A Comparative Analysis of Post-market Surveillance for Natural Health Products (NHPs)

Abstract

Natural health products (NHPs) are attractive due to the public’s perception that they are natural and safe but there is wide variety of risks associated with these products. Post-market surveillance is the key to control hazards produced from NHPs. A set of activities are involved in post-market surveillance designed to assure the safety, efficacy and quality of products after being launched into the market. Although post-market surveillance is an efficient tool to preserve the safety of users from adverse reactions of NHPs but there are various challenges associated with performing post-market surveillance specifically for NHPs. This research project is focused on defining a framework for performing post-market surveillance for NHPs and on identifying best practices in its application. An international comparative analysis was undertaken to formulate best practices by reviewing existing frameworks for post-market surveillance of NHPs in Australia, Germany, New Zealand, United Kingdom and United States. Evidence-based best practices are compared with the Canadian post-market surveillance framework to identify key gaps in the Canadian system. Recommendations are provided for bridging each gap, and making the Canadian NHPs surveillance system, strong according to the international standards of best practices.