• Title/Summary/Keyword: pharmaceutical

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Development Strategy for Pharmaceutical Industry against Korea-United States of America FTA

  • Lee, Jae-Jun;Park, Jin-Han
    • Journal of Evidence-Based Herbal Medicine
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    • v.1 no.2
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    • pp.17-26
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    • 2008
  • Nowadays the flow of international trade is that there seems to appear economic block significantly because most countries contract FTAs, so our market condition is changing to a severe competitive situation. Korea which has 70% of foreign dependence of trade must get involved in regionalism, and also actively promote FTA more than any other countries. FTA on February in 2006, the pharmaceutical industry are anxious. The pharmaceutical industry in Korea has recently come to a crisis that it is hard to expect a growth due to structure of profit and a change for the worse of management. If Korea-U.S. FTA are contracted in this kind of situation, domestic pharmaceutical companies will be at stake. We can anticipate that FTA with the country that has a strong competitive power like U.S. affect negatively on pharmaceutical industry, because the industry doesn't have enough self-competitiveness. Considering this kind of surroundings, we need to present the policy to enhance competitiveness for damage limitation on pharmaceutical industry by Korea-U.S. FTA. Under this background, this research has groped for a direction to strengthen the competitiveness to develop pharmaceutical industry in quality. The competitive enhancement plan is presented which is divided into the government policy part, the R&D part, and the management part. Although Korea-U.S. FTA is analyzed to wither the pharmaceutical industry, it would be thought that it is a good chance to upgrade domestic pharmaceutical industry if we make the best use of it, and also to make in roads into foreign market.

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International Harmonization of Compendium Monographs of Pharmaceutical Excipients: Its Progress and the Matters at Issue (의약품 첨가제의 공정서 각조의 국제 규격화 : 그 진행과 문제점)

  • Sekigawa, Fujio
    • Journal of Pharmaceutical Investigation
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    • v.23 no.4
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    • pp.231-254
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    • 1993
  • These days, it is not uncommon that a same kind of drug is circulated globally. However, the qualities of excipients used in the same drug have to be sometimes different depending on the different requirements in the qualities stipulated by each country. For a supplier of pharmaceutical excipients, it is generally necessary to carry out different tests on the same kind of testing criteria depending on the country of destination. Thus, the discrepancies between compendium requirements of pharmaceutical excipients create severe problems in various area of industrial activities. The decision of the United States Pharmacopoeia, European Pharmacopoeia and Japanese Pharmacopoeia Commissions to harmonize the requirements is a unique chance for the industries to overcome these problems. On the other hand, discrepancies of general test methods and requirements in each monograph of pharmaceutical excipient between the compendia valid at present are in most cases extensive. Consequently their harmonization needs a lot of detailed work requiring strong support from the industry. Based on these circumstances, pharmaceutical excipients councils have been established first in U.S.A. and successively in Europe and in Japan to contribute to the harmorization process. We should like to review here the progress since the Orlando Conference in 1991 and comment about the matters at issue with regard to the international harmonization of pharmaceutical excipients.

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