On September 2, 2026, ANVISA’s Board of Directors approved, during its 16th Public Ordinary Meeting, the draft Normative Instruction (IN) that formalizes the pilot project for an optimized quality review of registration applications for synthetic and semi-synthetic drug products, based on the Structured Quality Summary (Resumo Estruturado da Qualidade, REQ), led by the Synthetic Drug Quality Assessment Management (Gerência de Avaliação da Qualidade de Medicamentos Sintéticos, GQMED). Official publication of the rule still depends on legal review and remains subject to changes: this analysis reflects the draft made available by the Agency on August 27, 2026, and Vita will update this content once the final version is published.

What the REQ is and what problem it addresses

The initiative is part of ANVISA’s plan to reduce its registration review backlog. According to the Agency, the quality assessment stage is one of the process’s critical bottlenecks, given the high volume of applications, the complexity of dossiers, and the amount of information to be reviewed, factors that extend analysis timelines. The REQ is a technical-regulatory document filled out by the applicant company, presenting the dossier’s quality information in a standardized, organized format, including the technical-scientific rationale, the product’s critical aspects, and the location of the corresponding documentation. Per the draft, the REQ supports GQMED’s technical decision-making alongside the complete dossier, without replacing current technical requirements or taking precedence over other filed documents.

Eligibility criteria

According to the draft, applying the optimized review depends on cumulatively meeting criteria such as: GQMED not yet having started the technical quality review within the legal deadline set by Law No. 13,411/2016; the drug product belonging to the generic or similar category; the product not having a narrow therapeutic index; the REQ amendment having been filed within the deadline to be announced by ANVISA; and the REQ having been filled out in full according to the standard template and signed by the applicant company’s legal and technical representatives. Eligibility also depends on the product’s pharmaceutical form appearing in the rule’s Annex, which lists 19 covered pharmaceutical forms, including immediate or modified release tablets and capsules, injectable solutions, creams, gels, ointments, and suppositories.

Even when these criteria are met, the draft allows ANVISA to set aside the optimized review, with technical justification, when the product’s characteristics call for a more in depth evaluation. REQ amendments will also not be accepted if they alter the standard template, including translating fields into English, limit themselves to indicating where documents are located in the dossier without providing a structured summary, or rely extensively on screenshots instead of structured information.

Consequences and responsibilities

The optimized review can result in approval, a technical deficiency letter, or denial of the application, following the requirements already established under current regulations for synthetic and semi-synthetic drug product registration. Companies have 60 days to respond to deficiency letters and may request a meeting with ANVISA within 10 days of being notified. The draft also allows for virtual or in-person audits to verify the consistency of information declared in the REQ, along with consequences for repeated non-compliance: two or more applications found in breach of the rule bar the company from requesting the optimized review for 12 months.

Practical impact and next steps

The initiative is part of ANVISA’s broader effort to reduce registration review timelines by improving its work processes, without lowering the technical rigor required. As the rule remains under legal review, companies interested in the pilot project should follow the publication of the final Normative Instruction and the notice ANVISA will issue identifying which applications are eligible to request the optimized review.