On May 28, 2024, Brazilian President Luiz Inácio Lula da Silva approved new Law No. 14.874, containing new rules for human research. This milestone is the culmination of nearly a decade of negotiations since the original bill, PLS 200/2015, was presented in April 2015.
The new legislation, which takes effect on August 26, 2024, is set to provide a significant boost to sponsors conducting clinical trials in Brazil, offering enhanced security and certainty. Here’s a comprehensive look at the key aspects of this legislation.
- A streamlined review process: In the past, Brazil’s approval process was complex, often requiring double approvals by both local ECs and a federal review board, the National Research Ethics Commission (CONEP). The new law simplifies this process by stipulating that ethical analysis be conducted in a single instance by the EC, thereby reducing the number of review steps.
- More predictability for startup timelines: The legislation establishes new mandatory timelines for review by Ethics Committees and the National Health Surveillance Agency (Anvisa). Ethical review cannot exceed 30 business days from the date of acceptance of all research documents. If the EC requires additional information or documents from the sponsor, this deadline can be suspended for a maximum of 20 business days. Anvisa’s analysis of primary petitions for trials with human beings is not to exceed 90 business days.
- Revisions to the mandatory post-trial access requirement: The law provides greater clarity on conditions for access to the investigational drug post-trial, and when needed, provision will not be required after the product is made available by the National Health System.
Since the enactment of the new law, ANVISA has made some additional updates to the framework that regulates clinical research in Brazil. The new rules should make Brazil more attractive for investments in clinical research, and include updates such as:
- Possibility of advancing the import of investigational drugs for research while the dossier is being analyzed, allowing for a shorter time between the authorization of the research by Anvisa and the effective start of the clinical study.
- Stating that products imported for research must be stored under the responsibility of the sponsor until the study is authorized.
- Clear criteria for classifying the risk and complexity of clinical trials and experimental medicines and the definition of the Equivalent Foreign Regulatory Authorities (AREEs), aiming at the optimized analysis of petitions and the reduction of duplicate analysis.
- Harmonization of national regulatory practices with standards recommended by the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use (ICH), notably the ICH E6(R2) Good Clinical Practice Guide.
With the approval of this new legislation, clinical development activity in Brazil is likely to increase, providing greater access to trials for patients within the country and accelerating the availability of new treatments.
PSI CRO has a long history of conducting trials in Brazil, including administering the country’s first gene therapy. Due to our site relationships, our startup timelines for many countries in Latin America are already comparable to those in Europe. To learn more about Law No. 14.874 and whether Brazil makes sense for your pivotal trial, contact us today.
Reviewed by:
Oscar Podesta, Head of Latin America, Country Management
Julia Begalli, Head, Regulatory Affairs, Latin America
Livia Constantini, Regional Project Lead, Latin America
What to Know About Brazil’s New Clinical Research Law
On May 28, 2024, Brazilian President Luiz Inácio Lula da Silva approved new Law No. 14.874, containing new rules for human research. This milestone is the culmination of nearly a decade of negotiations since the original bill, PLS 200/2015, was presented in April 2015.
The new legislation, which takes effect on August 26, 2024, is set to provide a significant boost to sponsors conducting clinical trials in Brazil, offering enhanced security and certainty. Here’s a comprehensive look at the key aspects of this legislation.
Since the enactment of the new law, ANVISA has made some additional updates to the framework that regulates clinical research in Brazil. The new rules should make Brazil more attractive for investments in clinical research, and include updates such as:
With the approval of this new legislation, clinical development activity in Brazil is likely to increase, providing greater access to trials for patients within the country and accelerating the availability of new treatments.
PSI CRO has a long history of conducting trials in Brazil, including administering the country’s first gene therapy. Due to our site relationships, our startup timelines for many countries in Latin America are already comparable to those in Europe. To learn more about Law No. 14.874 and whether Brazil makes sense for your pivotal trial, contact us today.
Reviewed by:
Oscar Podesta, Head of Latin America, Country Management
Julia Begalli, Head, Regulatory Affairs, Latin America
Livia Constantini, Regional Project Lead, Latin America
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