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Regulatory Science/The Science Board/Standard Development

Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs)

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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[119KB].)
The JP edition or supplement of each implementation date is shown in the table “Implementation date of JP Editions and Supplements[23.4KB]”

As of July 3, 2024

Monographs（Pharmaceutical Excipients）

  • E-01 / Alcohol　<JP> Ethanol
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-02 / Dehydrated Alcohol　<JP> Anhydrous Ethanol
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-03 / Benzyl Alcohol　<JP> Benzyl Alcohol
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-04 / Calcium Disodium Edetate　<JP> Calcium Sodium Edetate Hydrate
Harmonization No. Sign-off Implementation
　Signed-off November 8, 2005[104KB] February 28, 2014
　Corr. of Sign-off cover sheet January 20, 2023[361KB] December 12, 2022
　Rev. 1 (Stage 2)  

 

  • E-05 / Calcium Phosphate Dibasic　<JP> Dibasic Calcium Phosphate Hydrate
Harmonization No. Sign-off Implementation
　Signed-off November 8, 2005[111KB] October 1, 2007
　Rev. 1 June 15, 2011[44.2KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[371KB] December 12, 2022

 

  • E-06 / Calcium Phosphate Dibasic Anhydrous 　<JP> Anhydrous Dibasic Calcium Phosphate
Harmonization No. Sign-off Implementation
　Signed-off November 8, 2005[112KB] October 1, 2007
　Rev. 1 June 15, 2011[43.0KB] October 1, 2012
　Rev. 2 September 13, 2017[36.7KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[26.3KB] -
　Corr. of Sign-off cover sheet January 20, 2023[376KB] December 12, 2022

 

  • E-07 / Carmellose Calcium 　<JP> Carmellose Calcium
Harmonization No. Sign-off Implementation
　Signed-off October 24, 2001[34.6KB] -
　Rev. 1 July 17, 2003[108KB] January 1, 2005
　Rev. 1, Corr. 1 January 20, 2023[995KB] June 28, 2024

 

  • E-08 / Carmellose Sodium　(Harmonization work in progress)

 

  • E-09 / Croscarmellose Sodium　<JP>Croscarmellose Sodium
Harmonization No. Sign-off Implementation
　Signed-off October 24, 2001[116KB] April 1, 2006
　Rev. of Sign-off cover sheet May 26, 2016[681KB] December 12, 2022
　Rev. 1 December 22, 2020[129KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[364KB] December 12, 2022
　Rev. 2 (Stage 2)  

 

  • E-10 / Cellulose, Microcrystalline　<JP> Microcrystalline Cellulose
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-11 / Cellulose, Powdered　<JP> Powdered Cellulose
Harmonization No. Sign-off Implementation
　Signed-off 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. 1 January 20, 2023[362KB] December 12, 2022

 

  • E-13 / Cellulose Acetate Phthalate　<JP> Cellacefate
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-14 / Citric Acid, Anhydrous　<JP> Anhydrous Citric Acid
Harmonization No. Sign-off Implementation
　Signed-off May 23, 2001[32.2KB] January 1, 2003
　Rev. 1 November 11, 2003[109KB] April 1, 2006
　Rev. 2 June 9, 2010[29.8KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[355KB] December 12, 2022

 

  • E-15 / Citric Acid, Monohydrate　<JP> Citric Acid Hydrate
Harmonization No. Sign-off Implementation
　Signed-off May 23, 2001[31.8KB] January 1, 2003
　Rev. 1 November 11, 2003[108KB] April 1, 2006
　Rev. 2 June 9, 2010[29.8KB] October 1, 2012
　Corr. of Sign-off cover sheet January 20, 2023[338KB] December 12, 2022

 

  • E-16 / Crospovidone　<JP> Crospovidone
Hamonization No. Sign-off Implementation
　Signed-off November 9, 2010[41.2KB] October 1, 2012
　Corr. of Sign-off cover sheet October 3, 2018[615KB] -
　Corr. of Sign-off cover sheet November 15, 2021[24.0KB] -
　Corr. of Sign-off cover sheet January 20, 2023[374KB] December 12, 2022

 

  • E-17 / Ethylcellulose　<JP> Ethylcellulose
Harmonization No. Sign-off Implementation
　Signed-off February 6, 2002[115KB] -
　Rev. 1 October 27, 2009[31.8KB] -
　Rev. 2 May 26, 2016[468KB] June 28, 2019
　Corr. of Sign-off cover sheet January 20, 2023[403KB] December 12, 2022

 

  • E-18 / Hydroxyethylcellulose　<JP> Hydroxyethylcellulose
Harmonization No. Sign-off Implementation
　Signed-off July 25, 2016[260KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[28.1KB] -
　Corr. of Sign-off cover sheet January 20, 2023[389KB] December 12, 2022
　Rev. 1 (Stage 1)  

 

  • E-19 / Hydroxypropylcellulose　<JP> Hydroxypropylcellulose
Harmonization No. Sign-off Implementation
　Signed-off June 27, 2013[24.2KB] April 1, 2016
　Rev. of Sign-off cover sheet September 13, 2017[498KB] June 28, 2019
　Corr. of Sign-off cover sheet November 15, 2021[27.3KB] -
　Corr. of Sign-off cover sheet January 20, 2023[368KB] December 12, 2022

 

  • E-20 / Hydroxypropylcellulose, Low Substituted　<JP> Low Substituted Hydroxypropylcellulose
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-21 / Hypromellose　<JP> Hypromellose
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-22 / Hypromellose Phthalate　<JP> Hypromellose Phthalate
Harmonization No. Sign-off Implementation
　Signed-off June 6, 2006[102KB] October 1, 2007
　Corr. 1 November 15, 2021[103KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[372KB] December 12, 2022

 

  • E-23 / Lactose, Anhydrous　<JP> Anhydrous Lactose
Harmonization No. Sign-off Implementation
　Signed-off 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)  

 

  • E-24 / Lactose, Monohydrate　<JP> Lactose Hydrate
Harmonization No. Sign-off Implementation
　Signed-off 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)  

 

  • E-25 / Magnesium Stearate　<JP> Magnesium Stearate
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-26 / Methylcellulose　<JP> Methylcellulose
Harmonization No. Sign-off Implementation
　Signed-off 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　<JP> Methyl Parahydroxybenzoate
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-28 / Petrolatum　<JP> Yellow Petrolatum
Harmonization No. Sign-off Implementation
　Signed-off November 15, 2021[203KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[423KB] December 12, 2022

 

  • E-29 / Petrolatum, White　<JP> White Petrolatum
Harmonization No. Sign-off Implementation
　Signed-off November 15, 2021[191KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[429KB] December 12, 2022

 

  • E-30 / Polyethylene Glycol　(Harmonization work in progress)　

 

  • E-31 / Polysorbate 80　<JP>Polysorbate 80
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-32 / Povidone　<JP> Povidone
Harmonization No. Sign-off Implementation
　Signed-off 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)  

 

  • E-36 / Silicon Dioxide　(Harmonization work in progress)

 

  • E-37 / Silicon Dioxide, Colloidal　(Harmonization work in progress)

 

  • E-38 / Sodium Chloride　<JP> Sodium Chloride
Harmonization No. Sign-off Implementation
　Signed-off 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　<JP> Sodium Starch Glycolate
Harmonization No. Sign-off Implementation
　Signed-off November 10, 2003[37.6KB] -
　Rev. 1 May 11, 2005[110KB] October 1, 2007
　Rev. 3 June 27, 2013[38.2KB] April 1, 2016
　Corr. of Sign-off cover sheet November 15, 2021[27.6KB] -
　Corr. of Sign-off cover sheet January 20, 2023[376KB] December 12, 2022

 

  • E-40 / Starch, Corn　<JP> Corn Starch
Harmonization No. Sign-off Implementation
　Signed-off 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)

 

  • E-41 / Starch, Potato　<JP> Potato Starch
Harmonization No. Sign-off Implementation
　Signed-off October 24, 2001[32.8KB] January 1, 2005
　Rev. 1 October 29, 2007[106KB] October 1, 2009
　Rev. 2 June 15, 2011[46.9KB] February 28, 2014

 

  • E-42 / Starch, Rice　<JP> Rice Starch
Harmonization No. Sign-off Implementation
　Signed-off October 25, 2006[95.3KB] October 1, 2009
　Rev. 1 November 6, 2013[454KB] April 1, 2016

 

  • E-43 / Starch, Wheat　<JP> Wheat Starch
Harmonization No. Sign-off Implementation
　Signed-off 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　<JP> Stearic Acid
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-45 / Sucrose　<JP> Sucrose
Harmonization No. Sign-off Implementation
　Signed-off October 30, 2007[107KB] October 1, 2012
　Rev. of Sign-off cover sheet June 27, 2013[32.9KB] -
　Rev. 1 (Stage 3A)  

 

  • E-46 / Talc　<JP> Talc
Harmonization No. Sign-off Implementation
　Signed-off November 10, 2003[147KB] -
　Rev. 1 June 3, 2008[33.6KB] April 1, 2011

 

  • E-48 / Ethyl Paraben　<JP> Ethyl Parahydroxybenzoate
Harmonization No. Sign-off Implementation
　Signed-off 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　<JP> Propyl Parahydroxybenzoate
Harmonization No. Sign-off Implementation
　Signed-off 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

 

  • E-50 / Butyl Paraben　<JP> Butyl Parahydroxybenzoate
Harmonization No. Sign-off Implementation
　Signed-off February 19, 2004[110KB] April 1, 2006
　Rev. 1 June 9, 2010[29.4KB] October 1, 2012
　Rev. 1, Corr. 1 December 22, 2020[179KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[377KB] December 12, 2022

 

  • E-51 / Glycerin　(Harmonization work in progress)

 

  • E-52 / Carmellose　<JP> Carmellose
Harmonization No. Sign-off Implementation
　Signed-off November 11, 2008[29.1KB] April 1, 2011
　Rev. 1 November 9, 2011[39.1KB] February 28, 2014
　Corr. of Sign-off cover sheet January 20, 2023[328KB] December 12, 2022

 

  • E-54 / Copovidone　<JP> Copovidone
Harmonization No. Sign-off Implementation
　Signed-off October 3, 2018[477KB] June 7, 2021
　Corr. 1 October 2, 2019[25.1KB] June 7, 2021
　Corr. of Sign-off cover sheet January 20, 2023[409KB] December 12, 2022
　Rev. 1 (Stage 1)  

 

  • E-55 / Gelatin　<JP> Gelatin
Harmonization No. Sign-off Implementation
　Signed-off (gelling grade) June 6, 2012[37.0KB] May 31, 2013
　Signed-off (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) November 6, 2013[529KB] April 1, 2016
　Corr. 2 (non-gelling grade) November 6, 2013[499KB] -
　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] -
　Signed-off (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

Note:
The gelling grade (E-55a) and the non-gelling grade (E-55b) were integrated into E-55 Gelatin in October, 2019. (Please also see the PDG October 2019 Tokyo Meeting Highlights[164KB].)
 

  • E-56 / Glucose Anhydrous/Monohydrate　<JP> Purified Glucose/Glucose Hydrate
Harmonization No. Sign-off Implementation
　Signed-off June 26, 2014[33.0KB] December 1, 2017
　Corr. 1 January 20, 2015[13.8KB] December 1, 2017
　Rev. of Sign-off cover sheet November 4, 2015[304KB] -
　Corr. of Sign-off cover sheet January 20, 2023[357KB] December 12, 2022

 

  • E-58 / Mannitol　<JP> D-Mannitol
Harmonization No. Sign-off Implementation
　Signed-off June 6, 2012[38.5KB] February 28, 2014
　Corr. 1 June 26, 2014[15.8KB] February 28, 2014
　Corr. of Sign-off cover sheet October 3, 2018[650KB] -
　Corr. of Sign-off cover sheet November 15, 2021[30.2KB] December 12, 2022
　Corr. of Sign-off cover sheet January 20, 2023[420KB] December 12, 2022

 

  • E-59 / Propylene Glycol　 (Harmonization work in progress)

 

  • E-60 / Sodium Laurylsulfate　<JP> Sodium Lauryl Sulfate
Harmonization No. Sign-off Implementation
　Signed-off November 13, 2014[452KB] December 1, 2017
　Rev. 1 October 2, 2019[17.7KB] 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　<JP> Isomalt Hydrate
Harmonization No. Sign-off Implementation
　Signed-off June 27, 2013[31.7KB] April 1, 2016
　Rev. of Sign-off cover sheet November 4, 2015[321KB] April 1, 2016
　Corr.1 November 29, 2016[233KB] June 28, 2019
　Corr. of Sign-off cover sheet October 3, 2018[455KB] -
　Corr. of Sign-off cover sheet January 20, 2023[356KB] 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)

 

Suppressed 2 items

Following two items were suppressed from the PDG work programme in October, 2018. (Please also see the PDG October 2018 Strasbourg Meeting Highlights[174KB].)

  • E-63 / Lactose for Inhalation
  • E-67 / Sodium Cetyl Sulfate

 

Suppressed 5 items

Following five items were suppressed from the PDG work programme in September, 2017. (Please also see the PDG September 2017 Rockville Meeting Highlights[60.5KB].)

  • E-12 / Cellulose Acetate
Harmonization No. Sign-off Implementation
　Signed-off October 24, 2001[108KB] -
　Rev. 1 February 5, 2003[107KB] -
　Rev. 2 November 7, 2012[32.5KB] -
　Rev. 3 July 21, 2016[226KB] -

 

  • E-33 / Saccharin　<JP> Saccharin
Harmonization No. Sign-off Implementation
　Signed-off February 5, 2003[106KB] April 1, 2006
　Rev. 1 June 27, 2013[30.8KB] April 1, 2016

 

  • E-34 / Saccharin, Sodium 　<JP> Saccharin Sodium Hydrate
Harmonization No. Sign-off Implementation
　Signed-off 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
Harmonization No. Sign-off Implementation
　Signed-off February 5, 2003[105KB] -

 

  • E-53 / Calcium Carbonate