EMA Unveils New Data in Mid-year Report
During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the EMA increased by 16%
During the first six months of 2014, the number of scientific advice and protocol assistance requests for human medicines received by the European Medicines Agency (EMA) increased by 16% compared with the same period in 2013, according to the agency’s mid-year report presented to the Management Board on 2 October 2014.
Among the other highlights in the report are:
- The number of orphan designation applications was 138, a 30% increase over results in the first six months 2013. There was an 8% increase in pediatric procedure applications.
- EMA received 43 initial evaluation applications between January and June 2014, an increase of 19% compared with the same period of last year. This rise was mostly due to more generics applications received. The annual forecast for initial applications has been revised upwards from 88 to 118.
- New orphan medicinal product applications saw an increase to 9 applications (from 5 in 2013) in the first six months of 2014, thus returning to the level of applications in 2011-2012. The number of new non-orphan medicinal product applications received by the end of June 2014 fell slightly, compared to the same period of 2013 (20 versus 24).
- Biological medicinal product applications remained at the same low level as in 2013, as was also the case for hybrid and abridged applications.
For a full copy of the mid-year report, click here. (PDF)
AI in Clinical Trials: A Long, But Promising Road Ahead
May 29th 2024Stephen Pyke, chief clinical data and digital officer, Parexel, discusses how AI can be used in clinical trials to streamline operational processes, the importance of collaboration and data sharing in advancing the use of technology, and more.
Including Women of Childbearing Age in Clinical Research
March 26th 2024In recognition of International Women's Month, we're featuring this recent talk between Associate Editor Miranda Schmalfuhs and Marie Teil, Global Head of UCB’s Women of Childbearing Age Program. They speak about the specific challenges women with chronic illnesses face when accessing appropriate treatment and participating in clinical trials, UCB's Women of Childbearing Age Program and it’s most successful strategies, and much more.
Empower Sponsor Success with Insights from Sites
October 3rd 2024Are you tired of clinical trial technology that slows down processes? Are your sites looking for more intuitive solutions? At YPrime, we’ve taken a deep dive into site experiences and perspectives, sharing ways to bridge the gap between sponsors, sites, and patients, to foster a more efficient clinical trial process.
