| Revista: | Brazilian Journal of Pharmaceutical Sciences |
| Base de datos: | PERIÓDICA |
| Número de sistema: | 000452063 |
| ISSN: | 1984-8250 |
| Autores: | Neves, Edvaldo Oliveira1 Sales, Paloma Michelle de2 Silveira, Dâmaris2 |
| Instituciones: | 1Agencia Nacional de Vigilancia Sanitaria, Brasilia, Distrito Federal. Brasil 2Universidade de Brasilia, Faculdade de Ciencias da Saude, Brasilia, Distrito Federal. Brasil |
| Año: | 2022 |
| Volumen: | 58 |
| País: | Brasil |
| Idioma: | Inglés |
| Tipo de documento: | Artículo |
| Enfoque: | Analítico, descriptivo |
| Resumen en inglés | The globalization of the pharmaceutical market has enabled access to a considerable number of new medicinal products. Consequently, the circulation of substandard medicinal products has also increased. To minimize this problem, post-marketing quality sampling and testing programs are performed to monitor and confirm that the medicinal products available in the market meet appropriate quality requirements. In this review, the post-approval sampling and testing procedures of six regulatory authorities were compared with the goal of strengthening these market surveillance systems. Similarities were observed between the procedures adopted by different regulatory authorities. However, the agencies were not always transparent about the results of these monitoring procedures. A probable mismatch between the registration procedures and the quality requirements listed in official compendiums was observed, which resulted in dissonance and contradiction between the specifications approved by the regulatory authorities and those required in the pharmacopeias. Therefore, strengthening harmonization projects related to these activities can help minimize such difficulties |
| Disciplinas: | Química |
| Palabras clave: | Química farmacéutica, Fármacos, Control de calidad, Productos farmacéuticos, Farmacopea |
| Keyword: | Medicinal chemistry, Drugs, Quality control, Pharmaceutical products, Pharmacopeia |
| Texto completo: | Texto completo (Ver HTML) Texto completo (Ver PDF) |
