LAUSR

National Pharmacovigilance Systems (PVS) manage health risks and identify, assess, and act to minimize them, contributing to adequate use of medicines, patient safety, and improved quality of care. Fast-track drug registration, which has become increasingly frequent, hinders assessment of the efficacy and safety of new drugs, adding difficulties to current regulation and health protection. The article applies indicators proposed by the World Health Organization to analyze the National PVS of Portugal and Brazil. Brazil's PVS was established later than that of Portugal, generates fewer safety signals, has a lower notification rate for suspected adverse drug events (ADEs), and displays difficulty in producing and disseminating information to health professionals and the population. Portugal has the advantage of being a member state of the European Medicines Agency. The article also suggests that the differences are related to the political and social context that hinders the implementation of public policies and compromises the effectiveness of the Brazilian PVS. Challenges for PVS include awareness-raising of health professionals, the adoption of methods to complement voluntary notification, pharmacovigilance of biological and genetic drugs, and assessment of the system's impact. An additional challenge for the Brazilian PVS is to improve the notifications' uptake and quality, including from industry, generate safety signals in the national context, and communicate risk in timely fashion to health professionals and the population.