Anvisa adopts new regulatory model
The purpose is to improve the development process of the Brazilian sanitary regulation
Anvisa's new regulatory model came into effect on April 1st, 2019, aiming at improving and qualifying Brazilian sanitary standards. The measure changes the construction and review of normative acts and simplifies internal work processes. It also stimulates the presentation of technical evidence for the elaboration of rules, with greater value given to the use of mechanisms of social participation.
The measure is focused on strengthening the Regulatory Impact Analysis (RIA), a methodology that allows for the evaluation and initial studies of regulations, so to provide qualified subsidies for the decision of the Board of Directors (Dicol).
According to the Agency, the new model also encourages technical areas to improve the planning and organization of the discussion of topics, among other advantages.
Interaction with the public
The new model values the diversification of mechanisms of social participation, so that there is greater interaction among Anvisa’s technical areas, private sector, government, society, and educational and consumer protection institutions.
In addition to the traditional tools, such as targeted or public consultations, hearings and sectoral dialogues, from now on it will also be possible to use a new social participation tool called Public Subsidies’ Survey (TPS).
TPS allows the discussion of technical documents, such as the preliminary RIA report. This report describes the problem under evaluation, the existing regulatory options for its solution, evidences that support the choice of presented alternatives, their advantages, finally indicating the best way to regulate.
To get to know the Agency's options for interaction with the public, please visit the Social Participation Menu, which describes the different mechanisms for seeking contributions on regulatory processes.
Under the new model, the typical 30-day period for public consultations was extended to a minimum of 45 days. In the case of consultations on matters that have international impact, the minimum period shall be of 60 days. In exceptional cases of duly motivated urgency and relevance, deadlines may be modified.
To provide greater transparency, several documents will be published online by Anvisa during the discussion on regulatory processes, and all the technical materials used to support proposals for public consultations on normative acts will be publicly available, except for confidential data.
The former Regulatory Initiative Proposal published in the Official Gazette (DOU) has been replaced by the Term of Opening of the Regulation Process (TAP), which has been simplified and will be publisehd directly in a specific area of Anvisa’s webiste. Only in exceptional cases will the TAP be published also in the DOU.
The deliberations by the Board of Directors and the RIA report will also be available to the public, in addition to the contributions received during the consultations and the reports on Social Participation Analysis (RAPS) and Analysis of Contributions (RAC), alongside with other information.
In Anvisa, the adoption of the model depends on adhesion, for a period of two years, which is the time given for the technical areas to transition and incorporate the new rules established by Ordinance (PRT) N. 1.741, as detailed in the Service Orientation (OS) N. 56, of December 2018.
Find out which documents define the guidelines and procedures for improving regulatory quality in ANVISA:
- Ordinance (PRT) N. 1.741/2018
- Service Orientation (OS) N. 56/2018