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HLTH 5816

Government Regulatory Processes

0.5 credit · Graduate

Regulatory agencies (Health Canada, US Food and Drug Administration, European Medicines Agency) will be compared. Harmonization efforts of national drug approval agencies, timelines for an investigational New Drug Application including labeling, accelerated approval, breakthrough designation, orphan drugs, and biologics licence application.

2026

Topics

  • breaks, and statutory holidays.
  • Course level learning outcomes
  • Classify health products and regulatory problems accurately and identify the pathway
  • evidence, authorization, and lifecycle consequences that follow.
  • Explain Canadian drug clinical-investigation and market-authorization processes and assess
  • how evidence, uncertainty, benefit-risk, labelling, and conditions interact.
  • Analyze post-market safety, risk-management, compliance, inspection, recall, and enforcement
  • Evaluate priority, conditional, exceptional-access, and other flexibility mechanisms without
  • Compare Health Canada, FDA, EMA, ICH, collaborative, and reliance approaches while
  • Locate, interpret, protect, and communicate regulatory information using appropriate public
  • databases, transparency mechanisms, confidentiality rules, and access routes.
  • Create defensible regulatory documentation that states authority, facts, evidence, uncertainty
  • analysis, recommendations, commitments, and legal effect with precision.
  • Evaluate emerging regulatory reforms by distinguishing enacted rules, commencement dates
  • Core reference set
  • every week.

Readings

  • processes, including information about the Academic Consideration Policy for Students in Medical and Other Extenuating Circumstances, are outlined on the Academic Accommodations website
Sources