製造販売後調査における被験者同意と倫理審査：全国病院調査
「緒言」 1979年の薬事法改正により再審査制度が導入され, 市販後調査が開始された. 続く法改正及び1991年の「新医薬品等の再審査の申請のための市販後調査の実施に関する基準: GPMSP省令」(Good Post-marketing Surveillance Practice; GPMSP)の施行を経て, 2004年には「医薬品の製造販売後の調査及び試験の実施の基準に関する省令: GPSP省令」(Good Post-marketing Study Practice; GPSP)が公布され, 現行の製造販売後調査制度が整備された. 製造販売後調査は, GPSP省令に規定される通り使用成績調査...
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| Published in | YAKUGAKU ZASSHI Vol. 138; no. 1; pp. 63 - 71 |
|---|---|
| Main Authors | , , , |
| Format | Journal Article |
| Language | Japanese |
| Published |
公益社団法人 日本薬学会
01.01.2018
日本薬学会 |
| Subjects | |
| Online Access | Get full text |
| ISSN | 0031-6903 1347-5231 |
| DOI | 10.1248/yakushi.17-00109 |
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| Abstract | 「緒言」 1979年の薬事法改正により再審査制度が導入され, 市販後調査が開始された. 続く法改正及び1991年の「新医薬品等の再審査の申請のための市販後調査の実施に関する基準: GPMSP省令」(Good Post-marketing Surveillance Practice; GPMSP)の施行を経て, 2004年には「医薬品の製造販売後の調査及び試験の実施の基準に関する省令: GPSP省令」(Good Post-marketing Study Practice; GPSP)が公布され, 現行の製造販売後調査制度が整備された. 製造販売後調査は, GPSP省令に規定される通り使用成績調査, 特定使用成績調査, 及び製造販売後臨床試験があり, GPSP省令に基づき実施される. 製造販売後臨床試験のみ, 「医薬品の臨床試験の実施に関する基準: GCP省令」も合わせて遵守する必要がある. Good Clinical Practice (GCP)では, 治験依頼者と規制当局以外にも, 試験実施医療機関及び医師に関する規定が示され, その目的は臨床試験における被験者保護と試験品質の確保である. |
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| AbstractList | 「緒言」 1979年の薬事法改正により再審査制度が導入され, 市販後調査が開始された. 続く法改正及び1991年の「新医薬品等の再審査の申請のための市販後調査の実施に関する基準: GPMSP省令」(Good Post-marketing Surveillance Practice; GPMSP)の施行を経て, 2004年には「医薬品の製造販売後の調査及び試験の実施の基準に関する省令: GPSP省令」(Good Post-marketing Study Practice; GPSP)が公布され, 現行の製造販売後調査制度が整備された. 製造販売後調査は, GPSP省令に規定される通り使用成績調査, 特定使用成績調査, 及び製造販売後臨床試験があり, GPSP省令に基づき実施される. 製造販売後臨床試験のみ, 「医薬品の臨床試験の実施に関する基準: GCP省令」も合わせて遵守する必要がある. Good Clinical Practice (GCP)では, 治験依頼者と規制当局以外にも, 試験実施医療機関及び医師に関する規定が示され, その目的は臨床試験における被験者保護と試験品質の確保である. |
| Author | 田代, 志門 松井, 健志 村上, 結香 漆原, 尚巳 |
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| DOI | 10.1248/yakushi.17-00109 |
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| References | 3) Ministry of Health and Welfare (MHW), Good Clinical Practice for Drugs (MHW Ministerial Ordinance of No. 28 of 1997), 1997. 8) Statistics Bureau, Ministry of Internal Affairs and Communications. “What is a sampling survey? —Survey method and planning—”: 〈http://www.stat.go.jp/teacher/c2hyohon.htm〉, cited 25 July, 2017. 12) Arima H., Jpn. J. Pharmacol. Ther., 39, 647-648 (2011). 2) Ministry of Health, Labour and Welfare (MHLW), Good Post-marketing Study Practice for drugs (MHLW Ministerial Ordinance No. 171 of 2004), 2004. 10) Kai Y., “Survey on Patient Consent in Post-market Studies,” Symposium on Ethics in Post-market Observational Studies, Tokyo, 18 November, 2015. 15) Statistics and Information Department, Minister's Secretariat, Ministry of Health, Labour and Welfare, “Survey of Medical Institutions, Statistics table 2, Yearly numbers of hospitals and beds by types of operator,” 2015. 7) Yamamoto H., Jpn. J. Pharmacol. Ther., 43, 474-477 (2015). 5) Arima H., Kondo N., Tasaki M., Teramoto T., Mizui T., Watanabe T., J. Jpn. Soc. Hosp. Pharm., 52, 1234-1242 (2016). 1) Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, “Good Post-marketing Surveillance Practice for re-examination application of new drugs (Yaku-hatsu No. 646),” 1991. 14) Urushihara H., Parmenter L., Tashiro S., Matsui K., Dreyer N., Pharmacoepidemiol. Drug Saf., 26, 1299-1306 (2017). 6) Irishio Y., Jpn. J. Pharmacol. Ther., 43, 470-473 (2015). 4) Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labour and Welfare, “Guidance of Risk Management Planning for Pharmaceuticals (Yaku-shoku-an hatsu 0411 No.1, Yaku-shoku-shinsa hatsu 0411 No. 2, April 11, 2012),” 2012. 13) The International Council for Harmonisation, “ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6.”: 〈http://www.ich.org/ichnews/newsroom/read/article/ich-reflection-on-gcp-renovation-modernization-of-ich-e8-and-subsequent-renovation-of-ich-e6.html〉, cited 25 July, 2017. 11) Independent external committee on investigation of SIGN study: investigator-initiated clinical research on chronic myeloid leukemia, “Investigation report on SIGN study,” Novartis Pharma K. K., Tokyo, 2 April, 2014. 9) World Medical Association (WMA), “Ethical Principles for Medical Research Involving Human Subjects,” 64th WMA General Assembly, Fortaleza, October 2013. |
| References_xml | – reference: 15) Statistics and Information Department, Minister's Secretariat, Ministry of Health, Labour and Welfare, “Survey of Medical Institutions, Statistics table 2, Yearly numbers of hospitals and beds by types of operator,” 2015. – reference: 2) Ministry of Health, Labour and Welfare (MHLW), Good Post-marketing Study Practice for drugs (MHLW Ministerial Ordinance No. 171 of 2004), 2004. – reference: 14) Urushihara H., Parmenter L., Tashiro S., Matsui K., Dreyer N., Pharmacoepidemiol. Drug Saf., 26, 1299-1306 (2017). – reference: 3) Ministry of Health and Welfare (MHW), Good Clinical Practice for Drugs (MHW Ministerial Ordinance of No. 28 of 1997), 1997. – reference: 8) Statistics Bureau, Ministry of Internal Affairs and Communications. “What is a sampling survey? —Survey method and planning—”: 〈http://www.stat.go.jp/teacher/c2hyohon.htm〉, cited 25 July, 2017. – reference: 5) Arima H., Kondo N., Tasaki M., Teramoto T., Mizui T., Watanabe T., J. Jpn. Soc. Hosp. Pharm., 52, 1234-1242 (2016). – reference: 6) Irishio Y., Jpn. J. Pharmacol. Ther., 43, 470-473 (2015). – reference: 12) Arima H., Jpn. J. Pharmacol. Ther., 39, 647-648 (2011). – reference: 4) Pharmaceuticals and Food Safety Bureau, Ministry of Health, Labour and Welfare, “Guidance of Risk Management Planning for Pharmaceuticals (Yaku-shoku-an hatsu 0411 No.1, Yaku-shoku-shinsa hatsu 0411 No. 2, April 11, 2012),” 2012. – reference: 1) Pharmaceutical Affairs Bureau, Ministry of Health and Welfare, “Good Post-marketing Surveillance Practice for re-examination application of new drugs (Yaku-hatsu No. 646),” 1991. – reference: 10) Kai Y., “Survey on Patient Consent in Post-market Studies,” Symposium on Ethics in Post-market Observational Studies, Tokyo, 18 November, 2015. – reference: 13) The International Council for Harmonisation, “ICH Reflection on “GCP Renovation”: Modernization of ICH E8 and Subsequent Renovation of ICH E6.”: 〈http://www.ich.org/ichnews/newsroom/read/article/ich-reflection-on-gcp-renovation-modernization-of-ich-e8-and-subsequent-renovation-of-ich-e6.html〉, cited 25 July, 2017. – reference: 7) Yamamoto H., Jpn. J. Pharmacol. Ther., 43, 474-477 (2015). – reference: 11) Independent external committee on investigation of SIGN study: investigator-initiated clinical research on chronic myeloid leukemia, “Investigation report on SIGN study,” Novartis Pharma K. K., Tokyo, 2 April, 2014. – reference: 9) World Medical Association (WMA), “Ethical Principles for Medical Research Involving Human Subjects,” 64th WMA General Assembly, Fortaleza, October 2013. |
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| Snippet | 「緒言」 1979年の薬事法改正により再審査制度が導入され, 市販後調査が開始された. 続く法改正及び1991年の「新医薬品等の再審査の申請のための市販後調査の実施に関する基... |
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| Title | 製造販売後調査における被験者同意と倫理審査：全国病院調査 |
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