REGULATION (EC) No 1394/2007 OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 13 November 2007 on advanced therapy medicinal products and amending Directive 2001/83/EC and Regulation (EC) No 726/2003

Published by EC

Advanced TherapyMarketing Authorisation

This Regulation lays down specific rules concerning the authorisation, supervision and pharmacovigilance of advanced therapy medicinal products.

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Magisterial hospital preparations – hospital exemptions

Published by IRDiRC

Regulatory AffairsEarly Access SupportAdvanced TherapyHospital ExemptionATMPs

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

Regulatory AffairsEarly Access SupportAdvanced TherapyRegenerative Medicine Advanced Therapy Designation

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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