Ingresso da Anvisa no International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) e seu impacto nas indústrias farmacêuticas brasileiras
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Data
2020-10-02
Autores
Munekata, Igor Rocha [UNIFESP]
Orientadores
Nappo, Solange Aparecida [UNIFESP]
Tipo
Trabalho de conclusão de curso de graduação
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Introdução - O International Council For Harmonisation of Technical Requirements for
Pharmaceuticals for Human Use (ICH) é uma relevante iniciativa de harmonização regulatória
global de requisitos técnicos para medicamentos de uso humano com participação principal
de autoridades regulatórias, indústrias e várias organizações internacionais, divididas entre
membros e observadores. Para a Agência Nacional de Vigilância Sanitária (Anvisa) tornar-se
um membro desta iniciativa, firmou-se o compromisso da implementação de todos os guias.
Objetivo - Este trabalho visa contextualizar o impacto da adoção dos guias por parte da
Agência brasileira nas regulamentações locais, no mercado farmacêutico e seus consequentes
impactos nas indústrias farmacêuticas instaladas no Brasil. Método - Realizou-se extensa
pesquisa em fontes de dados sobre o tema, como sítios eletrônicos de referência e
apresentações da agência, entre o período de 1999 a 2020. Conclusão - Alguns guias já
implementados causaram mudanças relevantes no contexto regulatório do país, gerando um
impacto para as indústrias se adaptarem. Ainda há um caminho longo para incorporação de
todos os guias, porém há de se considerar a fase de internacionalização que algumas empresas
nacionais estão atualmente, a dificuldade de adaptação às novas regras ditadas pelo ICH por
parte de empresas menores e o cenário de empresas multinacionais que pleiteiam por uma
maior harmonização. Todos estes fatores devem ser levados em conta para promover uma
harmonização e convergência regulatória com uma transitoriedade apropriada, de modo que
o impacto ao setor regulado seja o menor possível para que se alcance o objetivo estipulado
pelo ICH. Isto também permite que a Anvisa conquiste uma confiança regulatória, tendo um
alto nível de maturidade, o que garantirá ainda mais a qualidade, segurança e eficácia dos
medicamentos fabricados, comercializados e importados no país.
Introduction - The International Council For Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a relevant global regulatory harmonization initiative for human-use medicinal products with the primary participation of regulatory authorities, industries and several international organizations, divided among members and observers. For the National Health Surveillance Agency (Anvisa) to become a member of this initiative, it committed to the implementation of all guides. Objectives - This work aims to contextualize the impact of the adoption of guides by the Brazilian Agency on local regulations, in the pharmaceutical market and its consequent impacts on the pharmaceutical industries installed in Brazil. Method - Extensive research was carried out on data sources on the subject, such as reference websites and presentations of the agency, between 1999 and 2020. Conclusion - Some guides already implemented have caused relevant changes in the regulatory context of the country, generating an impact for industries to adapt. There is still a long way to go for the incorporation of all the guides, but we must consider the phase of internationalization that some national companies are currently in, the difficulty of adapting to the new rules dictated by ICH by smaller companies and the scenario of multinational companies that call for greater harmonization. All these factors should be taken into account in order to promote regulatory harmonization and convergence with an appropriate transience, so that the impact on the regulated sector is as small as possible in order to achieve the objective stipulated by the ICH. This also allows Anvisa to gain regulatory confidence, having a high level of maturity, which will further ensure the quality, safety and efficacy of medicines manufactured, marketed and imported in the country.
Introduction - The International Council For Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) is a relevant global regulatory harmonization initiative for human-use medicinal products with the primary participation of regulatory authorities, industries and several international organizations, divided among members and observers. For the National Health Surveillance Agency (Anvisa) to become a member of this initiative, it committed to the implementation of all guides. Objectives - This work aims to contextualize the impact of the adoption of guides by the Brazilian Agency on local regulations, in the pharmaceutical market and its consequent impacts on the pharmaceutical industries installed in Brazil. Method - Extensive research was carried out on data sources on the subject, such as reference websites and presentations of the agency, between 1999 and 2020. Conclusion - Some guides already implemented have caused relevant changes in the regulatory context of the country, generating an impact for industries to adapt. There is still a long way to go for the incorporation of all the guides, but we must consider the phase of internationalization that some national companies are currently in, the difficulty of adapting to the new rules dictated by ICH by smaller companies and the scenario of multinational companies that call for greater harmonization. All these factors should be taken into account in order to promote regulatory harmonization and convergence with an appropriate transience, so that the impact on the regulated sector is as small as possible in order to achieve the objective stipulated by the ICH. This also allows Anvisa to gain regulatory confidence, having a high level of maturity, which will further ensure the quality, safety and efficacy of medicines manufactured, marketed and imported in the country.