Through a combination of in-house and external partnerships with a range of regulatory experts and groups, EATRIS can provide regulatory support for most types of product including: Expert opinion, Orphan Drug Designation and Scientific Advice application at the EMA, Pre-clinical and clinical plan development, Informal scientific advice with selected national competent authorities, for highly complex projects,
access to EATRIS Regulatory Database (free of charge) that contains information about the regulatory requirements, guidelines and legislations from 27 EU countries (as well as Norway, Switzerland, Turkey and Israel) regarding drug and medical device development derived from the application of European legislation.

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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 AdviceExpedited ProgrammeBreakthrough Therapy DesignationRegulatory AffairsEarly Access Support

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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