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EMA – Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies

Over the past three years, EMA and the EUnetHTA 21 (European Network for Health Technology Assessment) consortium have delivered a number of milestones to prepare the EU for the entry into application of the Regulation on Health Technology Assessment. EUnetHTA 21 ceases to operate on 16 September 2023, but preparations will continue for the implementation of the Regulation, under the direction of the HTA Coordination Group.

Reviewing achievements over the years at their concluding meeting on 14 September 2023 in Amsterdam, EMA and EUnetHTA 21 highlighted a number of initiatives:

  • Completion of seven parallel joint scientific consultations (JSC) for medicines under the EUnetHTA 21 consortium contract. This joint work is intended to improve the generation of robust evidence that meets the needs of regulators and HTA bodies;
  • Discussion on evidence needs for advanced therapy medicinal products in oncology, addressing mutual challenges such as indirect comparison and addressing evidence gaps through post-licensing evidence generation.
  • Organisation of trainings for patients and healthcare professionals to facilitate their participation as experts in regulatory and HTA processes, alongside collaborative work on methodologies for engagement of patients and healthcare professionals in assessments;
  • Recommendations to optimise the assessment reports of EMA’s Committee for Human Medicines (CHMP) for each medicine in order to systematically document key elements of the assessment such as the eligible patient population, choice of comparator and endpoints, as well as relevance of subgroup data.

More information on the achievements is available in a Report on the implementation of the EMA-EUnetHTA 21 work plan 2021 – 2023.

More information on the EMA website.


OpenEdition vous propose de citer ce billet de la manière suivante :
vroby (11 mars 2024). EMA – Towards a permanent collaboration framework for EMA and Health Technology Assessment bodies. ELSIBI. Consulté le 16 février 2026 à l’adresse https://doi.org/10.58079/vzzb


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