EMA and EUnetHTA take stock of their cooperation

News 01/06/2021

The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) have published a PDF icon report on their achievements since 2017.  

The report covers the latest phase of an open and successful collaboration that began in 2010 and demonstrated the synergies between regulatory evaluation and health technology assessment (HTA) along the lifecycle of a medicine can be harnessed to speed up patients' access to innovative medicines.

By working together, EMA and EUnetHTA were able to help medicine developers enhance clinical research and become more efficient in generating the evidence relevant for both regulatory authorities and HTA bodies (HTAs). They provided guidance to developers on 59 development plans for new medicines and 16 post-licensing and/or post-launch evidence generation plans. Furthermore, they encouraged new ways to generate evidence to address both regulatory and HTA information needs, such as the use of patient registries.

As the relative effectiveness assessment of national HTA bodies builds on the outcome of the regulatory assessment performed by EMA, the collaboration fostered a more effective exchange of information. For 14 newly approved medicines, regulatory information was provided to HTAs at the time of authorisation to facilitate their production of joint HTA reports as a basis for national decisions on access. Another example is in the area of orphan medicines: a review of the evidence assessed by EMA and HTAs showed that the data needed for the regulatory assessment of the ‘significant benefit’ of an orphan medicine was similar to what is needed by HTAs to determine their added value. Therefore, early interaction with developers in this area is mutually beneficial.

The positive experience over the past decade highlights the importance of a sustainable scientific HTA cooperation structure as a partner for EMA to facilitate cross-fertilisation and collaborative work on methodologies and products.

Towards sustainable cooperation between regulators and HTAs at European level

Whilst the current EUnetHTA Joint Action 3 is drawing to a close, the collaboration between EMA and the European HTA community will continue. A legislative proposal from the European Commission aiming to boost EU cooperation between Member States on health technology assessment is currently being discussed at EU level. The collaboration between EMA and EUnetHTA provided essential technical input to inform this future legislative framework that aims to provide the legal foundations for a sustainable cooperation of HTAs at the European level, including their cooperation with regulators. It thus contributes to the objectives of the EU Pharmaceutical Strategy, in particular on aiming at life-cycle approach of evidence generation. 

For the transition phase, the European Commission is currently working on new arrangements to bridge the gap between the end of Joint Action 3 and the entry into force of the new legislation. The collaborative work during this interim period will be guided by a list of priority areas that is currently being finalised by EMA and HTAs, in cooperation with the European Commission. It will include aspects such as assessment methodologies or scientific approaches and will be published once agreed.


  • EUnetHTA is a network of organisations (from EU Member States, EEA and accession countries) and a large number of relevant regional agencies and not-for-profit organisations that produce or contribute to health technology assessment in Europe. EUnetHTA enables scientific cooperation between HTA bodies in Europe. It is co-funded by the Public Health Programme of the European Commission, DG Health and Consumers and performs the function of the scientific and technical cooperation of the HTA network established as per the Directive 2011/24/EU on the application of patients' rights in cross-border healthcare.

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