Evolving Research and Development Landscape for Rare Diseases: Growing Concerns Over Orphan Drug Lag in Japan. [PDF]
Clin Pharmacol TherPatients with rare diseases worldwide face substantial unmet therapeutic needs. In Japan, drug lag—delays in drug approval compared to other countries—has resurfaced as a pressing public health issue.
Enya K +5 more
europepmc +4 more sources
Perspectives in Clinical Research, 2021 Background: The approval process of every drug regulatory agency differs, and hence, the time required for the approval of a new drug varies. This results in a drug lag and India is no exception to this phenomenon.
Mahanjit Konwar +4 more
doaj +3 more sources
Assessing drug lag in new drug approvals by the Iran Food and Drug Administration compared to the U.S. FDA, EMA, and PMDA: A 20-year analysis (2001-2021). [PDF]
Medicine (Baltimore)The pharmaceutical industry is vital for healthcare advancement through innovative medications, improving lives. A substantial challenge is “Drug lag,” hindering patient access and increasing disease adjusted life years burdens.
Alipour S +3 more
europepmc +3 more sources
Drug Lag for Inflammatory Bowel Disease Treatments in the East and West. [PDF]
Inflamm Intest Dis, 2018 Background: Inflammatory bowel disease (IBD), though historically common in the West, is now increasingly prevalent in industrializing countries.
Okabayashi S, Kobayashi T, Hibi T.
europepmc +4 more sources
Trends in and Determinants of Approval Lag for Anticancer Drugs in Japan and the US: Role of Multi‐Regional Trials and Concurrent Approvals [PDF]
Clinical and Translational ScienceTimely access to treatment for cancer patients requires the accelerated approval of new anticancer therapies. However, the lengthy pharmaceutical approval process in Japan has contributed to what is known as “drug lag.” Although recent efforts to promote
Hitoshi Kanno, Kotone Matsuyama
doaj +4 more sources
Drug lag and key regulatory barriers in the emerging markets [PDF]
Perspectives in Clinical Research, 2010 There have been numerous investigations targeted at identifying whether a drug lag exists in the mature markets of the US, EU and Japan. This work focuses on the emerging markets because of the potential they hold for the future of the pharmaceutical ...
Harriet Wileman, Arun Mishra
doaj +3 more sources
Drug Lag and Associated Factors for Approved Drugs in Korea Compared with the United States. [PDF]
Int J Environ Res Public Health, 2022 (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.
Cho I, Han E.
europepmc +2 more sources
Eliminating the U.S. drug lag: Implications for drug safety
Journal of Risk and Uncertainty, 2013 An increase in new drugs first launched in the U.S. and shorter lags between first global drug launch and U.S. approval indicate that the U.S. drug lag has declined. This paper examines the impact of these changes on drug safety using adverse drug reaction data for FDA-approved drugs in 1990 to 2004. Results show two different effects.
Mary K. Olson
semanticscholar +4 more sources
Evaluation of drug lag and drug loss in Japan: participation in global phase III oncology trials. [PDF]
Int J Clin OncolDespite efforts to mitigate drug lag, discrepancies in drug approval timelines persist between Japan and the US, and increase in unapproved drugs has become a significant challenge.
Shiga K, Shibata T, Miyata T.
europepmc +2 more sources
Reimagining Early‐Phase Clinical Development in Japan: From Regulatory Obligation to Global Acceleration [PDF]
Clinical and Translational ScienceJapan has faced persistent challenges of “Drug Lag” and “Drug Loss”, partly due to the regulatory requirement for Japanese Phase I studies prior to global trial participation.
Yasunori Kawakita +6 more
doaj +2 more sources