Letter to Editor regarding article "Health Canada mum on overseas drug-manufacturing plant inspections: research" (Canadian Press - September 11, 2012)

2012-138
September 12, 2012

Alan Cassels views on the safety of "overseas" health products ("Health Canada mum on overseas drug-manufacturing plant inspections: research", Sept. 11, 2012) miss several important facts.

Canada has one of the safest drug regulatory systems in the world. Any foreign site that makes a drug product sold in Canada has to meet Canadian standards of good manufacturing practice (GMP). Health Canada verifies that these standards are being met in a number of ways, including its own inspection of foreign sites and information provided from trusted international partners.

If the evidence of good manufacturing practices is missing, the drug cannot be imported into Canada. The vast majority (almost 80 per cent) of foreign sites that make drugs for the Canadian market are in the U.S. or in countries where we have a formal treaty for mutual recognition of inspections.

Health Canada is taking steps to share more information with Canadians about how we regulate drugs and medical devices and protect them from unsafe products. This builds on information we already make available, including a list of establishment licences that allows the public to confirm whether a company has a valid licence, where the sites are located, any regulatory activity that has been authorized, the date of the last inspection, and whether there are applicable terms and conditions on an establishment licence.

Sincerely,

Paul Glover,
Assistant Deputy Minister
Health products and Food Branch
Health Canada

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