Health Canada joint review with FDA to speed up drug approvals process

Health Canada, the country's health care and drug regulator, is considering radical proposals for cutting the time it takes to approve new medicines, even proposing joint reviews with US regulatory counterpart, the Food and Drug Administration. The move is prompted by the real-ization that the delay in approving drugs in Canada is 640 days, compared with a mere 350 in the USA, according to the Ottawa, Canada-based trade association, Canada's Research-Based Pharmaceutical Companies (Rx&D). To make matters worse, manufacturers tend to apply for drug approvals earlier in the USA, because it is the world's largest market for pharmaceutical products anyway.

"Parallel review" the goal

The reforms Health Canada is considering involve the establishment of a pilot parallel review along with the FDA. Initially the purpose would be to exchange data and views, effectively testing to see whether the two agencies are able to work together with joint review of new drug appli-cations. The FDA has not commented on the idea.