New Rules for Clinical Research: Federal Government Bets on Regulation to Boost Innovation and Investment

Brazil, despite being among the top 20 countries in terms of the number of clinical trials, contributes less than 2% of global clinical research, with a total of 254 studies registered nationwide. With the goal of doubling these numbers and rising to the group of the 10 most influential countries in this area, the federal government, through Decree No. 12,651, of October 7, 2025, regulated the Clinical Research Law (Law 14,874/2024).

The new model aims to speed up the approval of studies. The new deadlines are as follows:

• The process for evaluating projects by Research Ethics Committees (CEPs) will be reduced from 180 days to 30 days.
• The analysis of primary petitions for clinical trials with human beings by the National Health Surveillance Agency (Anvisa) will be completed in up to 90 business days.
• For strategic research for the SUS (Brazil’s public healthcare system) and in health emergencies, the evaluation period is even shorter, at up to 15 business days.

The safety of participants is a central pillar of the new law. In cases of serious diseases with no alternative treatments, patients who demonstrate proven benefits will have their treatment guaranteed for up to five years after the study ends, with a pre-approved plan by the CEP. Additionally, free and informed consent has been defined in detail to ensure greater transparency.

Regarding the structure of the analysis and regulation system, the new National System of Ethics in Research with Human Beings (SINEP) will be composed of two bodies. The National Body of Ethics in Research (INAEP) will act as a normative, consultative, and supervisory body, balancing the protection of participants with the speed of protocol analysis. The CEPs, in turn, will remain as the fundamental bodies for ethical analysis, operating with greater autonomy and independence.

Finally, concerning the transition period, a working group will be established. According to the Secretary of Science, Technology and Innovation and the Industrial Health-Economic Complex, Fernanda De Negri, the National Ethics in Research Commission (CONEP) and the CEPs will continue to fully exercise their duties. The SINEP will be strengthened with modern governance tools, including the Human Research Platform, which will replace the current Plataforma Brasil by the end of next year, allowing for more integrated and effective monitoring of studies.

The new Decree is a key piece for operationalizing ethical research standards in Brazil, protecting research participants and keeping the public interest as a guide, which may help boost Brazil’s prominence in health-related scientific development.

For more content related to clinical research and other developments regarding the new regulation, do not hesitate to contact us at the following email address: pharma&regulatorio@kasznarleonardos.com.