Cargando…
Evaluation of Risk-Based Approaches to the Registration of Medicines: Current Status Among African Regulatory Authorities
BACKGROUND: Despite the worldwide need for increased access to safe and effective medicines, there is a lack of innovative medicines in many low- to middle-income countries. On the African continent, this is partly due to capacity limitations of National Regulatory Authorities (NRAs). One important...
Autores principales: | McAuslane, Neil, Bujar, Magda, Sithole, Tariro, Ngum, Nancy, Owusu-Asante, Mercy, Walker, Stuart |
---|---|
Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2023
|
Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC10113993/ https://www.ncbi.nlm.nih.gov/pubmed/37074548 http://dx.doi.org/10.1007/s40290-023-00472-0 |
Ejemplares similares
-
Quality Decision-Making Practices in Pharmaceutical Companies and Regulatory Authorities: Current and Proposed Approaches to Its Documentation
por: Bujar, Magdalena, et al.
Publicado: (2020) -
FDA Facilitated Regulatory Pathways: Visualizing Their Characteristics, Development, and Authorization Timelines
por: Liberti, Lawrence, et al.
Publicado: (2017) -
Evaluating Quality of Decision-Making Processes in Medicines' Development, Regulatory Review, and Health Technology Assessment: A Systematic Review of the Literature
por: Bujar, Magdalena, et al.
Publicado: (2017) -
The Qualitative Value of Facilitated Regulatory Pathways in Europe, USA, and Japan: Benefits, Barriers to Utilization, and Suggested Solutions
por: Bujar, Magdalena, et al.
Publicado: (2021) -
The Reliability and Relevance of a Quality of Decision Making Instrument, Quality of Decision-Making Orientation Scheme (QoDoS), for Use During the Lifecycle of Medicines
por: Bujar, Magdalena, et al.
Publicado: (2019)