The Drug Approval Process
In this short webinar, James Radke provides an overview of the drug approval process in Canada: Health Canada, CADTH, PMPRB, INESSS, pCPA, and the proposed National Pharmacare program.
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Tag: CADTH
Zeal Tips
Health Canada Approves a Third Cystic Fibrosis Drug
Health Canada has approved a third drug by Vertex Pharmaceuticals, Symdeko (tezacaftor/ivacaftor and ivacaftor), to treat a subpopulation of people with cystic fibrosis (CF).
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Neupro Patch Now Available for Treating Parkinson’s Disease Across Canada (Except in British Columbia)
It may have taken 5 years, but patients with Parkinson’s disease can now have access to Neupro (rotigotine) in all provinces and territories – except for British Columbia.
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Health Canada to Review ALS Drug (edaravone)
Health Canada has accepted Mitsubishi Tanabe Pharma Corporation’s New Drug Submission (NDS) for edaravone to treat patients with amyotrophic lateral sclerosis (ALS). Health Canada has also granted the drug a Priority Review so that it should take less than 6 months for the review process to be completed.
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The Drug Review Process in Canada
Anyone who has participated in the Canadian healthcare system understands that it is complicated. And like many endeavours, the more government agencies involved, the more complicated (and convoluted) it seems to get. The same is true for the approval and disbursement of new medicines.
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How to Get the Provincial Health Ministry to Change Their Mind: A Conversation with Cassie & Friends
In June 2016, the Canadian Agency for Drugs and Technologies in Health (CADTH) Canadian Drug Expert Committee approved the use of Ilaris (canakinumab) to treat children with systemic juvenile idiopathic arthritis (SJIA), not responding well to other treatments. As with many CADTH reviews, this one came with a caveat.
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Negotiating with CADTH: Lessons Learned from the Cystic Fibrosis Canada
In January 2016, Health Canada approved the use of Orkambi (lumacaftor/ivacaftor) for the treatment of patient with cystic fibrosis (CF) who had 2 copies of the F508del mutation in their CFTR gene. That was the beginning of the regulatory roller coaster that the CF community has been through the past 2 years.
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Talking to Health Ministries: A Conversation with The Canadian PBC Society
In May 2017, Health Canada approved Ocaliva (obeticholic acid) for the treatment of primary biliary cholangitis (PBC). More specifically, the drug was approved in combination with ursodeoxycholic acid (UDCA) in adults with an inadequate response to UDCA or as monotherapy in adults unable to tolerate UDCA.
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