Regulatory update for post-registration of biological products in Brazil

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Regulatory update for post-registration of biological products in Brazil

Home/Guidelines | Posted 29/10/2024 0 Post your comment

On 3June 2024, Resolution RDC No. 876 was published in Brazil in the Official Journal of the Union (DOU)[1], modifying the current regulations regarding the post-registration of biological products (RDC 413/2020).

Before the new resolution, companies and the National Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA) had to follow multiple protocols, leading to a backlog of requests. This made it difficult to process regularization efficiently, especially for combined petitions.

The purpose of the changes is, therefore, to optimize the process of filing petitions required to update the registration of biological products and to streamline their review by ANVISA.

In January 2024, ANVISA initiated a public consultation aimed at expediting the regulation of biosimilar drugs. The goal was to reduce dependence on high cost imported biological medicines and position Brazil as a significant regional exporter of more affordable biological therapies [2].

The Collegiate Board Resolution RDC No. 876, dated 28 May 2024, modifies the Collegiate Board Resolution No. 413 of 20 August 2020, which governs post-registration and the cancellation of biological products registration.

RDC 876/2024 was published with the goal of making specific adjustments to the text of the current regulation on post-registration changes of biological products (RDC 413/2020), particularly in its Art. 22. As mentioned earlier, the change was prompted by the disproportionate increase in the volume of requests for post-registration changes of biological products. Previously, Art. 22 required companies to request each change individually in cases where moderate and major quality changes were made to the same product.

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References
1. https://antigo.anvisa.gov.br/documents/10181/6662643/RDC_876_2024_.pdf/
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2. GaBI Online - Generics and Biosimilars Initiative. Public consultation for the modification of the biosimilars regulations in Brazil [www.gabionline.net]. Mol, Belgium: Pro Pharma Communications International; [cited 2024 Oct 29]. Available from: www.gabionline.net/policies-legislation/public-consultation-for-the-modification-of-the-biosimilars-regulation-in-brazil

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