Third EU HTA regulation implementing act proposes rules on exchanging information with EMA for joint clinical assessments

1 Jul 2024

Written by Joanne Walker

Health technology assessment Medical devices, pharmaceuticals and vaccines News Regulation

The European Commission has introduced a third implementing act to streamline the exchange of information in EU-level assessments of new health technologies.

The third implementing act establishes the framework for the cooperation between the Member State Coordination Group on Health Technology Assessment (HTACG) and the European Commission (EC) with the European Medicines Agency (EMA). These rules govern the exchange of information related to the joint clinical assessment (JCA) of medicinal products, medical devices, and in vitro diagnostic medical devices, as well as the joint scientific consultation (JSC) on these products.

Key details

The third act, ‘Health technology assessment – cooperation with the European Medicines Agency‘, details several procedural rules governing the collaboration between the HTACG, EC (acting as secretariat of the HTACG) and EMA to facilitate the exchange of information necessary for JCA as well as outlining the processes involved. This includes information on planning and forecasting for JCAs and JSCs, and identifying relevant experts such as patients and clinicians, addressing general scientific and technical matters. The act also delineates measures to guarantee the security and confidentiality of information exchanged between the EMA and the HTA secretariat, which is subsequently disseminated among the Coordination Group, its subgroups, and their members.

The EMA has also simultaneously updated its pre-authorization procedural advice for companies, outlining how to notify both the agency and secretariat of the HTACG regarding products that will undergo parallel regulatory review and JCA.

Next steps

The draft act is the third of six to be introduced by the EC before JCAs begin in January 2025. The EC adopted the first implementing act on May 23, 2024. The public consultation on the second implementing act closed on June 26, 2024. Similar to the other implementing acts, the EC is seeking public feedback on the proposed rules, with feedback sought by July 24, 2024.

Starting January 12, 2025, new oncology medicines and advanced therapy medicinal products (ATMPs) will be assessed at the EU level, aiming to ensure a consistent and thorough review of these innovative treatments across all EU countries.