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Implementation of a Framework for an Abridged Review Using Good Reliance Practices: Optimising the Medicine Regulatory Review Process in South Africa
BACKGROUND: This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an abridged review process in South Africa based on good re...
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| Pubblicato in: | Ther Innov Regul Sci |
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| Autori principali: | , , , , , |
| Natura: | Artigo |
| Lingua: | Inglês |
| Pubblicazione: |
Springer International Publishing
2020
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| Soggetti: | |
| Accesso online: | https://ncbi.nlm.nih.gov/pmc/articles/PMC7458939/ https://ncbi.nlm.nih.gov/pubmed/32865802 https://ncbi.nlm.nih.govhttp://dx.doi.org/10.1007/s43441-020-00144-0 |
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