The Patented Medicine Prices Review Board recently published the final version of its guidelines which operationalise the amendments to the Patented Medicines Regulations scheduled to come into force on 1 January 2021. This article provides a brief summary of the final framework for the price review process and highlights changes relative to the June 2020 draft guidelines.
Justice Manson of the Federal Court recently ordered the minister of health to issue a notice of compliance to Fresenius Kabi for IDACIO (adalimumab), a biosimilar of AbbVie's HUMIRA. The minister of health had completed its review of Fresenius Kabi's new drug submission for IDACIO; the only outstanding issue was whether Fresenius Kabi had addressed the patents listed on the Patent Register in respect of HUMIRA.
The Canadian Agency for Drugs and Technologies in Health (CADTH) recently announced the launch of new Procedures for CADTH Drug Reimbursement Reviews, which harmonise procedures under the CADTH's drug reimbursement review pathways. This article outlines the procedure's main highlights.
The minister of health recently approved the Interim Order Respecting the Prevention and Alleviation of Shortages of Drugs in Relation to COVID-19, which introduces new tools to address drug shortages, or the risk of drug shortages, that may be caused or exacerbated by the COVID-19 pandemic. This article examines some of the interim order's main features.
The minister of health recently approved the Interim Order Respecting the Importation, Sale and Advertising of Drugs for Use in Relation to COVID-19. Once approved by the governor in council, the interim order will be valid for only one year from the day on which it was signed by the minister, and product authorisations issued under the interim order will be valid only while the interim order is in effect.