Creating conditions for the success of the French industrial advanced therapy sector

Thérapie
Pierre Noel LirsacFrank Yates

Abstract

Although the European Union merely followed the initiatives of the United States and Japan by introducing special regimes for orphan medicinal products, it has introduced a special status for a new category of biological medicinal products, advanced therapy medicinal products (ATMPs), adopting specific associated regulations. European Regulation (which constitutes the highest legal instrument in the hierarchy of European law texts) [EC] No. 1394/2007, published in 2007, uses this term to define somatic cell therapy medicinal products, tissue-engineered products, and gene therapy medicinal products, possibly combined with medical devices. The stated objective was two-fold: both to promote their industrialization and market access, while guaranteeing a high level of health protection for patients. Since publication of the regulation, few marketing authorizations have been granted in Europe, and these have not been accompanied by commercial success. However, certain recent studies show that this is a growing sector and that France remains the leading European nation in terms of clinical trials. This round table brought together a panel of representatives of French public and private protagonists from the advanced therapy sector. T...Continue Reading

References

Nov 6, 1998·Science·J A ThomsonJ M Jones
Apr 28, 2000·Science·M Cavazzana-CalvoA Fischer
Mar 27, 2013·The New England Journal of Medicine·Stephan A GruppCarl H June

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