The European Commission has announced the opening of the new Joint Scientific Consultations (JSCs) periods under EU Health Technology Assessment (HTA) Regulation (Regulation (EU) 2021/2282) (sourced link).
JSCs enable health technology developers to obtain coordinated, EU-level feedback while planning clinical studies, focused on the evidence needs for a potential future Joint Clinical Assessment (JCA).
JSCs are relevant for developers of innovative medicinal products and eligible high-risk medical devices / IVDs expected to fall within the scope of EU joint work. They are particularly beneficial for obtaining early, harmonized guidance on clinical evidence generation strategies aligned with HTA expectations across Member States – reducing uncertainty, supporting better study design decisions, and strengthening the overall evidence package ahead of market access discussions.
Currently there are no public fees for JSCs, and developers may also request a parallel consultation with the European Medicines Agency (EMA) scientific advice, enabling joint discussion with EMA coordinators/experts and Member State HTA representatives.
At Barcelona Clinical Coordinating Center (BCCC), we closely follow these initiatives as part of our commitment to supporting innovation and efficient clinical development pathways.
We are pleased to offer our support and guidance to clients who may be interested in participating in these Joint Scientific Consultations. Our team can assist throughout the process, including eligibility and timing assessment, strategic preparation, documentation, and coordination, to help maximize the value of the consultation.
If you would like to explore how these Joint Scientific Consultations may benefit your project, please do not hesitate to contact us at info@bcccbarcelona.cat .
