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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 6, 2016
No. Harmonization Item 日局収載名等 Stage 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 6
6
6
6
6
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 6
6
6
6

6
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 6
6
6
6
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 6
4
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 6
6
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 6

6

4
Nov. 18, 2005

Jun. 15, 2011

 
E-07 Carmellose Calcium
Carmellose Calcium (Rev. 1)
カルメロースカルシウム 6
6
Oct. 24, 2001
Jul. 17, 2003
E-08 Carmellose Sodium (調和作業中) 3  
E-09 Croscarmellose Sodium
Croscarmellose Sodium (Sign-off cover sheet)
クロスカルメロースナトリウム 6
6
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 6
6

6

4
Feb. 18, 2004
May 11, 2005

May 26, 2016

 
E-11 Cellulose, Powdered
Cellulose, Powdered (Rev. 1)
Cellulose, Powdered (Rev. 1, Sign-off Cover Sheet)
粉末セルロース 6
6
6
Feb. 18, 2004
May 11, 2005
May 26, 2016
E-12 Cellulose Acetate
Cellulose Acetate (Rev. 1)
Cellulose Acetate (Rev. 2)
Cellulose Acetate (Rev. 3)
(日局は調和に不参加) 6
6
6
6
Oct. 24, 2001
Feb. 5, 2003
Nov. 7, 2012
July 21, 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 6
6

6
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 6
6
6
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 6
6
6
May 23, 2001
Nov. 11, 2003
Jun. 9, 2010
E-16 Crospovidone クロスポビドン 6 Nov. 9, 2010
E-17 Ethylcellulose
Ethylcellulose (Rev. 1)
Ethylcellulose (Rev. 2)
(日局原案作成中) 6
6
6
Feb. 6, 2002
Oct. 27, 2009
May 26, 2016
E-18 Hydroxyethylcellulose (日局原案作成中) 6 July 25, 2016
E-19 Hydroxypropylcellulose ヒドロキシプロピルセルロース 6 Jun. 27, 2013
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 6

6

6
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 6
6
6
6
6

4
Nov. 10, 2003
Jun. 6, 2012
Jun. 26, 2014
July 1, 2015
Oct. 26, 2016
 
E-22 Hypromellose Phthalate ヒプロメロースフタル酸エステル 6 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 6
6
6
6
6
6

2
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 6
6
6
3
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 6
6
6
6
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 6
6
6
6
6
4
Nov. 10, 2003
Nov. 8, 2005
Jun. 6, 2012
Jun. 26, 2014
July 1, 2015
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 6
6
6
Feb. 19, 2004
Jun. 10, 2009
Nov. 9, 2011
E-28 Petrolatum (調和作業中) 4  
E-29 Petrolatum, White (調和作業中) 4  
E-30 Polyethylene Glycol (調和作業中) 4  
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 6
6
6
6
6
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 6
6
6
6
6
Oct. 25, 2006
May 28 2007
Jun. 3, 2008
July 1, 2015
Nov. 4, 2015
E-33 Saccharin
Saccharin (Rev. 1)
サッカリン 6
6
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 6
6
6
6

6
Feb. 5, 2003
Feb. 18, 2004
Nov. 13, 2014
May 26, 2016

Oct. 26, 2016
E-35 Saccharin, Calcium (日局は調和に不参加) 6 Feb. 5, 2003
E-36 Silicon Dioxide (調和作業中) 4  
E-37 Silicon Dioxide, Colloidal (調和作業中) 4  
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 6
6
6
6
6
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 6
6

6
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 6
6
6
6
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 6
6
6
Oct. 24, 2001
Oct. 29, 2007
Jun. 15, 2011
E-42 Starch, Rice
Starch, Rice (Rev. 1)
コメデンプン 6
6
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 6
6
6
6

4
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 6
6
6
6

2
Jun. 3, 2008
Nov. 6, 2013
Nov. 13, 2014
July 1, 2015
E-45 Sucrose
Sucrose (Sign-off cover sheet)
精製白糖 6
6
Oct. 30, 2007
June 27, 2013
E-46 Talc
Talc (Rev. 1)
タルク 6
6
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 6
6
6
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 6
6
6
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 6
6
Feb. 19, 2004
Jun. 9, 2010
E-51 Glycerin (調和作業中) 3  
E-52
 
Carmellose
Carmellose (Rev. 1)
カルメロース 6
6
Nov. 11, 2008
Nov. 9, 2011
E-53 Calcium Carbonate (調和作業中) 4  
E-54 Copovidone (調和作業中) 4  
E-55a Gelatin, gelling type
Gelatin, gelling type (Corr. 1)
Gelatin, gelling type (Corr. 2)
Gelatin, gelling type (Corr. 3)
ゼラチン 6
6
6
6
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)
(日局は調和に不参加) 6
6

6

6
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)
(日局原案作成中) 6

6

6
Jun. 26, 2014

Jan. 20, 2015

Nov. 4, 2015
E-58 Mannitol
Mannitol (Corr. 1)
D-マンニトール 6
6
Jun. 6, 2012
Jun. 26, 2014
E-59 Propylene Glycol (調和作業中) 4  
E-60 Sodium Laurylsulfate
Sodium Laurylsulfate (Rev. 1)
ラウリル硫酸ナトリウム 6
4
Nov. 13, 2014
E-61 Starch, Pregelatinized (調和作業中) 3  
E-62 Sterile Water for Injection in Containers (調和作業中) 4  
E-63 Lactose for Inhalation (調和作業中) 3  
E-64 Isomalt
Isomalt (Sign-off cover sheet)
Isomalt(Corr.1)
イソマル水和物 6
6
6
Jun. 27, 2013
Nov. 4, 2015
Nov.29, 2016

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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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