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Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectives.
Can J Physiol Pharmacol. 2007 Sep; 85(9):952-5.CJ

Abstract

Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human clinical trials for many NHPs present a challenge to consumers, healthcare practitioners, and federal regulators. Canada's Natural Health Products Regulations mandate NHPs to be licensed. As the currently available unauthorized NHPs are being brought into compliance in Canada, the transition has produced some challenges, requiring ongoing public communication and education to promote the safe use of NHPs. This article will highlight Health Canada's key postmarket initiatives in strengthening the regulation of NHPs.

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Authors+Show Affiliations

Murty M
Health Canada, Marketed Biologicals, Biotechnology and Natural Health Products Bureau, Marketed Health Products Directorate, A/L 0701A, Tunney's Pasture, Ottawa, ON K1A0K9, Canada. mano_murty@hc-sc.gc.ca

MeSH

Adverse Drug Reaction Reporting SystemsBiological ProductsCanadaDrug IndustryHumansLegislation, DrugProduct Surveillance, PostmarketingRisk Assessment

Pub Type(s)

Journal Article

Language

eng

PubMed ID

18066142

Citation

Murty, Mano. "Postmarket Surveillance of Natural Health Products in Canada: Clinical and Federal Regulatory Perspectives." Canadian Journal of Physiology and Pharmacology, vol. 85, no. 9, 2007, pp. 952-5.
Murty M. Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectives. Can J Physiol Pharmacol. 2007;85(9):952-5.
Murty, M. (2007). Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectives. Canadian Journal of Physiology and Pharmacology, 85(9), 952-5.
Murty M. Postmarket Surveillance of Natural Health Products in Canada: Clinical and Federal Regulatory Perspectives. Can J Physiol Pharmacol. 2007;85(9):952-5. PubMed PMID: 18066142.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Postmarket surveillance of natural health products in Canada: clinical and federal regulatory perspectives. A1 - Murty,Mano, PY - 2007/12/11/pubmed PY - 2008/2/19/medline PY - 2007/12/11/entrez SP - 952 EP - 5 JF - Canadian journal of physiology and pharmacology JO - Can. J. Physiol. Pharmacol. VL - 85 IS - 9 N2 - Postmarket surveillance, particularly adverse reactions (ARs), forms an integral part of the ongoing safety evaluation for natural health products (NHPs). ARs can be related to many factors, including inherent toxicity, misuse, hypersensitivity, NHP-drug interactions, or product quality. High consumer use and limited safety and efficacy data from human clinical trials for many NHPs present a challenge to consumers, healthcare practitioners, and federal regulators. Canada's Natural Health Products Regulations mandate NHPs to be licensed. As the currently available unauthorized NHPs are being brought into compliance in Canada, the transition has produced some challenges, requiring ongoing public communication and education to promote the safe use of NHPs. This article will highlight Health Canada's key postmarket initiatives in strengthening the regulation of NHPs. SN - 0008-4212 UR - https://www.unboundmedicine.com/medline/citation/18066142/Postmarket_surveillance_of_natural_health_products_in_Canada:_clinical_and_federal_regulatory_perspectives_ L2 - http://www.nrcresearchpress.com/doi/full/10.1139/Y07-085?url_ver=Z39.88-2003&rfr_id=ori:rid:crossref.org&rfr_dat=cr_pub=pubmed DB - PRIME DP - Unbound Medicine ER -