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EU LRA Watchdog - August 2022

  


Europe Legal and Regulatory Affairs
Watchdog Update
August 2022

By:
Hind Al Belushi, PhD

Royal Hospital
Sultanate of Oman

Committee of Advance Therapy (CAT)

1. Minutes of the meetings

 a. Minutes of the meeting (15-17 June 2022)

b. Minutes of the meeting (11-13 May 2022)                                              

https://www.ema.europa.eu/en/documents/minutes/minutes-cat-meeting-11-13-may-2022_en.pdf

2. Agendas

 a. Agenda for the meeting (13-15 July 2022)

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-13-15-july-2022-meeting_en.pdf

 b. Agenda for the meeting (15-17 June 2022)

https://www.ema.europa.eu/en/documents/agenda/agenda-cat-agenda-15-17-june-2022-meeting_en.pdf

 

3. Monthly report
a. CAT quarterly highlights and approved ATMPs (July 2022).
b. 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


4. Updates and regulatory news

Step 4 Training presentation for E8(R1). The ICH E8(R1) General Considerations for Clinical Studies was finalised in October 2021 and sets out general principles on the conduct of clinical studies.

https://database.ich.org/sites/default/files/ICHE8%28R1%29_Step4Presentation_2022_0408.pdf

 

5. Open consultations

a. EMA open consultation (Reflection paper on data required in confirmatory studies of medicinal products for the treatment of type 2 diabetes)

https://www.ema.europa.eu/en/documents/scientific-guideline/reflection-paper-data-required-confirmatory-studies-medicinal-products-treatment-type-2-diabetes_en.pdf

 Open till 31 August 2022.

b.Call for Comments on the “WHO approach towards the development of a global regulatory framework for cell and gene therapy products

 https://cdn.who.int/media/docs/default-source/biologicals/bs2424_cgtp-document-for-2nd-public-consultation.pdf?sfvrsn=11a0c885_1

 Open till 09 September 2022.

 

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