Many nations in the developing world look to Brazil’s drug licensing agency, the National Agency of Sanitary Vigilance (ANVISA), as a model to emulate. Last week, the outgoing president of ANVISA, Jaime Oliveira, said ANVISA should decrease the time it takes to analyze the registration of new products and spend more time monitoring “what is on the pharmacy counter.”
Per Oliveria, ANVISA should dedicate more time going into drugstores and supermarkets to check whether the products it has already approved are being manufactured and sold according to appropriate quality standards.
This makes ANVISA the latest big nation regulatory agency to recognize the growing urgency in quality management and post-marketing surveillance. As more and more regulatory bodies (including the EMA and the USFDA) refocus their attentions on bioequivalence, API and excipient sourcing, and cGMPs, Mr. Oliveria’s statement reinforces the urgency and importance of both pre-market scrutiny and real world integrity.
ANVISA: The War is in the Store
Center for Medicine in the Public Interest is a nonprofit, non-partisan organization promoting innovative solutions that advance medical progress, reduce health disparities, extend life and make health care more affordable, preventive and patient-centered. CMPI also provides the public, policymakers and the media a reliable source of independent scientific analysis on issues ranging from personalized medicine, food and drug safety, health care reform and comparative effectiveness.
