INAEP Announces Progress on Brazil’s New National Clinical Research Platform
The National Research Ethics Authority (INAEP, in Portuguese), together with Brazil’s Ministry of Health, has launched a public webpage to provide updates on the development of the new National Clinical Research Platform, a system that is expected to gradually replace Plataforma Brasil and operationalize the new governance framework established under Law No. 14,874/2024.
The initiative forms part of the implementation of Brazil’s new National System for Ethics in Clinical Research (SINEP, in Portuguese) and aims to modernize the submission, ethical review, and monitoring of clinical research and other studies involving human participants. It is part of the broader transition triggered by Brazil’s new clinical research legal framework, which is gradually reshaping how clinical research is reviewed and overseen in Brazil.
According to the Ministry of Health, more than 3,100 stakeholders, including researchers, research institutions, and Research Ethics Committees (CEPs), participated in a nationwide public consultation conducted during the platform’s development process, providing feedback on the main challenges, inefficiencies, and improvement opportunities in the current research ethics review system.
The new platform is intended to streamline administrative procedures, increase transparency throughout the ethics review process, and improve the overall user experience. Planned features include:
- research-type-specific submission forms with fewer redundant fields;
- real-time tracking of study reviews and approvals;
- consolidated requests for clarification or amendments through a single feedback cycle;
- enhanced accessibility features;
- dedicated workflows for studies involving vulnerable populations; and
- mechanisms designed to strengthen participant protection and informed consent processes.
From a clinical research perspective, the consultation results reflect long-standing concerns raised by sponsors, CROs, research sites, and investigators, particularly regarding the simplification of submissions, shorter review timelines, greater transparency in regulatory workflows, increased consistency among Ethics Committees, and the broader use of automation and AI-supported tools.
The platform’s first development phase has already been completed and includes functionalities for registering and managing users, institutions, Ethics Committees, researchers, and research projects. These modules are currently undergoing testing in a homologation environment before broader implementation.
A relevant point for pharmaceutical companies and sponsors is that many of the priorities identified through the public consultation align with topics that had already been discussed by industry stakeholders. In this context, Sindusfarma (Brazil’s leading trade association representing pharmaceutical companies) coordinated a working group dedicated to the development of the new platform and prepared a consolidated set of industry recommendations, which was subsequently submitted to the relevant authorities.
Among the key proposals supported by the industry were:
(i) allowing sponsors and CROs to play a more direct role in study submission and follow-up activities,
(ii) improving efficiencies for multicenter studies,
(iii) harmonizing risk-classification criteria,
(iv) increasing transparency regarding Ethics Committee performance metrics,
(v) introducing automated document-verification tools, and
(vi) creating public tools to search and monitor ongoing research projects.
What to Expect
Although no formal timeline has yet been disclosed for future releases, the publication of the new monitoring webpage suggests that INAEP and the Ministry of Health intend to adopt a gradual and more transparent implementation strategy. This approach should allow researchers, institutions, sponsors, and other stakeholders to follow the platform’s development and participate in future testing and consultation cycles.
For sponsors, CROs, investigators, and research institutions, the expectation is that the new platform will improve regulatory predictability, reduce administrative burden, and enhance the efficiency of clinical trial submissions and ethics review processes in Brazil.
The Life Sciences & Healthcare team at Souto Correa Advogados is available to discuss any questions regarding these developments at lifesciences@soutocorrea.com.br.correa.com.br.