ArticleInternational journal of environmental research and public health2022
Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States.
Article in International journal of environmental research and public health, 2022. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers.
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13 citing papers in PubMed, 20 citations in OpenAlex.
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- Disparities in access to systemic therapies for patients with hepatocellular carcinoma: an analysis from the International Liver Cancer Association.The Lancet regional health. Europe · 2025Review
- Trends in and Determinants of Approval Lag for Anticancer Drugs in Japan and the US: Role of Multi-Regional Trials and Concurrent Approvals.Clinical and translational science · 2025Article
- Characteristics of Drugs from Non-Global Companies for Hematologic Malignancies and Impact on Global Regulatory Approval.Clinical pharmacology and therapeutics · 2025Article
- Disparities in the access to immune checkpoint inhibitors approved in the United States, the European Union and mainland China: a serial cross-sectional study.BMJ public health · 2025Article
- Drug lag and associated factors of orphan drugs approved by the U.S. in China.Frontiers in pharmacology · 2025Article
- Extent and causes of the collapse in the registration of innovative medications in Lebanon: A mixed-methods analysis.PloS one · 2025Article
- Research on unintroduced new drugs in South Korea from 2011 to 2020: approaches to prioritization and strategy.Translational and clinical pharmacology · 2024Article
- Asia Core Dossier: Standardizing CMC Requirement to Facilitate Best Case Submissions in Asia.Therapeutic innovation & regulatory science · 2024Article
- International comparison of availability for orphan drugs: focused on approved orphan drugs in South Korea.Journal of pharmaceutical policy and practice · 2024Article
- Trends and Clinical Characteristics of Next-Generation Sequencing-Based Genetic Panel Tests: An Analysis of Korean Nationwide Claims Data.Cancer research and treatment · 2024Article
- An Empirical Analysis of Anti-Cancer Drug Lags in South Korea.Inquiry : a journal of medical care organization, provision and financingArticle
Corrections and comments
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Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
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 (
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