European Medicines Agency (EMA) News Channel
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. The European Medicines Agency (EMA) will host an awareness session to present the European Union’s (EU) medicines regulatory system and EMA's role in it to international regulators and non-governmental organisations. A clear understanding of how medicines are regulated in different parts of the word is of prime importance in an increasingly globalised world where regulators rely on close cooperation. The European Medicines Agency (EMA) has launched a survey to better understand patients’ and healthcare professionals’ awareness of reporting adverse drug reactions, including for medicines under ‘additional monitoring’. Medicines under additional monitoring are monitored particularly closely by regulatory authorities. The European Medicines Agency (EMA) and the European Network for Health Technology Assessment (EUnetHTA) are stepping up their efforts to provide developers of medicines with simultaneous, coordinated advice on their development plans and facilitate alignment of data requirements. This initiative provides a single gateway for requests for parallel consultations with EMA and HTA bodies in the Member States on evidence-generation plans to support decision-making on marketing authorisation and health technology assessment. 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 version of EudraVigilance will go live on 22 November 2017 with enhanced functionalities for reporting and analysing suspected adverse reactions.