titredelaprésentation.pptVIP

g spi/topo/AIFA mars 2007 Accessibility of medicinal products before marketing authorisation : The French experience C. Bélorgey Division on Evaluation of medicinal products of Special Status and Clinical Trials 30 March 2007 Accessibility of medicinal products 1 – Facilitating inclusion in CTs: the French public clinical trials registry Need for transparency for CTs (1) Need for transparency for CTs (2) In France From national initiatives to an European clinical trials registry ? 2 – Developing a strong compassionate use system: the French ATU system ( Authorisations for temporary use) General principles of ATU (1) General principles of ATU (2) Criteria for ATU : treatment, prevention or diagnosis of a rare or a serious disease no satisfactory alternative method available in France efficacy and safety are presumed benefit expected for the patients authorisation for a limited period of time 2 types of ATU Some figures 600 MPs assessed since 1994 220 MPs subject to ATU in 2006 (57 new ones) Availability 10-12 months on average before MA Cohort ATU ? 108 since 1994. 10 in 2006 Nominative ATU 2006: 25 000 ATU ; 550 refusal / year therapeutic areas : Significant examples HIV: Zerit (D4T), Epivir (3TC), Crixivan (indinavir), Norvir (ritonavir), Invirase (saquinavir), Viracept (nelfinavir), Viramune (névirapine), Sustiva (effavirenz), Ziagen (abacavir), Fortovase (saquinavir), Rescriptor (delavirdine), Agenerase (amprénavir), adefovir, Norvir soft caps (ritonavir), Kaletra (lopinavir/ritonavir), tenofovir, atazanavir, Fuzeon, tipranavir, darunavir, TMC125, MK0518, maraviroc… Designated orphan medicinal products About 80 MPs in ATU/422 positive opinions by COMP Among the 35 MA or positive opinions by CHMP 24 ATU (70%) and 29 months in average before MA Where to find the information? www.afssaps.sante.fr Thank you! C. Bélorgey Division on Evaluation of medicinal products of Special Status and Clinical Trials March 2007 * * Marketing auth