We would like to inform you that The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program within its established parallel scientific advice (PSA), for complex generic medicinal products [products where complexity or uncertainty concerning the approval pathway or possible alternative approaches would benefit from early scientific engagement (e.g. complex Active Substance, formulation, pharmaceutical form, route of administration, novel indication or drug-device combination)], generally submitted and commonly known in Europe in Europe as “Hybrid generics”.
The PSA pilot program began on 15 September 2021.
You can find more information in the attached document.
Additional Europharm's comments:
This can be very useful and helpful if you are developing complex generic products commonly known as “Hybrid” generics in EU and wish to get guidance on the approval pathway for registration in both Eu and the FDA.Whis this special Pilot program you'll receive parallel (EU & FDA) Scientific advice.
1 . The PSA program is voluntary. To participate in the PSA program, applicants submit requests to EMA and FDA following the process delineated in this document. “Applicant” refers to: (a) a potential marketing authorisation applicant under the marketing authorisation process in the European Union, or (b) a potential applicant of an ANDA that is expected to be submitted to the FDA.
2. The PSA program focuses on sharing information and perspectives. Achieving harmonization and increased convergence are potential benefits of the PSA program. Following a PSA meeting, an applicant will have a clearer understanding of the agencies’ respective regulatory requirements and scientific recommendationsregarding the development program discussed. If advice from the two agencies is divergent, the applicant will have a clear understanding of the reasons for divergence.
3. Candidates for the PSA program include product development programs that may benefit from the PSA process by potential harmonized approaches. For example, the applicant may use the PSA program to determine whether a study design(s) might be acceptable to both regulatory agencies. Studies that may benefit from the PSA process include comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modelling and simulation.
4. Requests for PSA meetings will be granted based on the workload, availability of staff, and anticipated value to the PSA program. For each request, the agencies will hold one trilateral meeting with the applicant focused on the specific development issue raised. The trilateral meeting will generally be one and a half hours but may be longer based on the number and complexity of questions to be discussed in the meeting.