Portugal in Numbers

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MAPA PORTUGAL 2

Portugal in Numbers

A significant increase in the number and size of clinical studies has been observed in Portugal, covering different therapeutic areas.

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)

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