Traduction de «Production database » (Anglais → Français) :

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?

While there are some Canadians who might be capable of navigating the online databases necessary to stay on top of the latest news about their particular device — with appropriate product class, serial number, year of manufacture and the exact date a problem may have been reported — there are many more, for reasons of infirmity, lack of Internet access, language barriers, et cetera, who would be unable to navigate such a complex database.

(l) creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner.

(d) ensuring the dissemination of information on adverse reactions to medicinal products authorised in the Community, by means of a database permanently accessible to all Member States; health-care professionals, marketing authorisation holders and the public shall have appropriate levels of access to these databases, with personal data protection being guaranteed.

(l)creating a database on medicinal products, to be accessible to the general public, and ensuring that it is updated, and managed independently of pharmaceutical companies; the database shall facilitate the search for information already authorised for package leaflets; it shall include a section on medicinal products authorised for the treatment of children; the information provided to the public shall be worded in an appropriate and comprehensible manner.

The NBSGA also funds (along with the provincial Department of Agriculture, Fisheries and Aquaculture, and the federal Atlantic Canada Opportunities Agency) the Animal/Aquaculture Productivity and Health Information Network (APHIN) – an Internet-based fish health management database run from the Atlantic Veterinary College of the University of P.E.I. As part of B.C’. s October 1999 policy, the B.C. Salmon Farmers Association (BCSFA), in cooperation with the B.C. Ministry of Fisheries and the DFO, is developing a similar Fish Health Da ...[+++]tabase.