首页 > 资讯 > 加拿大卫生部宣布原料药生产将需符合GMP标准

出自识林

2012-11-16 Health Canada

加拿大卫生部于2012年11月13日在官方网站上发布声明，称将对药品生产采取更严格的监管措施，措施之一是药品活性成分（AI）的生产也必须符合药品生产 GMP标准，这里的AI包括所有在加拿大境内销售的药品的AI，无论其是否在加拿大境内生产。

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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.