ANVISA – List of Active Substances for Periodic Benefit-Risk Evaluation Reports (updated on December 20th, 2021)
On December 13th, 2021, ANVISA published the list of Periodic Benefit-Risk Assessment Reports (RPBR) with data lock point in the first half of 2022 to be submitted to the agency.
This list includes the COVID-19 vaccines authorized in Brazil. The RPBR must be submitted every six months for vaccines that have a definitive marketing authorization, and quarterly for those that have authorization for emergency use.
The list of drug substances for which RPBR must be submitted to Anvisa with a data lock point in the first half of 2022 is available through the link: https://bit.ly/3dZftgm. (updated on December 20th, 2021)
Anvisa had published the last version of the list, related to the RPBR with data lock point in the second half of 2021, on August 24th, 2021.
The Periodic Benefit-Risk Evaluation Reports must be prepared by the Marketing Authorization Holders and aim to assess the safety profile in defined periods after the publication of the product marketing authorization. This report will allow for a more efficient update of the safety profile of medicinal products by considering new or emerging safety information in the context of cumulative information on risks and benefits. Considering the data, ANVISA is able to determine if there are new risks identified for these drugs and/or if there were changes in the respective risk-benefit ratios.
For the submission of the RPBR, it is necessary to present the following documents, using the ANVISA submission code 11818:
Filled RPBR form, containing the executive summary
Spreadsheet for RPBR submission
Data compliance statement, including drug product data according to the approved instructions of use
Updated and approved product leaflet
The reports for products containing the drug substances included in the list, either as monodrugs or as combination products, should be presented.
The deadline for submission of the RPBR with data lock point in the first half of 2022 is also informed in the published list. (updated on December 20th, 2021)
Access the RPBR page on ANVISA’s website to check the complete information: https://bit.ly/2WnnO8p .
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