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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 Science
Timely 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

An evaluation of drug lag for new drugs approved by the Indian regulator relative to the United States, European Union, and Japanese regulatory agencies: A 15-year analysis (2004–2018)

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, Mitesh R Maurya, Tushar B Nishandar, Urmila M Thatte, Nithya J Gogtay   +4 more
doaj   +2 more sources

Reimbursement Lag of New Drugs Under Taiwan's National Health Insurance System Compared With United Kingdom, Canada, Australia, Japan, and South Korea [PDF]

Clinical and Translational Science, 2020
Drug lag—delayed approval or reimbursement—is a major barrier to accessing cutting‐edge drugs. Unlike approval lag, reimbursement lag is under‐researched.
Yi‐Ru Shih, Kai‐Hsin Liao, Yen‐Hui Chen, Fang‐Ju Lin, Fei‐Yuan Hsiao   +4 more
doaj   +2 more sources

Changes in the Review Period of Drug Application and a Drug Lag from the FDA and the EMA: An Industry Survey in South Korea Between 2011 and 2020. [PDF]

Ther Innov Regul Sci, 2023
Choi H, Lee H, Park B, Kim C, Lee J.
europepmc   +3 more sources

Regulatory Disparities Between US Accelerated Approval and Japanese Authorization of Oncology Drugs: An Analysis of Evidence Quality [PDF]

Clinical and Translational Science
While the accelerated approval (AA) program in the United States expedites the availability of drugs based on preliminary evidence to fulfill unmet medical needs, it has also raised significant concerns, including a lack of robust evidence of efficacy ...
Maho Iwata, Anju Murayama
doaj   +2 more sources

Predicting drug inactivation by changes in bacterial growth dynamics [PDF]

npj Antimicrobials and Resistance
Studying how antibacterials operate at subinhibitory concentrations reveals how they impede normal growth. While previous works demonstrated drugs can impact multiple aspects of growth, such as prolonging the doubling time or reducing the maximal ...
Carmen Li, Serkan Sayin, Ethan Hau Chian Chang, Amir Mitchell   +3 more
doaj   +2 more sources

Evolving Research and Development Landscape for Rare Diseases: Growing Concerns Over Orphan Drug Lag in Japan. [PDF]

Clin Pharmacol Ther
Enya K, Kageyama I, Kobayashi Y, Lim Y, Sengoku S, Kodama K.   +5 more
europepmc   +3 more sources

Drug lag and key regulatory barriers in the emerging markets

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   +2 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)
Alipour S, Nadimi Parashkouhi S, Mojahedian M, Abbasian H.   +3 more
europepmc   +2 more sources

Drug Lag for Inflammatory Bowel Disease Treatments in the East and West. [PDF]

Inflamm Intest Dis, 2018
Okabayashi S, Kobayashi T, Hibi T.
europepmc   +3 more sources