Quality defects during the marketing of pharmaceutical products and the role of regional regulatory authorities

Abstract

Introduction: Quality defects are breaches of quality specifications approved in the health authorization of a medicinal product for human use.

Objective: Describe the role of regional regulatory authorities in the presence of quality defects during the marketing of pharmaceutical products.

Methods: A qualitative, bibliographic and documentary review study was carried out with the use of keywords. National and international electronic publications related to the subject under study and the websites of national regulatory authorities, the World Health Organization and the Pan American Health Organization were consulted.

Conclusions: Regional regulatory authorities, in general, approach the surveillance of quality defects during the marketing of pharmaceutical products from their perspective as a country, and establish their own regulatory framework and priorities according to existing and expected health risks. These audit and control bodies continuously adapt to the changing needs related to the development of the pharmaceutical industry and the market and prevent with their effective action the commercialization of ineffective, harmful or poor quality medicines.