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Governance of natural health products regulation: an iterative process.
Health Policy. 2013 Jun; 111(1):86-94.HP

Abstract

OBJECTIVES

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+Show Affiliations

Department of Pediatrics, Faculty of Health Sciences, McMaster University, Canada. waljir@mcmaster.caNo affiliation info available

Pub Type(s)

Journal Article
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

23523344

Citation

Walji, Rishma, and Mary Wiktorowicz. "Governance of Natural Health Products Regulation: an Iterative Process." Health Policy (Amsterdam, Netherlands), vol. 111, no. 1, 2013, pp. 86-94.
Walji R, Wiktorowicz M. Governance of natural health products regulation: an iterative process. Health Policy. 2013;111(1):86-94.
Walji, R., & Wiktorowicz, M. (2013). Governance of natural health products regulation: an iterative process. Health Policy (Amsterdam, Netherlands), 111(1), 86-94. https://doi.org/10.1016/j.healthpol.2013.02.011
Walji R, Wiktorowicz M. Governance of Natural Health Products Regulation: an Iterative Process. Health Policy. 2013;111(1):86-94. PubMed PMID: 23523344.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Governance of natural health products regulation: an iterative process. AU - Walji,Rishma, AU - Wiktorowicz,Mary, Y1 - 2013/03/21/ PY - 2012/03/19/received PY - 2013/02/13/revised PY - 2013/02/28/accepted PY - 2013/3/26/entrez PY - 2013/3/26/pubmed PY - 2014/1/28/medline SP - 86 EP - 94 JF - Health policy (Amsterdam, Netherlands) JO - Health Policy VL - 111 IS - 1 N2 - OBJECTIVES: 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. SN - 1872-6054 UR - https://www.unboundmedicine.com/medline/citation/23523344/Governance_of_natural_health_products_regulation:_an_iterative_process_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0168-8510(13)00063-8 DB - PRIME DP - Unbound Medicine ER -