Health committee  CCSVI is a medical procedure. My group in my branch is responsible for approving different products. If a product was to be used and manufacturers wanted to come forward and advertise their product for use in a procedure such as CCSVI, they would have to come through us. To date,

Health committee  Thank you for that question. It's important to note that Health Canada, and specifically our branch, participates in many international initiatives with other regulators around the world. An example I mentioned was the International Conference on Harmonisation to set standards f

Health committee  I think the article you're referring to was in the CMAJ. Is that correct?

Health committee  I'm not familiar with that article. What I can tell you is that the fast-tracking process, or the priority review process, is a way for us to put the products that have the potential to have a really significant impact on the lives of Canadians at the front of the queue. I want

Health committee  The priority review process in Canada—I think it's called fast-tracking in the United States, but ours is priority review—doesn't change the standards. Those standards are the same whether a drug is fast-tracked or not. What it does is it responds to a concern that was voiced by

Health committee  Yes, if I could. I'd like to point out that for both personalized medicine or pharmacogenomics and also for nanotechnology, these are areas that have the potential to change significantly the delivery of health care. We've had a guidance document out on pharmacogenomics since 20

Health committee  I've been working in my department since 1980.

Health committee  My group is responsible for the evaluation of drugs and medical devices. Recently, we changed the cost recovery regime, which is the regime that really allows the manufacturers to provide money for our services in reviewing and evaluating new products. That was very helpful in al

Health committee  We are trying to move into an electronic environment in the review process, and that will save us money, such as on storage costs for paper. A drug submission is quite enormous, so to remove those storage costs is substantial. It also saves the industry. It fits into the idea of

Health committee  I would add that it underscores the need for our evaluators to stay up to speed as well on developments. One of the things we try to do is ensure they have access to experts in the various fields. We just won't be able to, nor should we, hire every leading-edge expert for doing t

Health committee  Yes. Again, I'm sorry. I'm familiar with the drug side, but there are equivalent policies on both sides. Last year, on the drug side, we got about 14 applications for a priority review. Of those—and I'm adding up numbers in my head—we granted six. The other eight were not grant

Health committee  Okay. We do a few things. I've already mentioned the priority review process, where we think something has a really significant opportunity to contribute to health care and health outcomes for Canadians. We also approve generic products. We do this in a way that respects the p

Health committee  I am sorry. I cannot give you the information you're looking for. I'm here from the regulatory branch, which deals with the regulation of health products and foods.

Health committee  We have a 30-day review period for those packages. Generally, we have a meeting with the manufacturer as well at that time, and point out any considerations we have. I'm talking about the drug side; the exact timeframes I'm more familiar with. Then there's a commitment for the ma

Health committee  No, the percentage is down below 5% for us.