Brazil: ANVISA streamlines post-registration changes for biological products

Date:06-05-2024

Resolution of the Collegiate Board (RDC) 876/2024, published by Brazil's National Health Surveillance Agency (ANVISA), modifies previous rule on post-registration changes and cancellation of biological products (RDC 413/2020). The aim of the changes is to optimize the process of submitting petitions necessary for updating the registration of biological products, as well as their analysis by ANVISA.

The amendment allows for the exemption of additional submissions for changes considered intrinsic (i.e., when a main change leads to other inevitable or consequential changes, and the same set of data is involved) besides the main change or the related set of main changes.

When RDC 413/2020 was published, it introduced many innovations regarding the procedures and processes necessary for requesting and evaluating post-registration changes. To clarify doubts, the Agency released guidance documents. However, after almost four years since its publication, the need for more significant adjustments arose to simplify and streamline submissions by companies.

This was because changes in the registration of biological products are often complex and involve several modifications collectively, which led to the need for multiple submissions to regularize a change, and this overload reflected a counterproductive scenario.

Thus, to address the large number of submissions received since 2020, which generated a significant backlog of analysis of often-related petitions, ANVISA decided to amend Article 22 of RDC 413/2020, exempting additional submissions.

Resolution (RDC) 876/2024 can be found at the following link.

https://antigo.anvisa.gov.br/legislacao#/visualizar/520307

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