How to Implement Clinical Trials in Portugal

Clinical trials for human-use medicines and clinical studies involving medical device intervention are an important step in the process of innovation and development, where a rigorous protocol design is undertaken to assess efficacy/performance (in the case of medical devices) and safety in humans.

In recent years, Portugal has been evolving its legislation, aligning with European guidelines, and aiming to create initiatives and organizations that seek to streamline and ensure the ethical rigor of clinical research processes. 

The conduct of clinical trials in the European Union (EU) underwent a significant transformation when the Clinical Trials Regulation (Regulation (EU) No. 536/2014) came into force on January 31, 2022. This regulation harmonizes the processes of submission, evaluation, and supervision of clinical trials in the EU through the Clinical Trials Information System (CTIS), which serves as the single entry point for submitting information related to clinical trials in the EU and the European Economic Area (EEA). The CTIS functions as a public page that provides the general public with detailed information about clinical trials conducted in the EU and EEA from the moment their respective applications are approved in the CTIS. Additionally, the CTIS has a workspace designated for clinical trial sponsors or their representatives and a workspace for the authorities of EU Member States, EEA countries, and the European Commission. 

You can access the most relevant regulatory information on human-use medicines and medical devices on the Ethics Committee for Clinical Research (CEIC) website and on the National Authority of Medicines and Health Products IP (Infarmed) website.

If you require regulatory support, you can obtain it through Portugal Clinical Studies.

The development of new drugs and, in particular, the activity of clinical studies (CS), provides a diverse set of direct and indirect benefits for the social and economic development of the country. Below, we present their contribution across three distinct areas depending on the beneficiary 

For patients: 

 • Early and free access. CS enable their participants to have early and free access to promising new drugs that are otherwise unavailable on the market 

 • Benefit for future patients. CS offer valuable insights for research, allowing the development of new treatments that may benefit future patients  

• Improvement of healthcare services. Due to high standards of rigor and quality, CS contribute to the improvement of various services provided in healthcare facilities  

• Potential to increase patient quality and/or life expectancy. Often, CS represent a last resort to improve quality of life or save the patient's life 

For the scientific community  

• Increase in scientific knowledge. CS strongly contribute to the creation and innovation of scientific knowledge in the country  

• Establishment of national and international research networks 

 • Development of research teams. Additionally, they contribute to the scientific advancement of healthcare professionals and the creation of centers of excellence  

• Talent retention 

For the economy  

• Public spending reduction and contribution to the sustainability of the National Health Service (SNS). Treatment for participants, previously supported by SNS, is funded by the sponsor  

• Value creation for other industries. CS stimulate value creation for other industries through the acquisition of goods and services (e.g., construction and maintenance of infrastructures, acquisition of equipment and consumables, and external services)  

• Job creation. Creation of qualified jobs for research activities and other indirect positions  

• Investment attraction 

A Clinical Study consists of any systematic study conducted on humans or using individual health data, intended to discover or verify the distribution or effect of health factors, health states or outcomes, health or disease processes, as well as the performance and/or safety of health interventions or services, through biological, behavioral, social, or organizational aspects. Clinical Studies are divided into:

Clinical Study without intervention: does not involve active intervention, solely includes observation, such as the evaluation of a potential risk. This category includes Observational Studies;

Clinical Study with intervention: any research that involves changing, influencing, or planning healthcare, behaviors, or knowledge of participants or caregivers, aimed at discovering or verifying health effects, including exposure to drugs, use of medical devices, surgical techniques, radiation therapy, application of cosmetic and personal hygiene products, physiotherapy interventions, psychotherapy interventions, transfusion use, cell therapy, participation in individual or group educational sessions, dietary interventions, access or organization of healthcare systems, or interventions classified as non-conventional therapy. This category includes Clinical Trials, Clinical Studies involving Medical Devices, and Clinical Studies of Cosmetic and Personal Hygiene Products.

Clinical trial: any research conducted on humans, aimed at discovering or verifying clinical, pharmacological, or other pharmacodynamic effects of one or more experimental drugs, identifying adverse effects of one or more experimental drugs, or analyzing the absorption, distribution, metabolism, and elimination of one or more experimental drugs to determine their safety and efficacy.​

SOURCE: Law 21/2014 of April 16, APIFARMA; PwC. Clinical trials in Portugal. Lisbon: PwC, (2019)