European Communities’ Committee for Proprietary Medicinal Products (CPMP) Working Party on Efficacy of Medicinal Products

Abstract

This note for guidance is directed to (a) pharmaceutical companies and (b) drug agencies of the member states. It states the “common minimal requirements”; indeed, despite sometimes highly different medical cultures and practices, the 12 member-states follow the same standards for new drugs evaluations. Therefore, these guidelines do not represent detailed technical recommendations for the investigator. Moreover, reference to or discussion of investigational techniques or procedures are intentionally omitted, except if a specific technique or procedure is considered to be of paramount interest (or at least desirable). Nevertheless, investigators should read with benefit this kind of document, which could help them to situate their intervention in the course of the premarketing studies.