Pharmacovigilance refers to the science and activities related to the detection, assessment, understanding, and prevention of adverse effects or any other drug-related problems. It plays a crucial role in ensuring the safety and efficacy of medications available to the public. Health Canada, as the federal department responsible for helping Canadians maintain and improve their health, has established comprehensive guidelines and regulations for pharmacovigilance to safeguard public health.

Health Canada oversees pharmacovigilance activities through its various branches and collaborations with other national and international organizations. Key roles include:

• Regulation and Compliance: Health Canada establishes regulations for the pharmaceutical industry to follow, ensuring compliance through inspections and audits.

• Adverse Reaction Reporting: The Canada Vigilance Program is Health Canada’s post-market surveillance program that collects and assesses reports of suspected adverse reactions to health products.

• Risk Management Plans: Health Canada requires pharmaceutical companies to develop and submit risk management plans that outline strategies to monitor and mitigate risks associated with their products.

• Safety Communications: Health Canada disseminates safety information and advisories to healthcare professionals and the public to inform them of potential risks associated with medications.

• Timely Reporting: Encouraging the prompt reporting of adverse reactions to enable timely risk assessment and intervention.

• Comprehensive Data Collection: Ensuring detailed information is collected about adverse reactions, including patient demographics, medical history, and concomitant medications.

• Collaborative Efforts: Promoting collaboration between healthcare professionals, patients, and pharmaceutical companies to enhance the detection and understanding of adverse reactions.

• Continuous Monitoring: Implementing ongoing surveillance and periodic re-evaluation of the safety profiles of marketed products.