It describes how medicines1 are authorised and monitored in the European Union (EU) and how the European medicines regulatory network - a partnership between the European Commission, the medicines regulatory authorities in EU Member States (MSs) and the European Economic Area (EEA), and the European Medicines Agency (EMA) - works to ensure that patients in the EU have access to high-quality, effec. [...] The diversity of experts involved EMA and the Member States cooperate and share expertise in the assessment of new medicinal in the regulation of medicines in products, the monitoring of their safety and the the EU encourages the exchange response to public health emergencies. [...] They also of knowledge, ideas, first-hand rely on each other for exchange of information in experience and best practice the regulation of medicines, for example regarding the reporting of side effects of between scientists striving for medicines, the oversight of clinical trials and the the highest standards for conduct of inspections of medicine manufacturers medicines’ regulation. [...] granted, decisions on price and reimbursement take place at the level of each Member State The experts are chosen on the basis of their considering the potential role and use of the scientific expertise and/or their experience with a medicine in the context of the national health specific disease and many of them are made system of that country. [...] These activities aim to foster the timely exchange of regulatory and scientific expertise The Accelerating Clinical Trials in the EU (ACT EU) and the development of best practices in the initiative aims to develop the EU further as a regulatory field across the world.
- Pages
- 12
- Published in
- Malta
