Legislation and Regulatory Amendments

In carrying out its compliance and enforcement functions, the Health Products and Food Branch Inspectorate applies the Food and Drugs Act (FDA) and its associated regulations.

The Inspectorate may engage in the development of new regulations to support effective compliance and enforcement activities. To ensure that the regulatory process is open and transparent, the Inspectorate encourages industry, consumers and other stakeholders to participate in and provide input on legislative, regulatory and policy issues. This is achieved by consulting upon regulatory amendment proposals prior to pre-publication in the Canada Gazette Part I, as well as during the formal regulatory amendment process.

Acts and Regulations

Notices and Early Consultation

• Consultation: Regulations Amending the Food and Drug Regulations 1447 - Good Manufacturing Practices
• Consultation on the Creation of a regulatory framework for the implementation of Good Manufacturing Practices for active pharmaceutical ingredients

Canada Gazette Part I

•  Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices) – Active Pharmaceutical Ingredients
• Notice of Intent Published in Canada Gazette Part I, December 7, 2002 and Good Manufacturing Practices Guide for Active Pharmaceutical Ingredients (ICH Topic Q7A)

Canada Gazette Part II

• Regulations Amending the Food and Drug Regulations (1475 - Good Manufacturing Practices) – Active Pharmaceutical Ingredients
• Canada Gazette Part II (December 15, 2004) Regulations Amending the Food and Drug Regulations (1356 - Disinfectants)