6 October 2015 - The Management Board heard an update on the European Medicines Agency’s (EMA) activities in the first half of 2015. Overall, the mid-year report for 2015 shows that the Agency’s operations were largely in line with its forecast. There was a notable increase in the Agency’s activities supporting innovation and development of medicines compared to the same period in 2014. Of the marketing authorisation applications for medicines containing a new active substance and for biosimilars that were submitted in the first half of 2015, 77% had received scientific advice. This demonstrates that EMA’s efforts to encourage medicines developers to seek interaction and dialogue with the Agency are paying off. Early dialogue supports the development of high-quality, effective and safe medicines that meet patients’ needs.

The number of requests for scientific advice and protocol assistance rose by 6% compared to the same period last year. Among these, the number of requests for parallel scientific advice with health technology assessment (HTA) bodies more than tripled (21 in the first half of 2015 compared to six in the first half of 2014). This procedure enables medicine developers to gain feedback from regulators and HTA bodies at the same time, early in the development of a medicine. This can streamline the generation of evidence needed to determine both a medicine's benefit-risk balance and its relative effectiveness so that patients can access new medicines in a timely manner.

For more details, go to: http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2015/10/news_detail_002409.jsp&mid=WC0b01ac058004d5c1