What EU Advanced Therapy Medicinal Products Regulation 1394/2007 - Cell, Gene, and Tissue Therapies requires
Regulation (EC) No 1394/2007 establishes the regulatory framework for Advanced Therapy Medicinal Products (ATMPs) in the EU, covering gene therapy, somatic cell therapy, tissue-engineered products, and combined ATMPs. ATMPs require centralised marketing authorisation through EMA. The Committee for Advanced Therapies (CAT) provides scientific recommendations. Hospital exemption allows ATMPs manufactured in a hospital for use in the same member state on a named-patient basis, but this exemption is conditional on national competent authority oversight and does not permit commercial supply.
Pillar: Biotech & Genomics · Authority: European Medicines Agency (EMA) · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX:32007R1394
SHA-256 integrity: 208905899cca467b4fb477a97050bfcaf9939e9f9c06bbbf584312f87ddb0abd
Primary Citations — 5 traced to source
- Article 2 (definitions), Article 7 (centralised procedure), Article 11 (hospital exemption) — Regulation (EC) No 1394/2007 on Advanced Therapy Medicinal Products
- ATMP classification, scientific advice, and marketing authorisation procedures — EMA Advanced Therapies - overview and regulatory guidance
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