European Medicines Agency (EMA) News Channel
The European Medicines Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have launched the ENCePP E-Register of Studies. This electronic register is a publicly accessible resource for the consultation of pharmaco-epidemiological and pharmacovigilance studies conducted by academic centres and other research organisations. The European Medicine Agency and the European Network of Centres for Pharmacoepidemiology and Pharmacovigilance (ENCePP) have awarded the first 'ENCePP study' seal to an observational study investigating the "long-term outcomes and adverse events of therapy with inhaled corticosteroids, long-acting beta-2-agonists and anticholinergic drugs in hospitalised patients with Chronic Obstructive Pulmonary Disease (COPD)". The European Medicines Agency welcomes the adoption of the new pharmacovigilance legislation by the European Parliament. This is a major step towards the legislation coming into force, currently expected for mid-2012. The new Directive and Regulation propose a number of changes that will strengthen the way the safety of medicines for human use is monitored in the European Union (EU). The European Medicines Agency (EMA) and the U.S. Food and Drug Administration (FDA) have extended their confidentiality arrangements related to medicinal products for human and veterinary use, following the positive experience gained since the initial arrangements were signed in September 2003. This cooperation will now continue indefinitely without the need for further renewal. The Committee for Medicinal Products for Human Use (CHMP) met on Wednesday 8 September to discuss the ongoing benefit-risk review of the rosiglitazone-containing medicines Avandia, Avandamet and Avaglim. The Committee discussed all of the available data on the risk of cardiovascular problems associated with rosiglitazone in order to prepare for its next scheduled meeting of 20-23 September 2010, when it expects to finalise its review. The European Medicines Agency has launched a review of Pandemrix on the request of the European Commission to investigate whether there is a link between cases of narcolepsy and vaccination with Pandemrix. A limited number of cases was reported, all collected through spontaneous reporting systems, mainly in Sweden and Finland. Pandemrix, an influenza vaccine, has been used since September 2009 for vaccination against H1N1 influenza in at least 30.8 million Europeans. The European Medicines Agency (EMA) and the Food and Drug Administration of the United States of America (US FDA) continue to seek potential candidate companies for a joint GMP inspection pilot programme for manufacturers of medicinal products. Companies that have submitted in parallel two equivalent marketing authorisation applications for the same medicinal product to both the EMA and the US FDA can request to participate in the pilot programme for joint pre-approval inspection should such an inspection be considered necessary by both agencies.