A new schedule for preparing Periodic Benefit-Risk Evaluation Reports (PBRER) took effect on August 4, 2026, following an announcement by Brazil’s Health Regulatory Agency (ANVISA) on August 5. The revision reorganizes periodicity criteria according to how long each medicine has been on the market, as well as the level of regulatory priority assigned by the Agency, aiming to making post-marketing monitoring more proportional to each product’s risk profile and to strengthening pharmacovigilance overall.

The role of the PBRER in pharmacovigilance

Under Resolution RDC No. 406/2020, which governs Brazil’s Good Pharmacovigilance Practices, Marketing Authorization Holders in Brazil are responsible for periodically reassessing the safety of each marketed product through the PBRER — the main mechanism for continuous monitoring of a medicinal product’s benefit-risk profile across its life cycle. The format follows the International Council for Harmonisation (ICH) E2C(R2) Guideline, which ANVISA adopted specifically so companies would not need to prepare safety reports in different formats and periodicities for each market, aligning what is required in Brazil with what is already submitted to regulatory authorities elsewhere. Adverse events must be described using the Medical Dictionary for Regulatory Activities (MedDRA).

This requirement is not new: it has been applied since 2020, under Resolution RDC No. 406/2020, to any medicinal product authorized in Brazil, whether or not its active substance appears on the European Union Reference Dates List (EURD List).

How the new periodicity structure works

The PBRER preparation schedule, effective August 4, 2026, now distinguishes between active substances listed and not listed on the EURD List, maintained by the European Medicines Agency (EMA):

▪ for active substances or combinations listed on the EURD List, the PBRER must be prepared based on the data lock point (DLP) indicated in the list itself, with the preparation frequency taken from the list’s “Submission Frequency” column — interpreted as preparation frequency by ANVISA. The list’s “Submission date” column does not define submission periodicity, instead, it indicates the deadline for the company to finalize the PBRER;

▪ for active substances or combinations not listed on the EURD List, periodicity is now tiered according to how long the molecule or combination has been authorized in Brazil:

— medicinal products authorized for less than 10 years: preparatoin every 6 months for the first 2 years, annually from the second to the fourth years after authorization, and every 3 years thereafter, up to 10 years;

— medicinal products authorized for more than 10 years, counted from the molecule’s first authorization in Brazil: preparation every 5 years;

— medicinal products authorized for more than 30 years, counted from the molecule’s first authorization in Brazil: preparation every 10 years.

For medicinal products prioritized by ANVISA, periodicity is defined according to risk and national relevance criteria and may differ from the criteria above; when prioritized medicines exist, the respective intervals will be published on ANVISA’s Portal.

What qualifies a medicine as prioritized

This category covers medicinal products already authorized and marketed in Brazil whose safety, effectiveness, or usage pattern differs from what’s observed elsewhere, being that due to epidemiological, demographic, genetic, or local clinical-practice factors, as well as medicinal products with particularities in their commercialization, distribution, or manufacturing in Brazil.

Reference dates for the preparation of the PBRER

– active substance with internationally harmonized data: International Birth Date (IBD) combined with the data lock point (DLP);

– active substance without harmonization to the EURD List: the medicinal product’s first authorization date in Brazil applies instead.