Portuguese Approval Process

The conduct of clinical trials in Portugal requires the prior authorization of INFARMED, IP, and favorable opinion of the National Ethics Committee for Clinical Research (CEIC). Clinical research in Portugal is regulated by the Law 21/2014 of 16 April covering all clinical research with humans including medicinal products, medical devices, cosmetics, food supplements, and all kinds of observational studies.

Clinical trial start-up time: 2 – 3 months.

Investigators and Sites

Portugal hosts many universities and central hospitals mostly located in major cities such as Lisbon, Porto, and Coimbra, with experienced staff to assist in the studies. Investigators are usually well experienced in conducting clinical research, and also an excellent command of English. Recruitment rates are generally high thanks to the close follow-up from the very time the protocol is submitted for approval. Patient compliance is good. Portugal has witnessed a significant increase both in the number of industry-sponsored trials and academic studies.