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Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States

Authors
 Inhye Cho  ;  Euna Han 
Citation
 INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH, Vol.19(5) : 2857, 2022-03 
Journal Title
INTERNATIONAL JOURNAL OF ENVIRONMENTAL RESEARCH AND PUBLIC HEALTH
ISSN
 1661-7827 
Issue Date
2022-03
MeSH
Drug Approval* ; Humans ; Orphan Drug Production* ; Pharmaceutical Preparations ; Rare Diseases ; United States ; United States Food and Drug Administration
Keywords
Korean Health Authority (MFDS) ; drug access ; drug lag ; new drug ; regulatory approval
Abstract
(1) Background: Drug lag, the delay between the first global regulatory approval and approval by the national health authorities in other countries, impacts the accessibility of drugs. Although the Korean pharmaceutical market has grown significantly, most of its innovative drugs for public health depend on imports from foreign pharmaceutical markets. (2) Methods: We extracted data from the official websites of the Korean Ministry of Food and Drug Safety (MFDS) and the US Food and Drug Administration. Information on new molecule entity drugs, approved as imported drugs by MFDS from 2000 to 2019, was extracted. Multivariate Cox proportional hazard models on drug approval were estimated. (3) Results: In total, 424 drugs were analyzed. Orphan drugs designated by MFDS were less likely to receive approval (HR = 0.731, 95% CI: 0.572-0.934). The drugs with Korean MAHs were less likely to obtain drug approval than those with MAHs of subsidiaries of multinational pharmaceutical companies (HR = 0.524, 95% CI: 0.371-0.738). In the analyses for non-orphan drugs (n = 37), oncology drugs that need local clinical study (HR = 0.247, 95% CI: 0.093-0.657) and drugs that need more patients in a local clinical study (HR = 0.993, 95% CI: 0.988-0.999) were less likely to receive approval, with longer drug lag. The higher number of clinical studies in Korea was associated with a shorter drug lag (HR = 2.133, 95% CI: 1.196-3.805). (4) Conclusions: Our findings imply that Korean pharmaceutical companies should augment their research capabilities for new drug development. Furthermore, consideration of orphan drugs used in rare diseases is needed for drug approval to ensure the availability of these drugs in the market without approval delays.
Files in This Item:
T9992023112.pdf Download
DOI
10.3390/ijerph19052857
Appears in Collections:
1. College of Medicine (의과대학) > Others (기타) > 1. Journal Papers
URI
https://ir.ymlib.yonsei.ac.kr/handle/22282913/194454
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