Regulatory Affairs

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All SubjectsRegulatory Affairs

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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Mechanism of Coordinated Access to OMPs

Published by IRDiRC

Research and Drug DevelopmentRegulatory AffairsEUnetHTAHTA BodiesReimbursementOrphan MedicineMechanism of Coordinated Access to OMPs

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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