Portugal in Numbers

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Portugal em Números

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 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)

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