000 02318nam  2200313za 4500
0019.833940
003CaOODSP
00520221107150327
007cr |||||||||||
008170327s2016    oncd    os   f000 0 eng d
040 |aCaOODSP|beng
0410 |aeng|afre
043 |an-cn---
0861 |aH82-27/2016-PDF
24500|aOrphan Drug Launch Monitor (ODLM) |h[electronic resource] = |bObservateur des médicaments orphelins (OMO).
24631|aObservateur des médicaments orphelins (OMO)
260 |a[Ottawa] : |bPatented Medicine Prices Review Board, |c[2016]
300 |a[1] p. : |bcol. charts
500 |aCaption title.
500 |aAt head of title: National Prescription Drug Utilization Information System.
520 |a"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.
546 |aText in English and French.
69207|2gccst|aDrugs
69207|2gccst|aPharmaceutical industry
69207|2gccst|aGovernment policy
7101 |aCanada. |bPatented Medicine Prices Review Board.
7102 |aNational Prescription Drug Utilization Information System (Canada)
792 |tOrphan Drug Launch Monitor (ODLM) |w(CaOODSP)9.833941
85640|qPDF|s310 KB|uhttps://publications.gc.ca/collections/collection_2017/cepmb-pmprb/H82-27-2016.pdf