EMA

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.

European Commission invites feedback on experience with the paediatric regulation

The European Commission has launched a public consultation on the experience gained with the paediatric regulation. Until 28 November 2012 all interested citizens and public and private organizations are invited to send their contribution to this consultation to the European Commission. The consultation builds on the European Medicines Agency's 'Five-year Report to the European CommissionExternal link icon', which reflects on the experience acquired as a result of the application of the Paediatric Regulation.

European Medicines Agency seeking participants for website user-experience research

The European Medicines Agency is seeking volunteers from the pharmaceutical industry to help develop its strategy for the future development of its websites, particularly: regulatory-affairs or regulatory-intelligence staff responsible for either innovative or generic medicines (human or veterinary); pharmacovigilance professionals (human or veterinary); maximum-residue-limit applicants; clinical-trial sponsors.

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