Legal Classification
[Human body elements, medicines/ATMPs (gene therapy, cell therapy, tissue engineering), medical devices]
- Legal framework for ATMPs, European Medicines Agency (EMA)
- Scientific recommendations on classification of advanced therapy medicinal products, European Medicines Agency (EMA)
- What are ATMPs, ATMP Sweden
- ATMP regulatory guide, ATMP Sweden
- Taking ATMP to market, Cell and Gene Therapy Catapult (CGT Catapult)
- EU Regulatory Pathways for ATMPs: Standard, Accelerated and Adaptive Pathways to Marketing Authorisation
- Manufacturing process development of ATMPs within a regulatory framework for EU clinical trial & marketing authorisation applications
- Advanced Therapy Medicinal Products for Rare Diseases: State of Play of Incentives Supporting Development in Europe
- European regulatory experience with advanced therapy medicinal products
- Regulatory Framework for Advanced Therapy Medicinal Products in Europe and United States