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New guidance is available for developers of medicines supported by EMA’s PRIME scheme (Cell and Gene Therapy Catapult – Regulatory Round-up – May 2022)

New guidance is available for developers of medicines supported by EMA’s PRIME scheme on the tools they can use to generate robust quality data packages for their MAA.

To learn more see, Toolbox guidance on scientific elements and regulatory tools to support quality data packages for PRIME and certain marketing authorisation applications targeting an unmet medical need | European Medicines Agency (europa.eu)

See all of Catapult’s Regulatory Round-up for May 2022 here.

Published on the 6th of June 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (3 août 2022). New guidance is available for developers of medicines supported by EMA’s PRIME scheme (Cell and Gene Therapy Catapult – Regulatory Round-up – May 2022). ELSIBI. Consulté le 11 octobre 2026 à l’adresse https://doi.org/10.58079/o61k


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