Last week, the Royal Decree 957/2020 which regulates the observational studies with medicines for human use was published in the BOE. This regulation will come into force on January 2, 2021 aims to simplify the procedures regulated by the Order SAS/3470/2009 taking into account the observational nature of these type of studies with drugs that…
This week is the Annual Pharmacovigilance Week, organized by Uppsala Monitoring Center and led in Spain by Agencia Española de Medicamentos y Productos Sanitarios (AEMPS). For one week in November, medicine regulators across the globe simultaneously share campaign materials on their social media channels, with the hashtag #MedSafetyWeek. The campaign of this year focuses on…
The European Commission (EC), the European Medicines Agency (EMA) and the Heads of Medicines Agencies(HMA) have co-signed a letter reminding all sponsors of clinical trials conducted in the European Union of their obligation to make summaries of results of concluded trials publicly available in the EU Clinical Trials Database (EudraCT). Transparency and public access to clinical trial results, whether positive or negative, are fundamental…