Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017

This article reviews the literature related to the “drug lag” issue, i.e., the issue of whether important new drugs are introduced relatively late, or, in certain cases, are introduced at all, in a particular country. The literature can be divided into two main parts: studies primarily related to the delay in introduction of new drugs and studies primarily related to the number of introduced new drugs. Most studies have found the United States, Sweden, and Norway to have a long delay in the introduction of new drugs. The United Kingdom and (West) Germany in general have the shortest delay. There are also large differences in the number of introduced new drugs. In most studies, the United States and Norway have introduced far fewer new drugs than any other industrialized country. In general (West) Germany, France, the United Kingdom, and Italy have introduced the largest number of new drugs. One of the reviewed studies presented a relationship between regulatory processing time and delay in introduction. Another study found an increasing influence of regulatory stringency on the number of introduced new drugs in a country. If a country's aim is to decrease the delay in introduction and/or to increase the introduction of important new drugs, a review of the local regulatory agencies and the regulations seems worthwhile.

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The Drug Lag: An Interpretive Review of the Literature

International Journal of Health Services ◽

10.2190/pc15-wpvk-5k1w-jcp4 ◽

1977 ◽

Vol 7 (3) ◽

pp. 359-381 ◽

Cited By ~ 5

Author(s):

Leonard G. Schifrin ◽

Jack R. Tayan

Keyword(s):

Information System ◽

Drug Users ◽

Drug Information ◽

New Drugs ◽

Weight Of Evidence ◽

Negative Effects ◽

New Drug ◽

Fundamental Reason ◽

Drug Lag ◽

The U.S

This article reviews the literature pertinent to the “drug lag” issue, in order to evaluate the evidence underlying the thesis that the U.S. has suffered from a slowdown in the rate and timing of new drug introductions, to the detriment of patients, because of the stricter requirements since 1962 regarding proof of safety and efficacy for new drugs. Comparing the post-1962 record in the U.S. with (a) the U.S. record before 1962 and (b) the post-1962 record in other, mainly Western European, countries, the weight of evidence and argument falls on the side of those who see a lag existing in the U.S. Other evidence, more subjective, supports the view that this lag imposes net positive costs on U.S. patients. However, it is not clear that the 1962 Drug Act is the sole, or even the main, cause of the lag. Instead, the drug information system and its inefficiencies emerge as the fundamental reason for the existence of a lag; hence, changes in the administration of the law by the Food and Drug Administration and greater efficiency by companies in supporting New Drug Applications can help close the gap, but probably only in minor degree. The solution to the lag problem lies in formulating and implementing a drug information system that quickly and accurately gathers, interprets, and disseminates information on the positive and negative effects of newly introduced drugs; with such a system, protection of drug users from undue risk is compatible with a greater rate and more rapid appearance of new drug discoveries.

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Availability and drug lag of new medicines in South Korea

European Journal of Public Health ◽

10.1093/eurpub/ckz186.388 ◽

2019 ◽

Vol 29 (Supplement_4) ◽

Author(s):

K Son

Keyword(s):

United States ◽

South Korea ◽

Statistical Estimation ◽

Cox Model ◽

The United States ◽

New Drugs ◽

Event History ◽

Factors Affecting ◽

Drug Lag ◽

Korean Market

Abstract Introduction This study aims to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate various factors affecting timely availability of new medicines in Korean market. Methods We construct two models for the analysis; logistic and Cox model. First, we provide the logistic regression to analyze the availability of new medicines in Korean market. Second, we are interested in the timely availability of new medicines in Korea. Therefore, we calculated the drug lag between the United States and South Korea, and applied an event history model for a statistical estimation. Results There have been 160 NDAs approved by the FDA in the United States between 2007 and 2015. Among 160 new drugs approved in the United States during the study period, 112 NDAs (70%) were also approved by the MFDS in Korea, while 48 new drugs (30%) are not currently available in the Korean market. In addition, we are interested in the order of timing for market approval for 112 NDAs that approved in both countries. Not surprisingly, 95 NDAs (85%) were approved in the United States, and then approved in Korea, while 17 NDAs (15%) were approved in Korea, and then approved in the United States. Conclusions Compared to the United States, a striking drug lag was observed in Korea. For the new drugs approved between 2007 and 2015, the median approval lag ranged from 1.72 years in 2013 to 5.84 years in 2007. Presence of the manufacturers in Korea and medicines belonging to the antineoplastic agents were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea compared to the reference. Key messages Compared to the United States, a striking drug lag was observed in Korea. Presence of the manufacturers in Korea were not only positively associated with the availability in Korea, but also accelerated the time to approval in Korea.

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Legislation, Regulation, Drug Lag, and New Drugs

JAMA ◽

10.1001/jama.1979.03290390083055 ◽

1979 ◽

Vol 241 (13) ◽

pp. 1405

Keyword(s):

New Drugs ◽

Drug Lag

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Notable Differences in Drug Lag Between Korea and Japan of New Drugs Between 2009 and 2017

Therapeutic Innovation & Regulatory Science ◽

10.1177/2168479019838468 ◽

2019 ◽

pp. 216847901983846

Author(s):

Sang-Won Lee ◽

So-Hee Park ◽

Inmyung Song ◽

Yunha Noh ◽

Hyekyung Park ◽

...

Keyword(s):

New Drugs ◽

Drug Lag

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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 ◽

10.4103/picr.picr_99_19 ◽

2021 ◽

Vol 0 (0) ◽

pp. 0

Author(s):

NithyaJ Gogtay ◽

Mahanjit Konwar ◽

MiteshR Maurya ◽

TusharB Nishandar ◽

UrmilaM Thatte

Keyword(s):

United States ◽

European Union ◽

The United States ◽

New Drugs ◽

Regulatory Agencies ◽

Drug Lag

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Two isoprenylated flavonoids from Dorstenia psilurus activate AMPK, stimulate glucose uptake, inhibit glucose production and lower glycemia

Biochemical Journal ◽

10.1042/bcj20190326 ◽

2019 ◽

Vol 476 (24) ◽

pp. 3687-3704 ◽

Cited By ~ 2

Author(s):

Aphrodite T. Choumessi ◽

Manuel Johanns ◽

Claire Beaufay ◽

Marie-France Herent ◽

Vincent Stroobant ◽

...

Keyword(s):

Glucose Uptake ◽

Human Cancer ◽

Glucose Production ◽

Liver Mitochondria ◽

New Drugs ◽

Structural Isomer ◽

Rat Liver Mitochondria ◽

Ionization Mass ◽

Ampk Activation ◽

Starting Point

Root extracts of a Cameroon medicinal plant, Dorstenia psilurus, were purified by screening for AMP-activated protein kinase (AMPK) activation in incubated mouse embryo fibroblasts (MEFs). Two isoprenylated flavones that activated AMPK were isolated. Compound 1 was identified as artelasticin by high-resolution electrospray ionization mass spectrometry and 2D-NMR while its structural isomer, compound 2, was isolated for the first time and differed only by the position of one double bond on one isoprenyl substituent. Treatment of MEFs with purified compound 1 or compound 2 led to rapid and robust AMPK activation at low micromolar concentrations and increased the intracellular AMP:ATP ratio. In oxygen consumption experiments on isolated rat liver mitochondria, compound 1 and compound 2 inhibited complex II of the electron transport chain and in freeze–thawed mitochondria succinate dehydrogenase was inhibited. In incubated rat skeletal muscles, both compounds activated AMPK and stimulated glucose uptake. Moreover, these effects were lost in muscles pre-incubated with AMPK inhibitor SBI-0206965, suggesting AMPK dependency. Incubation of mouse hepatocytes with compound 1 or compound 2 led to AMPK activation, but glucose production was decreased in hepatocytes from both wild-type and AMPKβ1−/− mice, suggesting that this effect was not AMPK-dependent. However, when administered intraperitoneally to high-fat diet-induced insulin-resistant mice, compound 1 and compound 2 had blood glucose-lowering effects. In addition, compound 1 and compound 2 reduced the viability of several human cancer cells in culture. The flavonoids we have identified could be a starting point for the development of new drugs to treat type 2 diabetes.

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