Therapy Classification Resources

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 

ATMPs

Various Legal Frameworks 

ATMPs   

Exempted ATMP pathways   

Named patients and compassionate use pathways   

Medicines prepared by pharmacists   

CAT scientific recommendations on classification   

ATMPs and Orphan Drugs   

• Orphan Medicines Regulation, Rare Diseases Europe (EURORDIS)

ATMPs and paediatric drugs   

ATMPs and Genetically Modified Organisms   

ATMPs and Medical Devices

Human body elements for therapeutic applications

• Recommendations for procurement of starting materials by apheresis for advanced therapy medicinal products

Not ATMPs: medical devices containing tissues and cells  

This section is in development.

Not ATMPs: Other

This section is in development.