Public Consultation launched yesterday from EU Commission on HTA cooperation with EMA
Pierre Mermet-Bouvier
eCOAs I Regulatory Affairs I Transparency I PMO I Regulatory Intelligence I Clinical Operations I Global and Transversal Teams I Process Improvement I Operational Excellence I Strategic Planning
Yesterday, the EU Commission launched the public consultation on the Commission Implementing Regulation laying down, pursuant to Regulation (EU) 2021/2282 of the European Parliament and of the Council, detailed procedural rules for the cooperation of the Member State Coordination Group on Health Technology Assessment and the Commission with the European Medicines Agency in the form of exchange of information as regards the joint clinical assessment of medicinal products and medical devices and in vitro diagnostic medical devices and as regards the joint scientific consultation on medicinal products and medical devices.
Consultation is end the 24Jul24.
Commission adoption is planned for Second quarter 2024.
The 10-page Commission Implementing Regulation can be downloaded at:
Retired pharmaceutical executive.
8 个月Pierre, Thanks again for sharing such relevant info.