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Advanced Therapy Medicinal Products (ATMPs) Classification 

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Regulatory AffairsEarly Access SupportAdvanced TherapyATMPs Classification

Companies can consult the European Medicines Agency (EMA) to determine whether a medicine they are developing is an advanced therapy medicinal product (ATMP). This is an opportunity for ATMP developers to receive confirmation that a medicine, which is based on genes, cells or tissues, meets the scientific criteria for defining an ATMP. The procedure can help developers to clarify the applicable regulatory framework since the beginning of the product development.

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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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