Health Canada



Health Canada

May 08, 2013 16:30 ET

Harper Government Strengthens Drug Safety with New Standards

Good Manufacturing Practices now apply to all active pharmaceutical ingredients

OTTAWA, ONTARIO--(Marketwired - May 8, 2013) - The Honourable Leona Aglukkaq, Minister of Health, today announced that Canada's Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active ingredients (AI) used in pharmaceutical drugs. These amendments will come into force in the fall of this year.

"Our Government is committed to protecting the health and safety of Canadians and their families," said Minister Aglukkaq. "That is why we are taking action to improve the safety of Canada's pharmaceutical drug supply."

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 as a pain reliever. GMP are an internationally accepted set of standards that help ensure drugs are produced and handled with good quality control.

"What these amendments mean is that the current high standards of drug safety in Canada are getting even stronger," added Minister Aglukkaq. "Among other things, they create a new record-keeping requirement that will help us trace active ingredients through the system, from their place of origin to the manufacturers that put them into products for consumers."

These requirements will apply to all AI manufacturers, packagers, labellers and importers. Health Canada has begun working with Canadian companies to help them better understand their new responsibilities in manufacturing drugs. The Department will also be making guidance documents available on the Health Canada web site and will continue to communicate with companies to help them better understand how to follow the new amendments.

Health Canada news releases are available on the Internet at www.healthcanada.gc.ca/media

Contact Information

  • Media Inquiries:
    Health Canada
    (613) 957-2983

    Cailin Rodgers
    Office of the Honourable Leona Aglukkaq
    Federal Minister of Health
    (613) 957-0200

    Public Enquiries:
    (613) 957-2991
    1-866 225-0709