EMA focuses on core tasks in 2015 annual report

The newly published European Medicines Agency’s (EMA) 2015 annual report focuses on the European regulator's core tasks which include the evaluation of medicines, support to research and development of new and innovative treatments and the monitoring of the benefits and risks of medicines in real life.

In his introduction, EMA Executive Director Guido Rasi, said 2015 had been a 'year of transition' and had given the regulator the opportunity to discuss with its EU partners 'how we can support and shape the transformation the medicine development and authorisation system is currently undergoing in order to improve the health of EU citizens'.

It is against this background that EMA adopted the first joint strategy for EMA and all national medicines agencies in the EU in December 2015.

'I am confident that this joint effort sets the European medicines regulatory network on the right course for the coming five years to keep pace with a rapidly changing environment,' added Rasi.

In 2015, the Agency recommended marketing authorisation for 93 medicines for human use, which include 39 new active substances, and 14 medicines for veterinary use, including seven new active substances.

In 2015, the Agency recommended marketing authorisation for 93 medicines for human use

Approximately one in two applicants who received a positive opinion for their medicine had received scientific advice from EMA during the development phase of their product; this figure rises to 85% for medicines containing a new active substance. Scientific advice is EMA’s key tool to promote the collection of high quality data on the benefits and risks of medicines.

For human medicines, more than 1.2 million reports on suspected side effects were recorded in EudraVigilance, the EU adverse drug reaction collection and management system, last year. More than 48,000 reports originated from patients in the European Economic Area (EEA), a 30% rise compared with 2014. This is a positive trend showing that patients increasingly make use of the opportunity to directly report on side effects they experience.

In 2015, the product information on many medicines was updated as new safety information had become available. The revised information will allow patients, healthcare professionals and veterinarians to make informed decisions based on the latest evidence when using or prescribing the medicine, the Agency said.

The annual report also highlights some of the main projects, initiatives and achievements in 2015 that have had a significant impact on the Agency and the way it operates. Among these are the preparation for the launch of PRIME (PRIority MEdicines) to support the development 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 implementation of various new pieces of legislation including a range of new activities to further strengthen the safety monitoring of medicines.

Another area highlighted in the report is the Agency's work to enhance the transparency of EMA processes and to provide access to the clinical trials data on which regulatory decisions are made.

The annual report also highlights some of the main projects, initiatives and achievements in 2015 that have had a significant impact on the Agency and the way it operates

Sir Kent Woods, Chair of the EMA Management Board, said in his foreword that this has 'raised some contentious issues', including freedom of information, commercial confidentiality and personal data protection.

'There is still more to be done but EMA has established itself at the leading edge of regulatory transparency internationally,' he said.

The report also contains three interviews with stakeholders and EMA representatives on topics of interest in the area of medicines and health in 2015, such as how data requirements from regulators and health technology assessment (HTA) bodies can be better aligned; whether the use of big data in healthcare is a challenge or an opportunity; and how immunotherapies bring new hope to cancer patients.