Brazil’s Health Regulatory Agency (ANVISA) has begun publishing queues of Good Manufacturing Practice (GMP) Certification applications that received priority for analysis and inspection scheduling, under Resolution RDC No. 1,032, of July 8, 2026, which amended Resolution RDC No. 497/2021.

How the prioritization works

The published lists present, in accordance with the criteria defined in Art. 5 of RDC No. 497/2021 (as amended by RDC No. 1,032/2026), the GMP applications with prioritized analysis and inspection scheduling. This allows the regulated sector to monitor the processing order of the included dossiers and plan their activities based on this schedule.

The queues will be updated periodically, reflecting the progress of ANVISA’s analyses and scheduled inspections. Companies can also contribute to these updates by reporting the marketing authorization process number and the prioritized certification application number through ANVISA’s CBPF–Registration Process Linkage Form.

Impact for the pharmaceutical industry

According to the Agency, publishing the queues is meant to support administrative efficiency and the optimization of public resources, giving companies greater predictability on the progress of their applications and strengthening risk-based management in GMP certification.

The updated queue of prioritized GMP applications linked to registration applications is available here.