multinational pediatric clinical trial. The process of making the request for joint review to final advice took approximately five to six months, which is the same timeframe for consulting with one agency.  
 
Most of the requests for scientific advice were from sponsors of gastroenterology drugs or treatments for rare diseases, followed by anti-infectives and oncology drugs, said FDA’s Shannon Thor, international policy analyst with FDA’s Europe office.
 
Most requests are accepted into the joint review program. From 2017 to 2021, 70% of the 37 submitted requests were accepted, and the remainder were withdrawn, either because they were too early in development, the applications had a medical device component, or other reasons.
 
One of the benefits of the program is that it enhances the transparency of the global review process, said Sandra Kweder, the deputy director of FDA’s Europe office.
 
“Historically, sponsors tend to visit one agency before the other and when that happens, they carry a message on the agency’s views to the second review. Often times, those views are not very accurately captured, and this can often create confusion. Our experience is that a PSA, while intensive, provides a mechanism to bring EMA and FDA to the table” at the same time, Kweder said.
 
 
To ensure that joint meetings run smoothly, sponsors should prepare and gather all the data before-hand, Kweder said. “I have been involved with every PSA procedure since 2016, and I can tell you that prepared sponsors who do their work up front have the best experience.”
 
In addition, sponsors should have “worked through their internal differences before the meeting,” she added
 
One factor that sponsors should consider when requesting meetings is that “timing matters.”  For example, requests made in July may take longer to process than requests in September because many staff members at the EMA science working party are not available in August. “If you submit a request in July, there may be a delay longer than usual than if you submit this in September.”
 
Overall, Kweder said that “by and large the vast majority of PSA procedures are considered highly rewarding by sponsors, FDA and EMA.”
 
The parallel advice program was launched by regulators in 2017, and in September 2021 was expanded to include joint and parallel reviews for complex generic products, or hybrid medicines as they are called in the EU (RELATED: FDA, EMA launch complex generic, hybrid product advice pilot, Regulatory Focus, 15 September 2021).
 
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