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Health Canada/Health Products and Food Branch Ratna Bose, Ratna.Bose@hc-sc.gc

Common Monographs – Over-the-Counter (OTC) Products Presentation to RCC Stakeholder Dialogue Session April 28, 2014. Health Canada/Health Products and Food Branch Ratna Bose, Ratna.Bose@hc-sc.gc.ca. Health and Human Services/Food and Drug Administration

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Health Canada/Health Products and Food Branch Ratna Bose, Ratna.Bose@hc-sc.gc

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  1. Common Monographs – Over-the-Counter (OTC) ProductsPresentation to RCC Stakeholder Dialogue SessionApril 28, 2014 Health Canada/Health Products and Food Branch Ratna Bose, Ratna.Bose@hc-sc.gc.ca Health and Human Services/Food and Drug Administration Steven Adah, Steven.Adah@fda.hhs.gov

  2. Content • Overview of the initiative • Progress update • Lessons learned and barriers to alignment • Lessons learned and catalysts to alignment • Current status • Next Steps • Questions

  3. Overview of the initiative • The objectives of the RCC OTC Monograph Working Group are to: • Make it easier for US and Canadian firms to do business on both sides of the border through greater regulatory alignment • Conduct a pilot program that develops and aligns monograph elements for a specific drug category • Indications • Active Ingredients and Dose • Directions of Use • Warnings • Provide recommendations on the feasibility for developing an aligned OTC drug monograph • Where are the greatest areas for alignment? • Where are the obstacles for collaboration? • How will future projects, teams, and communication methods be established?

  4. Progress update: What have we accomplished?

  5. Lessons Learned: Barriers to Alignment

  6. Lessons Learned: Catalysts to Alignment

  7. Current Status: Where are we now? • Current Status: • FDA: • Drafted a proposed rulemaking and currently in clearance • HC: • Developed a draft guidance document and awaiting internal approvals

  8. Looking Ahead: Where are we headed? • Goal • Short Term: Publication of proposed draft documents with aligned elements (ingredients, indication, directions, warnings, etc.) • Long Term: Both regulatory agencies are considering opportunities for continuation of the working group forum and further monograph alignment • Timing • Both agencies will publish their draft and final documents at the same time • Working together through the final rulemaking and comment periods • FDA • Publish a proposed rulemaking • Similar to other proposed rulemakings: there will be a comment period • Publication of a final rulemaking • HC • Publish a draft guidance document • Similar to other guidance documents: there will be a comment period • Publish a final guidance document

  9. Questions

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