Progress on science, medicines and health
EMA 2016 annual report published
The European Medicines Agency’s (EMA) 2016 annual report published yesterday 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.
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.
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.
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 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.
- Governance documents: Annual reports and work programmes
- Medicine evaluation figures
- About us
- What we do
- Annex 10 - 2016 annual report of the European Medicines Agency - Positive and negative opinions; Withdrawn applications (10/05/2017)
- Annexes - 2016 annual report of the European Medicines Agency (10/05/2017)
Latest News from
Joint press release by the Eurogroup President, Paschal Donohoe, and Finance Minister Sigrid Kaag following their meeting in The Hague19/05/2022 16:33:00
Minister of Finance Sigrid Kaag and the President of the Eurogroup, Paschal Donohoe, met in The Hague on Wednesday.
GCC: EU unveils Strategic Partnership with the Gulf19/05/2022 15:25:00
The High Representative and the European Commission yesterday adopted a Joint Communication on a 'Strategic Partnership with the Gulf' with the aim to broaden and deepen the European Union (EU)'s cooperation with the Gulf Cooperation Council (GCC) and its Member countries.
REPowerEU: A plan to rapidly reduce dependence on Russian fossil fuels and fast forward the green transition*19/05/2022 14:33:00
The European Commission yesterday presented the REPowerEU Plan, its response to the hardships and global energy market disruption caused by Russia's invasion of Ukraine.
Union for the Mediterranean (UfM) Member States commit to tackling the employment and employability challenges of the most vulnerable, especially among youth and women19/05/2022 13:25:00
The fifth Union for the Mediterranean (UfM) Ministerial on Employment and Labour, held on 17 and 18 May in Marrakech, Morocco, focused on “Employment and employability of the most vulnerable, especially among youth and women”.
EU steps up action to strengthen EU defence capabilities, industrial and technological base: towards an EU framework for Joint defence procurement19/05/2022 12:38:00
In response to the European Council tasking at the Versailles Summit, the Commission and the High Representative yesterday presented an analysis of the defence investment gaps, and propose further measures and actions necessary to strengthen the European defence industrial and technological base.
Ukraine: Commission presents plans for the Union's immediate response to address Ukraine's financing gap and the longer-term reconstruction19/05/2022 11:33:00
The Commission yesterday set out plans in a Communication for the EU's immediate response to address Ukraine's financing gap, as well as the longer-term reconstruction framework.
State aid: Commission approves a €30 million Maltese scheme to support the importation, manufacturing and wholesale of grains in context of Russia's invasion of Ukraine19/05/2022 10:33:00
The European Commission has approved a €30 million Maltese scheme to support companies active in the importation, manufacturing and wholesale of grains and other similar products in the context of Russia's invasion of Ukraine.
EU allocates €25 million in humanitarian aid for Palestinians17/05/2022 10:25:00
The EU yesterday announced €25 million in humanitarian aid to meet the basic needs of vulnerable Palestinians in the West Bank, East Jerusalem and Gaza.
Spring 2022 Economic Forecast: Russian invasion tests EU economic resilience17/05/2022 09:25:00
The outlook for the EU economy before the outbreak of the war was for a prolonged and robust expansion.