00000nam 2200000za 4500 9.833940 CaOODSP 20221107150327 cr ||||||||||| 170327s2016 oncd os f000 0 eng d CaOODSP eng eng fre n-cn--- H82-27/2016-PDF Orphan Drug Launch Monitor (ODLM) [electronic resource] = Observateur des médicaments orphelins (OMO). Observateur des médicaments orphelins (OMO) [Ottawa] : Patented Medicine Prices Review Board, [2016] [1] p. : col. charts Caption title. At head of title: National Prescription Drug Utilization Information System. "To stimulate drug development, a number of countries have adopted orphan drug regulatory frameworks. These include the United States (US) (1983), Singapore (1991), Japan (1993), Australia (1997), the European Union (EU) (1999/2000), Taiwan (2000) and South Korea (2003). The Orphan Drug Launch Monitor analyzes the international approval of designated orphan drugs and assesses their availability in Canada. This analysis focuses on a number of select orphan drugs reported at the active-substance level and identified based on the following criteria: drugs that received orphan designation and approval in the US and/or EU over the last decade (2005–2014); and drugs that only have orphan indications. The international market analyzed includes Canada and the seven PMPRB comparator countries (PMPRB7): France, Germany, Italy, Sweden, Switzerland, the United Kingdom (UK) and the US. The results report on sales and prices for 2014. Based on the selection criteria, 134 orphan drugs were identified, accounting for 2.9% of the international pharmaceutical sales in 2014"--Background and approach. Text in English and French. gccst Drugs gccst Pharmaceutical industry gccst Government policy Canada. Patented Medicine Prices Review Board. National Prescription Drug Utilization Information System (Canada) Orphan Drug Launch Monitor (ODLM) fre (CaOODSP)9.833941 PDF 310 KB https://publications.gc.ca/collections/collection_2017/cepmb-pmprb/H82-27-2016.pdf