The Centre of Excellence in Regulatory Science and Innovation for Advanced Therapies (CERSI-AT), established by the Cell and Gene Therapy Catapult and Birmingham Health Partners Centre for Regulatory Science and Innovation (CRSI) in February 2025, brings together industry, regulators, and academia to drive innovation and reform in ATMP regulation.
This quarterly email update will provide highlights of the latest news, progress and upcoming events from the CERSI-AT as presented in the full online version.
Read the full newsletter online
Latest news
Q1 progress - set up phase
We have been focussed on the overall programme set-up, building of the project teams for all clusters and have established our advisory board.
A webpage has been created to highlight the purpose of the centre and serve as a central platform to house future Centre outputs, e.g. newsletters, whitepaper and recordings.
Highlighting the UK’s Competitive Advantage
Cell and Gene Therapy Catapult have issued a white paper that provides detailed analysis of the UK's regulatory and market access environment for ATMP development, emphasising key areas where the UK differentiates favourably from other regions and highlighting to developers that the UK can serve as an attractive location for developing and commercialising ATMPs.
Events overview
Decentralised Manufacturing Workshop
Representatives from the Centre attended and contributed to the MHRA's Decentralised Manufacturing (DM) Workshop on 12 March 2025. The event focused on refining draft MHRA guidance for Manufacturing Authorisation, GxP inspections, clinical trials, Marketing Authorisation, and pharmacovigilance, specifically for DM models.
Read the full online newsletter for the key takeaways
GTMP Classification Workshop
CGT Catapult and the MHRA recently co-hosted a workshop to discuss potential updates to the UK's regulatory definitions of Advanced Therapy Medicinal Products (ATMPs). The discussions centred on how these definitions impact patients and stakeholders across the industry and clinical practice.
A position paper summarising the workshop's outcomes is in development.
CERSI-AT Symposium 2025
2nd October 2025, London
Save the date for our symposium investigating the feasibility and appetite for a non-clinical data repository. While the full agenda is to be confirmed, panels will be joined by the MHRA and the UK Centre of Excellence on In-Silico Regulatory Science and Innovation (UK CEiRSI).
Registration will open in the coming weeks.
Get Involved
To get involved, please contact us
For further information on the updates and more, read the full CERSI-AT update , including the EU and US, please visit the Cell and Gene Therapy Catapult’s monthly Regulatory Round Up.