Postmarket Surveillance for Natural Health Products in Canada
Postmarket Surveillance for Natural Health Products in Canada
In Canada, postmarket surveillance for natural health products (NHPs) is the ongoing monitoring of the safety, efficacy, and quality of NHPs after they have been authorized for sale. The Natural Health Products Regulations require that manufacturers, importers, and distributors of NHPs have systems in place to monitor their products’ safety and efficacy and take action if safety concerns arise.
Health Canada, the regulatory authority responsible for NHPs in Canada, also conducts postmarket surveillance of NHPs to ensure that they continue to be safe and effective for consumers.
Health Canada uses a variety of tools to conduct postmarket surveillance:
- Adverse reaction reporting: Health Canada relies on manufacturers, importers, and distributors, as well as consumers, to report adverse reactions associated with NHPs. These reports are used to identify safety concerns and take appropriate action.
- Compliance and enforcement: Health Canada regularly conducts inspections and audits of NHP facilities to ensure compliance with regulations and standards. Non-compliance may result in enforcement actions, such as product recalls or seizures.
- Market authorization reviews: Health Canada periodically reviews NHPs that have been authorized for sale to ensure that they continue to meet safety, efficacy, and quality requirements.
- Post-approval studies: Health Canada may require manufacturers, importers, or distributors of NHPs to conduct post-approval studies and evaluate safety, efficacy, or quality concerns.
Postmarket surveillance is essential to ensuring the safety and efficacy of NHPs in Canada. Manufacturers, importers, and distributors must cooperate with Health Canada in all postmarket surveillance activities [1].