The validation of analytical procedures is an integral part of the registration and post-registration stages of medicines, aiming to ensure the reliability of results and sustain technical evidence of quality.

Resolution RE No. 899/2003 represented the first structured milestone for the regulated sector by introducing guidelines for the validation of analytical and bioanalytical methods with an advisory nature, aiming at the standardization of concepts and practices in Brazil. Subsequently, RDC No. 166/2017 consolidated these requirements into a regulation, adopting a detailed approach by defining the parameters and criteria applicable to analytical validation for APIs, medicines, and biological products. Complementarily, Guide No. 10/2017 recommended models and procedures for statistical analysis to support compliance with the aforementioned regulation, already allowing the adoption of alternative approaches, provided they were technically and scientifically grounded in compliance with current regulatory requirements.

The experience gained since the publication of RDC No. 166/2017 has made it possible to identify that certain validation requirements currently required are not aligned with international guidelines. The theme, which was part of the Regulatory Agendas for 2021-2023, 2024-2025, and 2026-2027, resulted in Vote No. 65/2026/SEI/DIRE5/ANVISA, which approved the opening of a new regulatory stage.

As part of the international regulatory convergence, ANVISA published Public Consultation No. 1,391, dated March 25, 2026, aimed at the revision of RDC No. 166/2017. The proposed draft of the new RDC establishes general criteria for the validation of analytical procedures employed in APIs, medicines, and biological products in release and stability testing.

The main objective of the initiative is to harmonize and internalize national requirements with the guidelines of the International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH): ICH Q2(R2) (Validation of Analytical Procedures) and ICH Q14 (Analytical Procedure Development). Currently adopted by several international authorities, these guides reflect the scientific and regulatory evolution of the sector, seeking to raise the quality of analyses, strengthen sanitary safety, and provide greater predictability to the medicine regularization processes in the country.

In addition to the draft RDC, ANVISA presented the proposal for two guides based on the ICH Q2(R2) and ICH Q14 guidelines. Although the technical and scientific content is preserved in its entirety, the documents were internalized considering the administrative and legal framework in force in the country. This adaptation, present in the translation and in the cited references, ensures the necessary regulatory and advisory framework for the national scenario.

• References to Law No. 6,360/1976 and Law No. 9,782/1999, which establish the Agency’s competence.
• Terminologies and references to local regulations for the Brazilian scenario, such as post-registration changes (RDC No. 73/2016) and forced degradation studies (RDC No. 964/2025), ensuring harmony among ANVISA’s various internal regulations.

The proposed changes focus predominantly on the manner of planning, conducting, and documenting the studies, while preserving consolidated scientific parameters. The draft signals the transition toward a regulatory model based on principles and risk assessment, resulting in a regulation that is more aligned with ICH guidelines. This new approach provides the sector with greater evidence-based flexibility, while simultaneously requiring more in-depth technical discussions and robust scientific justifications for defining validation strategies conditioned on the method’s objective, the nature of the analyte, and the analytical technique employed.

In this context of alignment with ICH Q2(R2) and ICH Q14, key advancements include the possibility of adopting combined approaches for accuracy and precision, the treatment of robustness as data intrinsic to development, and the opening for discussions regarding the use of working standards.

The internalization of these guides transcends the execution of a checklist of tests, prioritizing the scientific demonstration that the procedure is fit for its intended purpose, which allows for a holistic view and a more assertive analysis of the total analytical error. In this perspective, robustness is integrated into the development phase as an essential element of method understanding, consolidating itself as a design attribute rather than just a final verification.

The following table summarizes, in a comparative manner, the requirements set forth in RDC 166/2017, in the text of the new draft of the RDC, and the ICH Q2(R2) and ICH Q14 Guidelines, highlighting the ongoing regulatory harmonization movement.

This international convergence runs in parallel with the proposal for eCTD (Electronic Common Technical Document) implementation, promoting modernization and a strategic vision not only in the form of dossier submission but in the very structuring of analytical validation data.

By aligning national requirements with global standards, the goal is to reduce local specificities and facilitate the evaluation of technical information in other countries, ensuring that the adopted strategies are supported by technically and scientifically sound rationales. This alignment favors the recognition of analytical data by other sanitary authorities and strengthens Brazil’s insertion into a more predictable and harmonized global regulatory environment.

The Public Consultation will be open for contributions from April 3, 2026, to June 1, 2026 (60 days). If your company needs assistance in understanding the impact of these changes, please contact us.