Regulations

In Canada, life-sciences-derived products and processes are regulated through a number of departments and agencies at the federal, and the provincial/territorial level. In addition, a number of guidelines that provide for interpretation and clearer understanding of regulatory requirements have been developed by the agencies. Regulations and guidelines are developed and continually revised based on the best available information. There are also a number of organizations promoting standards and quality assurance for life-sciences-derived products.

Information on these topics is listed below:

Overview
Canadian Regulations
Provincial and Territorial Regulations
International Regulations
Canadian Guidelines
Standards

Overview

Five main federal departments/agencies administer the relevant legislation. They are Environment Canada, the Canadian Food Inspection Agency, the Department of Fisheries and Oceans, Health Canada, and the Pest Management Regulatory Agency of Health Canada. The following diagram illustrates the role of each department/agency:

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Provincial and Territorial Regulations

Several different provincial and territorial departments administer acts and regulations that govern the life sciences sector. The following list provides links to legislative information for each province and territory:

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International Regulations

BioTrack

BioTrack was developed by the Organization for Economic Cooperation and Development (OECD). It lists regulations and regulatory developments for member countries.

Learn more about International Regulations.

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Canadian Guidelines

A number of guidelines exist that apply to the life sciences sector. The following list provides links to guidelines for life science-specific activities:

Canadian Food Inspection Agency

• Veterinary Biologics
• Feeds
• Seeds
• Fertilizers
• Plant Protection Policy
• Plants with Novel Traits Guidelines & Amendments
• Guidelines and Forms - Animal Health and Protection

Pest Management Regulatory Agency

• Regulatory Directives
• Publications

Health Canada

• Guidelines for the Safety Assessment of Novel Foods Volume I and II
• Good Manufacturing Practices (GMP) Guidelines
• Medical Devices

• All Other Therapeutic Products Programme Guidelines

Environment Canada

New Substances Guidelines

See BioRegulation for more detailed information.

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Standards

To be an accredited member of a standards organization, firms must have recognized procedures and systems in place to ensure the quality of the product(s) being manufactured. To learn more about standardization, conformity assessment, and the accreditation process, visit the Standards Council of Canada.

Canadian

• Canadian Standards Association (CSA)
• Canadian General Standards Board (CGSB)
• Institute for National Measurement Standards
• Bureau de Normalisation du Québec
• Underwriters' Laboratories of Canada

International

• International Conference on Harmonization (ICH)
• International Organization for Standardization(ISO)
• Association of Clinical Research Professionals (ACRP)
• Codex Standards for Biotechnology
• Good Manufacturing Practices (GMP)
• North American Plant Protection Organization