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)

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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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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Effectiveness of HCC treatments in real-world experiences.

Journal of Clinical Oncology ◽

10.1200/jco.2012.30.34_suppl.61 ◽

2012 ◽

Vol 30 (34_suppl) ◽

pp. 61-61 ◽

Cited By ~ 1

Author(s):

Glen I. Misek ◽

Mark Keckeisen ◽

Venkata K Jayanti

Keyword(s):

United States ◽

European Union ◽

Real World ◽

Late Stage ◽

The United States ◽

New Drugs ◽

The European Union ◽

Sorafenib Treatment ◽

One Year ◽

The Impact

61 Background: The global incidence of HCC is over 700,000 patients making it the sixth leading cancer. Recently new drugs have been approved to treat HCC. Nevertheless, prognosis is poor with a 5 year survival of 11%. Hence, it is important to understand if there are differences in OS in the Real World (RWE) based on patient demographics, comorbidities and whether current treatments are effective. Methods: A robust global database of HCC patients was constructed from patient chart data with nearly 4,000 unique patient records from the United States, the European Union, and Asia in 2011. Several hypotheses were tested including the impact of ethnicity, presence of Hep B or C or cirrhosis, stage at diagnosis and/or if current treatments used could predict PFS and /or OS. CART and CHAID analyses were conducted to help determine patient segments and treatment flows in conjunction with Kaplan-Meier plots to understand the differences in survival based key patient and treatment attributes. Results: One year survival appears to be associated with geography as it is significantly lower in China/ Korea compared to the United States and the European Union. Significantly higher one year survival rates are observed for HCC patients in the European Union and the United States receiving TACE compared with patients receiving sorafenib first line. However, in Asia there are no differences. Across all three regions sorafenib use does not effect OS in Stage IV patients. Further, no significant differences in one year survival are seen in patients with Hep C or B or cirrhosis compared to those with no history of liver disease. Sorafenib treatment duration in China appears to be substantially lower. Finally, Child-Pugh C patients had lower survival compared to Child-Pugh A or B patients. Conclusions: Early diagnosis, intervention and treatment of HCC appear to be important predictors of survival. Stratifying groups by type of drug treatment including sorafenib use does not appear to have a measurable effect on OS. Efforts aimed towards screening, early detection and treatment initiation during early stages to improve RWE for HCC patients may be more effective than expanding treatment with sorafenib in late stage patients. Given the lack of significance in OS for late stage patients treated with sorafenib across the globe, serious thought should be given its use for late stage patients.

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Harmonization of Ethics Policies in Pediatric Research

The Journal of Law Medicine & Ethics ◽

10.1111/j.1748-720x.2011.00551.x ◽

2011 ◽

Vol 39 (1) ◽

pp. 70-78 ◽

Cited By ~ 10

Author(s):

Valarie Blake ◽

Steve Joffe ◽

Eric Kodish

Keyword(s):

United States ◽

European Union ◽

Human Study ◽

The United States ◽

New Drugs ◽

European Medicines Agency ◽

The European Union ◽

Drug Marketing ◽

Technical Requirements ◽

Recent Initiative

The Food and Drug Administration (FDA) and the European Medicines Agency (EMA) have launched a recent initiative to enhance collaboration in research, with the intent to “ensure that clinical trials submitted in drug marketing applications in the United States and European Union are conducted uniformly, appropriately, and ethically.” This initiative recalls efforts from two decades ago when the United States, the European Union and Japan formed the International Conference on Harmonization of Technical Requirements for Registration of Pharmaceuticals for Human Use (ICH) as a mechanism for harmonizing clinical research regulations. The intent of harmonization was to improve patients’ “access to new drugs, to prevent unnecessary global development delays and to avoid animal and human study duplications” through policy reconciliation.FDA/EMA efforts at collaboration call for a reassessment of past harmonization efforts: to what extent are ICH member policies already synchronized and to what extent can they be harmonized in the future? This paper will focus on these questions through the lens of pediatric investigation.

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Russian Federation and the United States of America: geostrategic directions to manage the Ukrainian crisis

Tikrit Journal For Political Science ◽

10.25130/poltic.v0i16.143 ◽

2019 ◽

pp. 123

Author(s):

Attarid Awadh Abdulhameed

Keyword(s):

United States ◽

European Union ◽

National Security ◽

Russian Federation ◽

United States Of America ◽

The United States ◽

The European Union ◽

The Usa ◽

Ukrainian Crisis ◽

Zero Sum

Ukrainia Remains of huge importance to Russian Strategy because of its Strategic importance. For being a privileged Postion in new Eurasia, without its existence there would be no logical resons for eastward Expansion by European Powers. As well as in Connection with the progress of Ukrainian is no less important for the USA (VSD, NDI, CIA, or pentagon) and the European Union with all organs, and this is announced by John Kerry. There has always ben Russian Fear and Fear of any move by NATO or USA in the area that it poses a threat to Russians national Security and its independent role and in funence on its forces especially the Navy Forces. There for, the Crisis manyement was not Zero sum game, there are gains and offset losses, but Russia does not accept this and want a Zero Sun game because the USA. And European exteance is a Foot hold in Regin Which Russian sees as a threat to its national security and want to monopolize control in the strategic Qirim.

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COMPARATIVE ANALYSIS OF THE CURRENT FRENCH FOREIGN POLICY ACTIVITY

Journal of look to the past ◽

10.26739/2181-9599-2019-22-11 ◽

2019 ◽

Vol 22 (2) ◽

pp. 74-79

Author(s):

Nargiza Sodikova ◽

◽

Keyword(s):

United States ◽

European Union ◽

Foreign Policy ◽

International Security ◽

The United States ◽

Foreign Affairs ◽

Modern Time ◽

The European Union ◽

National Interests ◽

French Foreign Policy

Important aspects of French foreign policy and national interests in the modern time,France's position in international security and the specifics of foreign affairs with the United States and the European Union are revealed in this article

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Ocena antykryzysowej polityki gospodarczej Stanów Zjednoczonych i wybranych państw członkowskich Unii Europejskiej w latach 2005–2014

10.31338/1641-2478pe.2.16.2 ◽

2016 ◽

pp. 26-46

Author(s):

Marcin Jan Flotyński

Keyword(s):

United States ◽

European Union ◽

Financial Markets ◽

Global Economy ◽

Global Financial Crisis ◽

The United States ◽

The European Union ◽

High Volatility ◽

The Global Financial Crisis ◽

Domestic Products

The global financial crisis in 2007–2009 began a period of high volatility on the financial markets. Specifically, it caused an increased amplitude of fluctuations of the level of gross domestic products, the level of investment and consumption and exchange rates in particular countries. To address the adverse market circumstances, governments and central banks took actions in order to bolster the weakening global economy. The aim of this article is to present the anti-crisis actions in the United States and selected member states of the European Union, including Poland, and an assessment of their efficiency. The analysis conducted indicates that generally the actions taken in the United States in response to the crisis were faster and more adequate to the existing circumstances than in the European Union.

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