International – Good Regulatory Practices: ANVISA’s Regulatory Model for Brazil

In the past twenty years, the Brazilian regulator ANVISA has been increasingly working to improve regulatory processes and gain credibility in the field of health regulation. The Agency’s current position as a regional and global leader is the result of different efforts, and this article brings information about one of them – its adoption of Good Regulatory Practices.

The normative acts referred to below are any decisions enacted by ANVISA establishing norms, rules, standards or obligations. These include, among others, Resolutions, Norms, Normative Instructions, or Joint Acts with other government bodies.

The Brazilian Health Regulatory Agency (ANVISA) is an autonomous organization linked to the Ministry of Health and is part of the National Health System (SUS) as coordinator of the Brazilian Health Regulatory System (SNVS). ANVISA’s role is to promote the protection of the population’s health by controlling the production, marketing, and use of products and services subject to health regulation.

ANVISA’s current regulatory model has been in force since April 2019 as a means to improve Brazil’s health standards. This model changed the way of addressing development and review of normative acts by simplifying internal work processes, further encouraging regulations based on scientific and technical evidence, and enhancing social engagement. The introduction of this model is linked to ANVISA’s Strategic Planning, enabled by improvements introduced by the Agency during the past decade (such as the Regulatory Agenda [RA]) and optimized by tools that provide transparency to regulatory activities such as the Health Regulation Observatory…