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をご確認ください。
As of June 14, 2023
| Harmonization No. / Item | 日局収載名等 | Sign-off | 施行日 |
|---|---|---|---|
| E-01 / Alcohol | エタノール | ||
| 初回調和 | October 24, 2001 | - | |
| Rev. 1 | September 9, 2002 | April 1, 2006 | |
| Rev. 2 | November 7, 2012 | February 28, 2014 | |
| Rev. 2, Corr. 1 | June 27, 2013 | April 1, 2016 | |
| Rev. 2, Corr. 2 | June 26, 2014 | April 1, 2016 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | December 12, 2022 | |
| E-02 / Dehydrated Alcohol | 無水エタノール | ||
| 初回調和 | October 24, 2001 | - | |
| Rev. 1 | September 9, 2002 | April 1, 2006 | |
| Rev. 2 | November 7, 2012 | February 28, 2014 | |
| Rev. 2, Corr. 1 | June 27, 2013 | April 1, 2016 | |
| Rev. 2, Corr. 2 | June 26, 2014 | April 1, 2016 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | December 12, 2022 | |
| E-03 / Benzyl Alcohol | ベンジルアルコール | ||
| 初回調和 | July 18, 2000 | January 1, 2005 | |
| Rev. 1 | November 8, 2005 | April 1, 2006 | |
| Rev. 2 | June 3, 2008 | April 1, 2011 | |
| Rev. 2, Corr. 1 | June 15, 2011 | October 1, 2012 | |
| Rev. 2, Corr. 2 | December 22, 2020 | December 12, 2022 | |
| E-04 / Calcium Disodium Edetate | エデト酸カルシウムナトリウム水和物 | ||
| 初回調和 | November 8, 2005 | February 28, 2014 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| Rev. 1 | |||
| E-05 / Calcium Phosphate Dibasic | リン酸水素カルシウム水和物 | ||
| 初回調和 | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 15, 2011 | October 1, 2012 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-06 / Calcium Phosphate Dibasic Anhydrous | 無水リン酸水素カルシウム | ||
| 初回調和 | November 8, 2005 | October 1, 2007 | |
| Rev. 1 | June 15, 2011 | October 1, 2012 | |
| Rev. 2 | September 13, 2017 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-07 / Carmellose Calcium | カルメロースカルシウム | ||
| 初回調和 | October 24, 2001 | - | |
| Rev. 1 | July 17, 2003 | January 1, 2005 | |
| Rev. 1, Corr. 1 | January 20, 2023 | (June, 2024) | |
| E-08 / Carmellose Sodium | （調和作業中） | ||
| E-09 / Croscarmellose Sodium | クロスカルメロースナトリウム | ||
| 初回調和 | October 24, 2001 | April 1, 2006 | |
| Rev. of Sign-off cover sheet | May 26, 2016 | December 12, 2022 | |
| Rev. 1 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| Rev. 2 | |||
| E-10 / Cellulose, Microcrystalline | 結晶セルロース |
||
| 初回調和 | February 18, 2004 | - | |
| Rev. 1 | May 11, 2005 | April 1, 2006 | |
| Rev. 1, Rev. of Sign-off cover sheet | May 26, 2016 | June 28, 2019 | |
| Rev. 2 | September 13, 2017 | June 28, 2019 | |
| Rev. 3 | October 3, 2018 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-11 / Cellulose, Powdered | 粉末セルロース | ||
| 初回調和 | February 18, 2004 | - | |
| Rev. 1 | May 11, 2005 | April 1, 2006 | |
| Rev. 1, Rev. of Sign-off Cover Sheet | May 26, 2016 | December 12, 2022 | |
| Rev. 1, Corr. 1 | November 15, 2021 | - | |
| Rev. 1, Corr. 1 | January 20, 2023 | December 12, 2022 | |
| E-13 / Cellulose Acetate Phthalate | セラセフェート | ||
| 初回調和 | October 24, 2001 | January 1, 2005 | |
| Rev. 1 | November 9, 2010 | October 1, 2012 | |
| Rev. 1, Corr. 1 | June 6, 2012 | October 1, 2012 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-14 / Citric Acid, Anhydrous | 無水クエン酸 | ||
| 初回調和 | May 23, 2001 | January 1, 2003 | |
| Rev. 1 | November 11, 2003 | April 1, 2006 | |
| Rev. 2 | June 9, 2010 | October 1, 2012 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-15 / Citric Acid, Monohydrate | クエン酸水和物 | ||
| 初回調和 | May 23, 2001 | January 1, 2003 | |
| Rev. 1 | November 11, 2003 | April 1, 2006 | |
| Rev. 2 | June 9, 2010 | October 1, 2012 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-16 / Crospovidone | クロスポビドン | ||
| 初回調和 | November 9, 2010 | October 1, 2012 | |
| Corr. of Sign-off cover sheet | October 3, 2018 | - | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-17 / Ethylcellulose | エチルセルロース | ||
| 初回調和 | February 6, 2002 | - | |
| Rev. 1 | October 27, 2009 | - | |
| Rev. 2 | May 26, 2016 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-18 / Hydroxyethylcellulose | ヒドロキシエチルセルロース | ||
| 初回調和 | July 25, 2016 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| Rev. 1 | |||
| E-19 / Hydroxypropylcellulose | ヒドロキシプロピルセルロース | ||
| 初回調和 | June 27, 2013 | April 1, 2016 | |
| Rev. of Sign-off cover sheet | September 13, 2017 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-20 / Hydroxypropylcellulose, Low Substituted | 低置換度ヒドロキシプロピルセルロース | ||
| 初回調和 | November 13, 2014 | December. 1, 2017 | |
| Corr. 1 | July 1, 2015 | December. 1, 2017 | |
| Corr. 2 | October 26, 2016 | December. 1, 2017 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. 3 | January 20, 2023 | (June, 2024) | |
| E-21 / Hypromellose | ヒプロメロース | ||
| 初回調和 | November 10, 2003 | April 1, 2006 | |
| Rev. 1 | June 6, 2012 | February 28, 2014 | |
| Rev. 1, Corr. 1 | June 26, 2014 | April 1, 2016 | |
| Rev. 1, Corr. 2 | July 1, 2015 | December 1, 2017 | |
| Rev. 1, Rev. of Sign-off cover sheet | October 26, 2016 | June 28, 2019 | |
| Rev. 2 | September 13, 2017 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Rev. 2, Corr. 1 | January 20, 2023 | (June, 2024) | |
| E-22 / Hypromellose Phthalate | ヒプロメロースフタル酸エステル | ||
| 初回調和 | June 6. 2006 | October 1, 2007 | |
| Corr. 1 | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-23 / Lactose, Anhydrous | 無水乳糖 | ||
| 初回調和 | September 10, 2002 | - | |
| Rev. 1 | February 5, 2003 | April 1, 2006 | |
| Rev. 2 | November 8, 2005 | October 1, 2007 | |
| Rev. 3 | June 5, 2008 | October 1, 2009 | |
| Rev. 4 | November 9, 2010 | October 1, 2012 | |
| Rev. 4, Rev. of Sign-off cover sheet | October 26, 2016 | June 7, 2021 | |
| Rev. 4, Corr. 1 | October 2, 2019 | June 7, 2021 | |
| Rev. 4, Corr. 2 | January 20, 2023 | December 12, 2022 | |
| Rev. 5 | |||
| E-24 / Lactose, Monohydrate | 乳糖水和物 | ||
| 初回調和 | September 10, 2002 | April 1, 2006 | |
| Rev. 1 | October 25, 2006 | - | |
| Rev. 2 | June 5, 2008 | October 1, 2009 | |
| Rev. 2, Corr. 1 | October 2, 2019 | June 7, 2021 | |
| Rev. 2, Corr. 2 | January 20, 2023 | December 12, 2022 | |
| Rev. 3 | |||
| E-25 / Magnesium Stearate | ステアリン酸マグネシウム | ||
| 初回調和 | June 3, 2008 | October 1, 2012 | |
| Corr. 1 | November 11, 2008 | October 1, 2012 | |
| Corr. 2 | June 6, 2012 | October 1, 2012 | |
| Corr. 3 | June 27, 2013 | - | |
| Corr. of Sign-off cover sheet | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-26 / Methylcellulose | メチルセルロース | ||
| 初回調和 | November 10, 2003 | - | |
| Rev. 1 | November 8, 2005 | April 1, 2006 | |
| Rev. 2 | June 6, 2012 | February 28, 2014 | |
| Rev. 2, Corr. 1 | June 26, 2014 | April 1, 2016 | |
| Rev. 2, Corr. 2 | July 1, 2015 | December 1, 2017 | |
| Rev. 3 | September 13, 2017 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Rev. 3, Corr. 1 | January 20, 2023 | (June, 2024) | |
| E-27 / Methyl Paraben | パラオキシ安息香酸メチル | ||
| 初回調和 | February 19, 2004 | April 1, 2006 | |
| Rev. 1 | June 10, 2009 | October 1, 2012 | |
| Rev. 1, Corr. 1 | November 9, 2011 | October 1, 2012 | |
| Rev. 1, Corr. 2 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-28 / Petrolatum | 黄色ワセリン | ||
| 初回調和 | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-29 / Petrolatum, White | 白色ワセリン | ||
| 初回調和 | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-30 / Polyethylene Glycol | （調和作業中） | ||
| E-31 / Polysorbate 80 | ポリソルベート80 | ||
| 初回調和 | June 3, 2008 | February 28, 2014 | |
| Corr. 1 | October 27, 2009 | February 28, 2014 | |
| Corr. 2 | November 13, 2014 | April 1, 2016 | |
| Corr. 3 | July 1, 2016 | December 1, 2017 | |
| Rev. of Sign-off cover sheet | October 26, 2016 | - | |
| Corr. of Sign-off cover sheet | December 22, 2020 | Decemer 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | Decemer 12, 2022 | |
| E-32 / Povidone | ポビドン | ||
| 初回調和 | October 25, 2006 | April 1, 2016 | |
| Corr. 1 | May 8, 2007 | April 1, 2016 | |
| Corr. 2 | June 3, 2008 | April 1, 2016 | |
| Rev. 1 | July 1, 2015 | April 1, 2016 | |
| Rev. 1, Corr. 1 | November 4, 2015 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| Rev. 2 | |||
| E-36 / Silicon Dioxide | （調和作業中） | ||
| E-37 / Silicon Dioxide, Colloidal | （調和作業中） | ||
| E-38 / Sodium Chloride | 塩化ナトリウム | ||
| 初回調和 | May 23, 2001 | - | |
| Rev. 1 | October 24, 2001 | January 1, 2003 | |
| Rev. 2 | November 11, 2003 | April 1, 2006 | |
| Rev. 3 | November 6, 2013 | April 1, 2016 | |
| Rev. 3, Corr. 1 | May 26, 2016 | - | |
| Rev. 3, Corr. 2 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-39 / Sodium Starch Glycolate | デンプングリコール酸ナトリウム | ||
| 初回調和 | November 10, 2003 | - | |
| Rev. 1 | May 11, 2005 | October 1, 2007 | |
| Rev. 3 | June 27, 2013 | April 1, 2016 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-40 / Starch, Corn | トウモロコシデンプン | ||
| 初回調和 | October 24, 2001 | January 1, 2005 | |
| Rev. 1 | February 18, 2004 | April 1, 2006 | |
| Rev. 2 | October 29, 2007 | October 1, 2009 | |
| Rev. 3 | June 6, 2012 | February 28, 2014 | |
| Rev. 4 | |||
| E-41 / Starch, Potato | バレイショデンプン | ||
| 初回調和 | October 24, 2001 | January 1, 2005 | |
| Rev. 1 | October 29, 2007 | October 1, 2009 | |
| Rev. 2 | June 15, 2011 | February 28, 2014 | |
| E-42 / Starch, Rice | コメデンプン | ||
| 初回調和 | October 25, 2006 | October 1, 2009 | |
| Rev. 1 | November 6, 2013 | April 1, 2016 | |
| E-43 / Starch, Wheat | コムギデンプン | ||
| 初回調和 | October 24, 2001 | January 1, 2005 | |
| Rev. 1 | October 29, 2007 | October 1, 2009 | |
| Rev. 2 | June 15, 2011 | April 1, 2011 | |
| Rev. 2, Rev. of Sign-off cover sheet | November 4, 2015 | April 1, 2016 | |
| Rev. 3 | October 3, 2018 | June 7, 2021 | |
| Rev. 3, Corr. 1 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| E-44 / Stearic Acid | ステアリン酸 | ||
| 初回調和 | June 3, 2008 | February 28, 2014 | |
| Rev. 1 | November 6, 2013 | February 28, 2014 | |
| Rev. 1, Corr. 1 | November 13, 2014 | - | |
| Rev. 1, Rev. of Sign-off cover sheet | July 1, 2015 | April 1, 2016 | |
| Rev. 2 | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-45 / Sucrose | 精製白糖 | ||
| 初回調和 | October 30, 2007 | October 1, 2012 | |
| Rev. of Sign-off cover sheet | June 27, 2013 | - | |
| Rev. 1 | |||
| E-46 / Talc | タルク | ||
| 初回調和 | November 10, 2003 | - | |
| Rev. 1 | June 3, 2008 | April 1, 2011 | |
| E-48 / Ethyl Paraben | パラオキシ安息香酸エチル | ||
| 初回調和 | February 19, 2004 | April 1, 2006 | |
| Rev. 1 | June 10, 2009 | October 1, 2012 | |
| Rev. 1, Corr. 1 | November 9, 2011 | October 1, 2012 | |
| Rev. 1, Corr. 2 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-49 / Propyl Paraben | パラオキシ安息香酸プロピル | ||
| 初回調和 | February 19, 2004 | April 1, 2006 | |
| Rev. 1 | June 10, 2009 | October 1, 2012 | |
| Rev. 1, Corr. 1 | November 9, 2011 | October 1, 2012 | |
| Rev. 1, Corr. 2 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-50 / Butyl Paraben | パラオキシ安息香酸ブチル | ||
| 初回調和 | February 19, 2004 | April 1, 2006 | |
| Rev. 1 | June 9, 2010 | October 1, 2012 | |
| Rev. 1, Corr. 1 | December 22, 2020 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-51 / Glycerin | （調和作業中） | ||
| E-52 / Carmellose | カルメロース | ||
| 初回調和 | November 11, 2008 | April 1, 2011 | |
| Rev. 1 | November 9, 2011 | February 28, 2014 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-54 / Copovidone | コポビドン | ||
| 初回調和 | October 3, 2018 | June 7, 2021 | |
| Corr. 1 | October 2, 2019 | June 7, 2021 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| Rev. 1 | |||
| E-55a / Gelatin, gelling type | ゼラチン | ||
| 初回調和 | June 6, 2012 | May 31, 2013 | |
| Corr. 1 | November 7, 2012 | May 31, 2013 | |
| Corr. 2 | November 6, 2013 | April 1, 2016 | |
| Corr. 3 | October 26, 2016 | June 7, 2021 | |
| Rev. 2 | October 3, 2018 | June 7, 2021 | |
| E-55b / Gelatin, non-gelling grade | （日局は調和に不参加） | ||
| 初回調和 | June 6, 2012 | - | |
| Corr. 1 | November 7, 2012 | - | |
| Corr. 2 | November 6, 2013 | - | |
| Corr. 3 | October 26, 2016 | - | |
| Rev. 2 | October 3, 2018 | - | |
| E-55 / Gelatin | ゼラチン | ||
| Rev. 3 | October 2, 2019 | June 7, 2021 | |
| Corr. of Sign-off cover sheet | November 15, 2021 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-56 / Glucose Anhydrous/Monohydrate | 精製ブドウ糖／ブドウ糖水和物 | ||
| 初回調和 | June 26, 2014 | December 1, 2017 | |
| Corr. 1 | January 20, 2015 | December 1, 2017 | |
| Rev. of Sign-off cover sheet | November 4, 2015 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-58 / Mannitol | D－マンニトール | ||
| 初回調和 | June 6, 2012 | February 28, 2014 | |
| Corr. 1 | June 26, 2014 | February 28, 2014 | |
| Corr. of Sign-off cover sheet | October 3, 2018 | - | |
| Corr. of Sign-off cover sheet | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-59 / Propylene Glycol | （調和作業中） | ||
| E-60 / Sodium Laurylsulfate | ラウリル硫酸ナトリウム | ||
| 初回調和 | November 13, 2014 | December 1, 2017 | |
| Rev. 1 | October 2, 2019 | 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 | イソマル水和物 | ||
| 初回調和 | June 27, 2013 | April 1, 2016 | |
| Rev. of Sign-off cover sheet | November 4, 2015 | April 1, 2016 | |
| Corr.1 | November 29, 2016 | June 28, 2019 | |
| Corr. of Sign-off cover sheet | October 3, 2018 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 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） | ||
| E-71 / Purified Water | （調和作業中） | ||
| E-72 / Water for Injection | （調和作業中） |
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 | October 24, 2001 | - | |
| Rev. 1 | February 5, 2003 | - | |
| Rev. 2 | November 7, 2012 | - | |
| Rev. 3 | July 21, 2016 | - | |
| E-33 / Saccharin | サッカリン | ||
| 初回調和 | February 5, 2003 | April 1, 2006 | |
| Rev. 1 | June 27, 2013 | April 1, 2016 | |
| E-34 / Saccharin, Sodium | サッカリンナトリウム水和物 | ||
| 初回調和 | February 5, 2003 | - | |
| Rev. 1 | February 18, 2004 | April 1, 2006 | |
| Rev. 2 | November 13, 2014 | December 1, 2017 | |
| Rev. 2, Corr. 1 | May 26, 2016 | December 1, 2017 | |
| Rev. 2, Sign-off cover sheet | October 26, 2016 | - | |
| E-35 / Saccharin, Calcium | February 5, 2003 | - | |
| E-53 / Calcium Carbonate | - | - |