EU and Canada agree to exchange drug safety information
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EU and Canada agree to exchange drug safety information Regulatory health authorities in the European Union and Canada have signed agreements which will allow them to freely exchange confidential information relating to the authorisation and safety of medicines. The agreements were signed at a bilateral meeting in Brussels in December 2007 between the European Commission and the EMEA on one side, and the Health Products and Food Branch of Health Canada on the other. The agreements seek to allow earlier access to information, resulting in a strengthening of public health protection for both Canadian and EU health authorities. The confidential information to be included in the exchanges includes position papers on future legislation, regulatory guidance documents, scientific advice on product development, assessments of applications for marketing authorisations, and safety data relating to marketed medicines. This decision will potentially produce several benefits, including accelerated patient access to innovative drugs, and improved performance and safety due to the inclusion of regulatory experts from both Canada and the EU. Closer ties on medicines safety between European and Canadian regulatory authorities. Internet Document : [2 pages], 11 Jan 2008. Available from: URL: 801052447 http://www.emea.europa.eu
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Reactions 19 Jan 2008 No. 1185
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