Professional competencies in National Regulatory Agencies

Abstract

Introduction: professional skills allow the individual to take charge of their responsibilities; Training will make you achieve more and more skills, attitudes and knowledge.

Objectives: define professional competencies in regulatory authorities for medicines and medical devices according to their area of ​​work.

Methodology: a bibliographic review was carried out between December 2024 and March 2025, whose information was recovered from Google Scholar, through a strategy with Boolean operators. 41 bibliographic sources were consulted, resulting in 26 bibliographic references. Articles in English and Spanish and published in the last five years were considered. Those that did not have a complete text were excluded, as well as monographs.

Development: the structure of the Global Tool for the evaluation of national regulatory systems for medical products (GBT), of the World Health Organization (WHO), was taken as a reference to describe the professional competencies necessary for professionals who work in the areas of the National Regulatory Authorities (RNA).

Conclusions: among the main competencies that a regulatory affairs professional must possess are: possessing laboratory knowledge, surveillance and control of medications, medical equipment and devices; follow a strategic and innovative approach; master the legal provisions and control standards of their area of ​​action; foster a culture of cooperation and be a leader in the public health sector.