European Medicines Agency (EMA) News Channel
The European Medicines Agency is issuing this update in response to growing media reports about combined contraceptives and venous thromboembolism (blood clots in veins). It is well-established that combined contraceptives carry a very rare risk of blood clots, and that the risk differs between types of combined contraceptives. These products are constantly and rigorously kept under close monitoring. The European Medicines Agency has begun a review of its operations and processes, focused on increasing the efficiency of its scientific activities and information- and communication-technology operations. As part of this process, it will focus on the support provided to the Agency's scientific committees to help them deliver high-quality, consistent opinions. The Agency expects this process to result in a significant reorganisation of its staff during 2013. The European Medicines Agency's eSubmission web clientExternal link icon is now open for registration to all applicants. Registered applicants can start submitting centralised procedure Electronic Common Technical DocumentExternal link icon (eCTD) applications through the web client starting on 15 January 2013. The eSubmission web client is a free, web-based tool which is aimed for applicants with lower transmission volumes. The European Medicines Agency today published a report highlighting the outcomes of the workshop on access to clinical-trial data and transparency, which was hosted at the Agency on 22 November 2012. The report summarises the key interventions of the six panellists and other speakers, and outlines the next steps proposed by the Agency with regard to proactive publication of clinical-trial data once the marketing-authorisation process has ended. The European Medicines Agency supports World AIDS DayExternal link icon, which is taking place on Saturday 1 December 2012. World AIDS Day is held each year on 1 December and is an opportunity to raise awareness, commemorate those who have passed on, and celebrate victories such as increased access to treatment and prevention services. From 2011 to 2015, the theme is "getting to zero". The Agency plays a key role in the authorisation of medicines to treat HIV infection and AIDS. Since November 2005, all anti-HIV medicines in the European Union (EU) have had to be authorised centrally at a European level, rather than in each Member State separately. The European Commission has launched a public consultationExternal link icon on phasing-in requirements on a black symbol identifying medicines that are subject to additional monitoring. The concept of additional monitoring was introduced by the new European Union pharmacovigilance legislation, which started to apply in July this year. Medicines under additional monitoring will be identified with a black symbol in the product information, including the package leaflet inside every pack of the medicine. The European Medicines Agency has started publishing information on ongoing applications for extensions of indication of human medicines today in the minutes of the Pharmacovigilance Risk Assessment Committee (PRAC). The new level of transparency involves the publication of information on applications for changes to the authorised use of medicines where a change to the risk-management plan (RMP) is needed.