Draft key principles on the use of electronic product information (ePI) in the EU were reviewed by a stakeholders meeting, attended by PIF, at the European Medicines Agency (EMA) last week. Electronic product information will complement the paper patient information leaflets supplied with medicines and will be available for all licensed products. The development of ePI…
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’ (identified as those with an inverted black triangle). Regulatory authorities continuously look at reports of side effects alongside all the information they already have to make sure…
Comments invited: European Medicines Agency’s paper on addressing the needs of older people who take medicines
The European Medicines Agency (EMA) is inviting comments from the public on a reflection paper on how medicine developers can better address the needs of older people who take medicines. In general, older people are the highest users of medicines. According to Eurostat, they are expected to make up almost a third of all Europeans by 2050, and they…
The European Medicines Agency has begun publishing suspected side effect reports for medicines authorised in the European Economic Area (EEA) on a new public website: www.adrreports.eu. The information published relates to approximately 650 medicines and active substances authorised through the centralised procedure, which is managed by the Agency. Information on the website is presented in the form of a single report per medicine or active substance. Each report pulls together the total number of individual suspected side effect reports submitted to EudraVigilance by Member States and marketing-authorisation holders.
Page 1 of 1 —
Page 1 of 1 —