The European Commission has just adopted Implementing Regulation (EU) 2024/1381 laying down procedural rules for common clinical assessments of cancer and ATMP medicinal products at EU level to facilitate faster access to medicines in the EU.
On 23 May 2024, the European Commission adopted the first of six implementing regulations under the Regulation on Health Technology Assessment (HTA).
The purpose of the HTA Regulation is to improve the evidence base for the assessment of new medical technologies and to support Member States in making timely and evidence-based decisions on patient access to medicines.
The recently adopted Implementing Regulation (EU) 2024/1381 ("Implementing Regulation") lays down procedural rules for joint clinical assessments of cancer medicines and advanced therapy medicinal products ("ATMP").
The Implementing Regulation sets out, among other things, timelines and procedures for conducting joint clinical assessments. Annexes I-III contain templates for the assessment reports to provide national authorities with a scientific basis shortly after the granting of a marketing authorisation for a new medicine. In this way, the aim is to enable national authorities to make faster decisions on the use of new medicines in national healthcare systems.
It should be noted that analyses of health economics, pricing and deployment decisions are not part of the HTA Regulation and are therefore a national matter.
The Implementing regulation will enter into force on 12 January 2025. The remaining five implementing regulations under the HTA Regulation are expected to be adopted during 2024.
The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.