European Medicines Agency (EMA) News Channel
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. The European Medicines Agency is currently reviewing rosiglitazone to determine the impact of new data from recent publications on the risk of cardiovascular problems on the benefit- risk profile of these medicines. Prescribers in the European Union are reminded to strictly follow the current restrictions in the product information. Avandia (rosiglitazone) was initially authorised in the European Union in July 2000 as second-line diabetes type-2 treatment to be used when other treatments have either failed or are unsuitable for a patient. The European Medicines Agency (EMA) unveiled its new corporate website, the site has been completely redesigned and rebuilt to optimize usability for the Agency's key online audiences and build on existing activities to improve openness and transparency. The Agency website now receives an average of half a million unique visits per month and is a key resource for patients, healthcare professionals, regulators and those interested in the regulation and safety of medicines in the European Union. The European Medicines Agency has started a review of the rosiglitazone-containing anti-diabetes medicines Avandia, Avandamet and Avaglim, to determine whether new data on the risk of cardiovascular problems have an impact on their benefit-risk profile. The review by the Agency's Committee for Medicinal Products for Human Use (CHMP) follows the recent publication of further studies on the cardiovascular safety of rosiglitazone.