How to cope with Brazil's ANVISA Regulatory Challenges

Views:
 
     
 

Presentation Description

The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. In the federal public regulatory structure, the agency is connected to the Ministry of Health.

Comments

Presentation Transcript

Thank You:

How to cope with ANVISA 's Regulatory Challenges

Thank You:

Brazil Regulatory Authority ANVISA – Regulatory Challenges The Brazilian Health Surveillance Agency, commonly known as ANVISA, abbreviated from Portuguese “Agencia Nacional de Vigilancia Sanitaria,” is the food and drug regulatory agency in Brazil. In the federal public regulatory structure, the agency is connected to the Ministry of Health. ANVISA has a particular process in which they undertake regulatory submissions. Over the years there have been several changes to these guidelines and the greatest challenge faced by bio and pharmaceutical companies in this regards is their lack of proper knowledge.

Thank You:

Second visible challenge with ANVISA is that the regulations are present only in two languages, one is Portuguese and the other is English. The English version is not for all the content and hence it might be difficult for those without knowledge of Portuguese to comprehend. ANVISA’s registration process is often compared to that of the registration process of the US FDA because of certain uncanny resemblance. Brazil Regulatory Authority ANVISA – Regulatory Challenges

Thank You:

In case of drugs the updated norms indicate that every drug and Active Pharmaceutical Ingredients (APIs) whether manufactured in Brazil or has been imported needs to be registered under ANVISA. This is an established regulatory system that has been running over the years but still there is extreme complexity surrounding the registration process under the same. ANVISA is a new ICH member and thus is going through a revision process of all guidelines. Most updated guidelines under this regulatory authority is presented in a detailed manner and with a proper structure which prevents manufacturers from taking the risk. Brazil Regulatory Authority ANVISA – Regulatory Challenges

Thank You:

Challenges Faced by ANVISA Challenges Highlighted by ANVISA Solution for Regulatory Challges Read now at Brazil Regulatory Authority ANVISA – Regulatory Challenges

Thank You:

Thank You

authorStream Live Help