Pharmacists’ Legal Responsibilities in Pharmacies within the People’s Republic of China: The Quality Control of Medicines

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  • Yoshida Eiko
    Department of Pharmaceutical Laws and Related Laws, Faculty of Pharmaceutical Sciences, Toho University
  • Okawara Miki
    Department of Pharmaceutical Laws and Related Laws, Faculty of Pharmaceutical Sciences, Toho University
  • Liu Yiwei
    Keio University School of Medicine
  • Yano Yuichi
    FUTAGO Pharmacy Group
  • Yu Jing
    Yokohama University of Pharmacy
  • Kawasaki Tsutomu
    Subaru Communication Co., Ltd.
  • Akimoto Yoshio
    Medi-Quality Security Institute, Graduate School of Medical Sciences, Kanazawa University
  • Hiraga Hideaki
    Department of Pharmaceutical Laws and Related Laws, Faculty of Pharmaceutical Sciences, Toho University

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  • 中華人民共和国の薬局における薬剤師の法的責任:医薬品の品質管理

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Abstract

<p>China’s pharmaceutical market, the second largest in the world, has recently attracted the attention of many countries. However, Chinese pharmacists’ role in pharmacies and their legal responsibilities in China are not well known in Japan. Clarifying Chinese pharmacists’ legal obligations and identifying their specific roles may contribute to improvements in pharmacy operations in Japan. To investigate the Chinese legal system as it pertains to pharmacists in China, we used China’s official government website. In 2019, there were 516,003 pharmacists in China. As of 2020, the Chinese Pharmacist Act is still in the preparatory stage; however, the Administrative Regulation, which describes the system for licensing pharmacists, has been established. Article 1 of the Administrative Regulation states that Chinese pharmacists are responsible for the quality control of medications, as well as medication consultations. Another regulation, Good Supply Practice, specifies that the lot numbers of medications should be provided to patients at the time of dispensing. We believe that this is particularly beneficial to pharmaceutical traceability. Since 2017, the circulation of counterfeit HARVONI® combination tablets has been a problem in Japan. To secure and improve the quality of medications in Japan, we believe that it is important for pharmacists to understand that they are “responsible for the quality of the medicine” and to promote discussions on pharmacy quality control tasks.</p>

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