The National Sanitary Surveillance Agency (Anvisa) is advancing in the drafting of a resolution proposal aimed at regulating the Experimental Regulatory Environment, known as the Regulatory Sandbox, in the Brazilian health sector.

Based on the Legal Framework for Startups (Supplementary Law No. 182/2021¹), This mechanism allows companies and research centers to test innovative business models, technologies, and products under special conditions and under the direct supervision of the health authority.

The initiative marks an evolution in the agency's approach, which seeks to reconcile the promotion of scientific development and artificial intelligence with the unrestricted preservation of public health safety.

The purpose of the new general resolution of Anvisa

The issue has been discussed internally by the agency and will be submitted to the deliberation of the Collegiate Board in the coming months²..

According to the municipal director-president, Leandro Safatle, the general standard aims to establish clear criteria for the admission of projects, monitoring parameters and rules regarding the responsibilities of the participants.

The central objective is to apply regulatory flexibility in a manner proportional to the risks involved, ensuring that the public interest and the protection of the collective remain at the center of decisions.

Practical applications: biotechnology, artificial intelligence and precedents

In the field of human health, the sandbox model opens up expressive opportunities for different industrial and technological sectors:

• Medical devices and artificial intelligence: validation of diagnostic software (SaMD) and predictive tools applied to clinical practice.
• New assets and advanced therapies: the conduct of controlled tests of raw materials and therapeutic formulations before the final phase of commercial registration.
• Previous history of medicinal cannabis: DRC No. 1.014/2026³ It has already established an experimental model for up to five years for the cultivation and processing of inputs, serving as a regulatory laboratory for the future general standard.

As observed by Daniela Marreco, director of Anvisa, by making it feasible to produce regulated inputs and products intended for specific patients on a non-industrial and small-scale basis, the model contributes to improving the sanitary quality of the products effectively used by the population, in addition to allowing for the continuity of therapeutic treatment⁴. The supervised experimentation thus generates solid technical evidence to support future regulatory decisions in a safe and transparent manner.

Governance challenges and continuous monitoring

Unlike other economic sectors, such as finance or telecommunications, projects in the healthcare sector involve direct risks to the physical integrity and life of patients.

For this reason, the successful implementation of the Regulatory Sandbox at Anvisa will require:

• Strict eligibility criteria and precise delimitation of the hypotheses for temporary exemption from ordinary requirements.
• Agile mechanisms for reporting adverse events and the preventive cancellation of experimental authorizations in case of unforeseen risk.
• Clear definition of contractual governance and allocation of responsibilities between technology partners, investors, and manufacturers.
  
  

While the final resolution is awaited, regulated agents should closely monitor the discussions to identify windows of opportunity in research and development.

Understanding the Regulatory Sandbox in Health