GESTO platform: Publication of results of observational studies with medicinal products for human use

After approval of the RD 957/2020 which regulates observational studies with medicinal products for human use it is mandatory the publication of results of observational studies with medicinal products for human use in the spanish clinical trials registry, as we mentioned in a previous post. Thus, the AEMPS with the aim to facilitate this process…

CLINICAL TRIALS REGULATION (EU) 536/2014 IMPLEMENTATION TRAINING

Last month, The European Commission, Clinical Trials Facilitation and Coordination Group and European Medicines Agency (EC-DG SANTE/HMA-CTFG/EMA) imparted a joint training on the Clinical Trials Regulation (EU) 536/2014. The implementation to a European level implies a Harmonization of the submission of a clinical trial from all Member States of the part I documentation: documentation to…

New regulation for observational studies with medicines for human use in Spain

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…

EMA AND FDA MARKETING AUTHORIZATIONS: CONCORDANCES AND DISCORDANCES

EMA and FDA have published in joint an article entitled “A comparison of EMA and FDA decisions for new drug marketing applications 2014-2016: concordance, discordance and why”. Most of information were sourced from EMA´s European Public Assessment Reports (EPARs) and FDA reviews. The study consisted of comparing decisions on 107 new medicine applications at the…

Call for all sponsors to publish clinical trial results in EU database

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…

La protección de datos – Nueva regulación adaptada a la era digital

El Reglamento General de Protección de Datos (RGPD), que regula el tratamiento que realizan las personas, empresas u organizaciones de los datos personales relacionados con personas en la Unión Europea, fue aprobado por el Parlamento Europeo en abril de 2016, su ámbito de aplicación se extiende a todos los países miembros de la Unión Europea…