Procedures set up by many (but not all) National Member State to offer scientific advice to developers of new medicines. The procedures can be similar but often less formal than for CHMP scientific advice/protocol assistance at the EMA; they may include written advice and/or face-to-face meetings. The procedures are not limited only to orphan product development and may vary between Member States.

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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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