On August 12th, the National Health Surveillance Agency (ANVISA) launched Public Consultation – TPS No. 9, aiming to gather contributions from interested parties for the Preliminary Regulatory Impact Report. These contributions will assist in the development of a Regulatory Sandbox model to meet society’s needs as efficiently as possible. Stakeholders can submit their contributions until October 11, 2024, via this link.
Overview of the Regulatory Sandbox
The Regulatory Sandbox is an Experimental Regulatory Environment in which participating companies, after meeting established criteria and limits, receive temporary authorization granted and monitored by Anvisa for the development, production, and/or commercialization of innovative products and services subject to health surveillance.
In addition to offering a safe and controlled environment for companies, conducive to experimenting with innovative techniques, the Regulatory Sandbox also benefits Anvisa’s regulatory agenda. It allows the agency to closely monitor the sector’s technological evolution, proactively mapping industry trends, and adapting the regulatory framework to provide adequate legal security in a constantly changing environment.
In conclusion, the Regulatory Sandbox aims to foster the development of innovative products, services, or business models by creating favorable conditions for innovation-focused companies within a regulatory-flexible environment. This helps Anvisa gather insights to improve regulatory standards, ensuring they align with the market’s dynamism.
