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Early interactions with regulators 

Early interactions procedures with regulators have been established to support medicines’ development and mainly innovative medicines, and the specific challenges they face. The support comes in the form of services and regulatory procedures allowing medicines’ developers to interact with the regulators through existing mechanisms during the development of a medicinal product.

Here, we present some of those mechanisms that apply to medicinal products, especially innovative medicines including Advanced Therapy Medicinal Products (see: Support for innovative medicines’ development and sub-entries within), as well as mechanisms that are specific to Advanced Therapy Medicinal Products (see sub-entry: Support specific to ATMPs’ development at EMA level).



Published: 31/07/2023


Auxane Delage, EuroGCT information officer on Ethical, Legal and Societal Issues

Aurélie Mahalatchimy, EuroGCT WP4 Convenor, UMR 7318 DICE CERIC, Aix-Marseille University, CNRS, Aix-en-Provence- France