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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 are already  part of clinical practice.

From now on, the previous requirements to start the observational studies with medicines are limited to the favorable opinion of the CEIm and the agreement with the participating study sites, removing the classification by AEMPS.

In addition, in the prospective observational studies with medicines, it is possible for the Autonomous Communities to develop their own regulations based on their competences.

It is important to note that it will be mandatory to include prospective observational studies in the Spanish Clinical Trials Registry.

In the following link you can find all the information about this subject:

https://www.boe.es/diario_boe/txt.php?id=BOE-A-2020-14960

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Raising pharmacovigilance awareness in the #MedSafetyWeek

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 polypharmacy (which is defined as five or more medications) and the safe use of medicines in the elderly or those with complex conditions.

It has been published that currently one third of the world’s population over 75 years old take at least six medications per day, and more than one million people consume eight or more.

As a Contract Research Organization part of our work include monitoring clinical studies in which patient have a special conditions (most of them suffer chronic diseases and usually are elderly patients), therefore we need to be aware of this condition can increase the likelihood of suffer adverse drug reactions.

For more detailed information: La AEMPS celebra la #MedSafetyWeek con una campaña para sensibilizar sobre la importancia de notificar las sospechas de reacciones adversas a medicamentosmedsafetyweek

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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 for the protection and promotion of public health.

EMA has since September 2018 been identifying trials with missing results on a monthly basis and sending reminders to the sponsors of those trials to ensure compliance with the transparency rules and their follow up on their results reporting obligations.

For more information: https://www.ema.europa.eu/en/news/call-all-sponsors-publish-clinical-trial-results-eu-database