General Principles EMA-FDA Parallel Scientific Advice (Human Medicinal Products)

On 18 August 2021 the EMA published updated general principles on EMA-FDA parallel scientific advice.

The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) of the U.S. Department of Health and Human Services have a program to provide parallel scientific advice (PSA) to sponsors. The goal of the PSA program is to provide a mechanism for EMA assessors and FDA reviewers to concurrently exchange with sponsors their views on scientific issues during the development phase of new medicinal products (i.e., new human drugs and biologics). Such interactions are expected to increase dialogue between the two agencies and sponsors from the beginning of the lifecycle of a new product, provide a deeper understanding of the bases of regulatory decisions, optimize product development, and avoid unnecessary testing replication or unnecessary diverse testing methodologies. The agencies conduct PSA procedures under the auspices of the confidentiality arrangement between the European Commission, the EMA, and FDA.

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