08/25/2026 | AL1

https://al1.com.br/noticias/noticias/204115-em-apenas-tres-meses-brasil-sobe-para-12o-lugar-no-ranking-global-de-estudos-clinicos-com-seres-humanos 

According to a research published by Interfarma, Brazil jumps from 18th to 12th position in the global ranking of clinical trials initiated. Between 2020 and 2025, Brazil advanced three houses in the global ranking, reaching 18th position at the end of 2025. In the first quarter of 2026, the country reached 12th position, with 51 registered studies and 2.9% participation. Ou seja, the country took five years to climb three positions and now managed to advance five positions in just three months. This jump may be a consequence of the movement that has occurred in recent years, in particular Decree No. 12,651/2025, which regulates the Law of Clinical Research with Human Beings (Lei No. 14,874/2024) last year.

"There is no doubt that the main factor behind the changes that the sector lives today is the completion of the regulatory framework of clinical research with human beings and its regulation. The work and leadership of SCTIE/MS [Secretaria de Ciência, Tecnologia e Innovação em Saúde, do Ministério da Saúde] and “The INAEP [Instância Nacional de Ética em Pesquisa] has been fundamental for this progress,” says Fernando de Rezende Francisco, Executive Director of the Brazilian Association of Representative Organizations of Clinical Research (ABRACRO).

Through joint work between public authorities, the scientific community, research institutions and the production sector, important measures have been achieved in recent times and contribute to making the regulatory environment more efficient and competitive. Among them, we highlight the implementation of the Legal Framework for Clinical Research, the reduction of the time period for ethical evaluation of studies and the elimination of regulatory liabilities for clinical trials at Anvisa.

"Before the law exists, the regulations are in resolution and not in a law, and this creates legal uncertainty for researchers and sponsors, in addition to long approval periods that prejudice Brazil's international competitiveness. Now, with a state policy for clinical research and the composition of “A technical committee taking care of the regulation of ethics in research (INAEP) will make our processes more predictable and safe for everyone involved, especially for research participants,” says Fernando.

In addition to making it possible to improve the quality of life of patients and expand treatment options for different conditions, clinical research can contribute to reducing the ranks of the Unified Health System (SUS), generating new business, promoting economic development and attracting new strategic investments for the country. Currently, more than 40 thousand people participate annually in clinical trials in Brazil, a number that can double the investments in advanced clinical research in the country.

"The Ministry of Health is invested consistently in clinical research, because it includes all the benefits that the sector generates: economic, social, innovation and health. It is also necessary to reconhecer the work of the companies in the sector, which will adjust so that Brazil can have a law that becomes more competitive and now accompanies the changes, so that, in practice, the entire Brazilian society can reap these fruits and the country gains more prominence in the world census,” highlights Francisco.

In the coming years, Brazil is expected to place in the Top 10 of the world ranking of clinical studies initiated. “O country possesses extremely competent scientists, wide genetic diversity, and now with clearer laws and regulations, or Brazil has everything to become a reference in clinical research, obtain more investments and change the lives of patients who find us in clinical studies a hope of improving their health,” Francisco concludes.