Orphan Drug Launch Monitor (ODLM) = Observateur des médicaments orphelins (OMO).: H82-27/2016-PDF
"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.
Permanent link to this Catalogue record:
publications.gc.ca/pub?id=9.833940&sl=0
| Department/Agency | Canada. Patented Medicine Prices Review Board. National Prescription Drug Utilization Information System (Canada) |
|---|---|
| Title | Orphan Drug Launch Monitor (ODLM) = Observateur des médicaments orphelins (OMO). |
| Variant title | Observateur des médicaments orphelins (OMO) |
| Publication type | Monograph |
| Language | Bilingual-[English | French] |
| Format | Electronic |
| Electronic document | |
| Note(s) | Caption title. At head of title: National Prescription Drug Utilization Information System. Text in English and French. |
| Publishing information | [Ottawa] : Patented Medicine Prices Review Board, [2016] |
| Description | [1] p. : col. charts |
| Catalogue number |
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| Subject terms | Drugs Pharmaceutical industry Government policy |
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