Canada restricting drugs linked to Hospira plant in Italy due to data integrity concerns

Regulatory agency Health Canada is restricting the importation of drugs from manufacturing facilities operated by US injectable drugs and infusion technologies and biosimilars developer Hospira (NYSE: HSP) in Liscate, Italy, due to data integrity concerns.

This measure is to help mitigate any potential risk in light of recent findings from a trusted regulatory partner that raised concerns about the reliability of the laboratory data generated at this site. The move follows US Food and Drug Administration questioning of the reliability of laboratory data at the Italian plant (The Pharma Letter April 8).

The licences of Canadian companies that import drugs from this facility are being amended with terms and conditions that require independent third-party testing against the approved Canadian specifications prior to release of any medically necessary products to the Canadian market. Independent, third-party testing will provide confidence that the affected medically necessary products meet Canadian quality standards before being released for use by Canadians.