This Press release is brought to you by Health Canada.
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.
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.
Health Canada is taking steps now to make the necessary changes to establish this new approach.
For more information and the full press release please refer to the link above.