Drugs (ICS code: 11.120)

Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs; (57 page(s), in English), (57 page(s), in French)

The Government of Canada intends to make the Order Providing for Reliance on Decisions of, or Documents Produced by, Foreign Regulatory Authorities in Respect of Certain Drugs (the Order). This Order would deem the requirement for the Minister to examine specified information and material in a new drug submission to have been met based on decisions or documents produced by certain foreign regulatory authorities (FRAs). To ensure that the Order does not introduce unacceptable risks or uncertainties to health, safety or, if applicable, the environment, it would set out requirements that would need to be met, including that the drug belongs to a class of drugs identified on a list incorporated by reference (IbR List), that the manufacturer demonstrates that the drug has been authorized by an FRA on the IbR List that relates to the class, and that any differences in the drug related to the part of the submission that the manufacturer seeks to have deemed in comparison to the drug authorized by the FRA would not negatively impact its safety or effectiveness. Information in the submission relating to those differences would be examined by the Minister along with other aspects of the submission unique to the Canadian market (e.g., labelling). Where the Minister considers that the differences could potentially negatively impact the safety and effectiveness of the drug, deeming would not be used for that component of the submission and a full examination would take place.

Health Canada uses its existing authorities under the Food and Drugs Act and the Food and Drug Regulations (FDR) to consider information or other material obtained from other regulatory authorities in its examination of new drug submissions. To further support and increase the Department's use of reliance on FRAs, the Order would, where the requirements of the Order are met, deem parts of the Minister's examination to have been completed on the basis of an FRA's decision or document(s) under the following three scenarios:

·        drug submissions for which a decision has already been made by an FRA about a foreign drug (General Deeming),

·        drug submissions for which a decision by an FRA to authorize a foreign drug has not yet been made, provided the submissions are filed in Canada within 120 days of being filed with an FRA (120-day Filing), and

·       drug submissions subject to joint review by Health Canada with one or more FRAs (Joint Reviews).