National Scientific Advice with HTA bodies

Published by IRDiRC

Regulatory AffairsNational Scientific AdviceHTA BodiesReimbursementHTA National

Regional and national HTA bodies in Europe, provide recommendations on medicines and other health technologies that can be financed or reimbursed by the healthcare system in a particular Member State or region. The assessment criteria used by HTA bodies differ between Member States, in accordance with regional and national legislation.

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Early dialogue with payers /Medev – MoCA provides a mechanism for European countries to collaborate on coordinated access to orphan medicines in a voluntary, dialogue-based approach, intended to create a fluid set of interactions between key stakeholders, across all aspects of a product

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Joint EMA-HTA Scientific Advice

Published by IRDiRC

Regulatory AffairsScientific AdviceEUnetHTAHTA 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.

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