Legislative and regulatory modernization for therapeutic products.
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.
Office of Legislative and Regulatory Modernization, Health Products and Food Branch, Health Canada.
Maurica
M
Maher
D002170:Canada; D003257:Consumer Product Safety / Q000331:legislation & jurisprudence*; D018795:Device Approval / Q000331:legislation & jurisprudence; D017277:Drug Approval / Q000331:legislation & jurisprudence; D004335:Drug and Narcotic Control / Q000331:legislation & jurisprudence*; D006801:Humans