European Medicines Agency’s 2016 annual report published

The European Medicines Agency’s (EMA) 2016 annual report focuses on the Agency’s key achievements in the areas of medicine evaluation, support to research and development of new and innovative treatments and the safety monitoring of medicines in real life.

In 2016, the Agency recommended a marketing authorisation for 81 medicines for human use, including 27 new active substances. Many of these innovative substances build on the advances made in biomedical science and have the potential to make a difference for patients.

Veterinary

On the veterinary side, 11 medicines were recommended for approval, including six new active substances. A third of these medicines prevent viral or bacterial infections in food-producing animals.

Scientific advice

Approximately half of the applicants who were granted a positive opinion for their medicine had received scientific advice from EMA during the development phase of their product. Scientific advice is EMA’s key tool to promote the collection of high-quality data on the benefits and risks of medicines.

Safety monitoring

As a result of the safety monitoring of all medicines marketed in the European Union (EU), the product information for over 300 medicines for human use was updated on the basis of new safety data. The revised information allows patients and healthcare professionals to make informed decisions based on the latest evidence when using or prescribing the medicine.

Patient registries and real world data

EMA’s annual report also highlights some of the Agency’s main projects, initiatives and achievements in 2016. These include the launch of PRIME (PRIority MEdicines), an initiative to support the development of medicines that address unmet medical needs and the policy on the publication of clinical trial data for new medicines, a groundbreaking new initiative that turned EMA into one of the most transparent medicines regulators worldwide. Other developments showcased in the report include new ways to collect data on medicines such as big data, patient registries and real world data, and EMA’s contribution to addressing public health challenges, including antimicrobial resistance and the Zika virus outbreak.

The report also contains three interviews with stakeholders and EMA representatives on topics of major interest in the area of medicines and health in 2016: 

• vaccine hesitancy – a threat to public health;
• creating an agile organisation for the 21st century;
• how to reinforce surveillance of antimicrobial consumption.

The last part of the report provides a large amount of data and figures that illustrate the work of EMA and its impact.