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Regulatory Update

Posted 01 September 2011 | By Michael Matthews 

Recently, two pilot programs were completed by the European Medicines Agency (EMA), the US Food and Drug Administration (FDA) and Australian Therapeutic Goods Administration (TGA) to increase international collaboration on drug quality and safety. The two pilot programs included inspections on active pharmaceutical ingredient (API) manufacturers' and Good Clinical Practice (GCP) compliance. On 2 August 2011, EMA published a press release summarizing the results of these two programs.


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