Ordinance #124, dated February 6, 2026, has been published, establishing the Regulatory Monitoring Committee for Health Innovation, intended to monitor and support the regulatory assessment of innovative products and technologies.

Anvisa (the Brazilian Food and Drug Agency) has published, on February 10, 2026, Ordinance #124/2026, which establishes the Regulatory Monitoring Committee for Health Innovation.

The Committee’s mission is to monitor products and technologies considered innovative and of strategic interest to public health, providing support to Anvisa’s technical units and contributing to the improvement of the regulatory environment applicable to disruptive technologies. Its creation aims to ensure that health regulation is able to support the development of new health technologies, reduce vulnerabilities within the Brazilian Public Healthcare System (SUS), strengthen national production, and stimulate research and development, according to information available on Anvisa’s own website.

Among its responsibilities, the Committee will monitor and accompany the regulatory assessment of technologies submitted to Anvisa that show innovative characteristics and a high potential impact. It will also act as a coordinating authority between directorates and internal units, promoting integration and reducing fragmentation in decision‑making processes.

The Ordinance further establishes that the Committee will support overcoming technical or scientific knowledge gaps, encouraging partnerships with universities, research institutes, ad hoc specialists, as well as domestic and foreign regulatory authorities. The Committee may also propose regulatory or scientific solutions, as well as new regulations, when necessary to address the particularities of specific cases.

For classification purposes, the Ordinance defines criteria for what may be considered an innovative product or technology of strategic interest. Eligible products and technologies include those that demonstrate potential to provide significant therapeutic or technological advancement; significantly improve population health or quality of life; substantially increase survival; prevent death or disability; address an unmet medical need; strengthen the country’s capacity to respond to health emergencies; align with the Ministry of Health’s guidelines; or contribute to national technological and production sovereignty.

The Committee will simultaneously monitor up to five technologies, with the possibility of expansion depending on operational capacity. The range of categories covered is broad and includes new medicines, advanced biological products, biosimilars, radiopharmaceuticals, digital medical devices, high‑complexity diagnostic tests, advanced therapies, and digital solutions based on artificial intelligence.

The Committee’s operations incorporate “agile regulation” tools, including mechanisms to accelerate assessments when appropriate, such as: (1) priority review, (2) adaptive regulation, which allows adjustments to regulatory requirements based on product characteristics with technical or scientific justification, and (3) continuous submission, which allows parts of the dossier to be submitted as they are completed, eliminating the need to wait for the full dossier to begin the review.

Furthermore, the Committee may request support from external consultants in compliance with integrity and confidentiality requirements. It may also establish multidisciplinary working groups and implement post‑approval monitoring mechanisms, ensuring continuity in the risk‑benefit assessment.

The Committee’s governance will be composed of the heads of Anvisa’s five Directorates, who will serve as permanent deliberative members. Other Agency units may participate temporarily, depending on the nature of the technology under review, but without decision‑making power. The General Management of Knowledge, Innovation, and Research (GGCIP) will serve as the Executive Secretariat. The final technical assessment of products will remain the responsibility of the competent areas, with strategic support from the Committee.

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