The Spanish Agency for Medicines and Health Products (AEMPS) has published the ‘Memorandum of collaboration between the ethics committees of research with medicines (CEIm) for the evaluation and management of observational studies with medicines’, whose objective is to facilitate CEIm the consistent, rigorous and homogeneous application of the requirements established in Royal Decree 957/2020, of November 3, 2020, which regulates observational studies with drugs for human use.
Royal Decree 957/2020, which came into force on January 2, establishes a new scenario for conducting observational studies with drugs (EOm), as shown by this national regulatory body.
In this new context, the methodological, ethical and legal evaluation of the EOm protocols falls to the CEIm, their favorable opinion being an essential step for the realization of any EOm in Spain (directory of CEIm accredited in Spain).
This opinion will be unique, binding and recognized throughout the national territory. The application of this principle implies, for the CEIm, the challenge of evaluating and managing the projects in a consistent manner, from the moment they receive the proposal from the promoter and issue the opinion, until the completion of the study.
To promote the harmonization of criteria and actions, the AEMPS set up a working group with representatives from 19 CEIm. This group, whose composition is indicated in the document itself, agreed on the ‘Memorandum of collaboration between the ethics committees of research with drugs for the evaluation and management of observational studies with drugs‘.