On August 15, 2025, the Brazilian Food and Drug Administration (ANVISA) unveiled its Operational Tactical Plan for 2025-2026, aimed at temporarily improving the efficiency of its regulatory processes. For years, the Agency has been grappling with the challenge of excessive waiting times for market approval of medicines. The number of applications continues to grow at a rate that exceeds the capacity of ANVISA to process them, resulting in structural bottlenecks that directly impact the timely availability of medicines.
A significant contributing factor to this issue is the persistent shortage of staff. It is evident that, over the years, there has been a decline in the number of employees at ANVISA, whilst the complexity of regulatory demands has increased. This imbalance has prompted the Agency to adopt a range of approaches aimed at reducing backlogs, underscoring the need for optimizing regulatory processes without compromising on rigor or transparency.
The Tactical plan introduces two specific proposals: a Public Call for queue substitution, still awaiting publication, and a Public Call for Priority Review for the marketing approval of GLP-1 receptor agonists medicines, published on August 25, 2025.
The proposal aims to alter the logic of regulatory queues by allowing companies to withdraw a pending marketing approval that has not yet entered formal review and replace it with a marketing application for another medicine. Many applications that remain in the queue may no longer reflect genuine business interests. Accordingly, removing these would free up agency resources while enabling firms to advance submissions with greater strategic or therapeutic relevance. In theory, this would better align regulatory processes with real-world demands.
However, the measure further undermines the predictability of competition. Although Anvisa has recently begun disclosing which products are in the queue for marketing approval, it does not disclose neither the identity of the applicant, nor the position of the application – except when compelled by court order. Allowing substitutions without full transparency will make it even harder for companies to anticipate when competitors’ products may reach the market. This scenario is particularly concerning in the case of generic applications for products still under patent protection.
Under the proposed Public Call, eligible participants will be applicants with pending applications for generic, brand-generic, new, or innovative medicines, filed before July 16, 2025, and not yet under review. Although the Public Call has not yet been published, it is anticipated that applicants may submit petitions for the withdraw of marketing applications between September 1st and September 30th 2025. The applicants will then be able to use the vacated position to advance another marketing application. It is important to note that replacement will only be permitted within the same priority category, thus ensuring regulatory consistency.
The second proposal, regarding the priority review of marketings applications for GLP-1 receptor agonists, has been recently published by Anvisa on August 22, 2025 (Public Call #12/2025). The Call allows applicants with pending marketing applications for semaglutide and liraglutide, filed by August 25, 2025, that have not yet been subject to review, to request priority review. Applicants now have 15 days from publication to request the priority review.
This initiative was preceded by a formal request from the Ministry of Health on August 15, 2025 (Official Letter No. 1444/2025), same day Anvisa presented its Operational Tactical Plan, seeking an exception to the chronological review order for semaglutide- and liraglutide-based products. The request emphasized the relevance of these medicines to the Brazilian Public Health System (SUS), public-private partnerships under the Partnerships for Productive Development (PDPs), and the broader goals of the National Health Economic-Industrial Complex (CEIS).
During the presentation of Operational Tactical Plan, the Agency highlighted the points above mentioned, explaining the intention to ensure that regulatory action is aligned with both the urgency of public health issues and the objectives of industrial policy. Accelerating access to GLP-1 products could mitigate illicit trade, reduce costs, and strengthen Brazil’s CEIS.
While this initiative has the potential to expedite the review of the 9 pending applications for semaglutide and 7 for liraglutide, ANVISA’s limited resources mean that only three requests will be processed per semester. It is worth noting that prioritization requests will be handled under the administrative code for risk of shortage, as provided in Rule #204/2017. Therefore, any request for priority review constitutes full acceptance of all conditions of Rule #204/2017. This includes the obligation to commercialize the approved product within 365 days of market approval, as provided in article 8.
This timeline has the added effect of intensifying regulatory and market pressures, particularly in view of the upcoming patent expiry of Ozempic, one of the best-known GLP-1 medicines.
Conclusion
Although ANVISA's Operational Tactical Plan is intended to address urgent therapeutic needs and reduce bureaucratic backlogs, it also highlights ongoing challenges concerning transparency, fairness, and competitive balance in Brazil’s pharmaceutical market. The sector must closely monitor the Agency’s next steps, especially given the potential for regulatory unpredictability in market dynamics.
This is particularly relevant following the Senate’s confirmation, on August 19, 2025, of the three newly appointed members of ANVISA’s Board of Directors: Leandro Pinheiro Safatle, who has been appointed to the position of Director-President, is an economist, with a master’s degree in public health, and Former Executive Secretary of the Brazilian Drug Market Regulation Chamber (CMED) and Director of CEIS; Daniela Marreco Cerqueira is a biologist with PhD in molecular biology and specialization in sanitary surveillance. She has been working at Anvisa as a specialist in regulation and health surveillance since 2006, also being Executive Secretary of CMED; and Thiago Lopes Cardoso Campos, a lawyer with training in health law and public policy management. During their confirmation hearings, the new directors emphasized their commitment to faster yet rigorous reviews, expanded access to innovation, and closer integration with Brazil’s public health system.
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