
Portugal in Numbers

Number of Authorized Clinical Trials (CT)
CARG 2014-2024: +5.2%
(Graph 1)
Note: The period from 2012 to 2021 corresponds to CTs submitted under Directive no. 2001/20/EC of April 4; the period from 2022 to 2023 corresponds to CTs submitted under both legal frameworks.
* In 2022, 3 transition CTs included

Average total time for EC authorization
AEC request / Addition of PT as EM
(Chart 2)

Number of Active Clinical Trials
In Portugal, in the 1st quarter of 2025, there were 565 active interventional clinical trials, representing a 10% increase compared to the previous year.
As of December 31, 2024, there were 556 active interventional clinical trials. Compared to 2023, this represents a 6.3% increase, or 33 more clinical trials. This marks the second consecutive year of growth in the number of active clinical trials.
(Chart 3)

Number of CTs by Therapeutic Area
In Portugal, 43.7% of active clinical trials are in the field of Oncology, followed by inflammatory diseases with 11.3% and rare diseases with 8.4%.
(Chart 4)
Legend: PAH - Pulmonary Arterial Hypertension; Colitis U. +D. Chron - Ulcerative Colitis +D. Crohn; ATTR CM - Transthyretin Amyloid Cardiomyopathy; Respiratory Diseases - Respiratory Diseases (COPD, CF, Asthma, IPF); Others - Diseases with 6 or fewer CTs

Type of Sponsor for Active Clinical Trials
The majority of active CTs in Portugal, 90%, are exclusively initiated by the Pharmaceutical Industry (1 Sponsor).
(Chart 5)

Types of Experimental Test Medicines submitted by CTs
Request for CTA / Addition of PT as IMP
(Graph 6)

ATC Classification of Investigational Medicinal Products in Submitted CTs
Request for CTA / Addition of PT as IP
(Chart 7)

Distribution of Clinical Trials by Phases
The majority of the CTs are Phase III (72%), followed by Phase II (14%).
The earlier phases (Early Phase I, Phase I, and Phase I/Phase II) total 5.7% of active CTs.
(Chart 8)
Sources: INFARMED, I.P. (Charts 1; 2; 6) | APIFARMA (Charts 3; 4; 8) | APIFARMA (Chart 5) | INFARMED, I.P. (Chart 7)