PACP Committee News Release
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Standing Committee on Public Accounts |
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Comité permanent des comptes publics |
For immediate release
NEWS RELEASE
Action needed to ensure safety of pharmaceutical drugs
Ottawa, February 11, 2013 -
OTTAWA – Health Canada needs to respond without delay in making improvements to its pharmaceutical drug regulatory program, according to the Standing Committee on Public Accounts’ report presented today in the House of Commons by Committee Chair David Christopherson.
In an audit included in its 2011 Fall Report, the Office of the Auditor General (OAG) examined whether Health Canada fulfilled its responsibilities related to clinical trials, submission reviews, and post-market activities for the regulation of pharmaceutical drugs. The OAG concluded that Health Canada had not adequately fulfilled some of its key regulatory responsibilities. It had not adequately verified the regulatory compliance of clinical trials, did not review most drug submissions within its service standards, did not assess whether its bureaus were consistently interpreting and applying review procedures, and it did not complete safety assessments of marketed drugs or communicate safety concerns in a timely manner.
Officials from Health Canada told the Committee that Canada has one of the safest and most rigorous drug safety systems in the world, but there is always room for improvement. They submitted a detailed action plan, which was later updated, to address the OAG’s ten recommendations.
In its report, the Committee encourages Health Canada to complete its work on a database of authorized clinical trials, to improve its ability to meet its service standards for reviewing drug submissions, to complete safety assessments in a timely manner, and to develop conflict of interest guidelines specific to its pharmaceutical drug regulatory program. The Committee acknowledges that Health Canada has made progress, but it also needs to respond without delay in addressing the OAG’s recommendations.
The Committee recommends that Health Canada provide a report by March 31, 2013 on its progress in implementing its action plan and making improvements to its pharmaceutical drug regulatory program.
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