Reference
·Primary source
Thai FDA new drug registration approvals (2020-2024)
~450-500 approvals (2024)
The Thai Food and Drug Administration issued approximately 450-500 new drug registration approvals (NDR) in 2024 per FDA annual statistics, with the cohort split roughly 35-40% originator brands, 50-55% generics, and the residual biologics and biosimilars. Approvals dipped to roughly 380 in 2020 as COVID disrupted regulatory workflow, recovered to 420 in 2022, and continued the upward trajectory through 2024 as the FDA implemented digitised submission portals and accelerated parallel review for high-priority therapeutic categories (oncology, infectious disease, rare disease).
Figure in context
The Thai Food and Drug Administration issued approximately 450-500 new drug registration approvals (NDR) in 2024 per FDA annual statistics, with the cohort split roughly 35-40% originator brands, 50-55% generics, and the residual biologics and biosimilars. Approvals dipped to roughly 380 in 2020 as COVID disrupted regulatory workflow, recovered to 420 in 2022, and continued the upward trajectory through 2024 as the FDA implemented digitised submission portals and accelerated parallel review for high-priority therapeutic categories (oncology, infectious disease, rare disease).
Interpretation notes
What this tells you
The Thai Food and Drug Administration issued approximately 450-500 new drug registration approvals (NDR) in 2024 per FDA annual statistics, with the cohort split roughly 35-40% originator brands, 50-55% generics, and the residual biologics and biosimilars. Approvals dipped to roughly 380 in 2020 as COVID disrupted regulatory workflow, recovered to 420 in 2022, and continued the upward trajectory through 2024 as the FDA implemented digitised submission portals and accelerated parallel review for high-priority therapeutic categories (oncology, infectious disease, rare disease).
What not to do with it
Values are count of new drug registrations approved by Thai FDA, all categories.
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