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news.The US Department of Health and Human Services, the FDA and their counterparts in Europe and Australia plan to coordinate their work in a bid to improve the inspection processes of manufacturing facilities around the world, reported the PharmaTimes.
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According to Michael Leavitt, secretary of the US Department of Health and Human Services (HHS), the regulatory agencies in the US, EU and Australia will jointly plan, allocate for and conduct inspections of drug-manufacturing facilities.
The project will initially focus on manufacturers of active pharmaceutical ingredients and allocate more resources for monitoring high risk products. The program will also expedite access to products that meet the global standards.
The HHS claims that the present initiative is largely because of the FDA’s failure in curbing the imports of unsafe goods. Especially, the reported deaths caused due to contaminated versions of the blood-thinner heparin from China in 2007 and other safety issues have exposed the FDA’s limitations in ensuring the safety of the imports.