Access to therapeutic products : Accès aux produits thérapeutiques : le processus de réglementation au Canada

If the pre-clinical studies are testing) and in vivo (using animals) to assess promising, the sponsor1 must apply to the the performance of the drug, including HPFB for authorization to conduct a clinical assessment of the existence and extent of trial involving human subjects in Canada. [...] Medical Device Applications If, upon completing its review, HPFB finds Upon completion of the review of a Class III or that the submission fails to comply with the IV medical device, HPFB may issue a Medical requirements set out in the Food and Drugs Device Licence allowing the manufacturer to Act and Regulations, it will issue a Notice of sell the device in Canada. [...] It is used as a tool for the includes the product monograph, the label timely and efficient preparation of natural on the product package and the label on the health product applications by manufacturers product container. [...] These monographs must now include a new consumer information section clearly The Regulatory Process in Canada 15 Medical devices also have a label that must (2) Notice of Compliance Database include such information as the name of the The Notice of Compliance (NOC) database device, the name and address of the manu- provides searchable information on drugs facturer, and the product expiry date. [...] Activities information about the affected patient, the include inspection of specific incoming suspected association between the therapeu- shipments and close cooperation with the tic product and the adverse reaction, and the Canada Border Services Agency.