FDA-EMA Parallel Scientific Advice Pilot Program for Complex Generic/Hybrid Products
The US Food and Drug Administration (FDA) and the European Medicines Agency (EMA) launched a new pilot program to provide parallel scientific advice (PSA) to sponsors of complex generic drugs, or hybrid medicines, as they are called in the EU.
“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.” Moreover, the aim of the program is to increase dialogue between the two agencies and applicants from the beginning of the product development.
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Some examples of studies that may benefit from parallel scientific advice in the complex generic/hybrid product space include “comparative non-clinical and comparative clinical studies involving innovative bioequivalence study designs and the use of methodologies such as modeling and simulation.”
PSA program is voluntary and will only consider products that meet both the FDA’s definition of complex generic and EMA’s definition of a hybrid medicine as the regulatory definitions differ between the two jurisdictions.
Meeting requests for the pilot will be accepted beginning 15 September 2021 and will remain open until enough have been held for the agencies to assess the program.
There are 3 stages in the PSA meeting process:
- 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
- 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.
Read more about the general principles of the program and three stages process here.
For more details, visit the FDA website.
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This article provides general information and does not constitute regulatory or legal advice. Requirements should be confirmed for the specific study, applicable regulatory framework, and markets concerned.
