News Hub

Europe Legal and Regulatory Affairs - Watchdog Update April 2023


Alejandro Barquero, MPharm, MSc
ISCT Legal and Regulatory Affairs Committee: Europe
DanausGT Biotech Ltd.

Laura Mendieta, PhD
ISCT Legal and Regulatory Affairs Committee: Europe

Committee of Advance Therapy (CAT)

Committee for Advanced Therapies (CAT): Work Plan 2023 

Minutes of the meetings

Minutes of the meeting on 7-9 December 2022 


Draft Agenda for the meeting on 15-17 February 2023 

CAT meetings in 2025 and 2026 

Updates and regulatory news

European Parliament votes to extend Medical Device Regulation (MDR) transition period to avoid a shortage of life-saving products in the economic region and to extend the validity of certain device certificates. 

EMA Regulatory and scientific virtual conference on RNA-based medicines

EMA virtual technical media briefing on the RNA technology.

The European Pharmacopoeia (Ph. Eur.) 10th Edition has been obsolete since 01 January 2023. The Ph. Eur. 11th Edition and its supplements are available to subscribers on the dedicated European Pharmacopoeia online platform. 

ICH Q9 (R1) guideline has reached stage 4 of the process as of 18 January 2023 and will become effective as of 23 July 2023. 

UK NICE - More than 400 people set to benefit after NICE approves ground-breaking CAR-T therapy to treat aggressive form of blood cancer – February 26th 

MHRA to streamline clinical trial approvals in biggest overhaul of trial regulation in 20 years 

Guidance Documents

The ICH S12 Guideline on “Nonclinical Biodistribution Considerations for Gene Therapy Products” has reached Step 4 of the ICH Process on 14 March 2023. 

Accelerating Clinical Trials in the European Union (ACT EU) - Priority Action 3 concept paper: an EU multi-stakeholder platform for improving clinical trials 

Recommendation paper on decentralised elements in clinical trials 

Quick guide for sponsors – Clinical Trials Regulation 536/2014 in practice (Eudralex vol. 10) 

Open consultations

The European Pharmacopoeia (Ph. Eur.) has published the 59 texts (1 new general chapter, 5.1.13. Pyrogenicity, and 58 revised texts) concerned by the rabbit pyrogen test (RPT) replacement strategy for public consultation in Pharmeuropa 35.1 
Open to 31 March 2023

EMA Reflection paper on the “Criteria to be considered for the evaluation of new active substance (NAS) status of biological substances” open consultation
Open to 31 March 2023

British Pharmacopoeia - Non-mandatory, best practice guidance for T cell and NK cell characterisation assays 
Open to 01 May 2023

Concluded consultations

ICH guideline Q5A (R2) Viral safety evaluation of biotechnology products derived from cell lines of human or animal origin. Step 3 closed for comments.
Consultation closed on 10 February 2023

ICH guideline M11,  Cclinical electronic structured harmonised protocol (CeSHarP). Step 3 closed for comments.
Consultation closed on 26 February 2023

EMA guideline on the development and data requirements of  potency tests for veterinary cell-based therapy products and the relation to clinical efficacy.
Consultation closed on 28 February 2023

Public consultation on a multi-stakeholder platform to improve clinical trials in the EU 
Consultation closed on 03 March 2023

#Regional and Partner Updates