{"id":972,"date":"2020-08-10T14:59:20","date_gmt":"2020-08-10T17:59:20","guid":{"rendered":"https:\/\/www.vitapharmaconsulting.com\/en\/?post_type=noticias&p=972"},"modified":"2022-04-27T15:04:34","modified_gmt":"2022-04-27T18:04:34","slug":"anvisa-new-legislation-in-pharmacovigilance","status":"publish","type":"noticias","link":"https:\/\/www.vitapharmaconsulting.com\/en\/news\/2020\/08\/10\/anvisa-new-legislation-in-pharmacovigilance\/","title":{"rendered":"ANVISA – New Legislation in Pharmacovigilance"},"content":{"rendered":"
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On July 29th, it was published on Brazilian Official Gazette (DOU) the RDC N\u00ba 406\/2020, regarding the Good Pharmacovigilance Practices and the Normative Instruction (IN) N\u00ba 63\/2020, which provides information about the Periodic Report on Benefit-Risk Assessment (RPBR) to be submitted to ANVISA by the Marketing Authorisation Holder. These laws formalize the New Regulatory Framework in Pharmacovigilance and the internalization of ICH Guidelines related to actions in Pharmacovigilance.<\/p>\n

The RDC N\u00ba 406\/2020 considers the term Good Pharmacovigilance Practices comprising the entire system, including inspections, the responsibilities of marketing authorisation holders and the responsible for Pharmacovigilance.<\/p>\n

The new Regulatory Framework also changes the procedure for submiting the Periodic Report of Benefit-Risk Assessment (RPBR), which is no longer linked to the drug product marketing authorisation date in Brazil, but thereafter is based on the international registration date of the API. These lists will be published on the Anvisa Page and it is based of the list proposed by EMA (European Medicines Agency)<\/em>. The presentation of the new reports enables international regulatory convergence and, consequently, a greater volume of data shared between countries with greater productivity and effectiveness in the analysis of these data.<\/p>\n

See below the some changes brought about by the new legislations:<\/p>\n