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くすりによる重篤な健康被害に対する医療費等の支給を受けたい
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既承認の製品情報や日本薬局方等を開発の参考としたい
PMDAのレギュラトリーサイエンス・研究に関する取組みを知りたい
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戻る
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生物由来製品による健康被害に対する医療費等の支給を受けたい
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承認された医薬部外品の安全性情報等について知りたい
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再生医療等製品による健康被害に対する医療費等の支給を受けたい
添付文書、患者向医薬品ガイド、
承認情報等の情報は、
製品毎の検索ボタンをクリックしてください。
レギュラトリーサイエンス・基準作成調査・日本薬局方
日局におけるPDG調和文書への対応状況(医薬品各条)
調和合意された医薬品各条について、PDG (Pharmacopoeial Discussion Group:薬局方調和国際会議)の調和文書表紙(Sign-off Cover Sheet (注))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[358KB]をご参照ください。)
(注)PDG調和文書の表紙:各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[41.7KB]をご確認ください。
As of July 16, 2025
各条(医薬品添加物)
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 24, 2001[34.9KB] |
- |
Rev. 1 |
September 9, 2002[115KB] |
April 1, 2006 |
Rev. 2 |
November 7, 2012[37.4KB] |
February 28, 2014 |
Rev. 2, Corr. 1 |
June 27, 2013[32.7KB] |
April 1, 2016 |
Rev. 2, Corr. 2 |
June 26, 2014[19.2KB] |
April 1, 2016 |
Corr. of Sign-off cover sheet |
November 15, 2021[31.3KB] |
December 12, 2022 |
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E-02 / Dehydrated Alcohol 無水エタノール
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 24, 2001[30.5KB] |
- |
Rev. 1 |
September 9, 2002[109KB] |
April 1, 2006 |
Rev. 2 |
November 7, 2012[37.5KB] |
February 28, 2014 |
Rev. 2, Corr. 1 |
June 27, 2013[32.4KB] |
April 1, 2016 |
Rev. 2, Corr. 2 |
June 26, 2014[19.1KB] |
April 1, 2016 |
Corr. of Sign-off cover sheet |
November 15, 2021[31.4KB] |
December 12, 2022 |
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E-03 / Benzyl Alcohol ベンジルアルコール
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
July 18, 2000[27.2KB] |
January 1, 2005 |
Rev. 1 |
November 8, 2005[99.7KB] |
April 1, 2006 |
Rev. 2 |
June 3, 2008[28.9KB] |
April 1, 2011 |
Rev. 2, Corr. 1 |
June 15, 2011[32.1KB] |
October 1, 2012 |
Rev. 2, Corr. 2 |
December 22, 2020[434KB] |
December 12, 2022 |
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E-04 / Calcium Disodium Edetate エデト酸カルシウムナトリウム水和物
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E-05 / Calcium Phosphate Dibasic リン酸水素カルシウム水和物
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E-06 / Calcium Phosphate Dibasic Anhydrous 無水リン酸水素カルシウム
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E-07 / Carmellose Calcium カルメロースカルシウム
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E-08 / Carmellose Sodium (調和作業中)
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E-09 / Croscarmellose Sodium クロスカルメロースナトリウム
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E-10 / Cellulose, Microcrystalline 結晶セルロース
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 18, 2004[41.8KB] |
- |
Rev. 1 |
May 11, 2005[125KB] |
April 1, 2006 |
Rev. 1, Rev. of Sign-off cover sheet |
May 26, 2016[708KB] |
June 28, 2019 |
Rev. 2 |
September 13, 2017[465KB] |
June 28, 2019 |
Rev. 3 |
October 3, 2018[656KB] |
June 28, 2019 |
Corr. of Sign-off cover sheet |
November 15, 2021[35.1KB] |
- |
Corr. of Sign-off cover sheet |
January 20, 2023[408KB] |
December 12, 2022 |
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E-11 / Cellulose, Powdered 粉末セルロース
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 18, 2004[32.8KB] |
- |
Rev. 1 |
May 11, 2005[102KB] |
April 1, 2006 |
Rev. 1, Rev. of Sign-off Cover Sheet |
May 26, 2016[627KB] |
December 12, 2022 |
Rev. 1, Corr. 1 |
November 15, 2021[85.3KB] |
- |
Rev. 1, Corr. of Sign-off Cover Sheet |
January 20, 2023[362KB] |
December 12, 2022 |
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E-13 / Cellulose Acetate Phthalate セラセフェート
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 24, 2001[32.6KB] |
January 1, 2005 |
Rev. 1 |
November 9, 2010[45.4KB] |
October 1, 2012 |
Rev. 1, Corr. 1 |
June 6, 2012[27.8KB] |
October 1, 2012 |
Corr. of Sign-off cover sheet |
November 15, 2021[26.0KB] |
- |
Corr. of Sign-off cover sheet |
January 20, 2023[381KB] |
December 12, 2022 |
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E-14 / Citric Acid, Anhydrous 無水クエン酸
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E-15 / Citric Acid, Monohydrate クエン酸水和物
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E-16 / Crospovidone クロスポビドン
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E-17 / Ethylcellulose エチルセルロース
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E-18 / Hydroxyethylcellulose ヒドロキシエチルセルロース
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E-19 / Hydroxypropylcellulose ヒドロキシプロピルセルロース
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E-20 / Hydroxypropylcellulose, Low Substituted 低置換度ヒドロキシプロピルセルロース
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
November 13, 2014[451KB] |
December 1, 2017 |
Corr. 1 |
July 1, 2015[186KB] |
December 1, 2017 |
Corr. 2 |
October 26, 2016[24.3KB] |
December 1, 2017 |
Corr. of Sign-off cover sheet |
November 15, 2021[26.4KB] |
- |
Corr. 3 |
January 20, 2023[1,222KB] |
June 28, 2024 |
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E-21 / Hypromellose ヒプロメロース
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
November 10, 2003[131KB] |
April 1, 2006 |
Rev. 1 |
June 6, 2012[30.6KB] |
February 28, 2014 |
Rev. 1, Corr. 1 |
June 26, 2014[35.9KB] |
April 1, 2016 |
Rev. 1, Corr. 2 |
July 1, 2015[231KB] |
December 1, 2017 |
Rev. 1, Rev. of Sign-off cover sheet |
October 26, 2016[460KB] |
June 28, 2019 |
Rev. 2 |
September 13, 2017[30.2KB] |
June 28, 2019 |
Corr. of Sign-off cover sheet |
November 15, 2021[26.5KB] |
- |
Rev. 2, Corr. 1 |
January 20, 2023[1,927KB] |
June 28, 2024 |
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E-22 / Hypromellose Phthalate ヒプロメロースフタル酸エステル
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E-23 / Lactose, Anhydrous 無水乳糖
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
September 10, 2002[35.3KB] |
- |
Rev. 1 |
February 5, 2003[35.0KB] |
April 1, 2006 |
Rev. 2 |
November 8, 2005[118KB] |
October 1, 2007 |
Rev. 3 |
June 5, 2008[30.4KB] |
October 1, 2009 |
Rev. 4 |
November 9, 2010[55.5KB] |
October 1, 2012 |
Rev. 4, Rev. of Sign-off cover sheet |
October 26, 2016[778KB] |
June 7, 2021 |
Rev. 4, Corr. 1 |
October 2, 2019[29.6KB] |
June 7, 2021 |
Rev. 4, Corr. 2 |
January 20, 2023[1,536KB] |
December 12, 2022 |
Rev. 5 |
(Stage 1) |
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E-24 / Lactose, Monohydrate 乳糖水和物
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
September 10, 2002[115KB] |
April 1, 2006 |
Rev. 1 |
October 25, 2006[127KB] |
- |
Rev. 2 |
June 5, 2008[36.2KB] |
October 1, 2009 |
Rev. 2, Corr. 1 |
October 2, 2019[28.1KB] |
June 7, 2021 |
Rev. 2, Corr. 2 |
January 20, 2023[874KB] |
December 12, 2022 |
Rev. 3 |
(Stage 1) |
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E-25 / Magnesium Stearate ステアリン酸マグネシウム
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
June 3, 2008[34.1KB] |
October 1, 2012 |
Corr. 1 |
November 11, 2008[39.0KB] |
October 1, 2012 |
Corr. 2 |
June 6, 2012[25.2KB] |
October 1, 2012 |
Corr. 3 |
June 27, 2013[34.5KB] |
- |
Corr. of Sign-off cover sheet |
December 22, 2020[53.5KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[393KB] |
December 12, 2022 |
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E-26 / Methylcellulose メチルセルロース
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
November 10, 2003[130KB] |
- |
Rev. 1 |
November 8, 2005[124KB] |
April 1, 2006 |
Rev. 2 |
June 6, 2012[31.3KB] |
February 28, 2014 |
Rev. 2, Corr. 1 |
June 26, 2014[18.6KB] |
April 1, 2016 |
Rev. 2, Corr. 2 |
July 1, 2015[219KB] |
December 1, 2017 |
Rev. 3 |
September 13, 2017[32.7KB] |
June 28, 2019 |
Corr. of Sign-off cover sheet |
November 15, 2021[26.0KB] |
- |
Rev. 3, Corr. 1 |
January 20, 2023[1,884KB] |
June 28, 2024 |
-
E-27 / Methyl Paraben パラオキシ安息香酸メチル
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 19, 2004[112KB] |
April 1, 2006 |
Rev. 1 |
June 10, 2009[27.8KB] |
October 1, 2012 |
Rev. 1, Corr. 1 |
November 9, 2011[35.4KB] |
October 1, 2012 |
Rev. 1, Corr. 2 |
December 22, 2020[152KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[387KB] |
December 12, 2022 |
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E-29 / Petrolatum, White 白色ワセリン
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E-30 / Polyethylene Glycol (調和作業中)
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E-31 / Polysorbate 80 ポリソルベート80
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
June 3, 2008[28.7KB] |
February 28, 2014 |
Corr. 1 |
October 27, 2009[21.0KB] |
February 28, 2014 |
Corr. 2 |
November 13, 2014[481KB] |
April 1, 2016 |
Corr. 3 |
July 1, 2016[26.8KB] |
December 1, 2017 |
Rev. of Sign-off cover sheet |
October 26, 2016[450KB] |
- |
Corr. of Sign-off cover sheet |
December 22, 2020[53.3KB] |
Decemer 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[436KB] |
Decemer 12, 2022 |
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 25, 2006[116KB] |
April 1, 2016 |
Corr. 1 |
May 8, 2007[78.3KB] |
April 1, 2016 |
Corr. 2 |
June 3, 2008[30.6KB] |
April 1, 2016 |
Rev. 1 |
July 1, 2015[361KB] |
April 1, 2016 |
Rev. 1, Corr. 1 |
November 4, 2015[696KB] |
- |
Corr. of Sign-off cover sheet |
January 20, 2023[541KB] |
December 12, 2022 |
Rev. 2 |
(Stage 1) |
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E-36 / Silicon Dioxide (調和作業中)
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E-37 / Silicon Dioxide, Colloidal (調和作業中)
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E-38 / Sodium Chloride 塩化ナトリウム
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
May 23, 2001[32.9KB] |
- |
Rev. 1 |
October 24, 2001[35.2KB] |
January 1, 2003 |
Rev. 2 |
November 11, 2003[119KB] |
April 1, 2006 |
Rev. 3 |
November 6, 2013[489KB] |
April 1, 2016 |
Rev. 3, Corr. 1 |
May 26, 2016[433KB] |
- |
Rev. 3, Corr. 2 |
December 22, 2020[274KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[393KB] |
December 12, 2022 |
-
E-39 / Sodium Starch Glycolate デンプングリコール酸ナトリウム
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E-40 / Starch, Corn トウモロコシデンプン
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 24, 2001[32.3KB] |
January 1, 2005 |
Rev. 1 |
February 18, 2004[30.7KB] |
April 1, 2006 |
Rev. 2 |
October 29, 2007[107KB] |
October 1, 2009 |
Rev. 3 |
June 6, 2012[34.0KB] |
February 28, 2014 |
Rev. 4 |
July 3, 2024[525KB] |
(April, 2026) |
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E-41 / Starch, Potato バレイショデンプン
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E-42 / Starch, Rice コメデンプン
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E-43 / Starch, Wheat コムギデンプン
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
October 24, 2001[32.6KB] |
January 1, 2005 |
Rev. 1 |
October 29, 2007[111KB] |
October 1, 2009 |
Rev. 2 |
June 15, 2011[46.1KB] |
April 1, 2011 |
Rev. 2, Rev. of Sign-off cover sheet |
November 4, 2015[460KB] |
April 1, 2016 |
Rev. 3 |
October 3, 2018[234KB] |
June 7, 2021 |
Rev. 3, Corr. 1 |
December 22, 2020[261KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
November 15, 2021[30.0KB] |
- |
-
E-44 / Stearic Acid ステアリン酸
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
June 3, 2008[32.1KB] |
February 28, 2014 |
Rev. 1 |
November 6, 2013[468KB] |
February 28, 2014 |
Rev. 1, Corr. 1 |
November 13, 2014[293KB] |
- |
Rev. 1, Rev. of Sign-off cover sheet |
July 1, 2015[356KB] |
April 1, 2016 |
Rev. 2 |
November 15, 2021[376KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[391KB] |
December 12, 2022 |
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E-48 / Ethyl Paraben パラオキシ安息香酸エチル
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 19, 2004[112KB] |
April 1, 2006 |
Rev. 1 |
June 10, 2009[30.2KB] |
October 1, 2012 |
Rev. 1, Corr. 1 |
November 9, 2011[35.0KB] |
October 1, 2012 |
Rev. 1, Corr. 2 |
December 22, 2020[148KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[386KB] |
December 12, 2022 |
-
E-49 / Propyl Paraben パラオキシ安息香酸プロピル
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 19, 2004[111KB] |
April 1, 2006 |
Rev. 1 |
June 10, 2009[30.0KB] |
October 1, 2012 |
Rev. 1, Corr. 1 |
November 9, 2011[35.2KB] |
October 1, 2012 |
Rev. 1, Corr. 2 |
December 22, 2020[144KB] |
December 12, 2022 |
Corr. of Sign-off cover sheet |
January 20, 2023[381KB] |
December 12, 2022 |
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E-50 / Butyl Paraben パラオキシ安息香酸ブチル
Harmonization No. |
Sign-off |
施行日 |
初回調和 (gelling grade) |
June 6, 2012[37.0KB] |
May 31, 2013 |
初回調和 (non-gelling grade) |
June 6, 2012[205KB] |
- |
Corr. 1 (gelling grade) |
November 7, 2012[28.7KB] |
May 31, 2013 |
Corr. 1 (non-gelling grade) |
November 7, 2012[28.9KB] |
- |
Corr. 2 (gelling grade) |
June 26, 2014[36.4KB] |
April 1, 2016 |
Corr. 2 (non-gelling grade) |
June 26, 2014[55.2KB] |
- |
Corr. 3 (gelling grade) |
October 26, 2016[653KB] |
June 7, 2021 |
Corr. 3 (non-gelling grade) |
October 26, 2016[811KB] |
- |
Rev. 2 (gelling grade) |
October 3, 2018[204KB] |
June 7, 2021 |
Rev. 2 (non-gelling grade) |
October 3, 2018[490KB] |
- |
Rev. 3 (gelling grade and non-gelling grade) |
October 2, 2019[18.7KB] |
June 7, 2021 |
Corr. of Sign-off cover sheet (gelling grade and non-gelling grade) |
November 15, 2021[27.7KB] |
- |
Corr. of Sign-off cover sheet (gelling grade and non-gelling grade) |
January 20, 2023[382KB] |
December 12, 2022 |
(注)2019年10 月PDG東京会合議事要旨[357KB]で合意された通り、ゲル化グレード(E-55a)と非ゲル化グレード(E-55b)は統合されてE-55とされました。
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E-56 / Glucose Anhydrous/Monohydrate 精製ブドウ糖/ブドウ糖水和物
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E-59 / Propylene Glycol (調和作業中)
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E-60 / Sodium Laurylsulfate ラウリル硫酸ナトリウム
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E-61 / Starch, Pregelatinized (調和作業中)
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E-62 / Sterile Water for Injection in Containers (調和作業中)
-
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)
-
E-71 / Purified Water (調和作業中)
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E-72 / Water for Injection (調和作業中)
調和対象外項目
以下2項目については、2018年10月に三薬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[306KB]をご参照ください。)
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E-63 / Lactose for Inhalation
-
E-67 / Sodium Cetyl Sulfate
調和対象外項目
以下5項目については、2017年9月に三薬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[203KB]をご参照ください。)
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E-34 / Saccharin, Sodium サッカリンナトリウム水和物
Harmonization No. |
Sign-off |
施行日 |
初回調和 |
February 5, 2003[33.4KB] |
- |
Rev. 1 |
February 18, 2004[114KB] |
April 1, 2006 |
Rev. 2 |
November 13, 2014[501KB] |
December 1, 2017 |
Rev. 2, Corr. 1 |
May 26, 2016[293KB] |
December 1, 2017 |
Rev. 2, Sign-off cover sheet |
October 26, 2016[528KB] |
- |
-
E-35 / Saccharin, Calcium