Brazilian Health Regulatory Agency work in framing borderline products: a documentary research

Abstract

Introduction: The majority of  products subject to health surveillance can be easily  classified into medicines, medical devices, cosmetics, sanitizers or food, for purposes of regularization at the Brazilian Health Regulatory Agency (Anvisa). However, there are  products, called “borderline products”, that share characteristics of several of these categories simultaneously, making it difficult to comply with the current health legislation. Objective: To describe Anvisa’s role in the regulatory framework for borderline products for marketing purposes in Brazil. Method: Documentary research of a descriptive nature and qualitative and quantitative approach carried out based on documents produced by Anvisa, such as normative acts, reports and technical opinions and minutes of meetings. The elaboration of the narrative was based on a selective, judicious and iterative process. The numerical values were expressed in absolute and relative frequencies, the median being used as a measure of central tendency. Results: Twenty-seven documents were analyzed. Anvisa instituted a technical committee in October 2015, with the task of subsidizing decisions of its Collegiate Board (Dicol) on the framing of borderline products. It is formed by representatives from the marketing authorization areas, post-market monitoring, inspection and improvement of regulatory quality. The committee adopted five borderline demarcation criteria, based on the experience of other international regulatory agencies. Between 2017 and 2019, the committee issued ten opinions that had Dicol’s deliberations. In five cases, the border demarcation involved two types of product   categories, namely: drug products and medical devices. Sixty-two citations were identified in the eight borderline product framing opinions, most of which were classified as gray literature (n = 53; 85.5%). Conclusions: Anvisa has recently taken a more systematic and integrated approach to the issue of framing borderline products, with the creation of a technical committee formed by representatives of the areas responsible for product marketing authorization, inspection, monitoring and regulation. The current   conformation of the committee produced, in 2019, a greater number of opinions in relation to the previous years studied.