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ANVISA`s Regulatory guillotine

Date: 07/30/2019

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the areas analyzed the library for validation, they identified rules that were no longer being used and that could be withdrawn entirely”, observes Coutinho.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

 

Follow us on social media to get an update on the top news regarding the Brazilian regulatory system.

 

DOMO Salute Team

 

Useful Links:

 

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

http://portal.anvisa.gov.br/documents/219201/0/Justificativa_CP_Guilhotina-rev.pdf/8d4d1f62-3d5f-435e-bd43-86e08d0d35e1

 

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

http://portal.anvisa.gov.br/legislacao#/visualizar/399911

 

Guilhotina Regulatória – ANVISA

 

Em 2014, a ANVISA criou uma estratégia de gestão do estoque regulatório que promove medidas para o acompanhamento sistemático do seu acervo normativo, visando a melhoria da qualidade regulatória. A Guilhotina Regulatória, que faz parte desta estratégia, é um mecanismo de reforma do marco regulatório, identificação e revogação de atos normativos obsoletos.

 

De acordo com a servidora Raianne Liberal Coutinho, a agência verificou que a sociedade, assim como as próprias áreas da Agência, não tinham acesso às normas da instituição. A consequência disso era um grande volume de normas contraditórias, obsoletas, sem clareza, ou que traziam obrigações em excesso, sem que existisse um mecanismo de administração destas normas. Foi criado, então, um modelo de gestão cíclico composto por três iniciativas.

 

A primeira delas é a biblioteca de temas, que é uma forma de fornecer à sociedade e às áreas da agência acesso a todas as normas da ANVISA, categorizadas por assunto. Esse sistema facilita o acesso e, consequentemente,  diminui os riscos de criação de normas contraditórias, além de facilitar a identificação de atos normativos obsoletos..

 

Outro mecanismo criado para o modelo de gestão, foi a ferramenta de identificação de problemas, que consiste em um formulário alocado no portal da ANVISA ao qual qualquer pessoa – de dentro ou de fora da agência – tem acesso para relatar facilmente um problema em uma norma.

 

A terceira iniciativa é a chamada Guilhotina Regulatória. A primeira vez que a ANVISA adotou medidas para reduzir o estoque regulatório com a eliminação de normas obsoletas foi em 2016. Desde então, a Guilhotina Regulatória já revogou 349 normas da ANVISA, correspondendo à redução de aproximadamente um terço do estoque regulatório.

 

A mais recente ação decorrente da Guilhotina, foi a publicação da RDC 292 em 26/06, que revogou 166 normas da Agência consideradas obsoletas e outras oito normas da extinta Secretaria de Vigilância Sanitária do Ministério da Saúde (MS).

 

“A Guilhotina Regulatória é extremamente importante no contexto do grande volume de publicações de atos normativos, como verificado na ANVISA”, avalia o Diretor Fernando Mendes. Além de ressaltar a relevância da Guilhotina, o diretor justificou a necessidade de sua aplicação periódica ao mencionar que “Desde sua criação, em 1999, a Agência publica uma média de 87 atos por ano. Em 2003, este número atingiu o valor de 126 normas, o que corresponde a uma publicação a cada dois dias úteis”.

 

A revogação das normas obsoletas despolui o estoque regulatório, evitando gerar confusão para pessoas e empresas que utilizam a legislação da Agência, além de simplificar o acesso ao estoque e facilitar a compreensão do conjunto normativo, que passa a representar o coletivo das normas, de fato, vigentes.

 

Nossa equipe acredita que medidas como a Guilhotina Regulatória são interessantes para manutenção de um estoque regulatório simplificado e coerente, e mostram a iniciativa da agência para atingir este objetivo. Especificamente na área de produtos para saúde, tivemos até o presente momento a revogação de 12 Resoluções obsoletas em função de terem sido substituídas por novas normas ou por regulamentarem prazos os quais encontravam-se expirados.

 

Siga nossas redes sociais e acompanhe as principais notícias referentes ao sistema regulatório brasileiro. 

 

Equipe DOMO Salute

 

Links:

 

Confira a lista dos atos normativos indicados para a Guilhotina Regulatória e a justificativa para a sua revogação:

http://portal.anvisa.gov.br/documents/219201/0/Justificativa_CP_Guilhotina-rev.pdf/8d4d1f62-3d5f-435e-bd43-86e08d0d35e1

 

Acesse a RDC 292 e conheça os atos revogados:

http://portal.anvisa.gov.br/legislacao#/visualizar/399911

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