Close interaction between regulators, HTA bodies and other relevant bodies is critical to enable patient access to new health technologies. It also benefits 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.
For more information on how EMA works with partners, see:
The Regulation (EU) 2021/2282 on health technology assessment (HTAR) provides an EU framework for the assessment of health technologies such as medicines and medical devices. It does so by fostering collaboration and coordination between EU Member States.
In this context, the health technology assessment regulation also governs European cooperation between medicine regulators and HTA bodies. This cooperation is meant to build synergies between regulatory evaluation and HTA along the medicine lifecycle.
The regulation applies as of January 2025, having entered into force in January 2022.
Since 2023, the European Commission and EU Member States have been working on implementing acts that detail the procedural rules of the regulation.
During the preparatory phase, EMA contributed to the implementation activities by working closely with the European Commission's DG SANTE, the Member State Coordination Group on HTA (HTACG), and stakeholders representing the pharmaceutical industry, healthcare professionals, patients and academia.
EMA collaborates with the European Commission and the Member State Coordination Group on HTA (HTACG) by providing specific information as required by the health technology assessment regulation. The aim is to support the work of the coordination group.
The Commission ensures the secretariat for the coordination group.
An overview of the information that EMA shares with the Commission's HTA secretariat is outlined in the expandable panels below. Each panel highlights a domain area. Expand the panels to find out about related EMA responsibilities.
All processes detailed below are based on protecting confidential information and respecting the distinct remits of regulators and HTA bodies. For more details, see: Implementing act on exchange of information with the European Medicines Agency.
EMA makes information available as the implementation of the health technology assessment regulation progresses.
EMA provides information related to marketing authorisation applications and extensions of indications to the Commission's HTA secretariat supporting the coordination group.
This enables the coordination group to perform joint clinical assessments (JCA).
In their JCA collaboration, EMA and the HTA secretariat provide marketing authorisation applicants with the same pre-submission request form.
This facilitates submission notifications for JCA-relevant products. It also streamlines information exchange between EMA and the HTA secretariat.
From June 2024, applicants must declare in the letter of intent to EMA (i.e. within the pre-submission request form) if their application is subject to joint clinical assessment, in line with the health technology assessment regulation.
If this is the case, applicants must submit the letter of intent to EMA and the HTA secretariat (via its HTA IT platform) simultaneously. This enables the JCA preparatory phase to start in parallel with the marketing authorisation application (MAA) pre-submission phase.
Applicants must also communicate to EMA and the HTA secretariat any changes to the intended MAA submission date or decisions to no longer pursue the application. This is crucial if an application that was not initially expected to be subject to JCA still falls within its scope due to delays.
Related pre-authorisation guidance and the pre-submission request form are available via the link below:
For more information on the provision of information, see:
Applicants wishing to clarify if their upcoming application would potentially be subject to JCA should contact the HTA secretariat directly. For contact details, see:
EMA and the coordination group carry out parallel joint scientific consultations on medicines. This involves synchronised timing and preserving separate remits.
For more information, see:
EMA ensures the secretariat of medical device expert panels that provide input on the clinical and performance assessment of certain medical devices and in-vitro diagnostic medical devices.
This enables their conformity assessment for the EU market.
In this capacity, EMA provides the HTA secretariat information on medical devices classified as high-risk (class IIb or III) or in-vitro diagnostics (IVD) potentially in scope of joint clinical assessment.
EMA facilitates the involvement of medical device expert panels in the provision of parallel joint scientific consultation on medical devices.
EMA is running a pilot that enables the expert panels to provide scientific advice for manufacturers of high-risk medical devices. During this pilot, developers were able to indicate their willingness to have an HTA body observe their project. This is subject to confirmation from EMA.
For more information, see:
EMA provides the HTA secretariat with business pipeline information on planning and forecasting joint clinical assessment and joint scientific consultation for medicines and medical devices.
EMA supports the HTA secretariat on request to identify experts for work under the heath technology assessment regulation. This is one of the ways in which the HTA secretariat finds and recruits these experts. They include patients and clinical experts.
The technical work related to the HTA regulation builds on previous cooperation activities in Europe.
EMA began collaborating with the European Network for Health Technology Assessment (EUnetHTA) in 2010. EMA worked closely with this network until September 2023, when the final consortium concluded its activities.
Expand the panels below to access previous work plans and implementation reports, a comprehensive background on EMA - EUnetHTA cooperation and minutes from related meetings.
The joint achievements of EMA and EUnetHTA 21 included:
The EunetHTA21 consortium built on the foundations that the European Network for Health Technology Assessment (EUnetHTA) laid down.
For more information, see:
Between 2017 and 2021, EMA and EUnetHTA:
The EMA / EUnetHTA joint work plan for 2017-2021 and report on its implementation is available:
Between 2012-2015, EMA and EUnetHTA:
The EMA / EUnetHTA joint work plan for 2012-2025 and report on its implementation is available:
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.
For more information, see: