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Europe, US and Australia announce joint drug inspections

The US HHS has announced a new international initiative to enhance drug safety

The US Health and Human Services Department (HHS) has announced a new international initiative to enhance drug safety.

The Food and Drug Administration (FDA) will undertake the initiative, currently in the pilot stage, with its counterparts in Europe and Australia. Initially, the project will focus on makers of active pharmaceutical ingredients, concentrating on countries such as China and India, who produce a significant volume of the world's pharmaceutical raw materials.

Aiming to reduce duplication and to identify problems quickly, the authorities would share inspection schedules, results and other information.

"These programs will significantly increase our collaboration with international and private sector partners to enhance the safety of imported food and medical products," said HSS Secretary Mike Leavitt. "Working together, we intend to offer expedited access to those products shown to meet our standards and to focus more of our resources on those products that present higher risks."

In February 2008, Baxter International recalled it blood-thinning drug Heparin after a number of serious adverse reactions were reported. An investigation by the FDA identified a contaminant in the drug. These tighter inspections together with the sharing of information between authorities are a huge leap towards preventing a similar occurrence in the future.

10th July 2008


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