Health committee  Yes, absolutely.

Health committee  No, no, it will not. It will maintain the very high standard that we have.

Health committee  That is the absolute intent. It is actually to make sure that not only can we do that at the pre-market stage, but also that we can do it as the therapy goes out. We recognize that it's a complex job, but that's why we're trying to put in very good supervision.

Health committee  Yes. Well, they've been making a lot of changes as well. Again, we're not saying that progressive licensing is fast-tracking; rather, progressive licensing describes the way we generally market-authorize a drug, and there's no reduction in standards here. We're adding to the po

Health committee  We've been talking a lot with our colleagues in the FDA to learn from them, because we want to advance the best model that we can. Similarly, the Europeans have been very helpful to us in showing us what's worked for them as they've modernized.

Health committee  We anticipate there will be some elevation in the burdens, but you want to target that to the right place. A lot of the activities are occurring, as Dr. Berthiaume has mentioned. Pharmacovigilance planning is an example. We're receiving those now, because they're making them for

Health committee  It might help to reset that a little bit. When we do a market authorization, we're taking a look at studies in particular types of patients, who will be selected depending on what you want to prove with the drug. If it's for a cancer indication of a certain sort, you'll state th

Health committee  What the term “off-label” can mean there is that, again, when you studied it, you may not have combined those particular drugs. “Cocktail” means you're putting several drugs together in a treatment course; you may not have done a pre-market study or a clinical study on that, but

Health committee  My colleagues from the inspectorate would best answer that question for you, but I've certainly done enough briefings alongside them to know they are doing a lot of work at the border, and they've been very involved with us in working out the new policies. They also deal with col

Health committee  That would be the intention of the policies we have been trying to develop. You are correct that there is a long-standing obligation on manufacturers to report an adverse drug reaction no matter how it's used, whether it's used, as Marc pointed out, off-label or not. But the inte

Health committee  Yes. It's both benefits and risks, and we want to keep those concepts really quite close together.

Health committee  First of all, there are perhaps several misunderstandings around the term “progressive licensing”, which was not intended to mean, in our view, the same thing as moving drugs out earlier. What we meant by that is that we really want to make sure that as our knowledge about a dru

Health committee  They are certainly using a life cycle oversight model, and that's really what progressive licensing was intended to convey--that you're progressing over time in your knowledge about the therapy. In fact, we've done a lot of studying with the Europeans, because we think they've ad

Health committee  Yes, we are.

Health committee  Again, I would just caution that I can speak to the broader policy discussions we've been having. What we've identified is that the requirement for adverse drug reaction reporting is certainly down in the regulations right now. It appears in the architecture of the act in severa