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Regulation on Advanced Therapy Medicinal Products

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

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Regulation on Advanced Therapy Medicinal Products

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  1. Regulation on Advanced Therapy Medicinal Products Eucomed views Dr. Ing. Dario Pirovano May 11, 2006

  2. 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

  3. 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 Introduction

  4. Examples of human tissue engineered products

  5. Combined product

  6. Non viable tissue engineered product

  7. Viable tissue acting as a medical device

  8. 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 Coverage by the proposed Regulation First test: Is the ATP a medicinal product?

  9. 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 ATMP prepared & used in hospitals for individual patients

  10. It is important that all products containing or being made of human tissue engineered products are covered by Community legislation

  11. 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. What do we suggest

  12. Expertise with hybrid, complex & advanced medical devices Eucomed involved since the outset in the discussions on human tissue engineered products Why Eucomed can help

  13. Eucomedeucomed@eucomed.betel. +32 (2) 772 22 12 fax: +32 (2) 771 39 09 More information on: www.eucomed.org Eucomed Vademecum Contact details

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