Drug Regulatory Systems in Comparative Perspective: A Tri-National Study of the United States, the Philippines, and Ghana
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| Format: | Recurso digital |
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2025
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| _version_ | 1866901949772726272 |
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| author | Abishek R., Deevan Paul A.* |
| author_facet | Abishek R., Deevan Paul A.* |
| contents | <p><span>Making sure that medicinal products are safe, effective, and of guaranteed quality is crucial for public health protection, which is achieved through pharmaceutical regulation. This study compares the pharmaceutical regulatory systems of the United States, the Philippines, and Ghana, highlighting differences in structure, processes, and capacity. The U.S. FDA is a global standard, with robust approval pathways (IND, NDA, ANDA), strong post-marketing surveillance, and international harmonization. The Philippine FDA is undergoing reform, adopting the ACTD for ASEAN harmonization, but faces infrastructure and resource challenges. Ghana’s FDA has achieved WHO GBT Maturity Level 3 and engages in AMRH initiatives, though funding and technical limitations persist. The analysis underscores the need for ongoing investment in regulatory modernization and capacity building, especially in low- and middle-income countries.</span></p> |
| format | Recurso digital |
| id | zenodo_https___doi_org_10_5281_zenodo_15634462 |
| institution | Zenodo |
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| publishDate | 2025 |
| publisher | Zenodo |
| record_format | zenodo |
| spellingShingle | Drug Regulatory Systems in Comparative Perspective: A Tri-National Study of the United States, the Philippines, and Ghana Abishek R., Deevan Paul A.* CTD, ACTD, WHOGBT, USFDA, NDA, ANDA, FDA <p><span>Making sure that medicinal products are safe, effective, and of guaranteed quality is crucial for public health protection, which is achieved through pharmaceutical regulation. This study compares the pharmaceutical regulatory systems of the United States, the Philippines, and Ghana, highlighting differences in structure, processes, and capacity. The U.S. FDA is a global standard, with robust approval pathways (IND, NDA, ANDA), strong post-marketing surveillance, and international harmonization. The Philippine FDA is undergoing reform, adopting the ACTD for ASEAN harmonization, but faces infrastructure and resource challenges. Ghana’s FDA has achieved WHO GBT Maturity Level 3 and engages in AMRH initiatives, though funding and technical limitations persist. The analysis underscores the need for ongoing investment in regulatory modernization and capacity building, especially in low- and middle-income countries.</span></p> |
| title | Drug Regulatory Systems in Comparative Perspective: A Tri-National Study of the United States, the Philippines, and Ghana |
| topic | CTD, ACTD, WHOGBT, USFDA, NDA, ANDA, FDA |
| url | https://doi.org/10.5281/zenodo.15634462 |