EU HTA Regulation


EU Common HTA Assessment

In Autumn 2021, the European Commission passed legislation to create a legal framework for HTA collaboration in the EU. Starting in 2025, with gradual entry into force for different types of products, there will be a binding obligation on both manufacturers and member states to have a joint clinical assessment based on a dossier submitted by the manufacturer. The assessment will be non-binding for member states, but to be given “due consideration” in the national HTA.  As part of the objective to formalise and implement the legal framework for HTA collaboration in the EU, EunetHTA21 is a collaboration both to conduct joint HTA/EMA scientific advice and clinical assessments in the “interim period”, as well as support the future EU HTA system.  

EU HTA regulation implementation (2022 – 2030)

Objective: Formalise and implement the legal framework for HTA collaboration in EU

  • 2022-2024: Transition period
  • 2025: Implementation for new cancer and ATMP products
  • 2028: Implementation for new Orphan products
  • 2030: Implementation for remaining centrally authorised products and license extensions.



EUnetHTA21 (2021 -2023)

Objective: Build on achievement of EUnetHTA and support future EU HTA system under the HTA regulation.

Members: HTA agencies, lead by ZIN (the Netherlands)


Public Consultation of EUnetHTA 21 draft deliverables took place from 7th March 2022 until 31 August 2023.

EUnetHTA21 formally launched a series of  public consultations until August 2023 to collect feedback on draft guidelines for the methods and processes that will be used during the "interim period" and, importantly, inform the subsequent implementation of the legislation. The HTA ESIG was actively involved in this consultation and submitted comments on important methodological deliverables on behalf of EFSPI. You can view the comments we submitted here. Many of the final deliverables have now been published by EUnetHTA and can be viewed here. The consortium will cease operations on 16th September, before this date they advise to download any required materials from their website.

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EU HTA external engagement

On 14th September 2022, we presented 2 posters at the 7th EFSPI workshop on Regulatory Statistics 2022. You can view the posters presented here --> EFSPI Regulatory HTA Workshop September 2022 - HTA SIG EU HTA Posters.

On 14th November 2022, we hosted a webinar "Statistics in EU HTA - PICOs, Estimands & More!". If you missed it, watch the recording on Video on Demand!

We have recorded a series of 4 podcast episodes with The Effective Statistician:

  • Episode 1: What is EU HTA and why should statisticians care?
  • Episode 2: What is the role of estimands in the EU HTA?
  • Episode 3: Future implications of EU HTA and how Next Gen get involved
  • Episode 4: What will be the role of health economics in the future EU HTA?

In May 2023, EFSPI was appointed a member of the European Commission Stakeholder Network. You can view the full list of members here. Our two representatives are Christoph Gerlinger (Member of EFSPI council) and Anders Gorst-Rasmussen (Co-Chair of EFSPI HTA ESIG). You can view more news on HTAR from the European Commission on their HTA webpage

On 13th September 2023, we presented 2 posters at the 8th EFSPI workshop on Regulatory Statistics 2023. You can view the posters presented here.

On 15th November 2023, we presented a poster at ISPOR Europe 2023. You can view the poster presented here

On 7th December 2023, we hosted a webinar "Estimands, PICOs and Co. - Are we losing or gaining in translation?". If you missed it, watch the recording on Video on Demand!

On 26th February and 18th March 2024, we will be hosting a 2-part webinar "Indirect treatment comparisons - choosing the right tool for the job". If you are interested in attending, please register here.



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