Analysis of the new regulatory framework for active pharmaceutical ingredients in Brazil: an official pharmaceutical laboratory experience

Vigil Sanit Debate, Rio de Janeiro, 2023, v.11: e02161 | Published on: 17/08/2023

Abstract

Introduction: The new regulatory framework for active pharmaceutical ingredients comprises three resolutions edited by the National Health Surveillance Agency, the RDC No. 359, of March 27, 2020, the RDC No. 361, of April 1, 2020, and the RDC No. 672, of March 30, 2022.These regulations start new approaches to regularize the active pharmaceutical ingredient in the country. Objective: To demonstrate how the internalization of the legal and health requirements established by the new regulatory framework for active ingredients was absorbed and implemented by Farmanguinhos, an Official Pharmaceutical Laboratory. Method: Descriptive cross-sectional study based on data collection from the legal framework edited by the Brazilian Health Regulatory Agency, and the practical experience of Farmanguinhos, the main medicines supplier to the Ministry of Health. Results: The main result of this study was the survey of the needs for the implementation of the new framework by the Official Pharmaceutical Laboratories, observing the greater sanitary and regulatory rigor imposed on manufacturers of active ingredients and the reflection of this in the proposed adequacy of operational procedures at Farmanguinhos. Conclusions: This study concludes that it is up to the Official Pharmaceutical Laboratories to intermediate and act as facilitators in the relations between active pharmaceutical ingredients manufacturers, by reviewing their procedures and editing support tools, leading to the incorporation of requirements and, in parallel, facilitating the optimization of activities and actions aimed at the implementation of a new regulatory reality, both internally and by the manufacturers of inputs.