Health Canada

Summary of Expensive Drugs for Rare Diseases (EDRD) Working Group Webinar   Signals Decoded:   Stakeholder consultation is underway on a supplemental process for complex/specialized drugs that builds upon the existing national HTA and reimbursement process to make responsive funding decisions with a focus on non-oncology therapies. The supplemental process is a significant development in EDRD policy and it looks to streamline the evaluation and reimbursement process of eligible drugs…

CAPT Conference Workshop: Defining “Decision Grade” Real World Evidence (RWE) and its Role in the Canadian Context: A Design Sprint   On Sunday October 21, 2018, the Canadian Association of Population Therapeutics (CAPT) hosted a full day workshop to discuss recent advances in the dialogue on RWE in Canada from a Regulatory, HTA and Reimbursement perspective. The day was attended by participants invited from various stakeholder groups including Health Canada,…

Aligned Reviews Between Health Canada (HC) and Health Technology Assessment Organizations (HTAs)   Date: September 26th, 2018 Time: 10:00 AM - 11:30 AM Presenters: Alex Chambers (CADTH), Virginie Landreville (INESSS), M Coyer (HC), and T Richter (CADTH) Purpose: To describe the HC-HTA (CADTH and INESSS) aligned review process in more detail, and discuss any questions regarding this initiative. This initiative aims to improve regulatory review in order to obtain more…

Consultations Commence for Major Changes to Canadian Pharmaceutical Policy   On May 16, 2017, the Federal Minister of Health, the Hon. Jane Philpott presented several major announcements, which are likely to have significant impacts on both national and provincial/territorial pharmaceutical policy.  The announcements covered an array of developments including: changes to the regulations that govern how the Patented Medicine Prices Review Board (PMPRB) operates; enhancing the capacity of the pan-Canadian…

Health Canada Update   On March 10, 2017, Health Canada issued a guidance document which describes how it discloses confidential business information (CBI). This guidance document is meant for: health researchers, health professionals, patient groups, pharmaceutical industries, and medical device industries. The federal Minister of Health is authorized to disclose CBI to people to protect or promote public health or safety. As noted on the Health Canada website: “This guidance…

Health Canada Update   On February 24, 2017, Health Canada issued the Terms of Reference for the Scientific Advisory Panel on Opioid Use and Contraindications (SAP-OUC). According to Health Canada’s website, the SAP-OUC will “examine whether contraindications currently included in Canadian labelling of opioids are sufficient or should be modified, and whether additional contraindications should be added. While the Panel provides Health Canada with advice and recommendations, the decision-making responsibility…