• Publication Date: January 9, 2024
  • ISBN: Print (Hardback): 9781552216651
  • ISBN: Digital (PDF): 9781552216668
  • 364 pages; 6" x 9"

The Regulation of Drugs in Canada

The Food and Drugs Act and Related Intellectual Property Regimes


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Product Description

The Regulation of Drugs in Canada: The Food and Drugs Act and Related Intellectual Property Regimes provides an overview of the laws in Canada that govern the manufacture and sale of drugs that are subject to the Food and Drugs Act, including pharmaceuticals, vaccines, and natural health products. Among the laws that are discussed are the new regulatory pathways that were made in response to the COVID-19 pandemic. 

This book also describes the intellectual property framework that applies to drugs and explains the impact this framework has on the drug approval process, as well as its unique objective: to encourage innovation and incentivize bringing new therapeutic options to market. Authors Simon Carvalho, T. Nessim Abu-Zahra, and David Edwards explain how this framework regulates the competition between “brand-name manufacturers” who are the first to bring a drug to market and obtain patents and other intellectual property, and “generic” or “biosimilar” manufacturers, who manufacture and sell copies of brand-name products. 


Part I: The Regulation of Drugs Under the Food and Drugs Act


Federal Oversight over Drugs and an Overview of the Food and Drugs Act

Market Authorization of Drugs Under the Food and Drug Regulations

Prescription Drugs

Establishment Licensing and Good Manufacturing Practices for Drugs

On-Market Rules and Authorities

Other Ways in Which a Drug May Be Sold: Clinical Trials, Special Access, Extraordinary Use, Urgent Public Health Need, and Shortages

Other Classes of Drugs — Biologics, Blood, “Cells, Tissues, and Organs,” and Radiopharmaceuticals

Natural Health Products

Veterinary Drugs

COVID-19 Interim Orders

Part II: Intellectual Property and Pharmaceutical Products

Overview of Canada’s Pharmaceutical Intellectual Property Regime

Patenting of Pharmaceutical Products

The Patented Medicines (Notice of Compliance) Regulations

Data Protection

Certificates of Supplementary Protection

Patented Medicine Prices Review Board

Table of Cases


About the Authors

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