The Brazilian Health Regulatory Agency (Anvisa) has introduced a new list of subject codes for primary applications related to clinical trials of Advanced Therapy Products (ATPs), aligning with the requirements of Brazil’s updated Clinical Research Law (Law 14874/2024). This change marks a significant step in improving regulatory oversight and efficiency in clinical research involving human subjects.
Anvisa’s Datavisa system, which manages document submissions and processing, now includes streamlined codes to facilitate faster document triage and decision-making. This adjustment is timely, given the increasing volume of clinical trial applications Anvisa is receiving. The new subject codes, aligned with Law 14874/2024, also support adherence to a 90-business-day deadline for the review of primary applications.
Overview of New Subject Codes for Advanced Therapy Products
The updated subject codes apply to ATPs under investigation in clinical trials, divided by product class (I or II) and developer type (national or international). Below is a breakdown of the new codes and their descriptions:
| Code | Subject Description | Generated By |
|---|---|---|
| 12351 | Advanced Therapy Product – Approval for Clinical Development Dossier of ATP Class II: International Developer | 4685 |
| 12352 | Advanced Therapy Product – Approval for Clinical Development Dossier of ATP Class II: National Developer | 4685 |
| 12353 | Advanced Therapy Product – Approval for Clinical Development Dossier of ATP Class I: International Developer | 4685 |
| 12354 | Advanced Therapy Product – Approval for Clinical Development Dossier of ATP Class I: National Developer | 4685 |
The previous codes related to ATPs will be phased out from Datavisa, further enhancing the agency’s document management system.
Impact of Law 14874/2024 on Clinical Research in Brazil
Law 14874/2024, also known as the Clinical Research Law, is a comprehensive regulation for research involving human subjects. It mandates not only specific timeframes for the regulatory review process but also outlines ethical and procedural requirements for clinical trials, aiming to bolster participant safety and regulatory compliance across the board. Additionally, Anvisa is updating Resolution RDC 506/2021 to align its current clinical trial protocols with the new law. Until this updated resolution is published, the requirements set forth in RDC 506/2021 will remain effective, subject to adjustments per the new legislation.
Streamlining Regulatory Processes
The introduction of new subject codes is more than just a technical update; it represents Anvisa’s commitment to improving the efficiency of clinical trial evaluations. By simplifying the subject codes and setting a clear deadline for primary petition reviews, Anvisa is better equipped to handle the growing demand for ATP clinical trials in Brazil. This swift response supports regulatory compliance and ensures that research teams receive timely responses, allowing them to proceed with studies that may advance critical medical treatments.
As Brazil strengthens its regulatory framework, these changes signal a supportive environment for cutting-edge medical research while maintaining stringent ethical standards. With the compliance requirements of Law 14874/2024 now in effect, researchers and developers are encouraged to stay informed about the evolving regulatory landscape.
Conclusion
The newly implemented subject codes for Advanced Therapy Products reflect Brazil’s dedication to fostering an advanced regulatory environment for clinical research, especially in fields involving pioneering therapies. Researchers and clinical trial sponsors should familiarize themselves with these updates to ensure their submissions align with the latest standards and to avoid delays in the review process. As Brazil emerges as a global hub for advanced clinical research, Anvisa’s commitment to regulatory efficiency and participant safety will be instrumental in advancing both local and international medical innovations.