12 May 2016 - EMA publishes report on the first ten years of its SME initiative.

The EMA has published today a report summarising the experience with its small and medium-sized enterprise (SME) initiative over the last ten years. The initiative started in December 2005 when the SME Regulation came into force and the SME Office was established to address the needs of the smaller actors in the pharmaceutical development ecosystem.

SMEs are the backbone of Europe's economy. They represent 99% of all businesses in the European Union and provide two-thirds of the total private sector employment. In the pharmaceutical sector SMEs are the motor of innovation and play a major role in the development of new medicines for patients.

To support SMEs throughout all stages of medicines’ development, EMA’s SME Office provides active regulatory, financial and administrative support to registered SMEs.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2016/05/news_detail_002525.jsp&mid=WC0b01ac058004d5c1