Spring Intro 2023

23/03/2023

Parallel Consultation: EMA/EUnetHTA

• As of July 2017, EUnetHTA and EMA offer Parallel Consultations on evidence generation plans. • Parallel Consultations aim to allow medicine developers to obtain feedback from regulators and HTA bodies on their development plans to support decision-making on marketing authorisation, HTA, 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 has replaced the Parallel Scientific Advice procedure by EMA and HTA bodies which required medicine developers to contact Member States’ HTA bodies individually.

The Organisation for Professionals in Regulatory Affairs

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Parallel Consultation: EMA/EUnetHTA

• The procedure is a single gateway for Parallel Consultations with EMA, 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. How is this process going to change with the implementation of the new centralised HTA?

The Organisation for Professionals in Regulatory Affairs

https://eunethta.eu/services/early-dialogues/parallel-consultations/

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