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日局におけるPDG調和文書への対応状況(添加物)

 調和合意された添加物各条について、Sign-off欄の署名日を青字で示し、PDG Sign-off Cover Sheet(PDG調和文書の表紙)を掲載しています。

添加物

As of December 1, 2017

No. Harmonization Item 日局収載名等 Sign-off
E-01 Alcohol
Alcohol (Rev. 1)
Alcohol (Rev. 2)
Alcohol (Rev. 2, Corr. 1)
Alcohol (Rev. 2, Corr. 2)
エタノール Oct. 24, 2001
Sep. 9, 2002
Nov. 7, 2012
Jun. 27, 2013
Jun. 26, 2014
E-02 Dehydrated Alcohol
Dehydrated Alcohol (Rev. 1)
Dehydrated Alcohol (Rev. 2)
Dehydrated Alcohol (Rev. 2, Corr. 1)
Dehydrated Alcohol (Rev. 2, Corr. 2)
無水エタノール Oct. 24, 2001
Sep. 9, 2002
Nov. 7, 2012
Jun. 27, 2013
Jun. 26, 2014
E-03 Benzyl Alcohol
Benzyl Alcohol (Rev. 1)
Benzyl Alcohol (Rev. 2)
Benzyl Alcohol (Rev. 2, Corr. 1)
ベンジルアルコール Jul. 18, 2000
Nov. 8, 2005
Jun. 3, 2008
Jun. 15, 2011
E-04 Calcium Disodium Edetate
Calcium Disodium Edetate (Rev. 1)
エデト酸カルシウムナトリウム水和物 Nov. 18, 2005
 
E-05 Calcium Phosphate Dibasic
Calcium Phosphate Dibasic (Rev. 1)
リン酸水素カルシウム水和物 Nov. 18, 2005
Jun. 15, 2011
E-06 Calcium Phosphate Dibasic Anhydrous
Calcium Phosphate Dibasic Anhydrous (Rev. 1)
Calcium Phosphate Dibasic Anhydrous (Rev. 2)
無水リン酸水素カルシウム Nov. 18, 2005

Jun. 15, 2011

Sep. 13, 2017
 
E-07 Carmellose Calcium
Carmellose Calcium (Rev. 1)
カルメロースカルシウム Oct. 24, 2001
Jul. 17, 2003
E-08 Carmellose Sodium (調和作業中)  
E-09 Croscarmellose Sodium
Croscarmellose Sodium (Sign-off cover sheet)
クロスカルメロースナトリウム Oct. 24, 2001
May 26, 2016
 
E-10 Cellulose, Microcrystalline
Cellulose, Microcrystalline (Rev. 1)
Cellulose, Microcrystalline (Rev. 1, Sign-off cover sheet)
Cellulose, Microcrystalline (Rev. 2)
結晶セルロース Feb. 18, 2004
May 11, 2005
May 26, 2016

Sep. 13, 2017
E-11 Cellulose, Powdered
Cellulose, Powdered (Rev. 1)
Cellulose, Powdered (Rev. 1, Sign-off Cover Sheet)
粉末セルロース Feb. 18, 2004
May 11, 2005
May 26, 2016
E-13 Cellulose Acetate Phthalate
Cellulose Acetate Phthalate (Rev. 1)
Cellulose Acetate Phthalate (Rev. 1, Corr. 1)
セラセフェート Oct. 24, 2001
Nov. 9, 2010
Jun. 6, 2012
 
E-14 Citric Acid, Anhydrous
Citric Acid, Anhydrous (Rev. 1)
Citric Acid, Anhydrous (Rev. 2)
無水クエン酸 May 23, 2001
Nov. 11, 2003
Jun. 9, 2010
E-15 Citric Acid, Monohydrate
Citric Acid, Monohydrate (Rev. 1)
Citric Acid, Monohydrate (Rev. 2)
クエン酸水和物 May 23, 2001
Nov. 11, 2003
Jun. 9, 2010
E-16 Crospovidone クロスポビドン Nov. 9, 2010
E-17 Ethylcellulose
Ethylcellulose (Rev. 1)
Ethylcellulose (Rev. 2)
(日局原案作成中) Feb. 6, 2002
Oct. 27, 2009
May 26, 2016
E-18 Hydroxyethylcellulose (日局原案作成中) July 25, 2016
E-19 Hydroxypropylcellulose
Hydroxypropylcellulose (Sign-off cover sheet)
ヒドロキシプロピルセルロース Jun. 27, 2013
Sep. 13, 2017
 
E-20 Hydroxypropylcellulose, Low Substituted
Hydroxypropylcellulose, Low Substituted (Corr. 1)
Hydroxypropylcellulose, Low Substituted (Corr. 2)
低置換度ヒドロキシプロピルセルロース Nov. 13, 2014

July 1, 2015

Oct. 26, 2016
 
E-21 Hypromellose
Hypromellose (Rev. 1)
Hypromellose (Rev. 1, Corr. 1)
Hypromellose (Rev. 1, Corr. 2)
Hypromellose (Rev. 1, Sign-off cover sheet)
Hypromellose (Rev. 2)
ヒプロメロース Nov. 10, 2003
Jun. 6, 2012
Jun. 26, 2014
July 1, 2015
Oct. 26, 2016
 
Sep. 13, 2017
E-22 Hypromellose Phthalate ヒプロメロースフタル酸エステル Jun. 6. 2006
E-23 Lactose, Anhydrous
Lactose, Anhydrous (Rev. 1)
Lactose, Anhydrous (Rev. 2)
Lactose, Anhydrous (Rev. 3)
Lactose, Anhydrous (Rev. 4)
Lactose, Anhydrous (Rev. 4, Sign-off cover sheet)
Lactose, Anhydrous (Rev. 5)
無水乳糖 Sep. 10, 2002
Feb. 5, 2003
Nov. 8, 2005
Jun. 5, 2008
Nov. 9, 2010
Oct. 26, 2016
E-24 Lactose, Monohydrate
Lactose, Monohydrate (Rev. 1)
Lactose, Monohydrate (Rev. 2)
Lactose, Monohydrate (Rev. 3)
乳糖水和物 Sep. 10, 2002
Oct. 25, 2006
Jun. 5, 2008
E-25 Magnesium Stearate
Magnesium Stearate (Corr. 1)
Magnesium Stearate (Corr. 2)
Magnesium Stearate (Corr. 3)
ステアリン酸マグネシウム Jun. 3, 2008
Nov.11, 2008
Jun. 6, 2012
Jun. 27, 2013
E-26 Methylcellulose
Methylcellulose (Rev. 1)
Methylcellulose (Rev. 2)
Methylcellulose (Rev. 2, Corr. 1)
Methylcellulose (Rev. 2, Corr. 2)
Methylcellulose (Rev. 3)
メチルセルロース Nov. 10, 2003
Nov. 8, 2005
Jun. 6, 2012
Jun. 26, 2014
July 1, 2015
Sep. 13, 2017
E-27 Methyl Paraben
Methyl Paraben (Rev. 1)
Methyl Paraben (Rev. 1,  Corr. 1)
パラオキシ安息香酸メチル Feb. 19, 2004
Jun. 10, 2009
Nov. 9, 2011
E-28 Petrolatum (調和作業中)  
E-29 Petrolatum, White (調和作業中)  
E-30 Polyethylene Glycol (調和作業中)  
E-31 Polysorbate 80
Polysorbate 80 (Corr. 1)
Polysorbate 80 (Corr. 2)
Polysorbate 80 (Corr. 3)
Polysorbate 80 (Sign-off cover sheet)
ポリソルベート80 Jun. 3, 2008
Oct. 27, 2009
Nov. 13, 2014
July 1, 2016
Oct. 26, 2016
 
E-32 Povidone
Povidone (Corr. 1)
Povidone (Corr. 2)
Povidone (Rev. 1)
Povidone (Rev. 1, Corr. 1)
ポビドン Oct. 25, 2006
May 28 2007
Jun. 3, 2008
July 1, 2015
Nov. 4, 2015
E-36 Silicon Dioxide (調和作業中)  
E-37 Silicon Dioxide, Colloidal (調和作業中)  
E-38 Sodium Chloride
Sodium Chloride (Rev. 1)
Sodium Chloride (Rev. 2)
Sodium Chloride (Rev. 3)
Sodium Chloride (Rev. 3, Corr. 1)
塩化ナトリウム Mar. 23, 2001
Oct. 24, 2001
Nov. 11, 2003
Nov. 6, 2013
May 26, 2016
E-39 Sodium Starch Glycolate
Sodium Starch Glycolate (Rev. 1)
Sodium Starch Glycolate (Rev. 3)
デンプングリコール酸ナトリウム Nov. 10, 2003
May 11, 2005
Jun. 27, 2013
E-40 Starch, Corn
Starch, Corn (Rev. 1)
Starch, Corn (Rev. 2)
Starch, Corn (Rev. 3)
トウモロコシデンプン Oct. 24, 2001
Feb. 18, 2004
Oct. 29, 2007
Jun. 6, 2012
E-41 Starch, Potato
Starch, Potato (Rev. 1)
Starch, Potato (Rev. 2)
バレイショデンプン Oct. 24, 2001
Oct. 29, 2007
Jun. 15, 2011
E-42 Starch, Rice
Starch, Rice (Rev. 1)
コメデンプン Oct. 25, 2006
Nov. 6, 2013
E-43 Starch, Wheat
Starch, Wheat (Rev. 1)
Starch, Wheat (Rev. 2)
Starch, Wheat (Rev. 2, Sign-off cover sheet)
Starch, Wheat (Rev. 3)
コムギデンプン Oct. 24, 2001
Oct. 29, 2007
Jun. 15, 2011
Nov. 4, 2015

 
E-44 Stearic Acid
Stearic Acid (Rev. 1)
Stearic Acid (Rev. 1, Corr. 1)
Stearic Acid (Rev. 1, Sign-off cover sheet)
Stearic Acid (Rev. 2)
ステアリン酸 Jun. 3, 2008
Nov. 6, 2013
Nov. 13, 2014
July 1, 2015

 
E-45 Sucrose
Sucrose (Sign-off cover sheet)
精製白糖 Oct. 30, 2007
June 27, 2013
E-46 Talc
Talc (Rev. 1)
タルク Nov. 10, 2003
Jun. 3, 2008
E-48 Ethyl Paraben
Ethyl Paraben (Rev. 1)
Ethyl Paraben (Rev. 1, Corr. 1)
パラオキシ安息香酸エチル Feb. 19, 2004
Jun. 10, 2009
Nov. 9, 2011
E-49 Propyl Paraben
Propyl Paraben (Rev. 1)
Propyl Paraben (Rev. 1, Corr. 1)
パラオキシ安息香酸プロピル Feb. 19, 2004
Jun. 10, 2009
Nov. 9, 2011
E-50 Butyl Paraben
Butyl Paraben (Rev. 1)
パラオキシ安息香酸ブチル Feb. 19, 2004
Jun. 9, 2010
E-51 Glycerin (調和作業中)  
E-52
 
Carmellose
Carmellose (Rev. 1)
カルメロース Nov. 11, 2008
Nov. 9, 2011
E-54 Copovidone (調和作業中)  
E-55a Gelatin, gelling type
Gelatin, gelling type (Corr. 1)
Gelatin, gelling type (Corr. 2)
Gelatin, gelling type (Corr. 3)
Gelatin, gelling type (Rev. 2)
ゼラチン Jun. 6, 2012
Nov. 7, 2012
Nov. 6, 2013
Oct. 26, 2016
 
E-55b Gelatin, non-gelling grade
Gelatin, non-gelling grade (Corr. 1)
Gelatin, non-gelling grade (Corr. 2)
Gelatin, non-gelling grade (Corr. 3)
Gelatin, non-gelling grade (Rev. 2)
(日局は調和に不参加) Jun. 6, 2012
Nov. 7, 2012
Nov. 6, 2013
Oct. 26, 2016
E-56 Glucose Anhydrous/Monohydrate
Glucose Monohydrate, Corr. 1
Glucose Anhydrous/Monohydrate (Sign-off cover sheet)
精製ブドウ糖/ブドウ糖水和物 Jun. 26, 2014
Jan. 20, 2015
Nov. 4, 2015
E-58 Mannitol
Mannitol (Corr. 1)
D-マンニトール Jun. 6, 2012
Jun. 26, 2014
E-59 Propylene Glycol (調和作業中)  
E-60 Sodium Laurylsulfate
Sodium Laurylsulfate (Rev. 1)
ラウリル硫酸ナトリウム Nov. 13, 2014
E-61 Starch, Pregelatinized (調和作業中)  
E-62 Sterile Water for Injection in Containers (調和作業中)  
E-63 Lactose for Inhalation (調和作業中)  
E-64 Isomalt
Isomalt (Sign-off cover sheet)
Isomalt (Corr.1)
イソマル水和物 Jun. 27, 2013
Nov. 4, 2015
Nov. 29, 2016


 以下5項目については、2017年9月に三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。)

No. Harmonization Item 日局収載名等 Sign-off
E-12 Cellulose Acetate
Cellulose Acetate (Rev. 1)
Cellulose Acetate (Rev. 2)
Cellulose Acetate (Rev. 3)
  Oct. 24, 2001
Feb. 5, 2003
Nov. 7, 2012
July. 21, 2016
E-33 Saccharin
Saccharin (Rev. 1)
サッカリン Feb. 5, 2003
Jun. 27, 2013
E-34 Saccharin, Sodium
Saccharin, Sodium (Rev. 1)
Saccharin, Sodium (Rev. 2)
Saccharin, Sodium (Rev. 2, Corr. 1)
Saccharin, Sodium (Rev. 2, Sign-off cover sheet)
サッカリンナトリウム水和物 Feb. 5, 2003
Feb. 18, 2004
Nov. 13, 2014
May 26, 2016
Oct. 26, 2016
 
E-35 Saccharin, Calcium   Feb. 5, 2003
E-53 Calcium Carbonate   -

 

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日局におけるPDG調和文書への対応状況(添加物)
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