Health technology assessment bodies

The European Medicines Agency (EMA) has been working closely with health technology assessment (HTA) bodies since 2008. Regional and national HTA bodies provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular European Union (EU) Member State or region.

Close interaction between regulators, HTA bodies and other relevant bodies is critical to enable patient access to important new medicines and hence for the benefit of public health. This aims to reduce developmental resources, by re-shaping and focusing medicine development programmes to generate evidence relevant for regulators, HTA bodies and other stakeholders.

Cooperation also aims to facilitate the sequential decision making by sharing information in the context of the respective assessments. 

Cooperation with European HTA bodies

In the future, European cooperation between medicine regulators and HTA bodies will be governed by the Regulation on Health Technology Assessment (EU) 2021/228 when it takes effect in January 2025.

EMA is working closely with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium to prepare for the entry into application of the Regulation.

The European Commission has contracted EunetHTA21 to continue HTA cooperation in Europe, building on the foundations laid down by the former European Network for Health Technology Assessment (EUnetHTA) network since 2010.

Between 2021 and 2023, EMA and EUnetHTA 21 are focusing on the following jointly agreed priority areas:

  • Joint scientific consultation for robust evidence generation
  • Exchange of information on assessments of medicines
  • Generation of patient-relevant data and information to support decision-making
  • Methodologies to engage patients and healthcare professionals
  • Horizon scanning and preparedness of HTA and regulatory systems
  • Optimisation of regulatory outputs as reference for down-stream decision-making
  • Study methods and guidelines of real-world evidence
  • Tools to support assessment in smaller populations
  • Assessment work related to companion diagnostics

More information is available in the joint work plan below.

Between 2010 and 2021, EMA worked closely with EUnetHTA to build synergies between regulatory evaluation and HTA during the medicine lifecycle.

More information is available in joint work plans and implementation reports and in the EMA / EUnetHTA meeting minutes

EMA / EUnetHTA meeting minutes

Parallel consultation with regulators and HTA bodies

EMA offers consultations in parallel with HTA bodies. This aims to allow medicine developers to obtain feedback from regulators and HTA bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.

The procedure is a single gateway for parallel consultations with EMA, EUnetHTA 21 and HTA bodies on evidence-generation plans.

Consultations can take place before or after the product is on the market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.

For more information, see Parallel consultation with regulators and health technology assessment bodies.


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