Costanza Vignoli -

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have established a pilot program, starting from September 15th, to provide Parallel Scientific Advice (PSA) to applicants of marketing authorization applications (MAAs) for hybrid products (EMA) and abbreviated new drug applications (ANDAs) for complex generic drug products. This program aims at providing a mechanism for EMA and FDA to concurrently consider and jointly exchange with applicants the agencies’ points of view on scientific questions during the development phase of hybrid/complex generic products. 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 conduct PSA meetings under the confidentiality arrangement between the European Commission, the EMA, and FDA.

There are three stages in this pilot PSA meeting process:

1) Stage 1, applicants request a meeting with EMA and FDA;

2) 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;

3) 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.

Regulatory Pharma Net (RPN) has successfully supported companies in the early dialogue with EMA and FDA to optimize development in support of the targeted label indication and, to gain regulatory approval. RPN is ready to provide assistance with any new early dialogue procedures introduced by the authorities.

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