Regulation of substances by ANVISA: Historical-normative analysis and contribution to collective health

Abstract

In Brazil, the control of narcotics and pharmaceuticals of greater risk of use by the population follows provisions under Ordinance 344/1998 and the Resolutions of the Collegiate Board (RCB) of the National Health Surveillance Agency (ANVISA – Agência Nacional de Vigilância Sanitária. The inclusion of new substances in control lists is one of ANVISA’s duties, assigned since 1999. This article investigated the frequency of updates of control lists and substances included in the period between 1999 and 2024. In that purpose, a time series study was carried out through consultations to RCB published by ANVISA over that period. Ninety-two updates were identified which included 375 substances: 179 pharmaceuticals and 196 narcotics. List F2, of proscribed psychotropic substances, and list C1, of special controlled therapeutic substances, received 152 and 75 substances, respectively. It was observed, therefore, that narcotics inclusions exceeded those of pharmaceuticals, especially after 2013 (p=0.008), a period that followed the global rise of new psychoactive substances. The frequent inclusion of substances with high risk of addiction and irreversible damage to the body, whether pharmaceuticals or narcotics, reflects the commitment of ANVISA with the public health protection.