EMA Annual Report 2016

16/05/2017 News UEMO 1910 Views
EMA Annual Report 2016

On May 10th, The European Medicines Agency’s (EMA) published its 2016 annual report which 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.

The report highlights the agency’s recommendations to authorize the marketing of numerous innovative medicines which have the potential to make a difference for patients. Emphasis is also put on scientific advice, recognized as EMA’s key tool to promote the collection of high-quality data on the benefits and risks of medicines.

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.

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 is available here.

About author

Related articles