Classification and ethical issues regarding advanced therapy medicinal products

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Abstract

European Union’s (EU) Regulation No. 1394/2007 has introduced a new regulatory category of medicines – advanced therapy medicinal products, into the EU legal system. They are divided at present into three major groups: gene therapy, somatic cell therapy and tissue engineered medicinal products. The reasons for such classification are complex and vary in a broad spectrum comprised from political-legislative to scientific concerns. The aim of the paper is to discuss some classification issues that arise from the reluctance of the European legislator to address in a clearer way some important ethical issues with regard to those advanced therapies.

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Keywords

  • Advanced therapy medicinal products
  • Classification
  • Ethical issues

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