Facilitating Interaction between Industry and Regulatory Authorities in the European Economic Community

Abstract

Based on Schering AG's interface with regulatory agencies in the European Economic Community (EEC), the company sees three key issues regarding the approval application procedure which need to be resolved: the ever increasing size of dossiers, the lack of transparency in the review process, and the slowness in the exchange of information between regulatory assessors and industry experts during the approval process. This paper details Schering AG's experiences and makes recommendations for improving the efficiency of the process for both regulatory authorities and industry.