new directions in drug approval in canada
TRANSCRIPT
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Webinar Overview• Canada’s regulatory system• Health Canada’s modernization
initiative• The case for reform to support
access to treatments for lethal diseases
• Qs and As / Discussion
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Review process
Issuance of Notice of Compliance (NOC) and Drug Identification Number (DIN)
Product Label, Brochure & Monograph
Evaluation of Safety, Efficacy, Quality
Review of Submitted Information
New Drug Submission
• Clinical trials
• Establishment licensing, compliance monitoring, verification, investigation, and post-marketing safety
• Imported products, and the testing standards and manufacturing facilities where the products are produced
Health Canada Review
Health Canada also reviews…4
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Health Canada’s Role Today
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Evolving Lifecycle Approach
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Regulatory modernization
OBJECTIVES
Access to new
therapiesContinuous monitoring,
assessment and communication of
product information (benefits & harms)
throughout the product lifecycle
Optimal use of therapeutic products to maximize
benefits and minimize risks
• Protecting Canadians from Unsafe Drugs Act, 2014– Recall of unsafe products– Ability to impose tough new penalties on those who sell unsafe products (incl.
imposition of increased fines if violations are intentional)– Ability to compel companies to revise product labels, conduct additional
testing
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Regulatory modernization
– Mandatory adverse event reporting by health care institutions
– Improved transparency regarding Health Canada’s regulatory decisions
– Public posting of all Canadian clinical trial information
– Clarity regarding what constitutes confidential business information and requirement for disclosure when health risks are apparent
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What’s needed next on regulatory reform?
• The system costs lives and reduces quality of life• A new approach to clinical research is needed• Why we need to speed up the review process• How we can do it• It’s a question of ethics• National strategy for precision medicine• The role of the patient, patient voices and LSTN!
Progress-centered regulatory framework for lethal diseases
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• Special Access Program
• Orphan drugs
• National pharmacare
• Life-cycle reimbursement and patient access (progressive reimbursement)
Other relevant issues and opportunities11
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Canadian Cancer Survivor Network Contact Info
Canadian Cancer Survivor Network1750 Courtwood Crescent, Suite 210Ottawa, ON K2C 2B5Telephone / Téléphone : 613-898-1871E-mail [email protected] or [email protected] Web site www.survivornet.caBlog: http://jackiemanthornescancerblog.blogspot.com/Twitter: @survivornetcaFacebook: www.facebook.com/CanadianSurvivorNet Pinterest: http://pinterest.com/survivornetwork/