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Improving the EU system for the marketing authorisation of medicines

In 2013, the project “Improving the EU system for the marketing authorisation of medicines - Learning from regulatory practice” has been initiated. The goal was to provide a data–driven assessment of the regulatory system for marketing authorisation. Opportunities for improving the regulatory system were identified around a number of case studies. The project was supported by an unrestricted research grant from the European Federation of Pharmaceutical Industries and Associations (EFPIA) and the Association of the European Self-Medication Industry (AESGP).

Exon Consultancy and Utrecht University executed the project, with support of additional public and private partners providing data and expertise. A scientific analysis of topics in a number of key areas in the regulatory system was performed, including: pharmacovigilance & post-authorisation safety studies studies, the conditional marketing authorisation pathway, the decentralised & mutual recognition procedure and paediatric investigation plans. The results of this project were presented to key stakeholders in an interactive workshop in Brussels, organized by TOPRA. The workshop resulted in an important contribution to the debate on improving the regulatory system for the benefit of all stakeholders.

Project Partners