
Portugal in Numbers

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

Average total time for EC authorisation
AEC request / Addition of PT as EM
Chart 2.

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

Number of CTs by Therapeutic Area
In Portugal, 43.7% of active clinical trials are in the field of Oncology, followed by inflammatory diseases at 11.3% and rare diseases at 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
Chart 5. in Portugal, 90% of active CTs are sponsored exclusively by the Pharmaceutical Industry (one sponsor).

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