News Hub

EU LRA Watchdog - February 2022


Europe Legal and Regulatory Affairs 
Watchdog Update
February 2022


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

Committee of Advance Therapy (CAT)

Minutes of the meetings



Monthly report

Updates and regulatory news

A faster path to UK trials approvals: Combined review for clinical trials of investigational medicinal products (CIMPS) service launches.


Regulatory harmonization of clinical trials in the EU: Clinical Trials Regulation (CTR) to enter application and new Clinical Trials Information System (CTIS) to be launched.


Revision1 of ICH Q9 Quality Risk Management (ICH harmonized guideline)


EMA’s human medicines committee (CHMP) recommended seven medicines for approval at its January 2022 meeting. The CHMP gave a positive opinion for the new gene therapy Breyanzi* (lisocabtagene maraleucel) for the treatment of relapsed or refractory diffuse large B-cell lymphoma (DLBCL), primary mediastinal large B-cell lymphoma (PMBCL) and follicular lymphoma grade 3B (FL3B) after at least two previous lines of treatment.


Open consultations

Consultation on proposals for legislative changes for clinical trials to improve and strengthen UK clinical trials legislation from Medicine and Healthcare products regulatory agency.

Open to 14th March 2022.

Call to join a CT/CI assessment pilot of a new processes within the combined review application service for clinical trials of investigational medicinal products (CIMPS) aimed to improve the efficiency and speed of the applications.

Open now

Call for comments for a concept paper on the development and data requirements of potency tests for cell-based therapy products and the relation to clinical efficacy.

Open to 29th April 2022