Clinical research is the backbone of medical and scientific progress. It supports the development of new treatments, medicines, and devices that save and improve lives. Science advances through rigorous studies, offering hope and solutions for countless health conditions.
In Brazil, a country of continental dimensions with a vast and diverse population, the potential for clinical research is immense. However, historical regulatory challenges have hindered the full advancement of this vital sector.
On October 7 of this year, the Brazilian Government enacted a new regulatory framework of profound significance for the country's scientific and health landscape: Executive Order #12,651/2025. This Executive Order is not just another item in the vast national legislation, but a key piece that regulates Statute #14,874/2024, known as the Clinical Research Statute, establishing a new paradigm for conducting studies with human beings in Brazil.
At a time when innovation in healthcare is more vital than ever, this measure promises to untangle bureaucratic knots, attract investment, boost scientific development, and enhance participant safety.
1. MAIN PROVISIONS OF EXECUTIVE ORDER #12,651/2025
The primary objective of Executive Order #12,651/2025 is to regulate the conduct of clinical research involving human beings in Brazil. This regulatory framework is designed specifically to ensure the absolute protection of participants – a non-negotiable pillar of research ethics – while also promoting scientific integrity and efficiency throughout the research process.
As established, the Executive Order applies to all research that in any way involves human beings. This scope is fundamental and includes not only direct intervention studies with participants but also those using personal data, sensitive information, or biological material.
The changes introduced by the Executive Order are profound and aim to overcome historical bottlenecks that have hindered the development of clinical research in the country. The essence of these changes is to streamline and simplify processes without compromising ethical and health standards.
The following are the key positive aspects regulated by the aforementioned Executive Order:
Together, these provisions create a much more agile and predictable regulatory landscape, aligned with current needs, positioning Brazil as a more attractive and reliable partner in the global clinical research ecosystem.
2. Impact of the Executive Order on Attracting Clinical Research Investment
The regulatory environment is one of the most critical factors in attracting investment in any sector. In clinical research, this is irrefutable. Executive Order #12,651/2025, by introducing substantial changes to the way clinical studies are approved and conducted, reshapes the regulatory environment to transform Brazil into a hub for capital and innovation.
Simplification and greater predictability in regulatory processes are the main pillars for making Brazil more attractive to national and international investment in clinical research. Historically, bureaucracy, delays, and a lack of clarity in approval steps were significant barriers that discouraged global and local sponsors. Pharmaceutical and biotechnology companies operate in a high-risk, high-cost industry where time is a valuable resource. Every day of delay in approving a study can represent millions of dollars in lost opportunities and additional costs.
The drastic reduction in evaluation deadlines by CEPs (from 30) and by Anvisa (up to 90 business days, and 15 business days for strategic or emergency cases), together with the centralization of processes on a single electronic platform and the possibility of integrated ethical and health evaluation, significantly reduce uncertainty and waiting times. This regulatory agility increases Brazil's competitiveness on the global stage, encouraging companies and institutions to choose the country to conduct their clinical studies. By aligning its processes with international efficiency standards, Brazil signals its maturity and commitment to advancing science and health. Capital, by its nature, flows to where there is the least resistance and the greatest guarantee of return, and the Executive Order positions Brazil to be that destination.
With the new regulations, the expectation is a substantial increase in the number of clinical trials conducted in Brazil. Data from 2024, which recorded 254 clinical studies, serves as a starting point. The optimistic projection is that this number will double in the coming years, representing exponential growth that should directly impact the country's economic development.
This growth does not just translate into more clinical research; it will drive a series of economic benefits, as outlined below:
3. Strengthening Participant Safety and Security
The Executive Order enhances an already robust protection system, which has historically been guaranteed by the CEPs and the Brazilian Research Ethics Commission (CONEP – Comissão Nacional de Ética em Pesquisa). The new provisions are designed to provide more comprehensive and effective protection for participants:
4. Contextualization of Clinical Research in Brazil
To understand the relevance and transformative potential of Executive Order #12,651/2025, it is essential to contextualize Brazil's position in the global clinical research scenario prior to this important regulation. The country has always presented a paradoxical picture: on the one hand, immense potential, and on the other, participation below its capacity.
Despite historical challenges in its regulatory environment, Brazil has managed to remain a relevant player in the international clinical research scene. Currently, the country ranks among the top 20 nations in the global ranking of clinical studies. This position is indicative of the quality of its scientific base, the capability of its researchers, the existing infrastructure in centers of excellence, and the genetic and epidemiological diversity of its population, which is a highly valued factor in global research.
This epidemiological wealth, which encompasses everything from globally prevalent pathologies to rare diseases, makes the country a strategic location for developing medicines and treatments for a wide range of health conditions. Furthermore, the existence of a public healthcare system like SUS, with its reach and volume of services, offers a unique platform for recruiting participants and conducting large-scale studies.
On the other hand, this top-20 position is accompanied by a long-standing concerning statistic: Brazil participates in less than 2% of global clinical trials. This significant discrepancy between the country's potential and its effective global contribution highlighted the existence of major barriers that discouraged the full use of its capabilities, such as complex and lengthy regulatory processes, the lack of a harmonized platform, and high operating costs due to delays and uncertainty. All of these aspects are targeted by the Executive Order, which is designed to mitigate them.
The approval of the Executive Order is intended to significantly increase the volume of clinical research in Brazil, leveraging resources and fostering the country's scientific and economic development, positioning it as a leading destination for clinical research from now on.
