In a pivotal step toward modernizing its medication evaluation processes, Brazil’s National Health Surveillance Agency (ANVISA) has implemented an artificial intelligence (AI) tool to streamline impurity qualification analyses in pharmaceuticals. This innovation aims to speed up and enhance the efficiency of drug registration and post-registration processes, with a particular emphasis on ensuring product safety for the Brazilian public.

ANVISA’s AI tool enables faster, more accurate analysis of impurity qualification studies, applicable to new, innovative, generic, and similar medications. The impurity qualification process is critical when substance levels exceed the safety limits established by RDC 53/2015, as well as international guidelines and recognized pharmacopeias. In such cases, companies must provide data proving the safety of identified impurities.

“One of the primary advantages of this technology is its ability to reuse data from previously qualified impurities in prior analyses, enabling a more agile and structured verification process. Qualified impurities will thus have their safety swiftly confirmed, facilitating ANVISA’s decision-making through a more systematic data-based approach,” explained Viviane Kunisawa, partner at Daniel Law.

This measure aligns with the recent establishment of the Qualified Impurities List under Normative Instruction 258/2023, aimed at expediting analysis and improving process transparency. Beyond aiding ongoing analyses, the new AI tool is expected to positively impact future regulatory updates, making relevant information accessible and up to date for companies and researchers.

For processes already underway, all impurity qualification petitions will automatically transition to the new system, requiring no additional action from companies. ANVISA anticipates that AI implementation will accelerate the conclusion of many processes, reducing waiting times for new registrations and market updates.

ANVISA emphasizes that using AI in its processes underscores its commitment to protecting Brazilian public health while adopting more agile, efficient practices to meet the pharmaceutical sector’s regulatory demands.