General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil Home News and Papers General recommendations for harmonization of local regulations for post-approval submissions with WHO and ICH guidelines, example of Brazil 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. LoginRegister Now Login to access the free download Remember me BioPhorum downloadable documents and papers are freely available to download via our webisite. If you already have a user name and password enter it below to gain access to the download link. If you do not yet have a BioPhorum website account, please click the 'Register Now' link above to register and access the download. Lost Password? REGISTER BELOW Subscribe to Our Monthly Newsletter Submit a Comment Cancel reply Your email address will not be published. Required fields are marked *Comment Name * Email * Website Save my name, email, and website in this browser for the next time I comment. This site uses Akismet to reduce spam. Learn how your comment data is processed.