Close Monitoring of Apotex

Close Monitoring of Apotex

The Ministry of Health’s drug regulatory arm Medsafe is closely monitoring Apotex, Canada’s largest medicines manufacturer, following the United States placing an import ban on medicines produced at two manufacturing sites by this company.

The United States ban was put in place after the Food and Drug Administration (FDA) found deviations from accepted manufacturing processes at two Apotex manufacturing plants in Toronto in Canada.

In response to the FDA findings, Apotex has voluntarily recalled 40 medicines for the US market and three from the Canadian market. None of the affected batches of recalled medicines are available in New Zealand.

Medsafe Group Manager Dr Stewart Jessamine says its Canadian regulatory equivalent Health Canada started an audit this week of the two Canadian sites. The audit is being carefully followed by medicine regulatory authorities around the world.

Since last week's US import ban, Medsafe has been working with the FDA, Health Canada, PHARMAC and Apotex to determine the implications for New Zealand products manufactured at the affected sites.

"Like many other countries, Apotex products are used in New Zealand and both agencies are working closely on the issue to provide assurance that the public has access to affordable high quality medicines," says PHARMAC Medical Director Peter Moodie.

"Although the FDA report has raised questions about the manufacturing process at these two Canadian plants, there is no evidence that this has led to an increased risk to patient welfare for medicines made at these plants," Dr Jessamine said. "Our advice to patients at this time is to keep taking their medicines as prescribed."

Dr Jessamine says: "While the Health Canada audit will provide us with further information about these manufacturing sites, given the size and complexity of the manufacturing sites the site visits themselves are likely to take up to a month.

"We are actively managing this emerging situation and will inform healthcare professionals and consumers if the situation changes significantly", he said.

ENDS

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