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 procedure for advanced therapy medicinal products (ATMPs), including gene therapy, somatic cell therapy, and tissue-engineered products, within the European Union. It applies to manufacturers, sponsors, and marketing authorization holders of ATMPs under Article 8 and requires compliance with specific quality, safety, and efficacy standards.
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%3A32007R1394
SHA-256 integrity: 985451855df516462d59359f38a72f562e21f073ab4a32b847bd7389ce83768d
Primary Citations — 5 traced to source
- Regulation (EC) No 1394/2007, Article 2 - Definitions
- Regulation (EC) No 1394/2007, Article 4 - Quality, Safety and Efficacy Requirements
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