Last updated: 7 February 2024
See updates at the end of the post.
The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program to provide parallel scientific advice (PSA) to applicants of marketing authorisation applications (MAAs) for:
- hybrid products (EMA) and
- abbreviated new drug applications (ANDAs) for complex generic drug products, hereafter referred to as “complex products” (FDA).
What is the goal of the pilot PSA program?
The goal of the PSA program is to provide a mechanism for EMA and FDA to concurrently consider and jointly exchange with applicants the agencies’ views on scientific questions during the development phase of hybrid/complex generic products.
Such interactions are expected to increase dialogue between the two agencies and applicants from the beginning of the lifecycle of a hybrid/complex generic drug product.
Successful collaboration may provide applicants with a deeper understanding of the basis of regulatory decisions, optimize product development, and avoid unnecessary replication of
studies or unnecessary testing methodologies.
The agencies will conduct PSA meetings under the auspices of the confidentiality arrangement between the European Commission, the EMA, and FDA.
When did the pilot begin?
The pilot began on 15 September 2021 and meeting requests will be received until a sufficient number of PSA meetings are held to support the pilot program.
What are the three stages of the pilot PSA program?
The three stages in this pilot PSA program meeting process are:
- Stage 1, applicants request a meeting with EMA and FDA.
- Stage 2, EMA and FDA assess the meeting package, the agencies conduct a preparatory bilateral meeting, and then conduct a trilateral meeting with the applicant; and
- Stage 3, EMA and FDA communicate written responses to the applicant.
During and after conclusion of the pilot, each agency will evaluate the benefits and challenges of the program, including the resources required, and determine next steps.
More detailed information on the three stages is provided in this document.
Some more information about the pilot PSA program
- The PSA program is voluntary.
- The PSA pilot program focuses on sharing information and regulatory perspectives and allows prospective generic drug applicants to engage in concurrent scientific conversation on key issues with both agencies during the development phase
- Achieving harmonisation and increased convergence are potential benefits of the PSA program
- Under the pilot program, applicants can request a joint meeting with FDA and EMA to address specific scientific inquiries pertaining to the development of complex generic drugs or hybrid medicines.
- This joint meeting helps the applicant receive feedback from both regulatory bodies simultaneously, and work toward drug approval in both areas of the globe. It can also help align FDA and EMA’s scientific thinking on a particular drug application because there are potential differences in how the agencies assess these products under their jurisdictions.
- Following a PSA meeting, an applicant should have a clearer understanding of the agencies’ regulatory requirements, scientific recommendations, and areas where the agencies may diverge. By streamlining the regulatory process, the pilot program can help applicants avoid redundancy in testing and ultimately accelerate the market access of the drug.
- Prospective generic drug applicants may use the PSA pilot program to determine whether a study design, or designs, might be acceptable to both regulatory agencies. These include recommendations on comparative non-clinical and comparative clinical studies involving innovative bioequivalence (BE) study designs and methodologies such as modeling and simulation.
- Examples of good candidates for the PSA program include:
- Proposals for a single BE study that may satisfy both agencies, especially when FDA and EMA have different recommendations in their respective product-specific guidances.
- Proposals for scientific approaches with data/information to support the use of a common comparator in BE studies that are acceptable to both agencies.
- Proposals to use modeling and simulation to improve efficiency of the development program.
- Requests for PSA meetings will be granted based on th.e workload, availability of staff, and anticipated value to the PSA program
Further information
- FDA and EMA launch Parallel Scientific Advice Pilot Program for Complex Generics, 7 February 2024
- Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products (11 July 2023). Includes a podcast.
- FDA webinar (16 Mar 2022) on the PSA program here.
Source: FDA
Updates
| Date | Update(s) |
|---|---|
| 7 Feb 2024 | 1) The section, Some more information about the pilot PSA program was updated. 2) Item 1 added to the section, Further Information. |
| 11 Jul 2023 | Section Further Information updated. Link added to FDA page on Insights About the FDA/EMA Parallel Scientific Advice Program for Complex Generic/Hybrid Drug Products (11 July 2023). Includes a podcast. |
| 24 Jan 2023 | Addition of link to an FDA webinar (of 16 March 2022) on the PSA program. |