EMA

eSubmission Gateway release II and eSubmission web client now live for all applications for human medicines

The European Medicines Agency's Gateway release II and the eSubmission web client are now live for all applications for centralised procedure marketing authorisation for human medicines. Gateway release II is an upgraded version of eSubmission Gateway, the electronic submission channel that the Agency launched in 2012 to allow applicants to submit documents supporting all types of applications for human medicines to the Agency securely over the internet in the Electronic Common Technical Document (eCTD) format.

European Medicines Agency updates guideline on evaluation of anticancer medicines

The European Medicines Agency has finalised the revision of its guideline on the evaluation of anticancer medicinal products. This revision includes, amongst other topics: the use of biomarkers as an integrated part of the development of medicines, combination therapy studies, and the choice of endpoints in confirmatory trials. The Agency is responsible for the evaluation of all new anticancer medicines in the European Union. The guideline provides guidance on all stages of clinical drug development for the treatment of cancer.

European Medicines Agency update on combined contraceptives

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.

European Medicines Agency reviews its operations and prepares for reorganisation in 2013

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.

eSubmission web client for electronic submissions now available for registration

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.

European Medicines Agency sets out next steps on access to clinical-trial data

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.

World AIDS Day: 1 December 2012

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.

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