New tool makes the identification process faster for later grouping and systematization of data, says agency
A (National Health Surveillance Agency) on Friday (8.Nov.2024) which adopted a new tool that uses AI (artificial intelligence) to improve the analysis of impurity limits in medicines.
The objective is to optimize the analysis of qualification studies on the limits of impurities and degradation products in synthetic medicines, classified as new, innovative, generic and similar.
In Brazil, pharmaceutical companies must provide detailed data on impurities in their products. Anvisa analyzes this information to ensure that the quantities of impurities are within safe limits.
“The qualification analysis of impurities and degradation products is an integral part of the safety analysis within the scope of registration and post-registration of medicines. The activity is mandatory when the limits found in the products are higher than the limits established by the standard (RDC 53/2015), by international guides on the subject and by Pharmacopoeias recognized by Anvisa”he said in a note.
The introduction of AI allows for faster and more accurate identification of impurities, facilitating the grouping and systematization of data, offering information in a more structured way to assist Anvisa’s decision-making.
According to the agency, the new tool promises to bring efficiency to the process, taking advantage of previous knowledge about impurities that can occur in different medicines. This speeds up qualification analysis and contributes to more effective management of collected data.
All impurity qualification petitions awaiting analysis will be submitted to the new tool. For petitions already filed with the Agency, no additional action by the companies will be necessary, according to Anvisa.
