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. 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

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. 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?

9. 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

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

11. 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.

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

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