Bill C-338
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SUMMARY |
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This enactment establishes criteria for regulations to be made under
the Food and Drugs Act respecting the process for applications for the
approval of new drugs, the review of such applications and the making
of decisions. It mandates the due consideration of processes established
outside Canada and in particular requires the process to carried out as
least as quickly as the equivalent process in the European Community.
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It also requires sufficient staffing, open dealings with applicants
respecting the time to be taken and the professional independence of the
scientists who review applications.
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It requires the Minister to report annually to Parliament on the review
process.
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