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Brazil Gets Down To Implementing ICH Guidelines

 
• By Francesca Bruce

Brazil’s medicines regulator ANVISA has begun the process of implementing International Council for Harmonisation guidelines on areas such as clinical safety data management and the Common Technical Document.

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Brazil Works Towards Harmonization

ANVISA, Brazil’s medicines regulator, has implemented one set of International Council for Harmonisation (ICH) guidelines and is working on introducing others, it said at a recent meeting intended to update stakeholders from industry and the regulatory world on its ICH membership.

Brazil was accepted as an observer to the ICH in December 2015 and became a member in November 2016. A condition of membership was that ANVISA must introduce five ICH...

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