Parallel joint scientific consultation with regulators and health technology assessment bodies
HumanRegulatory and procedural guidanceResearch and developmentScientific advice
The European Medicines Agency (EMA) offers consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium, as of 2022. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies in European Union (EU) Member States on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.
This parallel joint scientific consultation initiative with EunetHTA 21 replaced parallel consultations with the former EunetHTA , and the former parallel scientific advice procedure by EMA and HTA bodies, whereby medicine developers had to contact Member State HTA bodies individually.
Consultations can take place before or after the product is placed on the EU market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.
Interactions between medicine developers, regulators and HTA bodies or other stakeholders to discuss the development plan enable evidence to be generated to meet the needs of respective decision-makers as efficiently as possible. This facilitates patient access to important new medicines and benefits overall public health.
It builds on previous initiatives and pilots on HTA-regulatory collaboration led by EMA, EUnetHTA and the European Commission. These include the Report of the pilot on parallel regulatory-health technology assessment scientific advice, EunetHTA's early dialogue initiative, the SEED project financed by the European Commission and joint research on levels of alignment between regulators and HTAs in parallel advice.
For more information see:
Guidance for applicants
Applicants wishing EUnetHTA 21 to take part in a parallel joint scientific consultation procedure should respond to an EUnetHTA 21 open call for joint scientific consultation, in line with the latest version of the joint guidance.
For the latest information on open calls for joint scientific consultation, see the EUnetHTA 21 website:
Health technology developers will be able to apply for parallel EMA-HTA body scientific advice from September 2023, when EUnetHTA 21 ceases to operate, until January 2025 when Regulation (EU) 2021/2282 on health technology assessment will become fully applicable. For more information, see Cooperation with European HTA bodies.
During this period, applicants may use this procedure to request the involvement of HTA bodies when applying for EMA scientific advice.
A minimum of two HTA bodies may participate on a voluntary basis.
The selection criteria are available in the Guidance on Parallel EMA/HTA body (HTAb) Scientific Advice for the Interim Period
The result of the selection will depend on the resources available to each HTA body.
As an outcome of the procedure, developers will receive a scientific advice letter from EMA and indvidual written recommendations from participating HTA bodies.
If the minimum number of HTA bodies is not reached, the request will continue as EMA-only scientific advice.
Joint guidance is available below which explains how to apply for the parallel consultation procedure, the actions for each party and timelines.
Guidance is also available on the parallel EMA-HTA body scientific advice.
Common templates are also available, which medicine developers should use for notifying EMA and EUnetHTA 21 of their intent to participate and provide information and questions as part of the procedure:
EMA's scope and fees for this procedure are the same as for standard scientific advice. For more information, see Fees payable to EMA.
Some HTA bodies may charge fees for participating in the parallel consultation procedure. The EUnetHTA JSC secretariat can provide information on HTA associated fees.
Benefits of parallel joint scientific consultation procedure
The procedure is a single gateway for parallel joint scientific consultations with EMA, EUnetHTA 21 and HTA bodies on evidence-generation plans.
The main benefits of the parallel joint scientific consultation procedure include:
- streamlined procedure for applicants;
- increased mutual understanding and problem-solving ability between EMA and HTA bodies through a more structured interaction;
- improved coordination with, and greater participation of HTA bodies in parallel consultations through EUnetHTA 21's Committee for Scientific Quality & Consistency in its configuration for Joint Scientific Consultations (CSCQ JSC)
The EUnetHTA JSC secretariat facilitates the centralised recruitment of HTA bodies to these procedures.
Patient representatives and healthcare professionals routinely participate in parallel consultation procedures to incorporate their views and experiences into discussions.