Anvisa Amends Standards for Registration of Biological Products

Brazil’s National Health Regulatory Agency (Anvisa) published RDC 876/2024, which modifies the existing regulation on registration changes and the cancellation of biological products, previously governed by RDC 413/2020. This update aims to streamline the protocol process for updating the registration of biological products and improve the efficiency of Anvisa’s analysis.

Key Changes in the New Resolution

Optimized Protocol Process: The primary goal of the changes is to optimize the process for submitting petitions required for updating the registration of biological products. This includes a more efficient evaluation process by Anvisa, reducing the administrative burden on companies and expediting the regulatory procedures.

Dispensation of Redundant Protocols: The new regulation allows for intrinsic changes—where a primary change necessitates other inevitable or consequential modifications, and the same set of data is involved—to be exempt from multiple protocols beyond the principal alteration or the set of related primary alterations. This adjustment simplifies the process by reducing the number of protocols required.

Background and Need for Change

Initial Implementation and Challenges: When RDC 413/2020 was initially published, it introduced numerous new procedures and flows for requesting and evaluating registration changes. Anvisa provided guidance documents to clarify these new procedures. However, nearly four years after its implementation, it became evident that significant adjustments were necessary to simplify and rationalize the protocol processes for companies.

Complexity of Biological Product Registrations: The registration changes for biological products are often complex and involve multiple modifications simultaneously. Previously, this complexity required several protocols to regularize a single change, leading to a counterproductive scenario with a significant backlog of petitions.

Specific Adjustments

Modification of Article 22: To address the high volume of protocols received since 2020, which resulted in a considerable queue of combined petition analyses, Anvisa amended Article 22 of RDC 413/2020. This amendment eliminates the need for additional protocols beyond the primary change, thereby streamlining the entire process.

Public Consultation and Feedback: It is noteworthy that this amendment was subject to public consultation. The report evaluating the feedback received is available on Anvisa’s portal, demonstrating the agency’s commitment to transparency and stakeholder engagement.

Implications for the Industry

The changes introduced by RDC 876/2024 are expected to significantly benefit the industry by reducing the administrative workload and accelerating the approval process for registration changes. By simplifying the regulatory requirements, Anvisa aims to foster a more efficient and responsive regulatory environment for biological products.