Regulators – Pharmaceuticals
Collaboration with the European Medicines Agencies (EMA)
The European Medicines Agency (EMA) is a decentralised agency of the European Union (EU) responsible for the scientific evaluation, supervision and safety monitoring of medicines in the EU.
The EMA-EUnetHTA collaboration, which began in 2010 based on recommendations from the High-level Pharmaceutical Forum, aims to harness synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine. Following initial work to improve the way data published by EU regulators as part of their benefit-risk assessment can contribute to relative effectiveness assessments by HTA organisations, additional topics of mutual interest were identified.
A first EMA-EUnetHTA work plan had been established for the years 2012-2015; a report on the outcomes of this joint work plan has been published in April 2016. Following up on the achievements and developments, a new joint work plan for the years 2017-2020 has been agreed. The overall goal of the collaboration is to improve efficiency and quality of processes, whilst respecting their respective remits and ensure mutual understanding and dialogue on evidence needs, to facilitate access to medicines for patients in the European Union. Areas for the EMA-EUnetHTA collaboration EMA and EUnetHTA have jointly identified several areas as focus of their European regulatory-HTA collaboration during 2017-2020. The three-year work plan is complementary to actions foreseen in EUnetHTA Joint Action 3, which runs until 2020. Furthermore, the activities in this work plan will feed into the implementation of the areas for collaboration identified in the reflection paper from the HTA network on Synergies between regulatory and HTA issues on pharmaceuticals and will be developed in close cooperation with the European Commission.
Additionally, The European Network for Health Technology Assessment (EUnetHTA) and the European Medicines Agency (EMA) have published a Technical Report on their achievements since 2017.
The identified priority areas for collaboration are:
- Early Dialogue / Scientific Advice.
- “Late dialogues” / peri-licensing advice.
- Information exchange between regulators and HTA bodies.
- Methodologies to identify the treatment eligible population.
- Significant benefit vs. added therapeutic value for orphan medicines.
- Unmet medical need and therapeutic innovation for priority setting.
- Patient and clinician engagement.
- Shared understanding of methodological approaches for design, analysis and interpretation of clinical trials and observational studies.
- Population-specific or Intervention-specific areas.
Discussions take place at the bi-annual meetings between the EUnetHTA and EMA representatives, via participation of EMA as observer in relevant activities of the EUnetHTA Joint Actions, by mutual commenting on specific documents produced by either of the organisations.
EUnetHTA 21 Work plan
EMA and the previous European Network for Health Technology Assessment (EUnetHTA), which was established through consecutive Joint Actions of which the last one concluded in May 2021, started their collaboration in 2010 based on recommendations from the High-level Pharmaceutical Forum, with the aim to harness synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine. A first EMA-EUnetHTA work plan was established for the years 2012-2015 and a report on the outcomes of this joint work published in April 2016. Subsequently, a second joint work plan for the years 2017-2021 was agreed and a report published in June 2021.
Following up on the achievements through such cooperation and the mutual trust and understanding developed through this joint technical work, EMA and EUnetHTA at their last bilateral during Joint Action 3 agreed to establish a list of priority areas for future collaboration between regulators and HTA at European level to continue future collaborative work. The overall goal of such collaboration is to improve efficiency and quality of processes, whilst respecting the respective remits of different decision makers, and ensure mutual understanding and dialogue on evidence needs, to facilitate access to medicines for patients in the European Union.
Subsequent to the award of the “Service contract for the provision of joint Health Technology Assessment (HTA) work supporting the continuation of EU cooperation on HTA” to the EUnetHTA 21 consortium, the European Commission has invited EMA and EUnetHTA 21 to establish a joint work plan for delivering on the previously identified priorities. Deliverables on HTA side will either be actioned by EUnetHTA 21 if related to their service contract delivery (see table of activities below), or alternatively through individual HTA bodies from the consortium or beyond, who are from a European (EU/EEA) Member State and express interest to participate. In the latter situation, individual HTA bodies represent their own position and not the views of EUnetHTA21. In addition, all deliverables part of EUnetHTA 21 that will be subject to a public consultation EMA is invited to participate.
The latest work plan can be found here.
Press releases:
- Press release 5 May 2020: On 3-Year Work Plan 2017-2021. Find the work plan here
- Press release 13 November 2017: On Joint Work Plan 2017-2020. Find the work plan here
- Press release 4 July 2017: On joint platform for parallel consultation. Find the guidelines here
- Press release 14 April 2016: On implementation of the joint work plan covering the period between November 2012 and December 2015. Find the implementation report here
- Press release 24 June 2014: Joint EMA-EUnetHTA press release on the publication of the article “Improving the contribution of regulatory assessment reports to health technology assessments – a collaboration between the European Medicines Agency and the European network for Health Technology Assessment” in Value in Health, the Journal of The International Society For Pharmacoeconomics And Outcomes Research.
- Press release 19 November 2013: On the EMA-EUnetHTA 3-year work plan. Find the work plan here.
- Press release May 14, 2013: On the EMA-EUnetHTA meeting in London, UK to review the progress of collaboration.
- Press release 16 February 2010: Collaboration on improving EPARs.
EUnetHTA-EMA meetings:
- EUnetHTA-EMA Bilateral Meeting minutes, 21 March 2023, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 25 November 2022, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 22 June 2022, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 28 April 2021, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 16 December 2020, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 13 July 2020, Online
- EUnetHTA-EMA Bilateral Meeting minutes, 21 November 2019, Diemen, Netherlands
- EUnetHTA-EMA Bilateral Meeting minutes, 4 July 2019, Diemen, Netherlands
- EUnetHTA-EMA Bilateral Meeting minutes, 7 December 2018, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 5 July 2018, Amsterdam, Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 15 December 2017, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 8 June 2017, Diemen, the Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 7 December 2016, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 23 November 2015, Copenhagen, Denmark
- EUnetHTA-EMA face-to-face meeting summary, 8 May, 2015, London, UK
- EUnetHTA-EMA face-to-face meeting summarry, 9 December 2014, Diemen, the Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 12 May, 2014, London, UK
- EUnetHTA-EMA face-to-face meeting summary, 10 December, 2013, Cologne, Germany
- EUnetHTA-EMA face-to-face meeting summary, 14 May, 2013, London UK
- EUnetHTA-EMA face-to-face meeting summary, 20 November 2012, Copenhagen Denmark
- EUnetHTA-EMA face-to-face meeting summary, 22 February, 2012, Paris France
- EUnetHTA-EMA face-to-face meeting summary, 7 March, 2011, Diemen Netherlands
- EUnetHTA-EMA face-to-face meeting summary, 3 June, 2010, London UK
- EUnetHTA-EMA face-to-face meeting summary, 11 February, 2010, London UK
