A pré-qualificação de medicamentos: análise comparativa entre OMS e Anvisa

Abstract

The production of medicines with quality, safety and efficacy is essential to meet national and international requirements, aiming at subsidizing pharmaceutical care within the public health. Given the strategic role in which the public health industrial complex is inserted, compliance with Good Manufacturing Practices (GMP) of the World Health Organization (WHO) is essential to export its drugs via international organizations. The objectives of this article were to identify the main technical requirements recommended by WHO and enforced by the Brazilian Health Regulatory Agency (Anvisa), for compliance and recognition of GMP for medicinal products, and to compare them critically, to obtain the prequalification of medicines. This literature and documentary review promoted a comprehensive approach on national regulations and WHO guidelines. This work enabled to show a high degree of harmonization concerning the topics/subtopics compared between WHO and the national standards guides imposed by Anvisa about GMP, which demonstrates an integration of the national legislation in the international context, corroborating the alignment between Anvisa and WHO regarding compliance with GMP.