Creating Conditions for the Success of The French Industrial Advanced Therapy Sector - 08/07/16
participants of round table N°5 of Giens XXX:
Pierre Angot 5, Estelle de Barbeyrac 6, Pascal Bilbault 7, Elisabeth Bourg 8, Odile Damour 9, Patrick Faure 10, Nicolas Ferry 11, Bénédicte Garbil 5, Jérôme Larghero 12, Marina Nguon 12, François Pattou 13, Stéphane Thumelin 14, Frank Yates 15, †pages | 12 |
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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. The discussions focused on the conditions to ensure the success of translational research and, more generally, the French advanced therapy sector. These enabled a number of obstacles to be identified, which once lifted, by means of recommendations, would facilitate the development and success of this sector.
Le texte complet de cet article est disponible en PDF.Keywords : advanced therapy medicinal product, advanced therapy medicinal product with hospital exemption, genetically modified organism, market access
Abbreviations : ADI, AFM, AMD, ANR, ANSM, AP-HP, ARIIS, ATMPs, ATMP-NR, C4C, CAR, CEA, CEPS, CHU, CIC, CNRS, CTA, CTAA, CTP, DGOS, DRIEE, CT, EFS, EMA, ERDF, GMP, GLP, GMO, HCB, HCRP, ICH, IP, Inserm, iPS, IT, LEEM, MA, MERRI, MIG, MIGAC, NIH, PE, PIA, RPIB, SMB, SATT
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Vol 70 - N° 1
P. 83-94 - janvier 2015 Retour au numéroBienvenue sur EM-consulte, la référence des professionnels de santé.
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