European Medicines Agency (EMA) News Channel
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. Regulators in the European Union (EU) and the United States (US) have agreed to recognise inspections of manufacturing sites for human medicines conducted in their respective territories on both sides of the Atlantic. Each year, national competent authorities from the EU and the US Food and Drug Administration (FDA) inspect many production sites of medicinal products in the EU, the US and elsewhere in the world, to ensure that these sites operate in compliance with good manufacturing practice (GMP). The European Medicines Agency (EMA) will launch a pilot project in February 2017 to test the added value and feasibility of tailored scientific advice for the development path of biosimilar medicines. Through this new initiative, EMA aims to provide developers of biosimilars with advice on the studies/tests they should be conducting, on the basis of the quality, analytical and functional data they have already available for the medicine. The European Medicines Agency (EMA) has adopted a new chapter to its guidelines on good pharmacovigilance practices (EU-GVP), entitled "Product- or population-specific considerations II: Biological medicinal products". Good pharmacovigilance practices are a set of measures designed to ensure the robustness of the system of safety monitoring. The new chapter provides guidance on how to better monitor and manage the safety of biological medicines to optimise the safe and effective use of these products in Europe.