Regulation on Advanced Therapy Medicinal Products

Regulation on Advanced Therapy Medicinal

Products

Eucomed viewsDr. 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

» pioneers in human tissue engineering technology including SMEs

www.eucomed.org

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

Examples of human tissue engineered products

Combined product

Non viable tissue engineered product

Viable tissue acting as a medical device

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?

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

It is important that all products containing or being made of human

tissue engineered products are covered by Community legislation

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.

Why Eucomed can help

• Expertise with hybrid, complex & advanced medical devices

• Eucomed involved since the outset in the discussions on human tissue engineered products

Contact details• Eucomed

[email protected]. +32 (2) 772 22 12 fax: +32 (2) 771 39 09

• More information on: www.eucomed.org

• Eucomed Vademecum