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Tissue-Engineering&
Advanced Therapies
Press Briefing 16 November 2005
European CommissionEnterprise and IndustryDirectorate-General
Dr Nils BehrndtDeputy Head of UnitPharmaceuticals Unit
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Advanced Therapies – What do we mean?
ChemicalsBiotechGene TherapyCell TherapyTissue Engineering
Advanced Therapies
Medicinal products based on• Genes : gene therapy• Cells: cell therapy• Tissues : tissue engineering
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Medical and economic importance
• Promising new treatment opportunities, e.g.– Skin replacement in burn victims– Reconstruction of blood vessels– Cancer– Alzheimer– Parkinson
• Today a limited market, but with huge potential
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The regulatory gap
Medical Devices
ChemicalsBiotechGene TherapyCell TherapyTissue Engineering
Advanced Therapies
Medicinal Products2001/83/EC
MedicalDevices93/42/EEC
?
Legislation
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Today’s regulatory patchwork
• autologous products • allogeneic productsRef. : Joint Research Centre, European Commission, 2004
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Overall objectives
• Guarantee a high level of health protection
• Harmonise and facilitate market access
• Foster competitiveness
• Provide overall legal certainty
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Regulatory levels of the overall approach
Regulatory frameworkRegulation on Advanced Therapies
Existing Legislation on Tissues & Cells,Medical Devices and Medicines
Technical Requirements
Guidelines
1
2
3
Proposal!
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Regulation on Advanced Therapies: Key elements
• No marketing without prior approval
• Demonstration of Quality, Safety & Efficacy against tailored technical requirements
• Scientific assessment by European Medicines Agency (new scientific Committee)
• Risk management & Long-term traceability
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Competitiveness Aspects
The approach provides e.g. for • Direct access to the Community market• Harmonised data protection of 10 years• Accelerated assessment• Scientific advice at reduced fee • Special incentives for SMEs
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Timing & Procedure
• Regulation to be adopted by Council/European Parliament
• Technical requirements should be ready shortly after adoption of the Regulation
• More information http://pharmacos.eudra.org/F2/advtherapies/index.htm