How to conduct a Clinical Trial in Portugal

 

Any research involving the participation of human subjects, in particular clinical trials, must be conducted in accordance with Good Clinical Practice (GCP), which constitutes a scientific and ethical quality standard for the design, conduct, recording and reporting of trial results. Compliance with these standards provides a public assurance that the rights, safety, and well¿being of trial participants are protected in line with the principles set out in the Declaration of Helsinki of the World Medical Association, and that the data generated in clinical trials are credible.

Clinical trials involving medicinal products for human use are subject to prior authorization by INFARMED ¿ the National Authority of Medicines and Health Products, I.P. (INFARMED, I.P.), following a technical¿scientific and ethical assessment of the clinical trial application, in accordance with Regulation (EU) No 536/2014 of the European Parliament and of the Council of 16 April 2014, and Law No 9/2026 of 6 March. The procedures related to the assessment of applications for clinical trials and applications for substantial modifications are subject to the payment of fees, charged by INFARMED, I.P., the amounts of which are set by ministerial order of the members of the Government responsible for the areas of finance and health. Details of each submission can be consulted in Information to Sponsor.