إجراء مقترح من كندا: المنتجات الصيدلانية

Health Canada is intending to make a Ministerial Class Exemption Order (Order) that would exempt low-risk non-prescription drugs (NPDs) that meet the applicable requirements of a Category IV monograph from Part C, Division 8 requirements of the Food and Drug Regulations (FDR). These products would be subject to Division 1 requirements of the FDR. Currently, drugs containing medicinal ingredients that have not been previously authorized in Canada are regulated as 'new drugs' under Division 8 of the FDR. This means that low-risk NPDs that contain a new medicinal ingredient are authorized through the same authorization process as prescription drugs that contain new medicinal ingredients. This results in a disproportionately high regulatory burden and cost for these lower-risk products.