The Minister of Health, Alexandre Padilha, during a visit to Ribeirão Preto, SP Valdinei Malaguti/EPTV Rare reactions to vaccines, unexpected side effects of medications and other possible signs of risk will now be monitored by a new body created by the Ministry of Health. The National Medicines Monitoring Center (CNMM), established by ordinance published this Friday (12), will be based at the National Health Surveillance Agency (Anvisa) and will have the mission of analyzing adverse events, issuing safety alerts and supporting the adoption of regulatory measures when necessary. The body will also represent the country in the World Health Organization's (WHO) global pharmacovigilance network, which brings together notifications of adverse events sent by more than 100 countries to detect rare or unexpected safety problems related to medicines and vaccines. Suspension of the Butantan dengue vaccine: what are the next steps What changes Although Anvisa already carried out pharmacovigilance activities, the new ordinance formalizes the national structure responsible for concentrating these actions and reinforces the country's integration into the international monitoring system. The center's responsibilities include: identify safety issues related to medicines and vaccines; develop databases and periodic analyzes of adverse events; manage safety signals; transmit Brazilian notifications to the WHO global network; disseminate alerts, bulletins and reports to health professionals; propose regulatory measures when risks to the population are identified. The text also defines that the National Immunization Program (PNI) will act as a collaborator of the new center in monitoring the so-called Events Supposedly Attributable to Vaccination or Immunization (Esavi), the technical name given to occurrences recorded after the application of vaccines. Relationship to the vaccine debate The publication comes at a time when the topic of vaccine safety has returned to the center of public health discussions. This week, health authorities and experts reinforced the importance of surveillance systems after discussions involving adverse events associated with dengue vaccines. Although the occurrence of serious reactions is considered rare, continuous monitoring of these cases is one of the pillars for evaluating the relationship between a health event and vaccination. According to the Ministry, the notification of an adverse event does not necessarily mean that it was caused by the vaccine or the medicine. The objective of monitoring systems is to gather a large volume of data to identify patterns, investigate possible associations and, when necessary, adopt security measures.