Developing an innovative biologic for two major regulatory markets can sometimes feel like solving the same problem twice. FDA and EMA may ask similar questions, but that does not mean they will always give the same answers. That is where Parallel Scientific Advice (PSA) can make the development conversation much more coordinated. Instead of navigating two separate scientific discussions in isolation, sponsors can put key development questions in front of both agencies through a structured interaction. The goal is not to force FDA and EMA to agree, but to help the sponsor understand both perspectives early enough to make smarter development decisions.
FDA CBER’s SOPP 8001.6 describes PSA as a voluntary process initiated at the sponsor’s request, although either FDA or EMA may suggest it as a mechanism for interaction. The process is intended primarily for specific scientific questions concerning the development of an eligible product. For CBER–EMA interactions, eligible products include cell therapies, gene therapies, tissue-engineered products, vaccines, and plasma derivatives.
The process starts with a focused set of questions. The sponsor submits a single set of scientific questions to both agencies. The questions should address specific development issues where input from both regulators would be valuable. Importantly, PSA is intended to address a defined set of questions, not become an ongoing series of consultations. For a CBER-regulated product, the request is forwarded to CBER’s Associate Director for International Affairs (ADIA), and the sponsor must ensure that the PSA request is submitted simultaneously to the designated FDA and EMA liaisons. CBER’s relevant product office evaluates the request and should make its decision within 14 calendar days of receiving the request. A request can be declined because of timing, workload, or the appropriateness of the product for the PSA process.
Once both agencies accept the request, FDA and EMA coordinate the practical details, including responsibilities for scheduling meetings and exchanging information. The sponsor must also provide authorization allowing the agencies to conduct the necessary inter-agency exchange, including relevant trade-secret information. The process generally involves an internal FDA meeting, a joint scientific discussion with EMA’s Scientific Advice Working Party (SAWP), and a concluding meeting involving FDA, EMA/SAWP, and the sponsor. The scientific discussion is integrated into the regular SAWP process, with the joint discussion occurring around Day 30 and the concluding sponsor meeting around Day 60.
The PSA does not guarantee identical FDA and EMA recommendations. Each agency provides independent advice according to its own procedures. The real value is understanding where the agencies converge, where they diverge, and, when they differ, the reasons underlying their respective perspectives.
A few things to consider for sponsors looking for a PSA. PSA is voluntary. The sponsor chooses to initiate the process, although FDA or EMA can recommend it. The process is designed around a focused, single set of scientific questions, not a broad or open-ended consultation. The FDA and EMA do not have to agree. Sponsors should plan for potentially different recommendations and use the interaction to understand the regulatory rationale behind those differences. The FDA decision target is 14 calendar days, while the substantive PSA process is coordinated with the EMA SAWP timetable, including discussions around Days 30 and 60. The interaction operates under FDA–EMA confidentiality arrangements, with sponsor authorization required for the inter-agency exchange of relevant information.
For companies developing advanced therapies, regulatory strategy is often as much about asking the right questions as it is about generating the right data. FDA–EMA Parallel Scientific Advice provides a structured opportunity to put important development questions on the table with both agencies at essentially the same point in the program.
The objective is not regulatory uniformity; FDA and EMA explicitly retain their independent scientific advice. The real benefit is greater transparency into each agency’s expectations, including the reasons for potential differences. For sponsors willing to prepare carefully, focus their questions, and engage early, PSA can become an important tool for reducing avoidable development divergence and making the path toward two regulatory markets more predictable.
