The statistics presented are related to clinical trials applications submitted to Infarmed after the transposition of Directive 2001/20 / EC of the European Parliament and of the Council of 4 April, to the national law.

Annual evolution 2005 to 4Q2022

This information is also available in a descriptive way in Infarmed`s annual activity reports and in tabular format at the Medicines Evaluation Directorate (DAM) indicators. 

For information about clinical trials assessed by Voluntary Harmonisation Procedure between Member States (VHP), you may consult the following data: Results of the Voluntary Harmonisation Procedure 2009 - 2014.

The conduct of clinical trial in Portugal is subject to Infarmed`s authorization and to an Ethics Committee favourable opinion. Data regarding clinical trials assessment by CEIC are available at CEIC webpage.