The European Medicines Agency’s (EMA) has published its annual report for 2016.
The report highlights the agency’s key achievements in the areas of medicine evaluation, including:
- 81 medicines (including 27 new active substances) for human use recommended for approval.
- 11 medicines (including 6 new active substances) for veterinary use were recommended for approval.
- Approximately half of the applicants who were granted a positive opinion for their medicine had received scientific advice from EMA during the development of their product.
- Product information for over 300 medicines for human use was updated on the basis of new safety data.
- PRIME (PRIority MEdicines), an initiative to support the development of medicines that address unmet medical needs, was launched.
- Publication of clinical trial data for new medicines was introduced.
Please click here to read more and access the full report.