Parallel 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) as of July 2017. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their evidence-generation plans to support decision-making on marketing authorisation and reimbursement of new medicines at the same time.
These consultations can take place before or after the product is placed on the European Union (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.
This initiative replaces the former parallel scientific advice procedure by EMA and HTA bodies, whereby medicine developers had to contact Member State HTA bodies individually.
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 Partners and networks: Health technology assessment bodies.
The procedure is a single gateway for parallel consultations with EMA, EUnetHTA and HTA bodies on evidence-generation plans.
The main benefits of the parallel 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's Early Dialogue Working Party (EDWP) and the EUnetHTA early dialogue (ED) secretariat.
The EUnetHTA ED secretariat facilitates the centralised recruitment of HTA bodies to these procedures.
Joint guidance is available from EMA and EUnetHTA, which explains how to apply for the parallel consultation procedure, the actions for each party and timelines:
- Guidance on parallel consultation
- 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
- Dates of 2020 Scientific Advice Working Party (SAWP) meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel consultation (EMA / EUnetHTA) requests
Applicants wishing EUnetHTA to take part in a parallel consultation procedure should respond to an EUnetHTA open call for early dialogue requests, in line with the latest version of the joint guidance on parallel consultation.
For the latest information on EUnetHTA open calls for early dialogue requests, please see the EUnetHTA website.
Common templates are also available from EMA and EUnetHTA, which medicine developers should use for notifying EMA and EUnetHTA of their intent to participate and provide information and questions as part of the procedure:
Some HTA bodies may charge fees for participating in the parallel consultation procedure. The EUnetHTA ED secretariat can provide information on HTA associated fees.