EMA-EUnetHTA Parallel Consultation

EMA-EUnetHTA Parallel Consultation

Parallel consultation between EUnetHTA and the European Medicines Agency

As of July 2017, EUnetHTA and the European Medicines Agency (EMA) offer parallel consultations on evidence generation plans. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies on their development plans to support decision-making on marketing authorisation, health technology assessment, 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.

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.

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.

Patient representatives and healthcare professionals also participate in the parallel consultation procedure on a routine basis so that their views and experiences are incorporated into discussions.

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:

Guidance on parallel consultation (PDF)

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:

Letter of intent for parallel consultation (FILE NAME BELOW: Letter of intent for parallel consultation EMA and EUnetHTA.docx)

Parallel consultation briefing document template (FILE NAME BELOW: Parallel consultation briefing document template .doc)

Some HTA bodies may charge fees for participating in the parallel consultation procedure. The EUnetHTA ED secretariat can provide information on HTA associated fees.

EMA’s scope and the fees it charges for this procedure are the same as for standard scientific advice. For more information, see Fees payable to EMA.

For information on participation of HTA bodies, please contact the EUnetHTA ED secretariat

For information on regulatory aspects, please contact the EMA scientific advice secretariat

Guidance on Parallel Consultation

Letter of intent for parallel consultation EMA and EUnetHTA

Parallel consultation briefing document template

DOICU template JA3

1Procedure for DOICU handling_JA3_2016

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