Lisbon, May 28, 2026 (Lusa) - Infarmed, Portugal's medicine authority, said on Thursday that the country shows a “very favourable evolution” in clinical research, as the number of approved clinical trials rose 31% since the implementation of the new European regulation.
“Portugal has shown a very favourable evolution regarding clinical research development,” the authority said in a statement, based on reports from the Organisation for Economic Co-operation and Development (OECD) and the European Federation of Pharmaceutical Industries and Associations (EFPIA).
The authority said Portugal authorised an average of 142.17 clinical trials per year between 2016 and 2021 – the six years preceding the European regulation's implementation.
This number rose to 185.75 in the first four years of the regulation's implementation, representing a growth of around 31%, Infarmed said, adding that this data proves that “Portugal is attracting the attention of companies wanting to carry out their clinical development in Europe.”
Clinical trials aim to discover or verify the effects of one or more experimental medicines, constituting an essential step for developing new treatments.
The statement added that the country had also strengthened its participation in the European evaluation, leading 22 multinational clinical trials in 2025, compared to just two in 2022.
Regarding clinical trials conducted only in Portugal, Infarmed said authorisation times improved, falling from 71 days in 2023 to 32 in 2025, and further dropping to 22 days in the first quarter of 2026.
The statement said the country had been involved from the start in the FAST EU project, which aims to reduce the number of authorisation days for multinational clinical trials from 106 days to 70 days.
The country participated in five of the 15 clinical trials submitted via FAST EU, acting as the reference member state in one of them, the authority said, adding that authorities approved the first two clinical trials within this scope within 70 days.
“This is a very important aspect, because Portugal is working with the deadline reduction requirements that the revision of the European regulation on clinical trials will implement, meaning two years in advance,” Infarmed said.
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