Which post-marketing database and studies does EMEA require
Gottfried Kreutz, Leng HengFederal Institute
for Drugs and Medical Devices, Department Clinical Pharmacology I,
Friedrich-Ebert-Allee 38, D-53113 Bonn, Germany
Correspondence to: Dr Kreutz
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The European process for assessment of pharmaceutical products is complex and presents with different levels. There is the European level with two major procedures resulting in decisions on approval after applications to market a pharmaceutical product in European countries. One is the centralised procedure organised by the European Medicines Evaluation Agency (EMEA). The other one is the mutual recognition procedure performed by consensus between Member States. The decisive body on the European level for medicines for humans is the Committee for Proprietary Medicinal Products (CPMP) with representation of two members from each of the countries of the European Union. This expert body is supported by others (Working Parties) where specialist competence within each of the areas and from each of the member states is providing ample opportunities for exchange of expertise and consensus discussions (fig 1).
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Medical regulatory requirements including clinical efficacy and
clinical safety aspects are discussed and
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