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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PRIME supports developers of medicines addressing an unmet medical need or which may bring major therapeutic advantage to patient with enhanced interaction and early dialogue to optimize the development of eligible medicines, improving clinical trial designs and speed up their evaluation and contribute to timely patients’ access. PRIME builds on the existing regulatory framework and tools already available such as scientific advice and accelerated assessment.

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FDA Expedited Program for serious conditions – Breakthrough Therapy Designation

Published by IRDiRC

Regulatory AffairsEarly Access SupportRegulatory AdviceExpedited ProgrammeBreakthrough Therapy Designation

Process designed to facilitate the development and expedite the review of drugs intended to treat a serious condition AND preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over available therapy on a clinically significant endpoint(s).

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