EMA

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.

Public consultation open on phasing-in of 'black symbol'

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.

European Medicines Agency increases transparency of ongoing applications for human medicines

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.

Update on seasonal influenza vaccines produced by Novartis Vaccines

A number of European Union (EU) Member States have halted the use, as a precautionary measure, of some anti-influenza vaccines manufactured by Novartis Vaccines, because of a suspected quality defect. The Italian Medicines Agency (AIFA) was first informed of the suspected quality defect by the manufacturer (Novartis Vaccines) located in Italy. The Italian authorities took prompt precautionary action and AIFA alerted all other Member States, the European Commission and the European Medicines Agency using the established mechanisms.

European Medicines Agency on track to meet core business targets for 2012

The European Medicines Agency’s Management Board discussed the Agency's annual mid-year report for 2012 at its meeting on 4 October. The mid-year report from the Executive Director to the Management Board provides an overview of the Agency's progress from January to June in implementing its 2012 work programme. Presenting the report to the Board, Executive Director Guido Rasi said that the progress of the Agency’s activities so far in 2012 was encouraging.

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