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Implementation of PDG harmonized texts into Japanese Pharmacopoeia (Monographs)

PDG (Pharmacopoeial Discussion Group) Signed-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.

As of October 2, 2019
Harmonization No. / Item JP Official Monograph Sign-off Implementation
E-01 / Alcohol
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Rev. 2, Corr. 2
Ethanol
Oct. 24, 2001
Sep. 9, 2002
Nov. 7, 2012
June 27, 2013
June 26, 2014

-
Apr. 1, 2006
Feb. 28, 2014
Apr. 1, 2016
Apr. 1, 2016
E-02 / Dehydrated Alcohol
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Rev. 2, Corr. 2
Anhydrous Ethanol
Oct. 24, 2001
Sep. 9, 2002
Nov. 7, 2012
June 27, 2013
June 26, 2014

-
Apr. 1, 2006
Feb. 28, 2014
Apr. 1, 2016
Apr. 1, 2016
E-03 / Benzyl Alcohol
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Benzyl Alcohol
July 18, 2000
Nov. 8, 2005
June 3, 2008
June 15, 2011

Jan. 1, 2005
Apr. 1, 2006
Apr. 1, 2011
Oct. 1, 2012
E-04 / Calcium Disodium Edetate
Signed-off
Rev. 1
Calcium Sodium Edetate Hydrate
Nov. 8, 2005

Feb. 28, 2014
E-05 / Calcium Phosphate Dibasic
Signed-off
Rev. 1
Dibasic Calcium Phosphate Hydrate

Nov. 8, 2005
June 15, 2011


Oct. 1, 2007
Oct. 1, 2012
E-06 / Calcium Phosphate Dibasic Anhydrous
Signed-off
Rev. 1
Rev. 2
Anhydrous Dibasic Calcium Phosphate
Nov. 8, 2005
June 15, 2011
Sep. 13, 2017

Oct. 1, 2007
Oct. 1, 2012
June 28, 2019
E-07 / Carmellose Calcium
Signed-off
Rev. 1
Carmellose Calcium
Oct. 24, 2001
July 17, 2003

-
Jan. 1, 2005
E-08 / Carmellose Sodium (Harmonization work in progress)    
E-09 / Croscarmellose Sodium
Signed-off
Rev. of Sign-off cover sheet
Croscarmellose Sodium
Oct. 24, 2001
May 26, 2016

Apr.1, 2006
(Spring, 2021)
E-10 / Cellulose, Microcrystalline
Signed-off
Rev. 1
Rev. 1, Rev. of Sign-off cover sheet
Rev. 2
Rev. 3
Microcrystalline Cellulose
Feb. 18, 2004
May 11, 2005
May 26, 2016

Sep. 13, 2017
Oct. 3, 2018

-
Apr. 1, 2006
June 28, 2019

June 28, 2019
June 28, 2019
E-11 / Cellulose, Powdered
Signed-off
Rev. 1
Rev. 1, Rev. of Sign-off Cover Sheet
Powdered Cellulose
Feb. 18, 2004
May 11, 2005
May 26, 2016

-
Apr. 1, 2006
 
E-13 / Cellulose Acetate Phthalate
Signed-off
Rev. 1
Rev. 1, Corr. 1
Cellacefate

Oct. 24, 2001
Nov. 9, 2010
June 6, 2012


Jan. 1, 2005
Oct. 1, 2012
Oct. 1, 2012
E-14 / Citric Acid, Anhydrous
Signed-off
Rev. 1
Rev. 2
Anhydrous Citric Acid
May 23, 2001
Nov. 11, 2003
June 9, 2010

Jan. 1, 2003
Apr. 1, 2006
Oct. 1, 2012
E-15 / Citric Acid, Monohydrate
Signed-off
Rev. 1
Rev. 2
Citric Acid Hydrate
May 23, 2001
Nov. 11, 2003
June 9, 2010

Jan. 1, 2003
Apr. 1, 2006
Oct. 1, 2012
E-16 / Crospovidone
Signed-off
Corr. of Sign-off cover sheet
Crospovidone
Nov. 9, 2010
Oct. 3, 2018

Oct. 1, 2012
 
E-17 / Ethylcellulose
Signed-off
Rev. 1
Rev. 2
Ethylcellulose
Feb. 6, 2002
Oct. 27, 2009
May 26, 2016

-
-
June 28, 2019
E-18 / Hydroxyethylcellulose
Signed-off
Hydroxyethylcellulose
July 25, 2016

June 28, 2019
E-19 / Hydroxypropylcellulose
Signed-off
Rev. of Sign-off cover sheet
Hydroxypropylcellulose
June 27, 2013
Sep. 13, 2017

Apr. 1, 2016
June 28, 2019
E-20 / Hydroxypropylcellulose, Low Substituted
Signed-off
Corr. 1
Corr. 2
Low Substituted Hydroxypropylcellulose

Nov. 13, 2014
July 1, 2015
Oct. 26, 2016


Dec. 1, 2017
Dec. 1, 2017
Dec. 1, 2017
E-21 / Hypromellose
Signed-off
Rev. 1
Rev. 1, Corr. 1
Rev. 1, Corr. 2
Rev. 1, Rev. of Sign-off cover sheet
Rev. 2
Hypromellose
Nov. 10, 2003
June 6, 2012
June 26, 2014
July 1, 2015
Oct. 26, 2016 

Sep. 13, 2017

Apr. 1, 2006
Feb. 28, 2014
Apr. 1, 2016
Dec. 1, 2017
June 28, 2019

June 28, 2019
E-22 / Hypromellose Phthalate
Signed-off
Hypromellose Phthalate
June 6. 2006

Oct. 1, 2007
E-23 / Lactose, Anhydrous
Signed-off
Rev. 1
Rev. 2
Rev. 3
Rev. 4
Rev. 4, Rev. of Sign-off cover sheet
Rev. 4, Corr. 1
Rev. 5
Anhydrous Lactose
Sep. 10, 2002
Feb. 5, 2003
Nov. 8, 2005
June 5, 2008
Nov. 9, 2010
Oct. 26, 2016

Oct. 2, 2019

-
Apr. 1, 2006
Oct. 1, 2007
Oct. 1, 2009
Oct. 1, 2012
(Spring, 2021)

(Spring, 2021)
E-24 / Lactose, Monohydrate
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Rev. 3
Lactose Hydrate
Sep. 10, 2002
Oct. 25, 2006
June 5, 2008
Oct. 2, 2019

Apr. 1, 2006
-
Oct. 1, 2009
(Spring, 2021)
E-25 / Magnesium Stearate
Signed-off
Corr. 1
Corr. 2
Corr. 3
Magnesium Stearate
June 3, 2008
Nov.11, 2008
June 6, 2012
June 27, 2013

Oct. 1, 2012
Oct. 1, 2012
Oct. 1, 2012
-
E-26 / Methylcellulose
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Rev. 2, Corr. 2
Rev. 3
Methylcellulose
Nov. 10, 2003
Nov. 8, 2005
June 6, 2012
June 26, 2014
July 1, 2015
Sep. 13, 2017

-
Apr. 1, 2006
Feb. 28, 2014
Apr. 1, 2016
Dec. 1, 2017
June 28, 2019
E-27 / Methyl Paraben
Signed-off
Rev. 1
Rev. 1,  Corr. 1
Methyl Parahydroxybenzoate
Feb. 19, 2004
June 10, 2009
Nov. 9, 2011

Apr. 1, 2006
Oct. 1, 2012
Oct. 1, 2012
E-28 / Petrolatum (Harmonization work in progress)    
E-29 / Petrolatum, White (Harmonization work in progress)    
E-30 / Polyethylene Glycol (Harmonization work in progress)    
E-31 / Polysorbate 80
Signed-off
Corr. 1
Corr. 2
Corr. 3
Rev. of Sign-off cover sheet
Polysorbate 80
June 3, 2008
Oct. 27, 2009
Nov. 13, 2014
July 1, 2016
Oct. 26, 2016

Feb. 28, 2014
Feb. 28, 2014
Apr. 1, 2016
Dec. 1, 2017
 
E-32 / Povidone
Signed-off
Corr. 1
Corr. 2
Rev. 1
Rev. 1, Corr. 1
Povidone
Oct. 25, 2006
May 8, 2007
June 3, 2008
July 1, 2015
Nov. 4, 2015

Apr. 1, 2016
Apr. 1, 2016
Apr. 1, 2016
Apr. 1, 2016
-
E-36 / Silicon Dioxide (Harmonization work in progress)    
E-37 / Silicon Dioxide, Colloidal (Harmonization work in progress)    
E-38 / Sodium Chloride
Signed-off
Rev. 1
Rev. 2
Rev. 3
Rev. 3, Corr. 1
Sodium Chloride
May 23, 2001
Oct. 24, 2001
Nov. 11, 2003
Nov. 6, 2013
May 26, 2016

-
Jan. 1, 2003
Apr. 1, 2006
Apr. 1, 2016
-
E-39 / Sodium Starch Glycolate
Signed-off
Rev. 1
Rev. 3
Sodium Starch Glycolate
Nov. 10, 2003
May 11, 2005
June 27, 2013

-
Oct. 1, 2007
Apr. 1, 2016
E-40 / Starch, Corn
Signed-off
Rev. 1
Rev. 2
Rev. 3
Corn Starch
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
Signed-off
Rev. 1
Rev. 2
Potato Starch
Oct. 24, 2001
Oct. 29, 2007
June 15, 2011

Jan. 1, 2005
Oct. 1, 2009
Feb. 28, 2014
E-42 / Starch, Rice
Signed-off
Rev. 1
Rice Starch
Oct. 25, 2006
Nov. 6, 2013

Oct. 1, 2009
Apr. 1, 2016
E-43 / Starch, Wheat
Signed-off
Rev. 1
Rev. 2
Rev. 2, Rev. of Sign-off cover sheet
Rev. 3
Wheat Starch
Oct. 24, 2001
Oct. 29, 2007
June 15, 2011
Nov. 4, 2015

Oct. 3, 2018

Jan. 1, 2005
Oct. 1, 2009
Apr. 1, 2011
Apr. 1, 2016

(Spring, 2021)
E-44 / Stearic Acid
Signed-off
Rev. 1
Rev. 1, Corr. 1
Rev. 1, Rev. of Sign-off cover sheet
Rev. 2
Stearic Acid
June 3, 2008
Nov. 6, 2013
Nov. 13, 2014
July 1, 2015

 

Feb. 28, 2014
Feb. 28, 2014
-
Apr. 1, 2016

 
E-45 / Sucrose
Signed-off
Rev. of Sign-off cover sheet
Sucrose
Oct. 30, 2007
June 27, 2013

Oct. 1, 2012
-
E-46 / Talc
Signed-off
Rev. 1
Talc
Nov. 10, 2003
June 3, 2008

-
Apr. 1, 2011
E-48 / Ethyl Paraben
Signed-off
Rev. 1
Rev. 1, Corr. 1
Ethyl Parahydroxybenzoate
Feb. 19, 2004
June 10, 2009
Nov. 9, 2011

Apr. 1, 2006
Oct. 1, 2012
Oct. 1, 2012
E-49 / Propyl Paraben
Signed-off
Rev. 1
Rev. 1, Corr. 1
Propyl Parahydroxybenzoate
Feb. 19, 2004
June 10, 2009
Nov. 9, 2011

Apr. 1, 2006
Oct. 1, 2012
Oct. 1, 2012
E-50 / Butyl Paraben
Signed-off
Rev. 1
Butyl Parahydroxybenzoate
Feb. 19, 2004
June 9, 2010

Apr. 1, 2006
Oct. 1, 2012
E-51 / Glycerin (Harmonization work in progress)    
E-52 / Carmellose
Signed-off
Rev. 1
Carmellose
Nov. 11, 2008
Nov. 9, 2011

Apr. 1, 2011
Feb. 28, 2014
E-54 / Copovidone
Signed-off
Corr. 1
Copovidone
Oct. 3, 2018
Oct. 2, 2019

(Spring, 2021)
(Spring, 2021)
E-55a / Gelatin, gelling type
Signed-off
Corr. 1
Corr. 2
Corr. 3
Rev. 2
Gelatin
June 6, 2012
Nov. 7, 2012
Nov. 6, 2013
Oct. 26, 2016
Oct. 3, 2018

May 31, 2013
May 31, 2013
Apr. 1, 2016
(Spring, 2021)
(Spring, 2021)
E-55b / Gelatin, non-gelling grade
Signed-off
Corr. 1
Corr. 2
Corr. 3
Rev. 2
(JP did not implement this item)

June 6, 2012
Nov. 7, 2012
Nov. 6, 2013
Oct. 26, 2016
Oct. 3, 2018


-
-
-
-
-
E-55 / Gelatin
Rev. 3
Gelatin
Oct. 2, 2019

(Spring, 2021)
E-56 / Glucose Anhydrous/Monohydrate
Signed-off
Corr. 1
Rev. of Sign-off cover sheet
Purified Glucose/Glucose Hydrate

June 26, 2014
Jan. 20, 2015
Nov. 4, 2015


Dec. 1, 2017
Dec. 1, 2017
-
E-58 / Mannitol
Signed-off
Corr. 1
Corr. of Sign-off cover sheet
D-Mannitol
June 6, 2012
June 26, 2014
Oct. 3, 2018

Feb. 28, 2014
Feb. 28, 2014
 
E-59 / Propylene Glycol (Harmonization work in progress)    
E-60 / Sodium Laurylsulfate
Signed-off
Rev. 1
Sodium Lauryl Sulfate
Nov. 13, 2014
Oct. 2, 2019

Dec. 1, 2017
(Spring, 2021)
E-61 / Starch, Pregelatinized (Harmonization work in progress)    
E-62 / Sterile Water for Injection in Containers (Harmonization work in progress)    
E-64 / Isomalt
Signed-off
Rev. of Sign-off cover sheet
Corr.1
Corr. of Sign-off cover sheet
Isomalt Hydrate
June 27, 2013
Nov. 4, 2015
Nov. 29, 2016
Oct. 3, 2018

Apr. 1, 2016
Apr. 1, 2016
June 28, 2019
-
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)    


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
Rev. 1
Rev. 2
Rev. 3
 
Oct. 24, 2001
Feb. 5, 2003
Nov. 7, 2012
July 21, 2016

-
-
-
-
E-33 / Saccharin
Signed-off
Rev. 1
Saccharin
Feb. 5, 2003
June 27, 2013

Apr. 1, 2006
Apr. 1, 2016
E-34 / Saccharin, Sodium
Signed-off
Rev. 1
Rev. 2
Rev. 2, Corr. 1
Rev. 2, Sign-off cover sheet
Saccharin Sodium Hydrate
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   - -

 

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