The U.S. Food and Drug Administration (FDA) and European Medicines Agency (EMA) recently released an updated “General Principles” statement regarding the agencies’ parallel scientific advice (PSA) program for human medical products.
The PSA program provides scientific advice and protocol assistance in parallel to sponsors. “Sponsor” refers to: in the US, the sponsor of an Investigational New Drug Application or the applicant that submits a New Drug Application or Biologics License Application; or in the European Union, a potential marketing authorisation applicant under the marketing authorisation process in the European Union.
The program provides a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicines. Such interactions are expected to provide a deeper understanding of the bases of regulatory decisions, optimize development, and avoid unnecessary testing replication or unnecessary diverse testing methodologies.
In the updated “General Principles” statement, published in April 2017, the EMA and FDA set out a number of general principles that aim to explain and clarify the PSA Program, including:
- PSA procedures are voluntary and usually occur at the request of the sponsor; in special circumstances, the EMA or FDA may also initiate the PSA process in full cooperation with the sponsor.
- Requests should focus primarily on specific questions or issues involving the development of a medicine for which the sponsor desires to have further scientific input from both agencies.
- Following PSA meetings, sponsors should have a clearer understanding of the regulators’ respective requirements and perspectives regarding the development program discussed, and if divergent, the reasons for the divergence.
- The best PSA candidates include important medicines, especially those for indications lacking development guidelines, or if they exist, those for which the agencies’ guidelines differ significantly. In addition, biosimilars, products with significant clinical safety, animal toxicology, or unique manufacturing concerns that could impede further product development are appropriate candidates.
- The number of PSA procedures will be limited. A PSA procedure should be a single occurrence focused on the specific development issue raised.
- The sponsor participates in a joint PSA meeting with both regulators during the PSA procedure. In addition, the agencies will conduct a pre-sponsor meeting via telephone or videoconference and may conduct a post-sponsor meeting in the same manner if needed.
- Sponsors should address one single “Request for PSA” letter to both agencies. In this request, the sponsor should provide certain information regarding the product, the benefits of a discussion, questions requiring clarification, and meeting goals.
- If a sponsor’s PSA request is not granted, the sponsor is free to pursue a scientific advice procedure with each agency individually (see Type B meetings here for FDA and here for EMA). Alternatively, both agencies can engage in a “consultative advice” where a limited number of experts from either side will be invited to participate in the discussions of the other.
The EMA and FDA have also published a timeline to illustrate the various steps of the PSA Program.