ANVISA – New Legislation in Pharmacovigilance

On July 29th, it was published on Brazilian Official Gazette (DOU) the RDC Nº 406/2020, regarding the Good Pharmacovigilance Practices and the Normative Instruction (IN) Nº 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.

The RDC Nº 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.

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). 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.

See below the some changes brought about by the new legislations:

  • Outsourcing of activities in Pharmacovigilance: The previous legislation (RDC Nº 4/2009) did not make clear the possibility of outsourcing activities in Pharmacovigilance, although the delegation of these were practiced by the Industries. The New Legislation formalizes the possibility of outsourcing activities, making clear the requirements, limitations and responsibilities.

  • Deadline for Adverse Event Notifications by the Marketing Authorisation Holder: The previous legislation (RDC nº 4/2009) had a period of 7 days for the marketing authorization holder to report serious adverse events to ANVISA and 15 days for other events. The New Legislation has a single deadline for notification of adverse events in general, which will be 15 days, regardless of their classification.

  • Self-inspection in Pharmacovigilance: The previous legislation (RDC Nº 4/2009) included a periodicity of Self-inspection in Pharmacovigilance, which should be conducted by the Marketing Authorisation Holder, at least once a year. The New Legislation provide the period of one year as preferential, and cannot exceed the period of two years for it.

  • Pharmacovigilance System: In the previous legislation (RDC Nº 4/2009), the minimum structural requirements of the Pharmacovigilance System were not specified. The New Regulatory Framework provides for structural and operational questions about this System.

  • Periodic Reports: The Periodic Pharmacovigilance Report (RPF) is now called the Periodic Benefit-Risk Assessment Report (RPBR). In addition, its format and content have been established in IN Nº 63/2020.

The New Pharmacovigilance Regulatory Framework comes into force on October 27, 2020.

Access the legislation using the links below:

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