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 made available on the market. The objective is to help generate optimal and robust evidence that satisfies the needs of both regulators and HTA bodies.
Interactions between medicines' developers, regulators and HTA bodies or other possible stakeholders to discuss the development plan means that evidence can be generated to meet the needs of respective decision-makers as efficiently as possible. This facilitates patient access to important new medicines and hence benefits overall public health.
This initiative replaces the parallel scientific advice procedure by EMA and HTA bodies which required medicine developers to contact Member States' HTA bodies individually.
It also 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.
Benefits of parallel procedure
The procedure is a single gateway for parallel consultations with EMA, EUnetHTA and HTA bodies on their 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.
Guidance for applicants
The procedure has four stages: submission of letter of intent to EMA and EUnetHTA simultaneously, pre-submission, evaluation and advice/outcome.
EMA and EUnetHTA have published joint guidance for the parallel consultation procedure which explains how to apply and highlights the actions for each party and preferable timelines:
- Dates of 2018 SAWP meetings and deadlines for submission of scientific advice, protocol assistance, qualification of biomarkers and parallel EMA-health-technology-assessment requests
- Guidance on parallel consultation
EMA and EUnetHTA have also published common templates, 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.
Applicants should note the submission deadlines for the scientific advice procedure including parallel consultations. For the submission deadlines, see Scientific advice and protocol assistance: Regulatory and procedural guidance.