Another attempt by Anvisa to be agile — will it work this time?
Introduction
Since I entered the regulatory field, in 2007I have been following the successive efforts of Anvisa to reduce the regulatory liability and to make the process of evaluating registrations, post-registrations, and approvals in clinical research more agile and predictable. There were many attempts, adjustments to internal workflows, prioritizations, and revisions of regulations—and, more recently, the agency has begun to... Listen to the regulated sector. more frequently, seeking collaboration from the companies themselves to brainstorm together on operational efficiency.
Today Anvisa published the RDC No. 997, of November 7, which establishes exceptional and temporary measures to optimize the queue for the analysis of medicines and biological products, valid until December 31, 2026The proposal is clear: to reduce the backlog of pending cases and bring more agility to the system. But, in practice, will this really bring the expected result without the need for summary rejections?
What changes with RDC 997/2025?
The new rule creates temporary mechanisms for management and redistribution of analysis queuesIntroducing concepts and strategies aimed at optimizing resources and prioritizing what truly matters.
Among the main points, the following stand out:
- Creating specific queues for petitions that fall under Relianceboth for clinical research how much for Registration and post-registration of medicines and biologics;
- Possibility of abbreviated or verified analyses, focusing only on the critical aspects of the dossier;
- Implementation of Exceptional Assessment Management Plans (Exceptional AMPs)which allow group similar processes and change the chronological order of analysis when there is proven efficiency gain;
- Replacing processes in the queue, through formal withdrawal, provided that it involves products from the same company and no analysis has yet begun;
- Anticipation of risk classification of pending items (as foreseen in RDC 823/2023This allows companies to anticipate and correct critical points before the formal analysis.
The standard also reinforces the commitment to transparency, determining that all changes in the chronological order of analysis are published on the Anvisa website, with informed motivation and impact.
Discussion: advances, risks, and the old trap of "punitive efficiency"
Throughout these almost 20 years of experience in regulatory affairsI closely followed Anvisa's various initiatives to balance speed and technical rigor. Some bore good fruit, others fell by the wayside.
The great merit of RDC 997 is recognizing that the problem of queues is not just a lack of priority, but of... flow managementThe creation of Exceptional PGAs It is a conceptual advancement, as it allows for a rationalization through technical similarityThis is something the private sector has been asking for for years. It's also positive to see the encouragement of its use. Reliance — after all, mutual trust between agencies is one of the main global strategies for regulatory optimization.
However, there is one point of concern. In the name of efficiency, it is common to see an increase in summary rejections — automatic negative decisions, often motivated by minor formal issues, rather than technical content.
In theory, Anvisa says it adopts a risk-based analysisIn practice, what is frequently seen is a zero tolerance Disproportionate, with petitions rejected for details that could be discussed technically. And this happens, above all, because the agency still faces... staff shortage and high turnover, which weakens the consistency of the analyses and hinders the balanced application of the very risk methodology it advocates.
Thus, there is a paradox: efficiency is sought, but without a solid structure for technical dialogue and intelligent prioritization, the risk is only... Replace slowness with quick rejection..
Conclusion: hope is the last thing to be rejected.
Despite the criticism, it's important to acknowledge that... RDC 997/2025 represents a legitimate effort by Anvisa in Improve queue management and reduce backlog. of processes. The fact that it involves technical areas and the process itself. Collegiate Board in the creation and approval of Exceptional PGAs This indicates that the agency is trying to act more strategically and less recklessly.
Perhaps, for the first time, we will see a more mature combination between administrative management, technical prioritization, and cooperation with the regulated sector..
The challenge will be to ensure that the speech of risk-based analysis be effectively implemented — with proportionality, dialogue, and technical coherence.
And perhaps, with this new approach, we can finally say that Anvisa has learned to find a balance. efficiency and regulatory fairness.
Because, ultimately, every regulator and every company wants the same thing: A system that works, protects health, and respects the time and effort of those who do science and innovation in Brazil..
And here, a broader perspective is needed: companies also need to evolve, continuously learning how to interpret, apply, and adapt to regulations, even when they seem inconsistent or challenging. Regulation is dynamic — and learning is mutual. And that was my purpose with LegalPharma.
I believe in this collaborative approach: The goal is to transform regulatory complexity into applied knowledge, strengthening both the agency and the companies in their shared mission of ensuring quality, safety, and access to healthcare.
What if it works this time?
