Regulatory Operations and Enforcement Branch
As Health Canada's dedicated compliance and enforcement branch, Regulatory Operations and Enforcement Branch (ROEB) works to inform and protect the people of Canada from health risks associated with health products, substances, and the environment.
About the branch
Established on April 4, 2016, ROEB provides regulatory oversight for a variety of product categories, including:
- cannabis
- medical devices
- biological products
- controlled substances
- pesticides control products
- tobacco and vaping products
- drugs for humans and animals
- consumer and natural health products
ROEB ensures that regulated parties involved in the manufacturing, distribution, import, and sale of these products comply with Canadian acts and regulations by conducting the following compliance and enforcement activities:
- We promote compliance by educating regulated parties and the public about their legal responsibilities and encouraging voluntary compliance.
- We monitor compliance through inspections, audits, product sampling, and reviewing reports to verify that parties adhere to regulations.
- When non-compliance is identified, we take enforcement action proportionate to the level of risk to public health and safety.
ROEB works closely with other branches across the department and collaborates with federal, provincial, and territorial partners, international regulatory bodies, and law enforcement agencies to harmonize regulatory practices and address non-compliance.
Branch directorates
Our work is carried out under the leadership of the Assistant Deputy Minister within the following directorates:
- Laboratories Directorate
- Planning and Operations Directorate
- Health Product Shortages Directorate
- Health Product Compliance Directorate
- Policy and Regulatory Strategies Directorate
- Consumer Products and Pesticides Directorate
- Medical Devices and Clinical Compliance Directorate
- Cannabis, Tobacco, and Controlled Substances Directorate