The Legal & Regulatory Affairs Committee was established in 2017 to guide the EBMT’s interactions with national and European regulatory authorities and other bodies.
The Committee anticipates a demanding workload and is happy to receive expressions of interest in joining from other EBMT colleagues with an interest in regulatory matters.
The LRAC will build on existing relationships and play a watchdog role in terms of reporting on changes in regulations and guidelines that affect our sector.
- Contact EBMT members who are already acting in an expert capacity with the EU in order to bring their knowledge and experience into the LRAC.
- Prepare the EBMT’s contribution to the EU’s evaluation of the Tissue and Cells Directives.
Recent activities with EBMT participation/attendance
- 27/10/2021 - Attended EU Commission Workshop – the future SoHO-X platform
- 14/10/2021 - Attended EU4HEALTH 2021 WORK PROGRAMME INFO SESSION
- 13/10/2021 - Attended online Impact Assessment session with DG SANTÉ
- 06/10/2021 - Meeting with Deputy Director General of DG SANTÉ as part of the CoRe SoHO alliance
- 23/09/2021 - Attended the Transform Alliance meeting https://transformalliance.eu/
- 17/09/2021 - Presented the EBMT Registry to the EU Network of Competent Authorities on Pricing and Reimbursement
- 30/06/2021 - 'Realising the Potential of Transformative Therapies: A European Pharmaceutical Strategy that Enables Safe and Timely Patient Access to Cell & Gene Therapies', hosted by the European Alliance for Transformative Therapies
- 09/06/2021 - EU Workshop on ‘Borderlines with Other Regulated Frameworks: Classification Advice and Interplay
- 08/06/2021 - EU Workshop Ethical Principles (Voluntary Unpaid Donation, Prohibition of Profit from the Human Body and BTC Allocation)
- 02/06/2021 - EU Workshop Refining the Scope of the BTC Legislation
- 27/05/2021 - GAPP Joint Action Technical Meeting
- 26/05/2021 - EU Workshop Strengthening Oversight (Inspection, Authorization, and Vigilance) - Operators
- 17/05/2021 - EU Workshop Better Protection of Donors for Non-Reproductive Tissues and Cells
- 06/05/2021 - EU Workshop Setting Technical Rules for BTC
- 05/05/2021 - EU Workshop Regulating for Sufficiency – tissues and cells
- 29/04/2021 - GAPP Joint Action Work Package 6 Technical Meeting
- 22/04/2021 - RWE4Decisions meeting Co-Creating RWE Excellence for Decision-Making: Meeting Regulatory and HTA/Payer Needs
- 16/04/2021 - DG SANTÉ NCAPR ‘pro-action’ coffee on CAR-T pricing and evidence
- 15/04/2021 - Submitted EBMT response to the EU Targetted Consultation on the Blood, Tissues and Cells Framework
- 08/02/2021 - MHRA (UK) Stakeholder Engagement Meeting on ATMP Centre Accreditation
The EBMT and the EHA announce a strategic partnership to empower Europe to become a global leader in the cellular therapy field for haematological diseases.
The Gemeinsame Bundesausschuss (G-BA) published its directions on the treatment of German patients with CAR T-cell therapies.
The LRAC and CTIWP have launched an open call for feedback and participation in workpackages (WP) - all EBMT Members as well as non members interested in CAR T therapies are invited to answer this open call until the September 1, 2019.
The EBMT registry has been qualified by EMA as a suitable platform for the collection of data for post-authorisation safety surveillance and efficacy studies.