7 December 2011
Regulations pertaining to health, therapeutic and personal care products (non-prescription drugs) and workplace chemicals all serve to minimize health risks to citizens while maximizing their safety. Although health and personal care product safety standards in Canada and the United States are amongst the highest in the world, further collaboration between the regulatory agencies will reduce costs for manufacturers of pharmaceutical and therapeutic products and improve the efficiency of the regulatory decision making process. This will, in turn, minimize delays in bringing health and consumer health products to the marketplace without compromising the safety, efficacy and quality of the products.
Increased regulatory cooperation in the area of health and personal care products and workplace chemicals will create efficiencies, reduce inspection duplication, enable products to be brought to market more quickly, facilitate trade, and lessen the potential for classification and labelling confusion. Specifically, the Joint Action Plan aims to enhance regulatory cooperation in these areas by implementing:
- A common secure electronic submission system to allow industry applicants to submit documents to Health Canada and the U.S. Food and Drug Administration;
- Common monographs (information on product specifications and use) for over-the-counter drugs;
- Mutual reliance on routine inspections of production facilities for drugs and personal care products; and
- Common classification and labelling requirements for workplace hazardous chemicals.
More details on these and other Regulatory Cooperation Council Joint Action Plan measures are available at http://actionplan.gc.ca/border.