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: