Brazilian Health Regulatory Agency – ANVISA

API Registration Department – COIFA

Assessment Policy CTD - 3.2.S

This document aims to provide transparency to ANVISA's assessment policy regarding the marketing authorization of APIs (RDC 57/2009). Additionally, it intends to encourage applicants and API manufacturers to act proactively, in the sense of submitting complete dossiers or updating them accordingly. Ultimately, the objective is to reduce the number of defficiency letters and to render the regulatory process more agile.

This document applies to synthetic and semi-synthetic APIs and, for now, it has limited applicability to APIs directly obtained through fermentation or extraction.

Color code:

**Documents that should be provided or whose absence should be justified by the API manufacturer.**

**Documents that are not required by the current legislation and that, for now, are not reasonably expected to be provided, except if by the API manufacturer's own initiative or when there is evidence of risk to the quality of the API.**

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