Pharmaceuticals: Canadian Regulations

This course will introduce you to essential areas of regulatory knowledge for a broad range of pharmaceutical, radiopharmaceutical and biologic products in Canada. You will learn about the Canadian regulatory framework and applicable legislation for prescription drugs, nonprescription drugs and natural health products. Topics covered include the organization of Health Canada, Good Manufacturing Practices (GMPs), submissions, patent listing, labeling, advertising and promotion and postapproval changes.

  • At A Glance
  • Learning Objectives
  • Lesson Titles
  • Registration Options

At A Glance

  • Target Audience: This program is designed for regulatory professionals and others in related departments interested in understanding the basics of the regulation of pharmaceuticals (prescription and nonprescription), radiopharmaceutical, natural health products and biologic products in Canada.
  • Learning Level: Basic
  • Total Length of Course: 6–12 Hours
  • RAC Credits: 6
  • Formats: PC and Tablet (iPad and Android)
  • Cost: Member $550; List $770
  • Need more information?
    View the RAPS Online University FAQs.

Learning Objectives

Upon completion of this course, students will be able to:

  • Identify applicable legislation and recognize how it fits within the Canadian framework
  • Classify drugs and understand factors impacting change of classification
  • Understand Health Canada’s organization and agency interactions
  • Recognize types of preapproval submissions
  • Comprehend timing requirements, eligibility criteria and methods of application of intellectual property protection
  • Categorize postapproval changes and submissions
  • Identify various types of postapproval activities
  • Apply knowledge in the development of a regulatory strategy plan for different product types

Lesson Titles

  • Lesson 1: Canadian Legislative Framework 
  • Lesson 2: New Drugs
  • Lesson 3: Old Drugs
  • Lesson 4: Clinical Trials and Special Access Programme
  • Lesson 5: Nonprescription Drugs/OTC Drugs
  • Lesson 6: Good Manufacturing Practice (GMP)
  • Lesson 7: Drug Labeling, Advertising and Promotion
  • Lesson 8: Postmarketing Activities

Registration Options

This course is available for purchase as follows: