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 sequential decision-making by sharing information in the context of the respective assessments.
European cooperation between medicine regulators and HTA bodies will be governed by the Regulation on Health Technology Assessment (EU) 2021/2282 when it becomes applicable in January 2025. The Regulation entered into force in January 2022.
Under the new legal framework, EMA will collaborate with the secretariat of the Member State Coordination Group on HTA (HTACG) to support this group's clinical assessments. EMA will also engage in parallel scientific consultations and help the HTACG identify emerging health technologies.
Since 2023, the European Commission and Member States have been drafting implementing acts to support operations under the new Regulation.
EMA is contributing to these preparatory activities by working closely with the European Commission's DG SANTE, the HTACG, and stakeholders such as the pharmaceutical industry, healthcare professionals, patients and academia.
For more information, see Implementation of the Regulation on health technology assessment.
The technical work related to the HTA regulation builds on continued cooperation activities in Europe. EMA began collaborating with HTA bodies in 2010 and worked closely with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium until September 2023, when the consortium concluded its activities.
The joint achievements of EMA and EUnetHTA 21 include:
More information is available in the document below.
The EunetHTA21 consortium continued HTA cooperation in Europe, building on the foundations laid down by the former European Network for Health Technology Assessment (EUnetHTA) network since 2010.
More information on the consortium 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.
The EMA / EUnetHTA joint work plan for 2017-2021 and report on its implementation is available:
Between 2017 and 2021, EMA and EUnetHTA:
The EMA / EUnetHTA joint work plan for 2012-2025 and report on its implementation is available:
Between 2012-2015, EMA and EUnetHTA:
Further information on the EMA / EUnetHTA project to improve the EPAR template is available in a scientific article published in the Value in Health journal:
The first joint EMA-EUnetHTA project in 2010 responded to a political recommendation to consider how the assessment of the benefits and risks of a medicine contained in European public assessment reports (EPAR) can best be used to inform the assessment of the relative effectiveness of new medicines for HTA purposes in EU Member States. This has resulted in a series of improvements to the EPAR template.
EMA and EUnetHTA have published the outcomes of this project in a scientific journal.
The cooperation had been subsequently expanded to other areas to help ensure that data generated by medicine developers is relevant for the needs of both 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 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.