The Regulation of Drugs in Canada. The Food and Drugs act and Related Intellectual Property Regimes - 2024
- Publisher:
- Irwin Law Inc.
- Publication date:
- 2023-12-22
- Authors:
-
T. Nessim Abu-Zahra
Simon Carvalho
David Edwards - ISBN:
- 978-1-55221-666-8
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
Preliminary Sections
Part I
- Introduction
- 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