IRDiRC E104 Building Block (National Member State Scientific Advice)

Published by IRDiRCECRIN

Clinical Trials Toolkit

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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