Flexibilization of Brazilian Good Manufacturing Practices requirements during COVID-19 outbreak in a comparative perspective

• Autor(a) principal: Cassano, Adriano Olian
• Data de Publicação: 2020
• Outros Autores: Areda, Camila Alves
• Tipo de documento: Artigo
• Idioma: por; eng
• Título da fonte: Vigilância Sanitária em Debate
• Texto Completo: https://visaemdebate.incqs.fiocruz.br/index.php/visaemdebate/article/view/1710
• topic: COVID-19; Anvisa; Good Manufacturing Practices; Medicines; Flexibilization; COVID-19; Anvisa; Boas Práticas de Fabricação; Medicamentos; Flexibilização

Introduction: The risk of drug shortages due to the COVID-19 pandemic required from national health authorities to take quick actions in order to avoid it and, at the same time, preserve the maintenance of a minimum standard of quality, safety and efficacy of medicines, as National Health Regulatory Agency (Anvisa) did by publishing RDC nº 392/2020. Objective: To carry out a comparative analysis between the exceptionalities listed in article 7 of RDC nº 392/2020 with the requirements of good manufacturing practices (GMP) exceptionally relaxed by foreign health authorities due to COVID-19, showing, whenever necessary, the impact of these requirements on the quality of medicines made available to the population. Method: A selective search was made for documents related to the temporary flexibility of GMP requirements for medicines and pharmaceutical ingredients during the COVID-19 pandemic at the electronic addresses on the internet of some health authorities. Such requirements were critically compared with those listed in article 7 of RDC nº 392/2020. Results: Exceptionalities were presented in a Table, detailing the topics and subtopics found in the analyzed documents of MHRA, EMA and Anvisa. More similarities were verified than differences between the flexible requirements, perhaps because RDC nº 392/2020 was prepared considering the documents referenced here from MHRA and EMA. Conclusions: Despite the mistakes pointed out and the criticisms made to RDC nº 392/2020, the merit of Anvisa cannot be diminished, as it was shown that regardless of the territory in which the regulatory agencies are located, there is considerable convergence among Brazilian expectations and those of the other health authorities consulted.