API inspections may not avert drug shortages in Britain

03/6/2013 | In-PharmaTechnologist.com

New EU import regulations of about 300 active pharmaceutical ingredients could result in shortages in Britain because of an estimated 300 sites that, lacking valid certifications, will require onsite inspections. Yet Britain's Medicines and Healthcare products Regulatory Agency says it lacks the resources to conduct inspections on such a scale. "Based on the latest analysis, inspection of those sites in third countries that are not planning to issue statements or apply for lisitng cannot be seen as a solution," the MHRA stated.

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