PDG (Pharmacopoeial Discussion Group) Sign-off Cover Sheets (which provide information such as on harmonized attributes, non-harmonized attributes, and local requirements as well as the signatures of three pharmacopoeias) on the harmonized monographs are listed. From the sign-offs on December 22, 2020, not only sign-off cover sheets but full texts of the harmonized documents are published. (See the PDG November 2020 Videoconference Meeting Highlights.)
The JP edition or supplement of each implementation date is shown in the table “Implementation date of JP Editions and Supplements”
As of June 14, 2023
| Harmonization No. / Item | JP Official Monograph | Sign-off | Implementation |
|---|---|---|---|
| E-01 / Alcohol | Ethanol | ||
| Signed-off | 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 | Anhydrous Ethanol | ||
| Signed-off | 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 | Benzyl Alcohol | ||
| Signed-off | 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 | Calcium Sodium Edetate Hydrate | ||
| Signed-off | 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 | Dibasic Calcium Phosphate Hydrate | ||
| Signed-off | 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 | Anhydrous Dibasic Calcium Phosphate | ||
| Signed-off | 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 | Carmellose Calcium | ||
| Signed-off | October 24, 2001 | - | |
| Rev. 1 | July 17, 2003 | January 1, 2005 | |
| Rev. 1, Corr. 1 | January 20, 2023 | (June, 2024) | |
| E-08 / Carmellose Sodium | (Harmonization work in progress) | ||
| E-09 / Croscarmellose Sodium | Croscarmellose Sodium | ||
| Signed-off | 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 | Microcrystalline Cellulose | ||
| Signed-off | 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 | Powdered Cellulose | ||
| Signed-off | 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 | - | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-13 / Cellulose Acetate Phthalate | Cellacefate | ||
| Signed-off | 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 | Anhydrous Citric Acid | ||
| Signed-off | 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 | Citric Acid Hydrate | ||
| Signed-off | 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 | Crospovidone | ||
| Signed-off | 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 | Ethylcellulose | ||
| Signed-off | 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 | Hydroxyethylcellulose | ||
| Signed-off | 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 | Hydroxypropylcellulose | ||
| Signed-off | 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 | Low Substituted Hydroxypropylcellulose | ||
| Signed-off | 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 | Hypromellose | ||
| Signed-off | 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 | Hypromellose Phthalate | ||
| Signed-off | 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 | Anhydrous Lactose | ||
| Signed-off | 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 | Lactose Hydrate | ||
| Signed-off | 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 | Magnesium Stearate | ||
| Signed-off | June 3, 2008 | October 1, 2012 | |
| Corr. 1 | November.1, 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 | Methylcellulose | ||
| Signed-off | 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 | Methyl Parahydroxybenzoate | ||
| Signed-off | 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 | Yellow Petrolatum | ||
| Signed-off | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-29 / Petrolatum, White | White Petrolatum | ||
| Signed-off | November 15, 2021 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-30 / Polyethylene Glycol | (Harmonization work in progress) | ||
| E-31 / Polysorbate 80 | Polysorbate 80 | ||
| Signed-off | 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 | December 12, 2022 | |
| Corr. of Sign-off cover sheet | January 20, 2023 | December 12, 2022 | |
| E-32 / Povidone | Povidone | ||
| Signed-off | 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 | (Harmonization work in progress) | ||
| E-37 / Silicon Dioxide, Colloidal | (Harmonization work in progress) | ||
| E-38 / Sodium Chloride | Sodium Chloride | ||
| Signed-off | 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 | Sodium Starch Glycolate | ||
| Signed-off | 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 | Corn Starch | ||
| Signed-off | 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 | Potato Starch | ||
| Signed-off | 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 | Rice Starch | ||
| Signed-off | October 25, 2006 | October 1, 2009 | |
| Rev. 1 | November 6, 2013 | April 1, 2016 | |
| E-43 / Starch, Wheat | Wheat Starch | ||
| Signed-off | 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 | Stearic Acid | ||
| Signed-off | 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 | Sucrose | ||
| Signed-off | October 30, 2007 | October 1, 2012 | |
| Rev. of Sign-off cover sheet | June 27, 2013 | - | |
| Rev. 1 | |||
| E-46 / Talc | Talc | ||
| Signed-off | November 10, 2003 | - | |
| Rev. 1 | June 3, 2008 | April 1, 2011 | |
| E-48 / Ethyl Paraben | Ethyl Parahydroxybenzoate | ||
| Signed-off | 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 | Propyl Parahydroxybenzoate | ||
| Signed-off | 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 | Butyl Parahydroxybenzoate | ||
| Signed-off | 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 | (Harmonization work in progress) | ||
| E-52 / Carmellose | Carmellose | ||
| Signed-off | 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 | Copovidone | ||
| Signed-off | 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 | Gelatin | ||
| Signed-off | 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 | (JP did not implement this item) | ||
| Signed-off | 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 | Gelatin | ||
| 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 | Purified Glucose/Glucose Hydrate | ||
| Signed-off | 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-Mannitol | ||
| Signed-off | 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 | (Harmonization work in progress) | ||
| E-60 / Sodium Laurylsulfate | Sodium Lauryl Sulfate | ||
| Signed-off | November 13, 2014 | December 1, 2017 | |
| Rev. 1 | October 2, 2019 | June 7, 2021 | |
| E-61 / Starch, Pregelatinized | (Harmonization work in progress) | ||
| E-62 / Sterile Water for Injection in Containers | (Harmonization work in progress) | ||
| E-64 / Isomalt | Isomalt Hydrate | ||
| Signed-off | 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 | (Harmonization work in progress) | ||
| E-66 / Myristyl Myristate | (Harmonization work in progress) | ||
| E-68 / Polysorbate 65 | (Harmonization work in progress) | ||
| E-69 / Calcium Silicate | (Harmonization work in progress) | ||
| E-70 / Polysorbate 20 | (Harmonization work in progress) | ||
| E-71 / Purified Water | (Harmonization work in progress) | ||
| E-72 / Water for Injection | (Harmonization work in progress) |
Following two items were suppressed from the PDG work programme in October, 2018. (Please also see the PDG October 2018 Strasbourg Meeting Highlights.)
| Harmonization No. / Item | JP Official Monograph | Sign-off | Implementation |
|---|---|---|---|
| E-63 / Lactose for Inhalation | - | - | |
| E-67 / Sodium Cetyl Sulfate | - | - |
Following five items were suppressed from the PDG work programme in September, 2017. (Please also see the PDG September 2017 Rockville Meeting Highlights.)
| Harmonization No. / Item | JP Official Monograph | Sign-off | Implementation |
|---|---|---|---|
| E-12 / Cellulose Acetate | |||
| Signed-off | October 24, 2001 | - | |
| Rev. 1 | February 5, 2003 | - | |
| Rev. 2 | November 7, 2012 | - | |
| Rev. 3 | July 21, 2016 | - | |
| E-33 / Saccharin | Saccharin | ||
| Signed-off | February 5, 2003 | April 1, 2006 | |
| Rev. 1 | June 27, 2013 | April 1, 2016 | |
| E-34 / Saccharin, Sodium | Saccharin Sodium Hydrate | ||
| Signed-off | 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 | - | - |