On July 23, 2026, ANVISA’s Medicinal Product Quality Assessment Unit (GQMED/GGMED) presented the PONTE Project (Optimization Program through a Technical Clarification Core), a pilot initiative that creates a structured channel for technical interaction between the Agency and companies during the quality assessment of medicinal products. The information was released by ABIFINA (Brazilian Fine Chemicals, Biotechnology and Specialty Industries Association, acronym from the Portuguese Associação Brasileira das Indústrias de Química Fina, Biotecnologia e suas Especialidades), which attended the presentation meeting.

What the project proposes

The objective is to reduce deficiency letters arising from information asymmetries, such as unresolved technical questions or difficulty in locating, in the dossier, data that is already there. In this way, ANVISA intends to shorten assessment time and the number of deficiency letter cycles, without compromising technical rigor or the formality of the administrative process. Participation is voluntary and, at this stage, limited to companies invited by the Agency. The interaction takes place in a dedicated Microsoft Teams environment, organized around three main tools:

• Technical Contextualization Meetings: presentation of specific aspects of the dossier before or during the assessment.
• Follow-up Channel: clarification of specific questions and location of information throughout the assessment.
• Compliance Alignment Meetings: clarification of the deficiency letters issued, to reduce repeated deficiencies and improve the quality of responses.

What does not change

ANVISA clarified that PONTE does not change the regulatory procedure or replace the formal submission of documents. At the end of the pilot, assessment time, the number of deficiency letters and the perception of participating companies will be evaluated, and these indicators will support a possible expansion of the initiative.

Interaction during the assessment at other authorities

Dialogue between authority and applicant throughout the assessment is not new internationally, and agencies such as the FDA and the EMA provide for information requests and clarification meetings during the review. PONTE brings ANVISA closer to this approach, still on a small scale and keeping the formal assessment as the central step.

What this means for companies

As the pilot is voluntary and limited to invited companies, most applicants will not yet have direct access to the channel. Even so, the design of the project indicates where the Agency identifies inefficiency: information that is in the dossier but hard to locate, and responses to deficiency letters that do not resolve the point raised and lead to new rounds. Dossiers with a clear structure, precise cross-references between modules and responses that point directly to the evidence are likely to benefit from this approach, with or without PONTE.

Vita supports companies in organizing dossiers and in preparing responses to quality deficiency letters, and follows the developments and possible expansion of the pilot.