Publication of the Ordinance establishing INAEP and defining its coordination
On December 4, 2025, Ordinance GM/MS No. 1,283 was published, appointing full and alternate members to compose the National Authority for Research Ethics (INAEP), a collegiate body regulated by Decree No. 12,651/2025 within the National System of Research Ethics Involving Human Subjects.
INAEP will be coordinated by Dr. Meiruze Sousa Freitas, currently director of the Department of Science and Technology at the Secretariat of Science, Technology and Innovation and of the Health Economic-Industrial Complex of the Ministry of Health.
Dr. Meiruze Sousa Freitas holds a degree in Pharmacy from UFMG, with a specialization in Pharmaceutical Technology from UFF. A career civil servant at Anvisa since 2007, she served as director of Anvisa’s Second Directorate (2020–2024) and acting president of the Agency (2020–2023). She played a strategic role in the emergency approval of COVID-19 vaccines and in implementing regulatory frameworks for clinical research. She currently leads science and technology policies at the Ministry of Health.
The ordinance also appoints representatives from the Ministry of Health, the National Health Council, the Ministry of Science, Technology and Innovation, the Ministry of Education, Anvisa, and Confap.
Is INAEP fully composed and functional?
The establishment of INAEP is an important step toward operationalizing the new regulatory framework for clinical research. Its responsibilities include:
- Drafting and updating research ethics standards;
- Accrediting and recognizing Research Ethics Committees (CEPs);
- Acting as an appellate body;
- Promoting technical and methodological training.
However, INAEP is not yet fully functional.
Article 12, item VII, of Decree No. 12,651/2025 requires the inclusion of 15 expert representatives with recognized expertise and relevant experience in research ethics involving human subjects, to be selected through a public process. These specialists have not yet been appointed, which limits the full composition of the collegiate body.
We will continue to monitor developments in the implementation of INAEP, including:
- Publication of its internal regulations;
- Selection process for expert representatives;
- Complementary rules on accreditation, biobanks, and integration with Anvisa.
The Life Sciences and Healthcare team at Souto Correa Advogados will continue to follow the next steps in INAEP’s implementation and remain available to provide guidance on legal and regulatory strategies.