医薬品の研究開発にかかる規制 : 倫理,ガイドライン,法令の基礎 (特集 臨床試験・治験の登録制度と情報の公開・利用)  [in Japanese] Regulations of drug development research : Basics of ethical principles, guidelines and laws  [in Japanese]

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Author(s)

    • 佐藤 元 Sato Hajime
    • 国立保健医療科学院政策技術評価研究部 Department of Health Policy and Technology Assessment, National Institute of Public Health

Abstract

医薬品開発研究の発展・振興と共に,これにかかわる多様な人々が備えるべき倫理,ガイドライン,法令などの規則は多岐にわたり増大している.これらは,研究の公正,被験者の保護,医薬品の有効性・安全性の保障などを目的として制定・運用されており,国際的協調が図られている.本稿は,医薬品研究開発の規制にかかる国内外の代表的機関,重要な規則の背景・原則および骨子について解説すると共に,最近の動向を紹介する.特に,前臨床試験および臨床試験の規範(GLP,GCP),医薬品製造の適正規範(GMP)について詳解した.加えて,臨床試験の公的データベースへの登録,情報公開の位置づけについて解説した.

Recently, more and more people with different professional backgrounds are involved in multiple stages of drug development processes and research, encompassing clinical trials. Given this diversity, there should be available a set of core laws, regulations, and guidelines that govern the processes and research. This article aims to introduce basic information regarding those rules and regulations. Ethical principles and regulatory objectives, national and international regulatory authorities, and core laws and guidelines are listed. The main focus is placed on the objectives, principles, rules, and tools of Good Laboratory Practice, Good Clinical Practice, and Good Manufacturing Practice Guidelines. In addition, the requirement of clinical trial registration to the open database is explained. Ongoing efforts by national and international authorities (agencies) for the international harmonization in this field are also presented.

Journal

  • Journal of the National Institute of Public Health

    Journal of the National Institute of Public Health 64(4), 382-391, 2015-08

    National Institute of Public Health

Codes

  • NII Article ID (NAID)
    110009972389
  • NII NACSIS-CAT ID (NCID)
    AA11751510
  • Text Lang
    JPN
  • ISSN
    1347-6459
  • NDL Article ID
    026816554
  • NDL Call No.
    Z19-152
  • Data Source
    NDL  NII-ELS 
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