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14 May 2014

Health Canada Confirms License Suspension of Biolyse Pharma for Serious Manufacturing Concerns

Health Canada has confirmed it has suspended the establishment licence of Biolyse Pharma Corporation's facility in St Catharines, Ont., because of significant concerns with the manufacturing process discovered during a recent inspection.


Injectable paclitaxel (6 mg/mL), used in the treatment of certain lung and breast cancers, is currently the only drug produced at that facility.


The suspension of the establishment license means Biolyse is not permitted to sell paclitaxel from that facility to the Canadian market until the serious manufacturing concerns are fully addressed and the suspension on their establishment licence is lifted.


To receive and maintain an establishment licence in Canada, a company must comply with Good Manufacturing Practices (GMP), which help to ensure that the drugs sold in Canada are safe, effective and of high quality. These guidelines are applied to all companies and are widely known.


Health Canada has confirmed that supplies of paclitaxel are available from another manufacturer that is licenced to produce it in Canada. The Department is also in regular contact with the provinces and territories regarding the supply situation. There has been no supply disruption caused by the licence suspension.


In the short term, Health Canada is allowing the Biolyse product currently on the market to continue to be used for treatment. However, Health Canada cannot be assured that future supplies of paclitaxel from Biolyse would be safe and effective for use by patients until the serious manufacturing violations are resolved.


Health Canada officials continue to work with the staff at Biolyse Pharma to resolve the issues identified during the inspection as quickly as possible.

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