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EU LRA Watchdog - August 2022


Europe Legal and Regulatory Affairs
Watchdog Update
August 2022

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)                                      

2. Agendas

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

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


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

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.


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)

 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

 Open till 09 September 2022.