7 de abril de 2019

BRAZIL NEWS: Anvisa has new regulatory model

From: www.anvisa.gov.br

Anvisa's new regulatory model came into effect this Monday (1/4), which aims to improve and qualify the country's health standards. The measure changes the way it handles the construction and review of normative acts and simplifies internal work processes. It also stimulates the presentation of technical evidences for the elaboration of rules and values ​​the use of mechanisms of social participation.

The measure is focused on strengthening the Regulatory Impact Analysis (RIA), a methodology that allows the evaluation and initial studies on the regulation to give qualified subsidies for the decision of the Board of Directors (Dicol).

According to the Agency, the new model also encourages the 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 between technical areas, regulated sector, government, society and institutions of education and consumer protection.

In addition to the usual forms, such as targeted or public consultations, audiences and sectoral dialogues, from now on it will also be possible to use the Public Allowance Survey (TPS), - or 'Tomada Pública de Subsídios' in Portuguese - a new social participation tool.

TPS allows the discussion of technical documents, such as the preliminary AIR report, which describes what the problem is under evaluation, what regulatory options exist for its solution, what evidence justifies the choice of alternatives presented, their advantages and, finally, points regulation.

To know the Agency's interaction options with the public, see the Social Participation Menu, which brings the different mechanisms for seeking contributions on regulatory processes.

Public consultation

Under the new model, the usual period of 30 days for public consultations was extended to a minimum of 45 days. In the case of consultations on matters of international impact, the minimum period shall be 60 days. In exceptional cases of duly motivated urgency and relevance, the deadlines may be modified.


To provide greater transparency, several documents will be published on the Anvisa Portal during the discussion on regulatory processes and all the technical materials used to substantiate proposals for public consultations on normative acts will be available to society, except 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), - or 'Termo de Abertura do Processo de Regulação' in Portuguese -  which has been simplified and will be divulged directly in a specific area of ​​the Anvisa website. Only in exceptional cases will the TAP be published also in the DOU.

Dicol's deliberations and the AIR report will also be available to the public, in addition to the contributions received during the consultations and reports on Social Participation Analysis (RAPS) - or and Analysis of Contributions (RAC), among other information.


Internally, the adoption of the model is by adhesion, but only for a period of two years, which is the time allowed for the technical areas to transition and incorporate the rules established by Ordinance Nº 1.741 and detailed in the Service Orientation (OS) nº 56, both of December of 2018.

Read more:
Find out which documents define the guidelines and procedures for improving regulatory quality: