What 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 726/2004 requires
This regulation establishes a centralized authorization pathway for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products…
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Pillar: Pharmaceuticals & Life Sciences · Authority: European Medicines Agency (EMA) on behalf of the European Union · Version: 1.0.0 · Last updated:
Primary source: https://eur-lex.europa.eu/legal-content/EN/TXT/?uri=CELEX%3A32007R1394
SHA-256 integrity: df94e19bce4707591cce981ff8755c4daf3c3b56ba87ca5b7e442b773926cc6c
Primary Citations — 5 traced to source
- Regulation (EC) No 1394/2007, Article 2 - Definitions of gene therapy, somatic cell therapy, and tissue-engineered products
- Regulation (EC) No 1394/2007, Article 8 - Quality, safety, and efficacy requirements for authorization
+ 3 more citations (full bibliography, deterministic workflow, actionable schema and crosswalks) included in the vault unlock — $0.01 via Skyfire / L402 / Direct Base USDC.
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- Discovery (free): /api/v1/nodes/eu-atmp-regulation-1394-pharma-gene-cell.json — 6-field metadata
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