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New Quality Innovation Expert Group (QIG) supports medicine innovation (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)

EMA has established a Quality Innovation Expert Group (QIG) to support innovative approaches for the development, manufacture, and quality control of medicines for the benefit of patients in the European Union (EU). These include, but are not limited to, new technologies, digitalisation, novel materials and novel devices, in line with the priorities highlighted in EMA’s Regulatory Science Strategy to 2025.

The Quality Innovation Expert Group was set up in September 2022 and is composed of eight members with a background in chemical, biological quality assessment and GoodManufacturing Practice (GMP) inspections.

The expertise of the QIG can also be called upon in the assessment of medicines using these innovative technologies in regulatory submissions such as scientific advicemarketing authorisation applications and related post-authorisation lifecycle changes. Please find details here.

See all of Catapult’s Regulatory Round-up for November 2022 here. Published on the 8th of December 2022.


OpenEdition vous propose de citer ce billet de la manière suivante :
adelage (25 janvier 2023). New Quality Innovation Expert Group (QIG) supports medicine innovation (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/o67i


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