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EU LRA Watchdog - April 2022

  

Europe Legal and Regulatory Affairs 
Watchdog Update
April 2022

By:

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

Committee for Advanced Therapies (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.

 

Recently added meeting documents

Minutes of the meetings

https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-8-10-december-2021_en.pdf

 

Agendas

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-11-13-april-2022-meeting_en.pdf

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-18-march-2022-meeting_en.pdf

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-16-17-february-2022-meeting_en.pdf

 

Monthly report

https://www.ema.europa.eu/en/documents/report/cat-monthly-report-application-procedures-guidelines-related-documents-advanced-therapies-december_en.pdf

 

Updates and regulatory news

A new gene therapy, Carvykti* (ciltacabtagene autoleucel), received a positive opinion for a conditional marketing authorisation for the treatment of multiple myeloma. Carvykti had support through the PRIME scheme, EMA’s platform for early and enhanced dialogue with developers of promising new medicines that address unmet medical needs.  Janssen.

https://www.ema.europa.eu/en/news/meeting-highlights-committee-medicinal-products-human-use-chmp-21-24-march-2022

 

Open consultations

Forms for comments for EMA open consultations

 https://www.ema.europa.eu/en/news-events/open-consultations

 

ICH guideline Q2(R2) on validation of analytical procedures Step 2b

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q2r2-validation-analytical-procedures-step-2b_en.pdf

Open to 31/07/2022

 

ICH guideline Q14 on analytical procedure development Step 2b

https://www.ema.europa.eu/en/documents/scientific-guideline/ich-guideline-q14-analytical-procedure-development-step-2b_en.pdf

Open to 31/07/2022

 

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