Legislative and regulatory modernization for therapeutic products.

Autor: Maher M; Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada.
Jazyk: angličtina
Zdroj: Journal of population therapeutics and clinical pharmacology = Journal de la therapeutique des populations et de la pharmacologie clinique [J Popul Ther Clin Pharmacol] 2010 Fall; Vol. 17 (3), pp. e341-8. Date of Electronic Publication: 2010 Oct 26.
Abstrakt: This presentation is intended to show how the work coming from scientists, physicians, and other healthcare professionals is incorporated into the regulatory assessment of therapeutic products in Canada. One of the primary objectives within the regulatory environment is to provide information back to healthcare professionals and patients in order to help them make informed decisions. The current regulatory system for health products in Canada and why it needs modernization is addressed; a "lifecycle approach" to the regulation of health products is presented; the Food and Consumer Safety Action Plan and Bill C-51, a bill to amend the Food and Drugs Act is reviewed; and the challenges and opportunities for Canada and its fellow regulators are examined.
Databáze: MEDLINE