Update on Periodic Benefit-Risk Assessment Reports ANVISA_Brazil

Update on Periodic Benefit-Risk Assessment Reports ANVISA_Brazil_Updated on 24 August 2021

Background:

In 2009, the first pharmacovigilance legislation at the national level was published in Brazil.

On 22 July 2020, after more than a decade, two new Pharmacovigilance legislation have been published.

1. Good Pharmacovigilance Practices for Marketing Authorisation Holders (MAH) of Medicinal Products for Human Use
2. Normative Instruction: Provides information about the Periodic Report on Benefit-Risk Assessment (RPBR) to be submitted to The Brazillian Health Surveillance Agency (Agencia Nacional de Vigilancia Sanitaria – ANVISA) by the MAH

Here you can find new Pharmacovigilance guidelines (Aggregate reports)

Changed Periodic Safety Report format from PSUR to Periodic Benefit-Risk Evaluation Report format (PBRER) – ICH-aligned

National Birth Date changed to International Birth Date (IBD) as a criterion in the preparation of periodic safety reports

Modified the intervals between the data lock point and the PBRER submission

70 days for PBRER of 12 months or less

90 days for PBRER more than 12 months in duration

90 days for exceptional PBRER unless otherwise determined by HA

Added the PBRER should be submitted to the health authority (HA) according to the periodicity available on the ANVISA web portal.

As per the new guidelines, ANVISA published the list of RPBRs to be submitted to ANVISA with a closing date in the second semester/2021.

Update on Periodic Benefit-Risk Assessment Reports ANVISA_Brazil

ANVISA has instructed the Drug Registration Holders (DRM) _ Which documents must be included in the RPBR submission?

it is necessary to observe the mandatory documentation in the checklist of the subject code “ 11818 – Periodic Benefit-Risk Assessment Report ”.

The completed RPBR Form and the Periodic Benefit-Risk Assessment Report, containing the Executive Summary (according to Normative Instruction No. 63/2020), must be presented.

In addition to these documents, the Worksheet for the submission of the Periodic Benefit-Risk Assessment Report (RPBR ) must be presented along with the Declaration of Data Compliance . In this spreadsheet, the drug data must be entered according to the Instructions for Use. This spreadsheet is a tool that will allow a simultaneous evaluation (by active principle) of the data sent by all holders of registration of that drug.

Finally, the petition must be accompanied by the updated and approved package insert for the drug.

Please find the details of the completed RPBR Form, Executive Summary, and the Worksheet for the submission of the Periodic Benefit-Risk Assessment Report from ANVISA Portal.

Find relevant articles:

ANVISA Published PBRER Scheduler 2021 first half (Brazil)

Ethiopia Pharmacovigilance guidelines

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