Greater Rigor and Safety: ANVISA’s New Guidelines for Impurities and Degradation Products in Medicines
The National Health Regulatory Agency (ANVISA) has published a new set of guidelines regarding the classification, identification, and control of impurities and degradation products in medicines. This update is crucial for the pharmaceutical industry as it establishes clearer and more rigorous criteria for demonstrating product safety and quality. The focus of the new guidelines is to harmonize national practices with international guidelines and ensure that acceptable limits for these substances are consistently monitored throughout the drug’s lifecycle, from production to expiration date.
New Guidance on Forced Degradation Studies for Medicines in Brazil
The stability of medicines is one of the fundamental pillars to ensure their efficacy, safety, and quality throughout their shelf life. In this context, forced degradation studies are essential tools for drug development and stability assessment. Recently, Anvisa published new guidance establishing clear directives for conducting these studies in Brazil, providing greater consistency and transparency for the pharmaceutical industry.