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  1. New Animal Drug Applications

FDA and European Medicines Agency Parallel Scientific Advice Program for Animal Drugs

The U.S. Food and Drug Administration provides scientific advice in parallel with the European Medicines Agency (EMA) for sponsors of animal drug products who intend to apply for approval of their products in both jurisdictions. 

The Parallel Scientific Advice (PSA) program enables the animal drug industry and the agencies that regulate them to proactively engage in concurrent scientific conversation with both agencies, the FDA and the EMA, and receive feedback on key issues during the development phase of new animal drug products. The agencies conduct PSA procedures under the auspices of the confidentiality arrangement between the European Commission, the EMA, and the FDA’s Center for Veterinary Medicine (CVM). 

The PSA program enables successful collaboration between FDA and EMA by increasing dialogue between the two agencies and optimizing the sponsor’s global product development program by enabling them to discuss specific questions regarding animal drug products. For example, the PSA program can enable sponsors to ask study design questions about effectiveness study inclusion/exclusion criteria (patient population), effectiveness study endpoints, use of adaptive designs, manufacturing questions, or use of alternative methods. It further provides sponsors with a deeper understanding of the basis for regulatory decisions from both agencies, helping sponsors avoid redundant replication of work and unnecessary testing replication or unnecessary diverse testing methodologies. Participation in the PSA program is voluntary and initiated by the sponsor. 

The FDA encourages animal drug sponsors who are interested in developing drug products for both the U.S. and European markets to engage the agencies and take advantage of this program, which aims to streamline global development of new animal drugs. Applicants/sponsors should send a single request with the subject “Request for PSA” to both VetScientificAdvice@ema.europa.eu at EMA and cvmia@fda.hhs.gov at CVM. For more information about submitting a request, see the “GENERAL PRINCIPLES EMA-FDA PARALLEL SCIENTIFIC ADVICE” document. For each approved PSA request, the agencies will hold one trilateral meeting with the sponsor focused on the specific development issues raised. 

More information and the procedure timetable are available in the documents below:

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