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www.fdanews.com/articles/138326-eu-working-toward-common-clinical-trial-application-for-all-member-states

EU Working Toward Common Clinical Trial Application for All Member States

July 12, 2011
To harmonize and facilitate the exchange of clinical trial information and assessments, the European Union is working toward a one-submission application for trial approval. The clinical trial applications, assessment and approval situation is not currently harmonized between the European Union member states, according to Deputy Head of Austria’s AGES PharmaMed Christa Wirthumer-Hoche.
International Pharmaceutical Regulatory Monitor