کد مقاله کد نشریه سال انتشار مقاله انگلیسی نسخه تمام متن
4197832 1279016 2013 9 صفحه PDF دانلود رایگان
عنوان انگلیسی مقاله ISI
Governance of natural health products regulation: An iterative process
موضوعات مرتبط
علوم پزشکی و سلامت پزشکی و دندانپزشکی سیاست های بهداشت و سلامت عمومی
پیش نمایش صفحه اول مقاله
Governance of natural health products regulation: An iterative process
چکیده انگلیسی

ObjectivesNatural 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.MethodsQualitative research involved a documentary analysis, semi-structured key informant interviews with government representatives, industry and consumer groups, and observation at a consultation meeting.ResultsThe 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.ConclusionsIn 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.

ناشر
Database: Elsevier - ScienceDirect (ساینس دایرکت)
Journal: Health Policy - Volume 111, Issue 1, June 2013, Pages 86–94
نویسندگان
, ,