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An Evaluation of Malaysian Regulatory Process for New Active Substances Approved in 2017 Using the OpERA Methodology
INTRODUCTION: The National Pharmaceutical Regulatory Agency (NPRA) embarked on a regulatory-strengthening program and is evaluating its processes. Optimising Efficiencies in Regulatory Agencies (OpERA) is a regulatory-strengthening program that provides benchmarking data that can define performance...
Autores principales: | Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md., Patel, Prisha |
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Formato: | Online Artículo Texto |
Lenguaje: | English |
Publicado: |
Springer International Publishing
2020
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Materias: | |
Acceso en línea: | https://www.ncbi.nlm.nih.gov/pmc/articles/PMC7458937/ https://www.ncbi.nlm.nih.gov/pubmed/32865804 http://dx.doi.org/10.1007/s43441-020-00140-4 |
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