The European Medicines Agency’s (EMA) 2015 annual report published emphases on the Agency’s central chores which are basically:
- Assessment of medicines
- Promoting research
- Development of new and advanced treatments
- Checking of the benefits and risks of medicines in real life
In 2015, the Agency suggested marketing endorsement for 93 medicines for human use, which comprise 39 new active ingredients, and 14 medicines for veterinary use, containing seven new active elements.
About one in two applicants who received a positive view for their medicine had received scientific guidance from EMA during the progress phase of their product; this figure rises to 85% for medicines containing a new active ingredient. Scientific guidance is EMA’s key tool to stimulate the collection of high quality data on the advantages and risks of medicines.
This is a positive trend showing that patients increasingly make use of the opportunity to directly report on side effects they experience. For human medicines, more than 1.2 million reports on suspected side effects were recorded. Over 48,000 reports instigated from patients in the European Economic Area, a 30% rise compared to 2014.
In 2015, the product information on many medicines was modernized as a new safety information had become available.
EMA’s annual report also shows some of the main projects, initiatives and achievements in 2015 that have had an important influence on the Agency and the way it functions. These are:
The preparation for the launch of Priority medicines to the maintenance and the advancement of medicines that address unmet medical needs
Initiatives to help fight antimicrobial resistance and other public health threats such as Ebola as well as the execution of various new pieces of legislation including a range of new activities to further support the safety checking of medicines.
The report also covers three interviews with stakeholders and EMA representatives on topics of major interest in the area of medicines and health in 2015, comprising:
- Best way of alignment for data requirements from regulators and health-technology-assessment (HTA) bodies.
- The way immunotherapies bring new hope to cancer patients.
- Use of big data in healthcare is challenging or an opportunity.
Date: 17/05/2016