European Medicines Agency (EMA) News Channel
The European Medicines Agency (EMA) has published today its first report summarising the Agency's actions carried out by two of its committees in 2016 and 2017 - the Committee for Medicinal Products for Human Use (CHMP) and the Committee for Medicinal Products for Veterinary Use (CVMP) - to support the implementation of the so-called 3Rs principles for more ethical use of animals in medicine testing across the European Union (EU). The European Commission’s Directorate-General for Health and Food Safety has launched a call for expressions of interest to represent patient organisations in the European Medicines Agency's (EMA) Committee for Orphan Medicinal Products (COMP). The call aims to fill three positions for COMP members nominated by the European Commission to represent patient organisations. The European Medicines Agency (EMA) will relocate to Amsterdam in the Netherlands. This decision was taken by the EU 27 Member States in the margins of the General Affairs Council (Art. 50). The Agency now has just over 16 months to prepare for the move and take up its operations in Amsterdam on 30 March 2019 at the latest. 1 November 2017 marks the coming into operation of further aspects of the mutual recognition agreement between the European Union (EU) and the United States (US) to recognise inspections of manufacturing sites for human medicines conducted in their respective territories. This agreement, which updates the agreement from 1998, allows for recognition of each other's inspection outcomes and hence for better use of inspection expertise and resources. The European Commission's Directorate-General for Health and Food Safety (DG SANTE) and the European Medicines Agency (EMA) have published a joint action plan to foster the development of advanced therapy medicinal products (ATMPs). The main aim is to streamline procedures and better address the specific requirements of ATMP developers. On 22 November 2017, the European Medicines Agency (EMA) will launch a new and improved version of EudraVigilance, the European information system of suspected adverse reactions to medicines that are authorised or being studied in clinical trials in the European Economic Area (EEA). The new system will have enhanced features for the reporting and analysis of suspected adverse reactions to support a better safety monitoring of medicines and a more efficient reporting process for stakeholders. The European Medicines Agency (EMA) has published the information it submitted to the European Commission in support of its assessment of the 19 Member States' bids to host the Agency. This decision comes following the recent publication of isolated pieces of information circulating in the press in order to complete the picture and set the record straight.