Traduction de «Contrôle de post-commercialisation » (Français → Anglais) :

13. Takes note that despite having started in 2011 the ex post controls to asses the legality and regularity of the implementation of grants awarded the Joint Undertaking lacks an overall ex post control strategy to cover the implementation of grant contracts and procurement contracts; urges the Joint Undertaking to define and implement an overall ex post control strategy that covers in full their expended budgetary resources;

13. Takes note that despite having started in 2011 the ex post controls to asses the legality and regularity of the implementation of grants awarded the Joint Undertaking lacks an overall ex post control strategy to cover the implementation of grant contracts and procurement contracts; urges the Joint Undertaking to define and implement an overall ex post control strategy that covers in full their expended budgetary resources;

Question No. 609 Ms. Anne Minh-Thu Quach: With respect to drug regulation and approval: (a) does the 2012 Economic Action Plan provide for decreases or increases in the financial and human resources allocated to (i) drug approval services, (ii) regulatory activities to evaluate and monitor the safety, efficacy and quality of drugs before and after they enter the marketplace, (iii) activities related to the review of submissions by drug manufacturers for market authorization and post-market changes, (iv) activities related to enforcing compliance with existing regulations, including those concerning clinical trials, drug manufacturing and the reporting of adverse drug reactions, (v) activities of the Patented Medicine Prices Review Board, (v ...[+++]i) services such as the Patent Register, Drug Product Database, Notice of Compliance, and Progressive Licensing Project, (vii) various areas of Health Canada such as the Marketed Health Products Directorate, Therapeutic Products Directorate, Biologics and Genetic Therapies Directorate, and the Veterinary Drugs Directorate; (b) for each of the programs and directorates listed in (a), (i) what is the estimated extent of the decreases or increases in human or financial resources, (ii) are positions expected to be cut and, if so, how many will be eliminated; (c) was a value-for-money assessment conducted for the drug approval process; and (d) what is the government’s financial allocation plan regarding drug regulation?

New legislation passed in the United States in September of 2007, the Food and Drug Administration Amendments Act, recognizes the importance of post-marketing drug safety by explicitly granting FDA the authority to require companies, under certain conditions, to make post-marketing safety-related labelling changes; to perform post-marketing studies and clinical trials to answer drug safety questions; and to implement risk evaluation and mitigation strategies for prescription products.

If we go forward—and we heard in this committee last week that it's the written prescription that means the diagnosis can't be put on it, because it's a scrappy piece of paper that can fly anywhere and have the diagnosis and the prescription on it—I would want to know, first from the Privacy Commissioner but also from Infoway, can we and could we, if we had the resources, go immediately to electronic prescribing that included the diagnosis, which would actually help us with off-label prescribing and would help us with everything from recalling a drug to all the things that we are worried about in this real-world safety, of what we're tal ...[+++]king about in post-market surveillance?

We think that Health Canada has done some very significant things over the past few years, including setting up the post-market, engaging patients fully, and developing the progressive licensing framework that sets up an ongoing opportunity to no longer call it just post-market surveillance, but to have ongoing input.