Revision of the EU GMP Guide Annex 11 “Computerised Systems” – Presentation of Concept Paper (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022)
The current EU GMP Guidance Annex 11 “Computerised Systems” has been in force since 2011. On 16th November 2022, the EMA (European Medicines Agency) published a 5-page “Concept-Paper on the revision of Annex 11 of the guidelines on Good Manufacturing Practice for medicinal products – Computerised Systems” to revise annex 11 in order to meet current technological and regulatory developments.
Comments on this concept paper can be submitted until 16th January 2023.
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). Revision of the EU GMP Guide Annex 11 “Computerised Systems” – Presentation of Concept Paper (Cell and Gene Therapy Catapult – Regulatory Round-up – November 2022). ELSIBI. Consulté le 19 février 2026 à l’adresse https://doi.org/10.58079/o67k





