The Amendments to The Food and Drug Regulations (1319- New Drugs For Extraordinary Use) came into force on March 25, 2011. These amendments affect the regulations regarding the design of appropriate clinical trials for a small number of emergency-use drugs, such as anthrax and pandemic influenza vaccines (collectively referred to as Extraordinary Use New Drugs or “EUND”). The Amendment creates a new type of drug submission for EUND within the Regulations and outlines the requirements for EUND submissions, labeling, plans for post-market safety and efficacy data acquisition, and annual reporting. Existing regulations that apply to other drugs such as data and patent protection apply to EUNDs as well. Because of the nature and intended purpose of EUNDs, manufacturers are only permitted to sell them to federal, provincial, territorial or municipal governments.
The full text of the EUND Amendments can be found at: Regulations Amending the Food and Drug Regulations.pdf
The new Fees in Respect of Drugs and Medical Devices Regulations came into force on April 1, 2011. These new fees constitute an update and consolidation of the various user fees regulations. Key elements of the new fees regulations include (1) establishing fees for regulatory activities (e.g., submission and examination of NDSs and SNDSs, dealer licenses and medical device licenses) and stipulating their amounts in a schedule; (2) establishing timing and allotment of fees payable; (3) providing fee mitigation measures; and (4) providing for an annual adjustment of fees. The fees are designed to lessen the increasing funding pressures on Heath Canada.
The full text of the new fees regulations (including the fee tables) can be found at: Fees in Respect of Drugs and Medical Devices Regulations.pdf