Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach

Noraisyah Mohd Sani, Siti Hidayah Kasbon, Kian Yee Yap, Muhamad Firdaus Abdullah, Rosliza Lajis, Azuana Ramli, Neil McAuslane, Magda Bujar, Adem Kermad

Open source

DOI
10.1007/s43441-025-00846-3
Published
2025-07-25
Container
Therapeutic Innovation & Regulatory Science
Publisher
Springer Science and Business Media LLC
Open access
unknown

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BibTeX

@article{allodium:10.1007/s43441-025-00846-3,
  title = {Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach},
  author = {Noraisyah Mohd Sani and Siti Hidayah Kasbon and Kian Yee Yap and Muhamad Firdaus Abdullah and Rosliza Lajis and Azuana Ramli and Neil McAuslane and Magda Bujar and Adem Kermad},
  year = {2025},
  journal = {Therapeutic Innovation \& Regulatory Science},
  doi = {10.1007/s43441-025-00846-3},
  url = {https://doi.org/10.1007/s43441-025-00846-3}
}

RIS

TY  - JOUR
TI  - Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach
AU  - Noraisyah Mohd Sani
AU  - Siti Hidayah Kasbon
AU  - Kian Yee Yap
AU  - Muhamad Firdaus Abdullah
AU  - Rosliza Lajis
AU  - Azuana Ramli
AU  - Neil McAuslane
AU  - Magda Bujar
AU  - Adem Kermad
PY  - 2025
JO  - Therapeutic Innovation & Regulatory Science
DO  - 10.1007/s43441-025-00846-3
UR  - https://doi.org/10.1007/s43441-025-00846-3
ER  - 

APA

Sani, N. M., Kasbon, S. H., Yap, K. Y., Abdullah, M. F., Lajis, R., Ramli, A., McAuslane, N., Bujar, M., & Kermad, A. (2025). Assessing the Malaysian Regulatory Process for Medicinal Product Approval: An OpERA Methodology and Standardized Reporting Approach. Therapeutic Innovation & Regulatory Science. https://doi.org/10.1007/s43441-025-00846-3

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