For synthetic and semisynthetic drug products, Resolutions RDC No. 753/2022 and RDC No. 948/2024 from ANVISA determine the cases in which the abbreviated development pathway may be used. This pathway allows for a reduction in the product’s development program, which can shorten time to market, provided that the evidence supporting the application is properly structured.

According to ANVISA Guide No. 61/2023, companies working with active pharmaceutical ingredients (APIs) with a well-established marketing authorization application and commercialization abroad can pursue the literature-based abbreviated development pathway for synthetic and semisynthetic drug products. This pathway is also applicable when an international reference product must be used as comparator, in cases where none is available in Brazil. It waives part of the clinical development typically required, but that waiver depends entirely on the rigor with which the existing evidence is gathered and presented, as well as on the outcome that evidence demonstrates as a whole.

Vita conducts the full technical chain this pathway requires: structured literature search, PRISMA-based screening, evidence quality assessment using GRADE, and risk of bias evaluation with RoB 2, AMSTAR 2, or ROBIS, depending on the design of the included studies. The process concludes with the safety and efficacy documentation, written in CTD format and ready to be incorporated into the marketing authorization application.

Beyond conducting the systematic review itself, Vita now also performs feasibility confirmation and meta-analysis, the latter also recommended by ANVISA in the guide.

This methodology has been applied and refined across real regulatory projects.

Companies evaluating whether an API fits this regulatory pathway are welcome to reach out.