regulation on advanced therapy medicinal products
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Regulation on Advanced Therapy Medicinal Products. Eucomed views Dr. Ing. Dario Pirovano May 11, 2006. Eucomed – Voice of the Medical Technology Industry in Europe. Eucomed represents directly and indirectly 4500 designers, manufacturers and suppliers of: medical technology - PowerPoint PPT PresentationTRANSCRIPT
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Regulation on Advanced Therapy Medicinal
Products
Eucomed viewsDr. Ing. Dario Pirovano
May 11, 2006
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Eucomed – Voice of the Medical Technology Industry in Europe
Eucomed represents directly and indirectly 4500 designers, manufacturers
and suppliers of:
» medical technology
» pioneers in human tissue engineering technology including SMEs
www.eucomed.org
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Introduction
Advanced Therapy Products
•Many advanced therapy products use multidisciplinary technologies
•Also many are combined products, i.e. incorporating a medical device and a cellular or tissue part
•ATP with different modes of action
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Examples of human tissue engineered products
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Combined product
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Non viable tissue engineered product
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Viable tissue acting as a medical device
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Coverage by the proposed Regulation
• Non viable: No • Viable acting as medicines: Yes• Viable acting as Medical Device: diverging views• Combined products:
– Yes if Medical Device is ancillary; – No if cellular/tissue part is ancillary
First test: Is the ATP a medicinal product?
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ATMP prepared & used in hospitals for individual patients
• Proposed exemption from the requirement for a marketing authorisation
– This should be limited to a single medical procedure specified for an identified patient under the supervision of the patient’s doctor
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It is important that all products containing or being made of human
tissue engineered products are covered by Community legislation
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What do we suggest
• Analyse options to cover these products adequately under EU law:
Ensuring a high level of health protection Adhering to the same four EU policy objectives and Taking into account the scientific and technical
characteristics of the products.
• Improve the legal certainty for the classification of ATPs and combined products.
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Why Eucomed can help
• Expertise with hybrid, complex & advanced medical devices
• Eucomed involved since the outset in the discussions on human tissue engineered products
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Contact details• Eucomed
[email protected]. +32 (2) 772 22 12 fax: +32 (2) 771 39 09
• More information on: www.eucomed.org
• Eucomed Vademecum