Specials Manufacturing in the UK

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  • Tsuji Kaori
    Global Security Research Institute, Keio University

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  • イギリスにおける未承認薬製造業（ｓｐｅｃｉａｌｓ　ｍａｎｕｆａｃｔｕｒｉｎｇ）
  • イギリス ニ オケル ミショウニンヤク セイゾウギョウ specials manufacturing

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Specials (unlicensed medicines) manufacturing in the UK was surveyed. The situation in the UK was mainly surveyed by close examination of the guidelines provided by the UK regulatory agency and by interviews with 4 specials manufacturers. Japan situation of extemporaneous preparations in hospital pharmacies was surveyed by literature search and compared with the UK situation.<br>In the UK, manufactures that hold "Manufacture Specials License" can provide pharmacies with unlicensed formulations. To meet pediatric needs, powder and liquid formulations were mainly provided by specials manufactures. Injectables and eye drops were provided by the manufactures that have aseptic units. Since specials manufactures were often generic manufactures or contract manufactures, specials were manufactured in quality control comparable with licensed medicines.<br>The most frequent extemporaneous formulations in Japan were compared to the UK situation. Unlicensed formulations in Japan were also unlicensed in the UK and "specials" were used to meet unmet needs.<br>There is no system for use of unlicensed medicines in Japan; however, measures for unmet needs should be discussed. Specials manufacturing in the UK could be a good reference.

Journal

  • Iryo To Shakai

    Iryo To Shakai 19 (2), 193-207, 2009

    The Health Care Science Institute

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