Anvisa opens public Consultation on Regulatory Sandbox

On August 8, 2024, the National Health Surveillance Agency (ANVISA) published Public Call Notice No. 11/2024 (“Call Notice”), with the purpose of obtaining contributions on the implementation of an experimental regulatory environment, known as a “Regulatory Sandbox”.

The matter is included in the 2024/2025 Regulatory Agenda and as part of Strategic Project No. 7 – Agile Regulation, of ANVISA’s 2024-2027 Strategic Plan.

Context and Challenges

The Regulatory Sandbox is a structure that allows companies to test business models and technologies under simplified and temporary regulatory conditions, under the supervision of regulatory agencies such as ANVISA.

At the federal level, the initiative is set forth in Law No. 182/2021, which established the legal framework for startups and innovative entrepreneurship in Brazil.

Now, ANVISA is assessing the feasibility of implementing the Regulatory Sandbox and seeks to understand how this model can be applied in the health sector, considering the complexity and challenges of health surveillance.

Public Consultation

ANVISA seeks to receive data and information to assist in decision-making on the regulatory impact analysis process. The consultation is open to everyone, including healthcare professionals, companies, entrepreneurs, associations and representative entities of the regulated sector, and educational institutions.

Interested parties can contribute until October 11, 2024, exclusively through the electronic form available on the ANVISA Portal.

The contributions shall, preferably, be based on technical and scientific evidence and will be analyzed by the agency. After this stage, ANVISA will prepare the final version of the regulatory analysis report, which will be submitted to the Collegiate Board for final decision.

Next Steps

According to the partial report made available by the agency, ANVISA plans to:

• Prepare a draft for a Collegiate Board Resolution;
• Conduct a Regulatory Sandbox pilot project;
• Develop a guidance manual on the topic, based on the results of the pilot project;
• Analyze the work necessary for ANVISA to conduct a full Regulatory Sandbox process;
• Prepare and publish the final Resolution;
• Prepare communication and training plans aimed at the internal and external public.

Our Life Sciences team is available to assist you with this matter and to provide any necessary clarifications to your company.

This bulletin is for information purposes only and should not be relied upon to obtain legal advice on any of the topics dealt with here. For additional information, please contact the leaders of the Lifesciences & Healthcare team.

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