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FDA and European Medicines Agency Announce Updates to Parallel Scientific Advice Program for New Animal Drugs

June 26, 2024

The U.S. Food and Drug Administration’s Center for Veterinary Medicine (CVM) and the European Medicines Agency (EMA) are announcing today recent updates to the Parallel Scientific Advice (PSA) program for new animal drug products to increase harmonization and facilitate development of new products to support animal health.

The animal drug industry and the agencies that regulate them are increasingly seeking opportunities to proactively engage in the early stages of drug product development. The PSA program allows for animal drug sponsors to engage in concurrent scientific conversation with both agencies, the FDA and the EMA, on key issues during the development phase of new animal drug products.

The program enables successful collaboration between the 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. 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.

While the program has existed for more than 15 years, recent updates include an addition of a trilateral meeting with the sponsor and both agencies; defined timelines for scientific advice and feedback; and preliminary written feedback to the sponsor.

In a previous version of the program, EMA would provide written feedback, while CVM met with the sponsor to verbally share its feedback, which was provided in writing following the meeting.  Differing communication mechanisms resulted in long timeframes. The agencies now have more defined timelines, and sponsor meetings will include both CVM and EMA. CVM is also aligning with the FDA’s human product program, the FDA’s Center for Drug Evaluation and Research, by providing preliminary written feedback to the sponsor prior to the meeting. The advice from both EMA and CVM will still be provided in writing following the meeting with 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 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.

For more information:

Issued by FDA Center for Veterinary Medicine.
For questions, Contact CVM.

 
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