title: Governance of natural health products regulation: an iterative process.
abstract: OBJECTIVE
  Natural health products (NHPs) are rapidly increasing in popularity, public consumption and of regulatory concern internationally. Canada has implemented regulations for these products in response to concerns over quality, safety and efficacy. We conducted a narrative review of the NHP regulations in order to understand the contextual factors underlying the regulations' implementation.
  
  
  METHODS
  Qualitative research involved a documentary analysis, semi-structured key informant interviews with government representatives, industry and consumer groups, and observation at a consultation meeting.
  
  
  RESULTS
  The research reflected difficulties in defining the products as they fall between drugs and foods. Challenges in implementation such as time to process applications, staffing issues and clarity around labelling and evidence assessment are highlighted. Areas where important steps were taken and process improvements made to streamline the procedures are emphasized.
  
  
  CONCLUSIONS
  In establishing a regulatory approach that comprehensively addresses NHPs as a distinct class of products, Health Canada's experience offers important insights. While several points of turbulence occurred through the implementation process, regulatory oversight has involved scrutinizing new products commensurate with their perceived inherent risks. Areas that require further progress include the development of a system of surveillance for adverse effects from both a passive reporting and an active surveillance perspective.
authors.affiliation: Department of Pediatrics, Faculty of Health Sciences, McMaster University, Canada. waljir@mcmaster.ca
authors.forename: Rishma
authors.initials: R
authors.lastname: Walji
authors.forename: Mary
authors.initials: M
authors.lastname: Wiktorowicz
mesh_terms: D001688:Biological Products / Q000592:standards*; D002170:Canada; D004348:Drug Labeling / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence / Q000458:organization & administration; D006077:Government Agencies; D006801:Humans
chemical_list: D001688:Biological Products