Brasília – The regulatory backlog at the National Health Surveillance Agency (Anvisa) remains a critical issue for the pharmaceutical sector, with the average approval time for generic drugs estimated at around three years and active pharmaceutical ingredient (API) evaluations taking up to five years. In contrast, the National Institute of Industrial Property (INPI) has made measurable progress in reducing its patent analysis queue and improving processing times.

As of mid-2025, the INPI reported 14,057 pending pharmaceutical patent applications—down from more than 18,000 in 2020. The average decision time has also improved, reaching approximately 4.9 years for drug patents and 5.7 years for biologics. These advances reflect process modernization efforts and the hiring of new patent examiners, which have increased productivity within the agency.

Industry representatives and government officials point to human resource shortages and procedural bottlenecks as the main causes of delays at Anvisa. To address these issues, the Ministry of Health has authorized the hiring of 129 new regulatory technicians through the “Agora Tem Especialistas” program, and 100 additional approved candidates from the last Anvisa recruitment have been called to serve. Experts agree that both agencies must maintain investment in staff and digital infrastructure to sustain efficiency gains and ensure timely evaluation of medicines and technologies.

Source: Futuro da Saúde

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