The European Medicines Agency (EMA) offers consultations in parallel with the European Network for Health Technology Assessment (EUnetHTA) 21 consortium. This aims to allow medicine developers to obtain feedback from regulators and health technology assessment (HTA) bodies in Europe 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 the parallel individual consultations with the former EunetHTA, and the former parallel scientific advice procedure by EMA and HTA bodies.
Consultations can take place before or after the product is placed on the market. The objective is to generate robust evidence that satisfies the needs of decision-makers.
To this end, a guidance was published in September 2022 to describe the process, timelines and actions for each party undertaking a parallel EMA/EUnetHTA 21 Joint Scientific Consultation. The inclusion of patients and clinical experts in the joint consultation is expected. The guidance also addresses practical issues related to this process, such as the fees and the processing of the documents to be submitted during the consultation procedure.
Interactions between all the stakeholders to discuss the medicine development plan allow to facilitate the patient access to relevant new medicines and to benefit overall public health.
For further details, read the guidance here!