Regulations to Amend the Food and Drug Regulations have been published, which would permit a new type of drug submission for certain types of drugs where there is a requirement to provide substantial evidence of safety and efficacy of the drug and, while there are ethical and/or logistical challenges in designing appropriate clinical trials for a small number of emergency use drugs, such as anthrax and pandemic influenza vaccines. The proposed regulations outline inclusion criteria for EUND submissions, as well as the requirements of EUNDs, labelling, post-market safety and efficacy studies and reporting. The intention regulations are intended to replace the current practice of using the Special Access Programme (SAP) to authorize the sale of EUNDs for broad distribution.

The regulatory impact statement notes that the cost to government stakeholders is not expected to be significant, given that their current roles and responsibilities within the existing drug development and authorization framework. It is anticipated that there will be significant benefit to Canadian patients who might use EUNDs, since there would be a pre-market review and enhanced post-market surveillance of these drugs. Further, the proposed regulatory framework would be aligned with the requirements set by U.S. and European regulatory authorities for drugs determined to be EUNDs.

Consequential amendments are proposed for the PMNOC Regulations. These amendments to the Food and Drug Regulations and the PMNOC Regulations have been published in Gazette, Part I, and interested persons may make representations with respect to these proposed regulations within 75 days of March 25, 2010.

For more information, please see the following links:

http://www.gazette.gc.ca/rp-pr/p1/2010/2010-04-03/html/reg3-eng.html

http://www.gazette.gc.ca/rp-pr/p1/2010/2010-04-03/html/reg4-eng.html