European Medicines Agency and civil society

The European Medicines Agency, the European Commission’s Agency charged with approving and monitoring medicines on the European market has a new Executive Director. Professor Guido Rasi, whose previous role was as Director-General of the Italian Medicines Agency (2008-2011), during which time he also served as a member of the European Medicines Agency’s Management Board. Professor Rasi was nominated as EMA Executive Director with a renewable 5-year mandate by the Management (...)

Following the end of the mandate of the European Medicines Agency (EMA) Executive Director Mr Thomas Lönngren on 31 December 2010, the agency is in the process of appointing a new Executive Director. The EMA’s Management Board has nominated Mr Guido Rasi on 8 June 2011 as the new Executive Director-designate. Mr Rasi previously served as Director-General of the Italian Medicines Agency and a Member of the European Medicines Agency’s Management Board since 2008. On Wedensday 13 (...)

The European Medicines Agency has recommended restricting use of Pandemrix, the vaccine issued following the outbreak of pandemic flu H1N1 in 2009. The review of Pandemrix was initiated to investigate a possible link between Pandemrix vaccination and narcolepsy, following an increased number of reported cases of narcolepsy among children and adolescents in Finland and Sweden following the H1N1 pandemic vaccination campaign in late 2009 and early 2010. The EMA was satisfied, after reviewing (...)

Due to transparency reasons, such as procurement, conflicts of interests and other concerns the European Parliament voted to block the 2009 accounts of the European Medicines Agency. The European Parliament’s budgetary control blocked the 2009 Discharge of the European Medicines Agency (EMA). The approval of the discharge’ is the Parliamentary check to authorize accounts for the EU institutions and how their budgets are implemented in a financial year. MEPs also raised (...)

On 18 February 2011 the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) adopted the EMA geriatric medicines strategy document. The strategy sets out the Agency’s vision for the development of medicines for older people by building on its existing activities. In particular, the Agency aims to: Ensure that the medicines used by older people are of high quality and are studied appropriately in the older population, both before and after (...)

The European Medicines Agency last week published its final ’Road map to 2015’, coinciding with the 16th anniversary of its inauguration. The ’Road map to 2015’ sets out the Agency’s vision in further developing its role as a European public-health agency in the field of medicines and has been drafted in consultation with the Agency’s partners and stakeholders to ensure as broad a consensus as possible on the best way forward. The document emphasises (...)

EPHA member organisation Health Action International (HAI) Europe has published a research article based on a survey pertaining to levels of financial disclosure and transparency among patient and consumer organisations at the European Medicines Agency (EMA). Based on the main findings of the study, HAI Europe concludes that "EMA appears to have failed in the monitoring and enforcement of its guidelines on financial transparency". In 2005, the European Medicines Agency (EMA) established (...)

In May 2010, the European Medicines Agency (EMA) published its first medicinal information “training manual” aimed at members of the general public. The manual, which explains the documents and processes used to review the patient information leaflet (PIL) and European public assessment report (EPAR), is designed to help European citizens gain a better understanding of how information on medicinal products is written and reviewed. It details all the documents, procedures and (...)

This is a communication from the European Medicines Agency. The organisation will be introducing some visual identity, web/e-mail adresses and organisational chart changes shortly. New visual identity, web/e-mail addresses and organisation chart of the European Medicines Agency Communication to all Agency partners, stakeholders and the public. This communication is intended to inform all interested parties about several important changes the European Medicines Agency will be introducing (...)

The European Medicines Agency (EMEA) announced the formal creation of its sixth scientific committee, the Committee for Advanced Therapies (CAT), which met for the first time on 15 January 2009. As a result of new European Union legislation on the regulation of advanced-therapy medicinal products, EMEA has introduced the CAT. The CAT will play a central role in the assessment of innovative medicines based on gene therapy, somatic cell therapy and tissue engineering. These advanced (...)