Canada strengthens drug safety with GMP now to apply to all APIs

9 May 2013

Canada’s Health Minister Leona Aglukkaq this week announced that Canada's Food and Drug Regulations have been amended to extend the requirements for Good Manufacturing Practices (GMP) to active pharmaceutical ingredients (APIs) used in medicines. 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, adding: "That is why we are taking action to improve the safety of Canada's pharmaceutical drug supply."

An API is the ingredient or combination of ingredients in a drug that delivers a health benefit to a patient. An example of a common API is acetaminophen, which is used as a pain reliever. GMPs are an internationally accepted set of standards that help ensure drugs are produced and handled with good quality control.

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