EMA publishes report on the SME Initiative

Ten years ago, the European Commission, together with the European Investment Bank (EIB), launched the SME Initiative in order to help small and medium Enterprises (SMEs) develop new medicines.


The Initiative provides financial assistance and help with issues related to market approval. The European Medicines Agency (EMA) has now published a report on the impact of this Initiative and the role played by SMEs in the pharmaceutical sector. Overall, the picture is very positive. According to the report, not only do SMEs play an important role in research and development of medicinal products but the number of approved products has increased as a result of the project. Approximately ten to fifteen per cent of all applications for marketing authorisation were submitted by SMEs, of these around 74 per cent were approved. SMEs also are pivotal in the development of orphan medicinal products for the treatment of rare diseases because around 42% of products developed by SMEs fall into this category. The companies involved in the initiative also stressed the positive impact of the Initiative. Due to its success and positive feedback from stakeholders, the EMA welcomes projects to support SMEs in the pharmaceutical sector and has called for a continuation of the various initiatives.