Healthcare & Life Sciences, Smart & Biggar updates

Canada

Contributed by Smart & Biggar
Few significant changes made in final PMPRB guidelines
  • Canada
  • 25 November 2020

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.

Federal Court orders minister of health to issue NOC to Fresenius Kabi for biosimilar
  • Canada
  • 25 November 2020

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.

CADTH harmonises drug reimbursement review process
  • Canada
  • 11 November 2020

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.

Health Canada issues interim order respecting drug shortages relating to COVID-19
  • Canada
  • 11 November 2020

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.

New interim order for COVID-19 drugs has wide-reaching impact
  • Canada
  • 04 November 2020

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.


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