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Last updated on April 19, 2014 at 8:43 EDT

Harper Government Moves to Strengthen Drug Safety

November 13, 2012

OTTAWA, Nov. 13, 2012 /CNW/ – The Honourable Leona Aglukkaq, Minister of
Health, today announced that Canada’s Food and Drug Regulations will become even stronger.

Currently in Canada, internationally accepted high quality standards -
known as Good Manufacturing Practices (GMP) – are required for the
production of pharmaceutical drugs.  To make sure that the health and
safety of Canadian consumers and their families are even more
protected, the active ingredients (AI) in these drugs will be subject
to these same standards. An AI is the ingredient or combination of
ingredients in a drug that delivers a health benefit to a patient. An
example of a common AI is acetaminophen, which is used in the
pain-reliever Tylenol.

“These stronger regulations will improve the safety of drugs used by
Canadians and their families,” said the Honourable Leona Aglukkaq,
Minister of Health. “They will help make sure that all AI in drugs sold
in Canada, no matter where they come from, are manufactured according
to high standards.”

The amendments to the Food and Drug Regulations will extend GMP requirements to apply to all active ingredients used in
drugs for human use sold in Canada, no matter where in the world they
are produced. The amendments will also create a new record-keeping
requirement in order to trace the AI from beginning to end in the
manufacturing process.

“There has been a growing concern over the quality of AI by health
regulators around the world,” added the Honourable Leona Aglukkaq.
“These amendments show our government’s commitment to help protect the
health and safety of Canadians and strengthen partnerships with other
health regulators.”

The international community of pharmaceutical regulators and
manufacturers has developed and adopted GMP guidelines specifically for
AI. These amendments will bring Canada into line with its international
partners.

Health Canada is taking steps now to make the necessary changes to
establish this new approach.

Également disponible en français.

SOURCE Health Canada


Source: PR Newswire