Magisterial hospital preparations – hospital exemptions

Published by IRDiRC

Early Access SupportAdvanced TherapyHospital ExemptionATMPsRegulatory Affairs

Article 28 of the ATMP Regulation also empowers Member States to permit the manufacturing and use of certain non- routine produced advanced therapies that have not been authorised by the Commission under certain conditions (so-called “Hospital Exemption”) outside the scope of the Medicinal Product Directive 2001/23.

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Regenerative Medicine Advanced Therapy (RMAT) Designation

Published by IRDiRC

Advanced TherapyRegenerative Medicine Advanced Therapy DesignationRegulatory AffairsEarly Access Support

The RMAT Designation is analogous to the Breakthrough Designation designed for traditional drug candidates but applies to regenerative medicine treatments, and allows companies to interact with the FDA more frequently during the clinical development of the therapy. An RMAT-designated therapy is eligible for priority review and accelerated approval.

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