Cargando…
Quality of medicines: Deficiencies found by Brazilian Health Regulatory Agency (ANVISA) on good manufacturing practices international inspections
The circulation of poor quality medicines, especially in the developing countries, is a public health concern. Compliance with good manufacturing practices (GMP) is essential to ensure the quality, efficacy, and safety of medicines. This study evaluated the outcomes of the Brazilian Health Regulator...
Autores principales: | Geyer, Andrea Renata Cornelio, Sousa, Varley Dias, Silveira, Dâmaris |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Public Library of Science
2018
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6082550/ https://www.ncbi.nlm.nih.gov/pubmed/30089162 http://dx.doi.org/10.1371/journal.pone.0202084 |
Ejemplares similares
-
A Baseline Analysis of Regulatory Review Timelines for ANVISA: 2013–2016
por: Patel, Prisha, et al.
Publicado: (2020) -
Main Reasons for Registration Application Refusal of Generic and Similar Pharmaceutical Drug Products by the Brazilian Health Regulatory Agency (ANVISA)
por: do Carmo, Ana Cerúlia Moraes, et al.
Publicado: (2017) -
Medical devices registration by ANVISA (Agência Nacional de Vigilância Sanitária)
por: Machado, Aline Fernanda Perez, et al.
Publicado: (2011) -
Good clinical practice regulatory inspections: Lessons for Indian investigator sites
por: Marwah, R., et al.
Publicado: (2010) -
Descriptive Analysis of Good Clinical Practice Inspection Findings from U.S. Food and Drug Administration and European Medicines Agency
por: Sellers, Jenn W., et al.
Publicado: (2022)