OBJECTIVES: Recent regulatory changes in the Brazilian medicines market may be associated with alterations in quality and quantity of market approvals. This study aimed to analyze the profile and trends of medicines approvals in Brazil between 2012 and 2017.

METHODS: A retrospective search of market approved medicines was carried out in the National Health Surveillance Agency (Anvisa) website, between September and November 2018. Search variables included medicine regulatory category (biologic, new, generic, similar, dynamized, phyto-therapeutic, radiopharmaceutical and specific), active substance and dosage form, approval type (market approvals granted/year or expired/cancelled), date (Jan 01 2013 to Dec 31 2017). Outcome variables were total number of market approvals, total number of dosage forms and annual proportion of approvals within each regulatory category. Descriptive analysis was performed. Linear regression using Pearson's correlation coefficient (R²) was done for trend evaluation of proportions within regulatory category.

RESULTS: Relative frequency of approvals granted by active substance increased during the period, from 49.0% to 96.1% between 2012-2017. In turn, frequency of cancelled/expired approvals decreased (51.0% to 3.9%). The same trends were observed for number of granted and cancelled/expired approvals for dosage forms. From 2014 to 2015, a 2.6-fold increase in approvals by active substance and a 3.2-fold increase in approvals of dosage forms was identified. For regulatory categories excepting biologics, a non-linear dependency between time and number of approvals was observed. For biologics, a strong linear growth trend was seen. In general, proportions within category varied in accordance to total number of approvals. Important increases were seen from 2014 to 2015 for biologics (1.8-fold), generics (2.7-fold), and similars (6-fold).

CONCLUSIONS: RDC n° 37/2014 prioritized claims and shortened the time for pre-approval analyses, leading to an increase in market approvals of some categories of medicines. While broadening the market, it poses considerable difficulties for appropriate regulation in Brazil.