In 2014, ANVISA created a management model for its regulatory stock based on the organization of thecurrent rules, monitoring their effectiveness and generating inputs for their review. The goal was, and still is, to make the stock more efficient, rational, clear and understandable.

According to civil servant Raianne Liberal Coutinho, the agency realized that they weren’t providing easy access to the set of rules. The consequence was a large volume of conflicting, obsolete and unclear regulations.  In order to achieve a better control, the agency has created a cyclical management model that focuses on reviewing its normative acts. With this in mind, three initiatives have been set up.

The first one is the Themes Library, which is a way of providing society and the agency’s departments with access to all ANVISA’s rules, categorized into subjects. The system reduces the risk of creating conflicting rules, as the areas have easy access to all the regulations in force. The organized collection made it possible to easily identify the existence of obsolete normative acts.

“When the areas analyzed the library for validation, they identified rules that were no longer being used and that could be withdrawn entirely”, observes Coutinho.

Another mechanism created was The problem identification tool: an online form available on ANVISA’s website that anyone – inside or outside the agency – can access in order to easily report a problem with any specific rule. When the Agency identifies problems with a rule, it goes back into the regulatory agenda.

The third initiative is the so-called Regulatory Guillotine. “It is an unique mechanism to revoke a set of rules”, said Coutinho.  The first time ANVISA has taken actions to reduce the regulatory stock by eliminating obsolete regulations was in 2016. Since then, the Regulatory Guillotine has revoked 349 rules, which represents one-third of the existing regulation.

The last resulting action was RDC 292, published in June 26th , that withdrew 174 rules that were considered obsolete after public consultation.

“The Regulatory Guillotine is extremely important in the context of ANVISA’s amount of published rules. Since 1999 ANVISA publishes an average of 87 rules per year. From 2003, it has reached the amount of 126 rules per year, which means a new rule every two working days” – states ANVISA’s director Fernando Mendes.

By removing obsolete rules, the Agency is cleaning up the regulatory stock and making it easier to understand the normative set – that will now comprehend only the rules that are currently in effect.

Our team believes actions such as The Regulatory Guillotine are important to keep a simple coherent regulatory stock and they also demonstrate how actively the agency is working towards that goal. Talking specifically about medical devices, we had 12 revoked resolutions that were obsolete – they had been substituted in the past or set deadlines that were already expired.

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DOMO Salute Team

Check the list of rules that have been nominated for the Regulatory guillotine and the specific reason. (Portuguese)

Check RDC 292 and learn which rules have been recently revoked. (Portuguese)