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...

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Detalles Bibliográficos
Autores principales: Sani, Noraisyah Mohd, McAuslane, Neil, Kasbon, Siti Hidayah, Ahmad, Rosilawati, Yusof, Faridah Aryani Md., Patel, Prisha
Formato: Online Artículo Texto
Lenguaje:English
Publicado: Springer International Publishing 2020
Materias:
Original Research
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

Internet

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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