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EU LRA Watchdog Update October 2022

  

Europe Legal and Regulatory Affairs
Watchdog Update
October 2022


Hind Al Belushi, PhD
ISCT Legal and Regulatory Affairs Committee: Europe
Royal Hospital
Sultanate of Oman

Committee of Advance Therapy (CAT)

The Committee for Advanced Therapies (CAT) is the European Medicines Agency’s (EMA) committee responsible for assessing the quality, safety and efficacy of advanced therapy medicinal products (ATMPs) and following scientific developments in the field.

 

Minutes of the meetings

Minutes of the meeting on 10-12 August 2022

https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-10-12-august-2022_en.pdf

 

Minutes of the meeting on 13-15 July 2022

https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-13-15-july-2022_en.pdf

 

Agendas

Agenda for the meeting on 5-7 October 2022

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-5-7-october-2022-meeting_en.pdf

 

Agenda for the meeting on 7-9 September 2022

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-7-9-september-2022-meeting_en.pdf

 

Meetings report

CAT quarterly highlights and approved ATMPs (July 2022).

https://www.ema.europa.eu/en/documents/report/cat-quarterly-highlights-approved-atmps-july-2022_en.pdf

CAT quarterly highlights and approved ATMPs (April 2022).

https://www.ema.europa.eu/en/documents/report/cat-quarterly-highlights-approved-atmps-april-2022_en.pdf

 

Updates and regulatory news

FDA User Fee Programs Reauthorized
https://www.cellandgene.com/doc/fda-user-fee-programs-reauthorized-fda-s-cber-is-a-clear-winner-0001

European Commission

The European Commission (EC) is the executive of the European Union (EU). It operates as a cabinet government, with 27 members of the Commission (informally known as "Commissioners") headed by a President, currently Ursula von der Leyen.

 

Revision: Manufacture of Sterile Medicinal Product

https://health.ec.europa.eu/latest-updates/revision-manufacture-sterile-medicinal-products-2022-08-25_en

Manual on Borderline and Classification in the Community Regulatory Framework for Medical Devices (September 2022)

https://health.ec.europa.eu/latest-updates/manual-borderline-and-classification-community-regulatory-framework-medical-devices-september-2022-2022-09-07_en

 

The Rules Governing Medicinal Products in the European Union Volume 4 EU Guidelines for Good Manufacturing Practice for Medicinal Products for Human and Veterinary Use

https://health.ec.europa.eu/system/files/2022-08/20220825_gmp-an1_en_0.pdf

 

EMA is launching a pilot to support academics and non-profit developers of advanced therapy medicinal products (ATMPs) in the European Economic Area (EEA).

https://www.ema.europa.eu/en/news/ema-pilot-offers-enhanced-support-academic-non-profit-developers-advanced-therapy-medicinal-products

 

Extension of European Commission Decision Reliance Procedure (EC DRP) until 31 December 2023.

https://www.gov.uk/government/news/european-commission-decision-reliance-procedure-ec-drp-extension



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