News Release
2003-86
November 18, 2003
For immediate release
Health Canada and U.S. Food and Drug Administration sign Memorandum of Understanding
for closer collaboration
OTTAWA - U.S. and Canadian officials met today for the signing of a Memorandum of Understanding
(MOU) that will further enhance cooperation between Health Canada and the U.S. Food and
Drug Administration. Dr. Mark McClellan, Commissioner of Food and Drugs (US Food and Drug
Administration, Department of Health and Human Services) and Diane Gorman (Assistant Deputy
Minister, Health Products and Food Branch, Health Canada) signed the MOU.
This MOU builds on existing collaborative efforts between Health Canada and the U.S. FDA.
In general, it will better enable the two regulatory authorities to share information on
the post-market safety of therapeutic products, information related to the review and evaluation
of new product submissions and information on product investigations and enforcement activities.
"We are very pleased with this significant achievement," said Diane Gorman. "This will
greatly enhance our ability in Canada to more rapidly identify benefits and risks associated
with therapeutic products, as well as enable us to have a more efficient therapeutic product
evaluation process to allow Canadians to have faster access to important new therapies."
Assistant Deputy Minister Gorman and Commissioner McClellan recognize they face a number
of common challenges in regulating therapeutic products for safety, efficacy and quality,
and can both benefit from better sharing of information, knowledge and best practices.
Initially, the collaboration will lead to a better understanding of decisions taken by
the two regulatory authorities, enable the exchange of information related to the review
and evaluation of investigational and marketing applications, and improve the ability to
share information related to enforcement activities and product investigations, such as
cross-border issues.
The signing of this MOU is part of Health Canada's commitment to enhance its regulatory
performance. Health Canada is continuing to improve its operations in order to enhance
timeliness of product reviews, transparency and communications related to pre-market and
post-market activities. The 2002 Speech from the Throne committed the Government of Canada
to accelerate reforms in the regulatory process for drug approvals to ensure that Canadians
have faster access to the safe drugs they need. The 2003 Budget identified $190 million
to address this issue.
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Media Inquiries:
Krista Apse
Health Canada
(613) 954-4807
Farah Mohamed
Office of Anne McLellan
Minister of Health
(613) 957-1694
Public Inquiries:
(613) 957-2991
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