Inspired by international models, legislation aims to accelerate access to new medicines in the country
The federal government regulated, on Tuesday (7.Oct.2025), the law, known as the Clinical Research Law, which intends to bring more legal security, attract investments in innovation and boost a strategic sector for the country’s scientific and industrial development, while while strengthening the safety and security of study participants, ensuring that advances are made ethically and responsibly.
Brazil is among the 20 countries in the global ranking of clinical studies, but participates in less than 2% of global clinical research. Brazil has the potential to be among the 10 most relevant countries in the world in this area.
“Often, a university or an institute wants to carry out a drug evaluation project and, today, in Brazil, this takes an average of up to 6 months, in some cases, up to 1 year, for approval through the various stages of the current system. This system was created in the 90s and met the need to have a research ethics system in the country. But, with this new instrument approved by the National Congress and regulated by the president, we are modernizing this system to shorten approval deadlines”said the Minister of Health, Alexandre Padilha.
In 2024, Brazil registered 254 clinical studies. The expectation is to double this number and reverse the downward trend from 2022, when regulatory frameworks in other countries have become more competitive. After the Covid-19 pandemic, countries such as China, the United Kingdom, members of the European Union, India, Canada and the United States reassessed their clinical research regulatory frameworks, seeking to increase competitiveness, stimulate innovation and facilitate access to new technologies.
“Several studies evaluate the potential for investment growth, which should more than triple in Brazil, from industries, universities and international cooperation for these research studies in the country. This is decisive to also attract the production of medicines and diagnostics. Therefore, it is a regulatory framework that will allow Brazil to have more research in the area of health and, at the same time, attract investments, products and generate employment and income here in Brazil”, declared the minister.
With a population of approximately 214 million people and wide genetic and cultural diversity, the country has unique conditions to attract investments from global institutions and strengthen the SUS (Unified Health System).
Faster analysis, more access
The new model reduces the project evaluation process by CEPs (Research Ethics Committees) from 180 days to 30 days. The evaluation by Anvisa (National Health Surveillance Agency) will take up to 90 working days. Strategic research for the SUS and cases of emergency health situations will be evaluated within 15 working days.
“This agility reduces bureaucracy in the system and expands investments in the country, increasing access for those in need. It is a courageous and bold decision, which strengthens the sovereignty of our country, in addition to modernizing the research ethics analysis systemisa, make it more efficient, both in protecting the participant and in analyzing projects”, evaluates the secretary Science, Technology and Innovation and the Health Economic-Industrial Complex, Fernanda De Negri.
+ safety and protection of participants
The new law determines that, in cases of serious illnesses and without treatment alternatives, patients who show proven benefits are guaranteed continued treatment for up to 5 years after the end of the research, through a prior plan approved by the CEP.
The offer of the medicine may also be terminated in situations such as the participant’s decision, cure, emergence of a therapeutic alternative, lack of benefit or record of a serious adverse reaction.
The protection of participants was also reinforced, with the definition of free consent and more detailed clarifications. Specific rules for research with vulnerable groups –such as children, pregnant women, indigenous peoples and people deprived of liberty– were defined to ensure differentiated ethical treatment, specific safeguard measures and greater security. There was also a clear definition of the responsibilities of researchers, sponsors and institutions.
With information from
