Parallel joint scientific consultation with regulators and health technology assessment bodies
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
pilot on regulatory-HTA parallel 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:
Applicants wishing EUnetHTA 21 to take part in a parallel joint scientific consultation procedure should respond to a EUnetHTA 21 open call for joint scientific consultation, in line with the latest version of the joint guidance on parallel joint scientific consultation.
For the latest information on EUnetHTA 21 open calls for joint scientific consultation, please see the EUnetHTA 21 website: |
Joint guidance is available, which explains how to apply for the parallel consultation procedure, the actions for each party and timelines:
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Guidance on parallel consultation
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Dates of 2021 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
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Dates of 2022 Scientific Advice Working Party (SAWP) meetings and submission deadlines scientific advice, protocol assistance, qualification of biomarkers and EMA/EUnetHTA parallel consultation requests
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.
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.