Availability and drug lag of new medicines in South Korea

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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Do Free Trade Agreements Matter to Drug Lag? Recent Evidence From Korea After the Korea–U.S. Free Trade Agreement

International Journal of Health Services ◽

10.1177/0020731419898335 ◽

2020 ◽

Vol 50 (2) ◽

pp. 147-155

Author(s):

Kyung-Bok Son

Keyword(s):

United States ◽

Free Trade ◽

Cox Model ◽

Free Trade Agreements ◽

Trade Agreement ◽

The United States ◽

Marketing Approval ◽

Drug Lag ◽

Korean Market ◽

Korus Fta

The KORUS FTA includes various clauses on marketing approval of new medicines and their reimbursement decisions. We aim to capture the availability of new medicines, to measure drug lags for new medicines, and to demonstrate the effect of the KORUS FTA on the timely availability of new medicines in the Korean market. We selected new drug applications approved in the United States between 2007 and 2015, calculated the drug lag, which was defined as the time difference between the date of regulatory approval in the United States and in Korea, and constructed a logistic and Cox model to capture the effect of the variables of interest on the availability and drug lag of new medicines in the Korean market. The FDA in the United States approved 160 NDAs between 2007 and 2015. The KORUS FTA does not increase the availability of new medicines or shorten the drug lag of new medicines. However, the presence of the manufacturer in Korea was significantly related to the availability and drug lag in the Korean market. It is noteworthy that the presence of the manufacturer, which is a kind of by-product of free trade in pharmaceuticals, affected drug lag.

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Trade Complementarity and the Balance of Payments Constraint Hypothesis: A New Free Trade Agreement between Mexico and South Korea

Mathematics ◽

10.3390/math8101708 ◽

2020 ◽

Vol 8 (10) ◽

pp. 1708

Author(s):

Luis Quintana-Romero ◽

Nam Kwon Mun ◽

Roldán Andrés-Rosales ◽

José Álvarez-García

Keyword(s):

United States ◽

South Korea ◽

Free Trade ◽

Free Trade Agreement ◽

Trade Agreement ◽

The United States ◽

New Era ◽

External Sector ◽

Korean Market

Market diversification is one of the keys to success in the new era of world trade. Highly competitive countries have accomplished positive and sustained growth rates by not depending on a single market for their exports and imports. In Mexico, on the contrary, 80% of exports and 45% of imports concentrate in the United States. The South Korean market represents an opportunity for the Mexican economy, as the relationship between the two countries has strengthened in recent decades. This opportunity would promote greater economic growth for both countries if they reached a Free Trade Agreement, as we show in this work. The aim of this research is to assess the complementarity between these countries and estimate their external long-term equilibrium using the Thirlwall trade restriction model. Results confirm the existence of trade complementarity between the two economies and show that these are able to achieve long-term equilibrium in the external sector. Additionally, the Mexican economy would not face balance of payment constraints for growth when trading with South Korea, as it currently does with the United States.

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The Drug Lag Issue: The Debate Seen from an International Perspective

International Journal of Health Services ◽

10.2190/9y32-x86y-m3f0-jqfc ◽

1992 ◽

Vol 22 (1) ◽

pp. 53-72 ◽

Cited By ~ 21

Author(s):

Fredrik Andersson

Keyword(s):

United States ◽

United Kingdom ◽

Processing Time ◽

The United States ◽

International Perspective ◽

West Germany ◽

New Drugs ◽

Regulatory Agencies ◽

The United Kingdom ◽

Drug Lag

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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