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General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil

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This concept paper outlines BioPhorum’s considerations regarding Anvisa’s intention to adopt WHO guidelines while meeting the related ICH ones. These are complementary guidelines and both should be considered by agencies as the most up-to-date recommendations for handling post-approval changes.

The paper demonstrates how national regulatory agencies and biomanufacturers can make use of both guidelines and introduces the desired principles for national regulations.

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