HTA - Commission adopts rules for cooperation with the European Medicines Agency
The European Commission adopted an Implementing Regulation that sets out the rules for cooperation with the European Medicines Agency in the joint work carried out under the Health Technology Assessment (HTA) Regulation.
These rules define the information to be shared:
- for planning and forecasting of joint clinical assessments and joint scientific consultations;
- for identifying patients, clinical experts and other relevant experts to be involved in these joint procedures;
- on general scientific and technical matters related to health technology assessment.
The Implementing Regulation also concerns the security of sharing and protection of confidential information exchanged between the European Medicines Agency and the HTA secretariat within the Commission, and with the Member State Coordination Group on HTA and its subgroups.
The HTA Regulation foresees the adoption of implementing acts, detailing the procedural rules for the different elements in the Regulation.
This is the second of six acts which must be adopted before 12 January 2025, the date of application of the HTA Regulation. The first implementing act was adopted by the Commission on 23 May 2024.
More information:
- Implementing the EU Health Technology Assessment Regulation
- Regulation 2021/2282 on Health Technology Assessment
- Regolamento di esecuzione (UE) 2024/2699 della Commissione, del 18 ottobre 2024, che stabilisce, a norma del regolamento (UE) 2021/2282 del Parlamento europeo e del Consiglio, norme procedurali dettagliate per la cooperazione del gruppo di coordinamento degli Stati membri per la valutazione delle tecnologie sanitarie e della Commissione con l’Agenzia europea per i medicinali sotto forma di scambio di informazioni, per quanto riguarda la valutazione clinica congiunta dei medicinali, dei dispositivi medici e dei dispositivi medico-diagnostici in vitro e per quanto riguarda la consultazione scientifica congiunta sui medicinali e sui dispositivi medici
source: https://ec.europa.eu/newsroom/sante/items/852894/en