調和合意された医薬品各条について、PDG (Pharmacopoeial Discussion Group:日米欧三薬局方検討会議)の調和文書表紙(Sign-off Cover Sheet*)を掲載しています。なお、2020年12月22日の調和合意分より、調和文書表紙だけではなく、調和文書全体を公開しております。(詳しくは、2020年11月PDGテレビ会議議事要旨をご参照ください。)
*PDG調和文書の表紙:三薬局方による署名及び調和・非調和項目や独自記載事項等の情報を記載。
改正版と施行日の対応についてはこちらをご確認ください。
As of Jan. 20, 2023
Harmonization No. / Item | 日局収載名等 | Sign-off | 施行日 |
---|---|---|---|
E-01 / Alcohol 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Corr. 2 Corr. of Sign-off cover sheet |
エタノール | Oct. 24, 2001 Sep. 9, 2002 Nov. 7, 2012 June 27, 2013 June 26, 2014 Nov. 15, 2021 |
- Apr. 1, 2006 Feb. 28, 2014 Apr. 1, 2016 Apr. 1, 2016 Dec. 12, 2022 |
E-02 / Dehydrated Alcohol 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Corr. 2 Corr. of Sign-off cover sheet |
無水エタノール | Oct. 24, 2001 Sep. 9, 2002 Nov. 7, 2012 June 27, 2013 June 26, 2014 Nov. 15, 2021 |
- Apr. 1, 2006 Feb. 28, 2014 Apr. 1, 2016 Apr. 1, 2016 Dec. 12, 2022 |
E-03 / Benzyl Alcohol 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Corr. 2 |
ベンジルアルコール | July 18, 2000 Nov. 8, 2005 June 3, 2008 June 15, 2011 Dec. 22, 2020 |
Jan. 1, 2005 Apr. 1, 2006 Apr. 1, 2011 Oct. 1, 2012 Dec. 12, 2022 |
E-04 / Calcium Disodium Edetate 初回調和 Corr. of Sign-off cover sheet Rev. 1 |
エデト酸カルシウムナトリウム水和物 | Nov. 8, 2005 Jan. 20, 2023 |
Feb. 28, 2014 Dec. 12, 2022 |
E-05 / Calcium Phosphate Dibasic 初回調和 Rev. 1 Corr. of Sign-off cover sheet |
リン酸水素カルシウム水和物 | Nov. 8, 2005 June 15, 2011 Jan. 20, 2023 |
Oct. 1, 2007 Oct. 1, 2012 Dec. 12, 2022 |
E-06 / Calcium Phosphate Dibasic Anhydrous 初回調和 Rev. 1 Rev. 2 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
無水リン酸水素カルシウム | Nov. 8, 2005 June 15, 2011 Sep. 13, 2017 Nov. 15, 2021 Jan. 20, 2023 |
Oct. 1, 2007 Oct. 1, 2012 June 28, 2019 - Dec. 12, 2022 |
E-07 / Carmellose Calcium 初回調和 Rev. 1 Rev. 1, Corr. 1 |
カルメロースカルシウム | Oct. 24, 2001 July 17, 2003 Jan. 20, 2023 |
- Jan. 1, 2005 (June, 2024) |
E-08 / Carmellose Sodium | (調和作業中) | ||
E-09 / Croscarmellose Sodium 初回調和 Rev. of Sign-off cover sheet Rev. 1 Corr. of Sign-off cover sheet Rev. 2 |
クロスカルメロースナトリウム | Oct. 24, 2001 May 26, 2016 Dec. 22, 2020 Jan. 20, 2023 |
Apr.1, 2006 Dec. 12, 2022 Dec. 12, 2022 Dec. 12, 2022 |
E-10 / Cellulose, Microcrystalline 初回調和 Rev. 1 Rev. 1, Rev. of Sign-off cover sheet Rev. 2 Rev. 3 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
結晶セルロース | Feb. 18, 2004 May 11, 2005 May 26, 2016 Sep. 13, 2017 Oct. 3, 2018 Nov. 15, 2021 Jan. 20, 2023 |
- Apr. 1, 2006 June 28, 2019 June 28, 2019 June 28, 2019 - Dec. 12, 2022 |
E-11 / Cellulose, Powdered 初回調和 Rev. 1 Rev. 1, Rev. of Sign-off Cover Sheet Rev. 1, Corr. 1 Corr. of Sign-off cover sheet |
粉末セルロース | Feb. 18, 2004 May 11, 2005 May 26, 2016 Nov. 15, 2021 Jan. 20, 2023 |
- Apr. 1, 2006 Dec. 12, 2022 - Dec. 12, 2022 |
E-13 / Cellulose Acetate Phthalate 初回調和 Rev. 1 Rev. 1, Corr. 1 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
セラセフェート | Oct. 24, 2001 Nov. 9, 2010 June 6, 2012 Nov. 15, 2021 Jan. 20, 2023 |
Jan. 1, 2005 Oct. 1, 2012 Oct. 1, 2012 - Dec. 12, 2022 |
E-14 / Citric Acid, Anhydrous 初回調和 Rev. 1 Rev. 2 Corr. of Sign-off cover sheet |
無水クエン酸 | May 23, 2001 Nov. 11, 2003 June 9, 2010 Jan. 20, 2023 |
Jan. 1, 2003 Apr. 1, 2006 Oct. 1, 2012 Dec. 12, 2022 |
E-15 / Citric Acid, Monohydrate 初回調和 Rev. 1 Rev. 2 Corr. of Sign-off cover sheet |
クエン酸水和物 | May 23, 2001 Nov. 11, 2003 June 9, 2010 Jan. 20, 2023 |
Jan. 1, 2003 Apr. 1, 2006 Oct. 1, 2012 Dec. 12, 2022 |
E-16 / Crospovidone 初回調和 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
クロスポビドン | Nov. 9, 2010 Oct. 3, 2018 Nov. 15, 2021 Jan. 20, 2023 |
Oct. 1, 2012 - - Dec. 12, 2022 |
E-17 / Ethylcellulose 初回調和 Rev. 1 Rev. 2 Corr. of Sign-off cover sheet |
エチルセルロース | Feb. 6, 2002 Oct. 27, 2009 May 26, 2016 Jan. 20, 2023 |
- - June 28, 2019 Dec. 12, 2022 |
E-18 / Hydroxyethylcellulose 初回調和 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
ヒドロキシエチルセルロース | July 25, 2016 Nov. 15, 2021 Jan. 20, 2023 |
June 28, 2019 - Dec. 12, 2022 |
E-19 / Hydroxypropylcellulose 初回調和 Rev. of Sign-off cover sheet Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
ヒドロキシプロピルセルロース | June 27, 2013 Sep. 13, 2017 Nov. 15, 2021 Jan. 20, 2023 |
Apr. 1, 2016 June 28, 2019 - Dec. 12, 2022 |
E-20 / Hydroxypropylcellulose, Low Substituted 初回調和 Corr. 1 Corr. 2 Corr. of Sign-off cover sheet Corr. 3 |
低置換度ヒドロキシプロピルセルロース | Nov. 13, 2014 July 1, 2015 Oct. 26, 2016 Nov. 15, 2021 Jan. 20, 2023 |
Dec. 1, 2017 Dec. 1, 2017 Dec. 1, 2017 - (June, 2024) |
E-21 / Hypromellose 初回調和 Rev. 1 Rev. 1, Corr. 1 Rev. 1, Corr. 2 Rev. 1, Rev. of Sign-off cover sheet Rev. 2 Corr. of Sign-off cover sheet Rev. 2, Corr. 1 |
ヒプロメロース | Nov. 10, 2003 June 6, 2012 June 26, 2014 July 1, 2015 Oct. 26, 2016 Sep. 13, 2017 Nov. 15, 2021 Jan. 20, 2023 |
Apr. 1, 2006 Feb. 28, 2014 Apr. 1, 2016 Dec. 1, 2017 June 28, 2019 June 28, 2019 - (June, 2024) |
E-22 / Hypromellose Phthalate 初回調和 Corr. 1 Corr. of Sign-off cover sheet |
ヒプロメロースフタル酸エステル | June 6. 2006 Nov. 15, 2021 Jan. 20, 2023 |
Oct. 1, 2007 Dec. 12, 2022 Dec. 12, 2022 |
E-23 / Lactose, Anhydrous 初回調和 Rev. 1 Rev. 2 Rev. 3 Rev. 4 Rev. 4, Rev. of Sign-off cover sheet Rev. 4, Corr. 1 Rev. 4, Corr. 2 Rev. 5 |
無水乳糖 | Sep. 10, 2002 Feb. 5, 2003 Nov. 8, 2005 June 5, 2008 Nov. 9, 2010 Oct. 26, 2016 Oct. 2, 2019 Jan. 20, 2023 |
- Apr. 1, 2006 Oct. 1, 2007 Oct. 1, 2009 Oct. 1, 2012 June 7, 2021 June 7, 2021 Dec. 12, 2022 |
E-24 / Lactose, Monohydrate 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Corr. 2 Rev. 3 |
乳糖水和物 | Sep. 10, 2002 Oct. 25, 2006 June 5, 2008 Oct. 2, 2019 Jan. 20, 2023 |
Apr. 1, 2006 - Oct. 1, 2009 June 7, 2021 Dec. 12, 2022 |
E-25 / Magnesium Stearate 初回調和 Corr. 1 Corr. 2 Corr. 3 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
ステアリン酸マグネシウム | June 3, 2008 Nov.11, 2008 June 6, 2012 June 27, 2013 Dec. 22, 2020 Jan. 20, 2023 |
Oct. 1, 2012 Oct. 1, 2012 Oct. 1, 2012 - Dec. 12, 2022 Dec. 12, 2022 |
E-26 / Methylcellulose 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Corr. 2 Rev. 3 Corr. of Sign-off cover sheet Rev. 3, Corr. 1 |
メチルセルロース | Nov. 10, 2003 Nov. 8, 2005 June 6, 2012 June 26, 2014 July 1, 2015 Sep. 13, 2017 Nov. 15, 2021 Jan. 20, 2023 |
- Apr. 1, 2006 Feb. 28, 2014 Apr. 1, 2016 Dec. 1, 2017 June 28, 2019 - (June, 2024) |
E-27 / Methyl Paraben 初回調和 Rev. 1 Rev. 1, Corr. 1 Rev. 1, Corr. 2 Corr. of Sign-off cover sheet |
パラオキシ安息香酸メチル | Feb. 19, 2004 June 10, 2009 Nov. 9, 2011 Dec. 22, 2020 Jan. 20, 2023 |
Apr. 1, 2006 Oct. 1, 2012 Oct. 1, 2012 Dec. 12, 2022 Dec. 12, 2022 |
E-28 / Petrolatum 初回調和 Corr. of Sign-off cover sheet |
黄色ワセリン | Nov. 15, 2021 Jan. 20, 2023 |
Dec. 12, 2022 Dec. 12, 2022 |
E-29 / Petrolatum, White 初回調和 Corr. of Sign-off cover sheet |
白色ワセリン | Nov. 15, 2021 Jan. 20, 2023 |
Dec. 12, 2022 Dec. 12, 2022 |
E-30 / Polyethylene Glycol | (調和作業中) | ||
E-31 / Polysorbate 80 初回調和 Corr. 1 Corr. 2 Corr. 3 Rev. of Sign-off cover sheet Corr. 2 of Sign-off cover sheet Corr. of Sign-off cover sheet |
ポリソルベート80 | June 3, 2008 Oct. 27, 2009 Nov. 13, 2014 July 1, 2016 Oct. 26, 2016 Dec. 22, 2020 Jan. 20, 2023 |
Feb. 28, 2014 Feb. 28, 2014 Apr. 1, 2016 Dec. 1, 2017 - Dec. 12, 2022 Dec. 12, 2022 |
E-32 / Povidone 初回調和 Corr. 1 Corr. 2 Rev. 1 Rev. 1, Corr. 1 Corr. of Sign-off cover sheet Rev. 2 |
ポビドン | Oct. 25, 2006 May 8, 2007 June 3, 2008 July 1, 2015 Nov. 4, 2015 Jan. 20, 2023 |
Apr. 1, 2016 Apr. 1, 2016 Apr. 1, 2016 Apr. 1, 2016 - Dec. 12, 2022 |
E-36 / Silicon Dioxide | (調和作業中) | ||
E-37 / Silicon Dioxide, Colloidal | (調和作業中) | ||
E-38 / Sodium Chloride 初回調和 Rev. 1 Rev. 2 Rev. 3 Rev. 3, Corr. 1 Rev. 3, Corr. 2 Corr. of Sign-off cover sheet |
塩化ナトリウム | May 23, 2001 Oct. 24, 2001 Nov. 11, 2003 Nov. 6, 2013 May 26, 2016 Dec. 22, 2020 Jan. 20, 2023 |
- Jan. 1, 2003 Apr. 1, 2006 Apr. 1, 2016 - Dec. 12, 2022 Dec. 12, 2022 |
E-39 / Sodium Starch Glycolate 初回調和 Rev. 1 Rev. 3 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
デンプングリコール酸ナトリウム | Nov. 10, 2003 May 11, 2005 June 27, 2013 Nov. 15, 2021 Jan. 20, 2023 |
- Oct. 1, 2007 Apr. 1, 2016 - Dec. 12, 2022 |
E-40 / Starch, Corn 初回調和 Rev. 1 Rev. 2 Rev. 3 Rev. 4 |
トウモロコシデンプン | Oct. 24, 2001 Feb. 18, 2004 Oct. 29, 2007 June 6, 2012 |
Jan. 1, 2005 Apr. 1, 2006 Oct. 1, 2009 Feb. 28, 2014 |
E-41 / Starch, Potato 初回調和 Rev. 1 Rev. 2 |
バレイショデンプン | Oct. 24, 2001 Oct. 29, 2007 June 15, 2011 |
Jan. 1, 2005 Oct. 1, 2009 Feb. 28, 2014 |
E-42 / Starch, Rice 初回調和 Rev. 1 |
コメデンプン | Oct. 25, 2006 Nov. 6, 2013 |
Oct. 1, 2009 Apr. 1, 2016 |
E-43 / Starch, Wheat 初回調和 Rev. 1 Rev. 2 Rev. 2, Rev. of Sign-off cover sheet Rev. 3 Rev. 3, Corr. 1 Corr. of Sign-off cover sheet |
コムギデンプン | Oct. 24, 2001 Oct. 29, 2007 June 15, 2011 Nov. 4, 2015 Oct. 3, 2018 Dec. 22, 2020 Nov. 15, 2021 |
Jan. 1, 2005 Oct. 1, 2009 Apr. 1, 2011 Apr. 1, 2016 June 7, 2021 Dec. 12, 2022 - |
E-44 / Stearic Acid 初回調和 Rev. 1 Rev. 1, Corr. 1 Rev. 1, Rev. of Sign-off cover sheet Rev. 2 Corr. of Sign-off cover sheet |
ステアリン酸 | June 3, 2008 Nov. 6, 2013 Nov. 13, 2014 July 1, 2015 Nov. 15, 2021 Jan. 20, 2023 |
Feb. 28, 2014 Feb. 28, 2014 - Apr. 1, 2016 Dec. 12, 2022 Dec. 12, 2022 |
E-45 / Sucrose 初回調和 Rev. of Sign-off cover sheet Rev. 1 |
精製白糖 | Oct. 30, 2007 June 27, 2013 |
Oct. 1, 2012 - |
E-46 / Talc 初回調和 Rev. 1 |
タルク | Nov. 10, 2003 June 3, 2008 |
- Apr. 1, 2011 |
E-48 / Ethyl Paraben 初回調和 Rev. 1 Rev. 1, Corr. 1 Rev. 1, Corr. 2 Corr. of Sign-off cover sheet |
パラオキシ安息香酸エチル | Feb. 19, 2004 June 10, 2009 Nov. 9, 2011 Dec. 22, 2020 Jan. 20, 2023 |
Apr. 1, 2006 Oct. 1, 2012 Oct. 1, 2012 Dec. 12, 2022 Dec. 12, 2022 |
E-49 / Propyl Paraben 初回調和 Rev. 1 Rev. 1, Corr. 1 Rev. 1, Corr. 2 Corr. of Sign-off cover sheet |
パラオキシ安息香酸プロピル | Feb. 19, 2004 June 10, 2009 Nov. 9, 2011 Dec. 22, 2020 Jan. 20, 2023 |
Apr. 1, 2006 Oct. 1, 2012 Oct. 1, 2012 Dec. 12, 2022 Dec. 12, 2022 |
E-50 / Butyl Paraben 初回調和 Rev. 1 Rev. 1, Corr. 1 Corr. of Sign-off cover sheet |
パラオキシ安息香酸ブチル | Feb. 19, 2004 June 9, 2010 Dec. 22, 2020 Jan. 20, 2023 |
Apr. 1, 2006 Oct. 1, 2012 Dec. 12, 2022 Dec. 12, 2022 |
E-51 / Glycerin | (調和作業中) | ||
E-52 / Carmellose 初回調和 Rev. 1 Corr. of Sign-off cover sheet |
カルメロース | Nov. 11, 2008 Nov. 9, 2011 Jan. 20, 2023 |
Apr. 1, 2011 Feb. 28, 2014 Dec. 12, 2022 |
E-54 / Copovidone 初回調和 Corr. 1 Corr. of Sign-off cover sheet Rev. 1 |
コポビドン | Oct. 3, 2018 Oct. 2, 2019 Jan. 20, 2023 |
June 7, 2021 June 7, 2021 Dec. 12, 2022 |
E-55a / Gelatin, gelling type 初回調和 Corr. 1 Corr. 2 Corr. 3 Rev. 2 |
ゼラチン | June 6, 2012 Nov. 7, 2012 Nov. 6, 2013 Oct. 26, 2016 Oct. 3, 2018 |
May 31, 2013 May 31, 2013 Apr. 1, 2016 June 7, 2021 June 7, 2021 |
E-55b / Gelatin, non-gelling grade 初回調和 Corr. 1 Corr. 2 Corr. 3 Rev. 2 |
(日局は調和に不参加) | June 6, 2012 Nov. 7, 2012 Nov. 6, 2013 Oct. 26, 2016 Oct. 3, 2018 |
- - - - - |
E-55 / Gelatin Rev. 3 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
ゼラチン | Oct. 2, 2019 Nov. 15, 2021 Jan. 20, 2023 |
June 7, 2021 - Dec. 12, 2022 |
E-56 / Glucose Anhydrous/Monohydrate 初回調和 Corr. 1 Rev. of Sign-off cover sheet Corr. of Sign-off cover sheet |
精製ブドウ糖/ブドウ糖水和物 | June 26, 2014 Jan. 20, 2015 Nov. 4, 2015 Jan. 20, 2023 |
Dec. 1, 2017 Dec. 1, 2017 - Dec. 12, 2022 |
E-58 / Mannitol 初回調和 Corr. 1 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
D-マンニトール | June 6, 2012 June 26, 2014 Oct. 3, 2018 Nov. 15, 2021 Jan. 20, 2023 |
Feb. 28, 2014 Feb. 28, 2014 - Dec. 12, 2022 Dec. 12, 2022 |
E-59 / Propylene Glycol | (調和作業中) | ||
E-60 / Sodium Laurylsulfate 初回調和 Rev. 1 |
ラウリル硫酸ナトリウム | Nov. 13, 2014 Oct. 2, 2019 |
Dec. 1, 2017 June 7, 2021 |
E-61 / Starch, Pregelatinized | (調和作業中) | ||
E-62 / Sterile Water for Injection in Containers | (調和作業中) | ||
E-64 / Isomalt 初回調和 Rev. of Sign-off cover sheet Corr.1 Corr. of Sign-off cover sheet Corr. of Sign-off cover sheet |
イソマル水和物 | June 27, 2013 Nov. 4, 2015 Nov. 29, 2016 Oct. 3, 2018 Jan. 20, 2023 |
Apr. 1, 2016 Apr. 1, 2016 June 28, 2019 - Dec. 12, 2022 |
E-65 / Isostearyl Alcohol | (調和作業中) | ||
E-66 / Myristyl Myristate | (調和作業中) | ||
E-68 / Polysorbate 65 | (調和作業中) | ||
E-69 / Calcium Silicate | (調和作業中) | ||
E-70 / Polysorbate 20 | (調和作業中) |
以下2項目については、2018年10月に三局間調和作業計画の対象外とされました。
(詳しくは2018年10月PDGストラスブール会合議事要旨をご参照ください。)
Harmonization No. / Item | 日局収載名等 | Sign-off | 施行日 |
---|---|---|---|
E-63 / Lactose for Inhalation | - | - | |
E-67 / Sodium Cetyl Sulfate | - | - |
以下5項目については、2017年9月に三局間調和作業計画の対象外とされました。
(詳しくは2017年9月PDGロックビル会合議事要旨をご参照ください。)
Harmonization No. / Item | 日局収載名等 | Sign-off | 施行日 |
---|---|---|---|
E-12 / Cellulose Acetate 初回調和 Rev. 1 Rev. 2 Rev. 3 |
Oct. 24, 2001 Feb. 5, 2003 Nov. 7, 2012 July 21, 2016 |
- - - - |
|
E-33 / Saccharin 初回調和 Rev. 1 |
サッカリン | Feb. 5, 2003 June 27, 2013 |
Apr. 1, 2006 Apr. 1, 2016 |
E-34 / Saccharin, Sodium 初回調和 Rev. 1 Rev. 2 Rev. 2, Corr. 1 Rev. 2, Sign-off cover sheet |
サッカリンナトリウム水和物 | Feb. 5, 2003 Feb. 18, 2004 Nov. 13, 2014 May 26, 2016 Oct. 26, 2016 |
- Apr. 1, 2006 Dec. 1, 2017 Dec. 1, 2017 - |
E-35 / Saccharin, Calcium | Feb. 5, 2003 | - | |
E-53 / Calcium Carbonate | - | - |