2
EP JP USP EP JP USP EP JP USP Alcohol Oct. 24, 2001 Nov. 2001 Jan. 1, 2003 _ Rev. 1 Sep. 9, 2002 _ Mar. 31, 2006 2005.06.02 _ Apr. 1, 2006 2005.08.01 _ Apr. 1, 2006 2005.08.01 Rev. 2 Nov. 7, 2012 Mar. 2013 Feb. 28, 2014 2013.09.27 April 1, 2014 Feb. 28, 2014 2014.08.01 Apr. 1, 2014 Feb. 28, 2014 Rev. 2, Corr. 1 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2013.11.22 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016) Rev. 2, Corr. 2 Jun. 26, 2014 (Mar, 2016) 2014.11.21 Jan. 1, 2015 (Apr, 2016) (Dec. 1, 2015) Jan. 1, 2015 (Apr, 2016) Alcohol, Dehydrated Oct. 24, 2001 Nov. 2001 Jan. 1, 2003 _ Rev. 1 Sep. 9, 2002 _ Mar. 31, 2006 2005.06.02 _ Apr. 1, 2006 2005.08.02 _ Apr. 1, 2006 2005.08.02 Rev. 2 Nov. 7, 2012 Mar. 2013 Feb. 28, 2014 2013.09.27 April 1, 2014 Feb. 28, 2014 2014.08.01 Apr. 1, 2014 Feb. 28, 2014 Rev. 2, Corr. 1 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2013.11.22 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016) Rev. 2, Corr. 2 Jun. 26, 2014 (Mar, 2016) 2014.11.21 Jan. 1, 2015 (Apr, 2016) (Dec. 1, 2015) Jan. 1, 2015 (Apr, 2016) Benzyl Alcohol Jul. 18, 2000 Mar. 2002 Dec. 28, 2004 2005.03.31 April 1, 2003 Jan. 1, 2005 2005.03.31 _ Jan. 1, 2005 2005.03.01 Rev. 1 Nov. 8, 2005 March 2004 Mar. 31, 2006 2008.02.01 April 1, 2006 Apr. 1, 2006 2008.08.01 _ Apr. 1, 2006 2008.08.01 Rev. 2 Jun. 3, 2008 Jun. 2008 Mar. 24, 2011 2010.04.01 Jul. 1, 2009 Apr. 1, 2011 2010.10.01 _ Apr. 1, 2011 2010.10.01 Rev. 2, Corr. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 2011.11.23 Jan. 1, 2013 Oct. 1, 2012 2012.12.01 _ Oct. 1, 2012 2012.12.01 Butyl Paraben Feb. 19, 2004 Mar. 31, 2006 2005.11.01 Apr. 1, 2006 2006.01.01 _ Apr. 1, 2006 2006.01.01 Rev. 1 Jun. 9, 2010 Jun. 2010 Sep. 27, 2012 2012.11.30 Jul. 1, 2011 Oct. 1, 2012 2013.12.01 _ Oct. 1, 2012 2013.12.01 Calcium Disodium Edetate Nov. 18, 2005 Mar. 2006 Feb. 28, 2014 2007.06.01 April 1, 2007 Feb. 28, 2014 2007.12.01 _ Feb. 28, 2014 2007.12.01 Calcium Phosphate Dibasic Dihydrate Nov. 18, 2005 Mar. 2006 Sep. 28, 2007 2007.06.01 April 1, 2007 Oct. 1, 2007 2007.12.01 _ Oct. 1, 2007 2007.12.01 Rev. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 N/A Jan. 1, 2013 Oct. 1, 2012 N/A _ Oct. 1, 2012 N/A Anhydrous Calcium Phosphate Dibasic Nov. 18, 2005 Mar. 2006 Sep. 28, 2007 2007.06.01 April 1, 2007 Oct. 1, 2007 2007.12.01 _ Oct. 1, 2007 2007.12.01 Rev. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 N/A Jan. 1, 2013 Oct. 1, 2012 N/A _ Oct. 1, 2012 N/A Carmellose Nov. 11, 2008 Mar. 2009 Mar. 24, 2011 2009.11.01 April 1, 2010 Apr. 1, 2011 2010.10.01 _ Apr. 1, 2011 2010.10.01 Rev. 1 Nov. 9, 2011 Mar. 2012 Feb. 28, 2014 2012.04.27 April 1, 2013 Feb. 28, 2014 2013.05.01 _ Feb. 28, 2014 2013.05.01 Carmellose Calcium Oct. 24, 2001 Mar. 2003 April 1, 2004 _ Rev. 1 Jul. 17, 2003 _ Dec. 28, 2004 2006.06.01 _ Jan. 1, 2005 2006.08.01 _ Apr. 1, 2006 2006.08.01 Croscarmellose Sodium Oct. 24, 2001 Mar. 2006 Mar. 31, 2006 2005.02.01 April 1, 2007 Apr. 1, 2006 2005.04.01 _ Apr. 1, 2006 2005.04.01 Cellulose, Microcrystalline Feb. 18, 2004 2005.09.01 2005.09.01 _ 2005.09.01 Rev. 1 May 11, 2005 Mar. 2006 Mar. 31, 2006 2006.06.01 April 1, 2007 Apr. 1, 2006 2006.08.01 _ Apr. 1, 2006 2006.08.01 Cellulose Powder Feb. 18, 2004 2005.09.01 2005.09.01 _ 2005.09.01 Rev. 1 May 11, 2005 Mar. 2006 Mar. 31, 2006 2006.06.01 April 1, 2007 Apr. 1, 2006 2006.08.01 _ Apr. 1, 2006 2006.08.01 Cellulose Acetate Oct. 24, 2001 _ Rev. 1 Feb. 5, 2003 Mar. 2003 2004.11.01 April 1, 2004 2005.01.01 _ 2005.01.01 Rev. 2 Nov. 7, 2012 Mar. 2013 2013.09.27 April 1, 2014 2014.08.01 April 1, 2014 Cellulose Acetate Phthalate Oct. 24, 2001 Nov. 2007 Dec. 28, 2004 2004.11.01 Jan. 1, 2009 Jan. 1, 2005 2005.01.01 _ Jan. 1, 2005 2005.01.01 Rev. 1 Nov. 9, 2010 Nov. 2010 Sep. 27, 2012 2011.11.23 Jan. 1, 2012 Oct. 1, 2012 2012.12.01 _ Oct. 1, 2012 2012.12.01 Rev. 1, Corr. 1 Jun. 6, 2012 Mar. 2013 Sep. 27, 2012 N/A March 1, 2014 Oct. 1, 2012 N/A April 1, 2014 Oct. 1, 2012 Citric Acid Anhydrous May 23, 2001 Nov. 2002 Dec. 27, 2002 Jan. 1, 2004 Jan. 1, 2003 _ Jan. 1, 2003 Rev. 1 Nov. 11, 2003 _ Mar. 31, 2006 2004.11.01 _ Apr. 1, 2006 2005.01.01 _ Apr. 1, 2006 2005.01.01 Rev. 2 Jun. 9, 2010 Mar. 2013 Sep. 27, 2012 2011.10.14 April 1, 2014 Oct. 1, 2012 2012.08.01 April 1, 2014 Oct. 1, 2012 2012.08.01 Citric Acid Monohydrate May 23, 2001 Nov. 2002 Dec. 27, 2002 Jan. 1, 2004 Jan. 1, 2003 _ Rev. 1 Nov. 11, 2003 _ Mar. 31, 2006 2004.11.01 _ Apr. 1, 2006 2005.01.01 _ Apr. 1, 2006 2005.01.01 Rev. 2 Jun. 9, 2010 Mar. 2013 Sep. 27, 2012 2011.10.14 April 1, 2014 Oct. 1, 2012 2012.08.01 April 1, 2014 Oct. 1, 2012 2012.08.01 Crospovidone Nov. 9, 2010 Mar. 2011 Sep. 27, 2012 2011.02.25 April 1, 2012 Oct. 1, 2012 2011.12.01 Jan. 1, 2016 Oct. 1, 2012 2011.12.01 Ethylcellulose Feb. 6, 2002 Mar. 2002 2004.11.01 April 1, 2003 2005.01.01 _ 2005.01.01 Rev. 1 Oct. 27, 2009 Nov. 2012 2011.02.01 Jan. 1, 2014 2011.08.01 Jan. 1, 2014 2011.08.01 Ethyl Paraben Feb. 19, 2004 Mar. 31, 2006 2005.06.01 Apr. 1, 2006 2005.08.01 _ Apr. 1, 2006 2005.08.01 Rev. 1 Jun. 10, 2009 Jun. 2009 Sep. 27, 2012 2011.02.01 Jul. 1, 2010 Oct. 1, 2012 2011.08.01 _ Oct. 1, 2012 2011.08.01 Rev. 1, Corr. 1 Nov. 9, 2011 _ Sep. 27, 2012 2012.04.27 _ Oct. 1, 2012 2013.05.01 _ Oct. 1, 2012 2013.05.01 Gelatine, gelling grade Jun. 6, 2012 Mar. 2013 May 31, 2013 2012.09.28 April 1, 2014 May 31, 2013 2013.04.01 _ May 31, 2013 Corr. 1 Nov. 7, 2012 _ May 31, 2013 N/A _ May 31, 2013 N/A _ May 31, 2013 Corr. 2 Nov. 6, 2013 _ (Mar, 2016) (Sep. 2015) _ (Apr, 2016) (Aug. 1, 2016) Jan. 1, 2015 (Apr, 2016) Gelatine, non-gelling grade Jun. 6, 2012 Mar. 2013 2012.09.28 April 1, 2014 2013.04.01 _ Corr. 1 Nov. 7, 2012 _ N/A _ N/A _ Corr. 2 Nov. 6, 2013 _ (Sep. 2015) _ N/A Jan. 1, 2015 Glucose Anhydrous/Monohydrous Jun. 26, 2014 Nov. 2014 (Fall, 2017) TBD Jan. 1, 2016 (Fall, 2017) TBD Jan. 1, 2016 (Fall, 2017) Glucose Monohydrous, Corr.1 Jan. 20, 2015 _ (Fall, 2017) TBD N/A (Fall, 2017) TBD _ (Fall, 2017) Hydroxypropylcellulose Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2014.02.28 Jan. 1, 2015 (Apr, 2016) Jan. 1, 2015 (Apr, 2016) Hydroxypropylcellulose, Low Substituted Nov. 13, 2014 Mar. 2015 (Fall, 2017) TBD April 1, 2016 (Fall, 2017) TBD April 1, 2016 (Fall, 2017) Corr. 1 July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017) Hypromellose Nov. 10, 2003 Mar. 2006 Mar. 31, 2006 2007.06.01 April 1, 2007 Apr. 1, 2006 2007.12.01 _ Apr. 1, 2006 2007.12.01 Rev. 1 Jun. 6, 2012 Nov. 2012 Feb. 28, 2014 2013.04.26 Jan. 1, 2014 Feb. 28, 2014 2014.05.01 Jan. 1, 2014 Feb. 28, 2014 Rev. 1, Corr. 1 Jun. 26, 2014 Nov. 2014 (Mar, 2016) 2015.05.01 Jan. 1, 2016 (Apr, 2016) 2015.05.01 Jan. 1, 2016 (Apr, 2016) Rev. 1, Corr. 2 July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017) Hypromellose Phthalate Jun. 6. 2006 Jun. 2006 Sep. 28, 2007 2005.02.01 Jul. 1, 2007 Oct. 1, 2007 2005.04.01 _ Oct. 1, 2007 2005.04.01 Isomalt Jun. 27, 2013 Nov. 2013 (Mar, 2016) (Sep. 2015) Jan. 1, 2015 (Apr, 2016) (Aug. 1, 2016) Jan. 1, 2015 (Apr, 2016) PDG TIMETABLE FOR IMPLEMENTATION of Mongraphs As of Jnly 1, 2015 Stage 6A Item Sign-off Stage 6C Adoption and Publication Stage 6B Regional Implementation Indication

Stage 6A Stage 6B Stage 6C EP JP USP EP JP USP EP JP USP · EP JP USP EP JP USP EP JP USP ... 2005 Mar. 2006 Feb. 28, 2014 2007.06.01 April 1, ... 2003 _ Dec. 28, 2004 2006.06.01

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Page 1: Stage 6A Stage 6B Stage 6C EP JP USP EP JP USP EP JP USP · EP JP USP EP JP USP EP JP USP ... 2005 Mar. 2006 Feb. 28, 2014 2007.06.01 April 1, ... 2003 _ Dec. 28, 2004 2006.06.01

EP JP USP EP JP USP EP JP USP

Alcohol Oct. 24, 2001 Nov. 2001 ― Jan. 1, 2003 ― _ ―

Rev. 1 Sep. 9, 2002 _ Mar. 31, 2006 2005.06.02 _ Apr. 1, 2006 2005.08.01 _ Apr. 1, 2006 2005.08.01

Rev. 2 Nov. 7, 2012 Mar. 2013 Feb. 28, 2014 2013.09.27 April 1, 2014 Feb. 28, 2014 2014.08.01 Apr. 1, 2014 Feb. 28, 2014

Rev. 2, Corr. 1 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2013.11.22 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016)

Rev. 2, Corr. 2 Jun. 26, 2014 (Mar, 2016) 2014.11.21 Jan. 1, 2015 (Apr, 2016) (Dec. 1, 2015) Jan. 1, 2015 (Apr, 2016)

Alcohol, Dehydrated Oct. 24, 2001 Nov. 2001 ― Jan. 1, 2003 ― _ ―

Rev. 1 Sep. 9, 2002 _ Mar. 31, 2006 2005.06.02 _ Apr. 1, 2006 2005.08.02 _ Apr. 1, 2006 2005.08.02

Rev. 2 Nov. 7, 2012 Mar. 2013 Feb. 28, 2014 2013.09.27 April 1, 2014 Feb. 28, 2014 2014.08.01 Apr. 1, 2014 Feb. 28, 2014

Rev. 2, Corr. 1 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2013.11.22 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016)

Rev. 2, Corr. 2 Jun. 26, 2014 (Mar, 2016) 2014.11.21 Jan. 1, 2015 (Apr, 2016) (Dec. 1, 2015) Jan. 1, 2015 (Apr, 2016)

Benzyl Alcohol Jul. 18, 2000 Mar. 2002 Dec. 28, 2004 2005.03.31 April 1, 2003 Jan. 1, 2005 2005.03.31 _ Jan. 1, 2005 2005.03.01

Rev. 1 Nov. 8, 2005 March 2004 Mar. 31, 2006 2008.02.01 April 1, 2006 Apr. 1, 2006 2008.08.01 _ Apr. 1, 2006 2008.08.01

Rev. 2 Jun. 3, 2008 Jun. 2008 Mar. 24, 2011 2010.04.01 Jul. 1, 2009 Apr. 1, 2011 2010.10.01 _ Apr. 1, 2011 2010.10.01

Rev. 2, Corr. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 2011.11.23 Jan. 1, 2013 Oct. 1, 2012 2012.12.01 _ Oct. 1, 2012 2012.12.01

Butyl Paraben Feb. 19, 2004 Mar. 31, 2006 2005.11.01 Apr. 1, 2006 2006.01.01 _ Apr. 1, 2006 2006.01.01

Rev. 1 Jun. 9, 2010 Jun. 2010 Sep. 27, 2012 2012.11.30 Jul. 1, 2011 Oct. 1, 2012 2013.12.01 _ Oct. 1, 2012 2013.12.01

Calcium Disodium Edetate Nov. 18, 2005 Mar. 2006 Feb. 28, 2014 2007.06.01 April 1, 2007 Feb. 28, 2014 2007.12.01 _ Feb. 28, 2014 2007.12.01

Calcium Phosphate Dibasic Dihydrate Nov. 18, 2005 Mar. 2006 Sep. 28, 2007 2007.06.01 April 1, 2007 Oct. 1, 2007 2007.12.01 _ Oct. 1, 2007 2007.12.01

Rev. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 N/A Jan. 1, 2013 Oct. 1, 2012 N/A _ Oct. 1, 2012 N/A

Anhydrous Calcium Phosphate

DibasicNov. 18, 2005 Mar. 2006 Sep. 28, 2007 2007.06.01 April 1, 2007 Oct. 1, 2007 2007.12.01 _ Oct. 1, 2007 2007.12.01

Rev. 1 Jun. 15, 2011 Nov. 2011 Sep. 27, 2012 N/A Jan. 1, 2013 Oct. 1, 2012 N/A _ Oct. 1, 2012 N/A

Carmellose Nov. 11, 2008 Mar. 2009 Mar. 24, 2011 2009.11.01 April 1, 2010 Apr. 1, 2011 2010.10.01 _ Apr. 1, 2011 2010.10.01

Rev. 1 Nov. 9, 2011 Mar. 2012 Feb. 28, 2014 2012.04.27 April 1, 2013 Feb. 28, 2014 2013.05.01 _ Feb. 28, 2014 2013.05.01

Carmellose Calcium Oct. 24, 2001 Mar. 2003 ― April 1, 2004 ― _ ―

Rev. 1 Jul. 17, 2003 _ Dec. 28, 2004 2006.06.01 _ Jan. 1, 2005 2006.08.01 _ Apr. 1, 2006 2006.08.01

Croscarmellose Sodium Oct. 24, 2001 Mar. 2006 Mar. 31, 2006 2005.02.01 April 1, 2007 Apr. 1, 2006 2005.04.01 _ Apr. 1, 2006 2005.04.01

Cellulose, Microcrystalline Feb. 18, 2004 ― 2005.09.01 ― 2005.09.01 _ ― 2005.09.01

Rev. 1 May 11, 2005 Mar. 2006 Mar. 31, 2006 2006.06.01 April 1, 2007 Apr. 1, 2006 2006.08.01 _ Apr. 1, 2006 2006.08.01

Cellulose Powder Feb. 18, 2004 ― 2005.09.01 ― 2005.09.01 _ ― 2005.09.01

Rev. 1 May 11, 2005 Mar. 2006 Mar. 31, 2006 2006.06.01 April 1, 2007 Apr. 1, 2006 2006.08.01 _ Apr. 1, 2006 2006.08.01

Cellulose Acetate Oct. 24, 2001 ― ― _ ―

Rev. 1 Feb. 5, 2003 Mar. 2003 ― 2004.11.01 April 1, 2004 ― 2005.01.01 _ ― 2005.01.01

Rev. 2 Nov. 7, 2012 Mar. 2013 ― 2013.09.27 April 1, 2014 ― 2014.08.01 April 1, 2014 ―

Cellulose Acetate Phthalate Oct. 24, 2001 Nov. 2007 Dec. 28, 2004 2004.11.01 Jan. 1, 2009 Jan. 1, 2005 2005.01.01 _ Jan. 1, 2005 2005.01.01

Rev. 1 Nov. 9, 2010 Nov. 2010 Sep. 27, 2012 2011.11.23 Jan. 1, 2012 Oct. 1, 2012 2012.12.01 _ Oct. 1, 2012 2012.12.01

Rev. 1, Corr. 1 Jun. 6, 2012 Mar. 2013 Sep. 27, 2012 N/A March 1, 2014 Oct. 1, 2012 N/A April 1, 2014 Oct. 1, 2012

Citric Acid Anhydrous May 23, 2001 Nov. 2002 Dec. 27, 2002 ― Jan. 1, 2004 Jan. 1, 2003 ― _ Jan. 1, 2003 ―

Rev. 1 Nov. 11, 2003 _ Mar. 31, 2006 2004.11.01 _ Apr. 1, 2006 2005.01.01 _ Apr. 1, 2006 2005.01.01

Rev. 2 Jun. 9, 2010 Mar. 2013 Sep. 27, 2012 2011.10.14 April 1, 2014 Oct. 1, 2012 2012.08.01 April 1, 2014 Oct. 1, 2012 2012.08.01

Citric Acid Monohydrate May 23, 2001 Nov. 2002 Dec. 27, 2002 ― Jan. 1, 2004 Jan. 1, 2003 ― _ ― ―

Rev. 1 Nov. 11, 2003 _ Mar. 31, 2006 2004.11.01 _ Apr. 1, 2006 2005.01.01 _ Apr. 1, 2006 2005.01.01

Rev. 2 Jun. 9, 2010 Mar. 2013 Sep. 27, 2012 2011.10.14 April 1, 2014 Oct. 1, 2012 2012.08.01 April 1, 2014 Oct. 1, 2012 2012.08.01

Crospovidone Nov. 9, 2010 Mar. 2011 Sep. 27, 2012 2011.02.25 April 1, 2012 Oct. 1, 2012 2011.12.01 Jan. 1, 2016 Oct. 1, 2012 2011.12.01

Ethylcellulose Feb. 6, 2002 Mar. 2002 ― 2004.11.01 April 1, 2003 ― 2005.01.01 _ ― 2005.01.01

Rev. 1 Oct. 27, 2009 Nov. 2012 ― 2011.02.01 Jan. 1, 2014 ― 2011.08.01 Jan. 1, 2014 ― 2011.08.01

Ethyl Paraben Feb. 19, 2004 Mar. 31, 2006 2005.06.01 Apr. 1, 2006 2005.08.01 _ Apr. 1, 2006 2005.08.01

Rev. 1 Jun. 10, 2009 Jun. 2009 Sep. 27, 2012 2011.02.01 Jul. 1, 2010 Oct. 1, 2012 2011.08.01 _ Oct. 1, 2012 2011.08.01

Rev. 1, Corr. 1 Nov. 9, 2011 _ Sep. 27, 2012 2012.04.27 _ Oct. 1, 2012 2013.05.01 _ Oct. 1, 2012 2013.05.01

Gelatine, gelling grade Jun. 6, 2012 Mar. 2013 May 31, 2013 2012.09.28 April 1, 2014 May 31, 2013 2013.04.01 _ May 31, 2013

Corr. 1 Nov. 7, 2012 _ May 31, 2013 N/A _ May 31, 2013 N/A _ May 31, 2013

Corr. 2 Nov. 6, 2013 _ (Mar, 2016) (Sep. 2015) _ (Apr, 2016) (Aug. 1, 2016) Jan. 1, 2015 (Apr, 2016)

Gelatine, non-gelling grade Jun. 6, 2012 Mar. 2013 ― 2012.09.28 April 1, 2014 ― 2013.04.01 _ ―

Corr. 1 Nov. 7, 2012 _ ― N/A _ ― N/A _ ―

Corr. 2 Nov. 6, 2013 _ ― (Sep. 2015) _ ― N/A Jan. 1, 2015 ―

Glucose Anhydrous/Monohydrous Jun. 26, 2014 Nov. 2014 (Fall, 2017) TBD Jan. 1, 2016 (Fall, 2017) TBD Jan. 1, 2016 (Fall, 2017)

Glucose Monohydrous, Corr.1 Jan. 20, 2015 _ (Fall, 2017) TBD N/A (Fall, 2017) TBD _ (Fall, 2017)

Hydroxypropylcellulose Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2014.02.28 Jan. 1, 2015 (Apr, 2016) Jan. 1, 2015 (Apr, 2016)

Hydroxypropylcellulose, Low

SubstitutedNov. 13, 2014 Mar. 2015 (Fall, 2017) TBD April 1, 2016 (Fall, 2017) TBD April 1, 2016 (Fall, 2017)

Corr. 1 July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017)

Hypromellose Nov. 10, 2003 Mar. 2006 Mar. 31, 2006 2007.06.01 April 1, 2007 Apr. 1, 2006 2007.12.01 _ Apr. 1, 2006 2007.12.01

Rev. 1 Jun. 6, 2012 Nov. 2012 Feb. 28, 2014 2013.04.26 Jan. 1, 2014 Feb. 28, 2014 2014.05.01 Jan. 1, 2014 Feb. 28, 2014

Rev. 1, Corr. 1 Jun. 26, 2014 Nov. 2014 (Mar, 2016) 2015.05.01 Jan. 1, 2016 (Apr, 2016) 2015.05.01 Jan. 1, 2016 (Apr, 2016)

Rev. 1, Corr. 2 July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017)

Hypromellose Phthalate Jun. 6. 2006 Jun. 2006 Sep. 28, 2007 2005.02.01 Jul. 1, 2007 Oct. 1, 2007 2005.04.01 _ Oct. 1, 2007 2005.04.01

Isomalt Jun. 27, 2013 Nov. 2013 (Mar, 2016) (Sep. 2015) Jan. 1, 2015 (Apr, 2016) (Aug. 1, 2016) Jan. 1, 2015 (Apr, 2016)

PDG TIMETABLE FOR IMPLEMENTATION of MongraphsAs of Jnly 1, 2015

Stage 6A

Item Sign-off

Stage 6C

Adoption and Publication

Stage 6B

Regional Implementation Indication

Page 2: Stage 6A Stage 6B Stage 6C EP JP USP EP JP USP EP JP USP · EP JP USP EP JP USP EP JP USP ... 2005 Mar. 2006 Feb. 28, 2014 2007.06.01 April 1, ... 2003 _ Dec. 28, 2004 2006.06.01

EP JP USP EP JP USP EP JP USP

Stage 6A

Item Sign-off

Stage 6C

Adoption and Publication

Stage 6B

Regional Implementation Indication

Lactose Anhydrous Sep. 10, 2002 Nov. 2002 ― Jan. 1, 2004 ― _ ―

Rev. 1 Feb. 5, 2003 Mar. 2006 Mar. 31, 2006 ― April 1, 2007 Apr. 1, 2006 ― _ Apr. 1, 2006 ―

Rev. 2 Nov. 8, 2005 _ Sep. 28, 2007 2007.11.01 _ Oct. 1, 2007 2008.05.01 _ Oct. 1, 2007 2008.05.01

Rev. 3 Jun. 5, 2008 Jun. 2008 Sep. 30, 2009 2012.02.01 Jul. 1, 2009 Oct. 1, 2009 2012.08.01 _ Oct. 1, 2009 2012.08.01

Rev. 4 Nov. 9, 2010 Nov. 2010 Sep. 27, 2012 2011.08.01 Jan. 1, 2012 Oct. 1, 2012 2012.08.01 _ Oct. 1, 2012 2012.08.01

Lactose Monohydrate Sep. 10, 2002 Nov. 2002 Mar. 31, 2006 ― Jan. 1, 2004 Apr. 1, 2006 - _ Apr. 1, 2006 -

Rev. 1 Oct. 25, 2006 ― ― ― ― ― ― _ ― ―

Rev. 2 Jun. 5, 2008 Jun. 2008 Sep. 30, 2009 2011.09.30 Jul. 1, 2009 Oct. 1, 2009 2012.08.01 _ Oct. 1, 2009 2012.08.01

Magnesium Stearate Jun. 3, 2008 Jun. 2008 Sep. 27, 2012 2010.02.01 Jul. 1, 2009 Oct. 1, 2012 2010.08.01 _ Oct. 1, 2012 2010.08.01

Corr. 1 Nov.11, 2008 Jun. 2009 Sep. 27, 2012 2011.11.01 Jul. 1, 2010 Oct. 1, 2012 2012.05.01 _ Oct. 1, 2012 2012.05.01

Corr. 2 Jun. 6, 2012 _ Sep. 27, 2012 2012.10.01 _ Oct. 1, 2012 2012.10.01 _ Oct. 1, 2012

Corr. 3 Jun. 27, 2013 Nov. 2013 ― (Sep. 2015) Jan. 1, 2015 ― (Aug. 1, 2016) Jan. 1, 2015 ―

Mannitol Jun. 6, 2012 Nov. 2012 Feb. 28, 2014 2014.02.28 Jan. 1, 2014 Feb. 28, 2014 2014.12.01 Jan. 1, 2014 Feb. 28, 2014

Corr. 1 Jun. 26, 2014 _ Feb. 28, 2014 2014.09.26 N/A Feb. 28, 2014 2015.08.01 _ Feb. 28, 2014

Methyl Cellulose Nov. 10, 2003 ― 2008.02.01 ― 2008.08.01 ― 2008.08.01

Rev. 1 Nov. 8, 2005 Mar. 2006 Mar. 31, 2006 2010.04.01 April 1, 2007 Apr. 1, 2006 2010.10.01 Apr. 1, 2006 2010.10.01

Rev. 2 Jun. 6, 2012 Nov. 2012 Feb. 28, 2014 2013.04.26 Jan. 1, 2014 Feb. 28, 2014 2014.05.01 Jan. 1, 2014 Feb. 28, 2014

Rev. 2, Corr. 1 Jun. 26, 2014 Nov. 2014 (Mar, 2016) 2014.11.21 Jan. 1, 2016 (Apr, 2016) (Dec. 1, 2015) Jan. 1, 2016 (Apr, 2016)

Rev. 2, Corr. 2 July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017)

Methyl Paraben Feb. 19, 2004 _ Mar. 31, 2006 2005.06.01 _ Apr. 1, 2006 2005.08.01 _ Apr. 1, 2006 2005.08.01

Rev. 1 Jun. 10, 2009 Jun. 2009 Sep. 27, 2012 2011.02.01 Jul. 1, 2010 Oct. 1, 2012 2011.08.01 _ Oct. 1, 2012 2011.08.01

Rev. 1, Corr. 1 Nov. 9, 2011 Sep. 27, 2012 2012.04.27 Oct. 1, 2012 2013.05.01 _ Oct. 1, 2012 2013.05.01

Polysorbate 80 Jun. 3, 2008 Dec. 2008 Feb. 28, 2014 2010.02.01 Jul. 1, 2009 Feb. 28, 2014 2010.08.01 _ Feb. 28, 2014 2010.08.01

Corr. 1 Oct. 27, 2009 Nov. 2009 Feb. 28, 2014 2010.07.30 Jan. 1, 2011 Feb. 28, 2014 2010.10.01 _ Feb. 28, 2014

Corr. 2 Nov. 13, 2014 Nov. 2014 (Mar, 2016) 2015.04.24 Jan. 1, 2016 (Apr, 2016) (May 1, 2016) Jan. 1, 2016 (Apr, 2016)

Povidone Oct. 25, 2006 Nov. 2007 (Mar, 2016) 2009.08.01 Apr. 1, 2008 (Apr, 2016) 2009.08.01 _ (Apr, 2016) 2009.08.01

Corr. 1 May 28 2007 Jun. 2008 (Mar, 2016) 2011.02.25 Jul. 1, 2009 (Apr, 2016) 2011.12.01 _ (Apr, 2016) 2011.12.01

Corr. 2 Jun. 3, 2008 Dec. 2008 (Mar, 2016) 2011.02.25 Jul. 1, 2009 (Apr, 2016) 2011.12.01 _ (Apr, 2016) 2011.12.01

Rev. 1 July 1, 2015 (Mar, 2016) (Apr, 2016) (Apr, 2016)

Propyl Paraben Feb. 19, 2004 Jun. 2001 Mar. 31, 2006 2005.02.01 Jul. 1, 2002 Apr. 1, 2006 2005.04.01 _ Apr. 1, 2006 2005.04.01

Rev. 1 Jun. 10, 2009 Jun. 2009 Sep. 27, 2012 2011.02.01 Jul. 1, 2010 Oct. 1, 2012 2011.08.01 _ Oct. 1, 2012

Rev. 1, Corr. 1 Nov. 9, 2011 _ Sep. 27, 2012 2012.04.27 _ Oct. 1, 2012 2013.05.01 _ Oct. 1, 2012 2013.05.01

Saccharin Feb. 5, 2003 Nov. 2004 Mar. 31, 2006 2006.02.01 Jan. 1, 2006 Apr. 1, 2006 2006.04.01 _ Apr. 1, 2006 2006.04.01

Rev. 1 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2014.02.28 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016)

Saccharin Calcium Feb. 5, 2003 – ― 2007.06.01 – ― 2007.08.01 – ― 2007.08.01

Saccharin Sodium Feb. 5, 2003 ― ― _ ―

Rev. 1 Feb. 18, 2004 Nov. 2004 Mar. 31, 2006 2007.06.01 Jan. 1, 2006 Apr. 1, 2006 2007.08.01 _ Apr. 1, 2006 2007.08.01

Rev. 2 Nov. 13, 2014 Mar. 2015 (Fall, 2017) 2015.04.24 April 1, 2016 (Fall, 2017) (May 1, 2016) April 1, 2016 (Fall, 2017)

Sodium Chloride Mar. 23, 2001 ― ― _ ―

Rev. 1 Oct. 24, 2001 Nov. 2002 Dec. 27, 2002 ― Jan. 1, 2004 Jan. 1, 2003 ― _ ― ―

Rev. 2 Nov. 11, 2003 _ Mar. 31, 2006 postponed Apr. 1, 2006 N/A _ Apr. 1, 2006

Rev. 3 Nov. 6, 2013 Mar. 2014 (Mar, 2016) 2014.11.21 April 1, 2016 (Apr, 2016) (Dec. 1, 2015) April 1, 2015 (Apr, 2016)

Sodium Laurylsulfate Nov. 13, 2014 Mar. 2015 (Fall, 2017) 2015.04.24 April 1, 2016 (Fall, 2017) (May 1, 2016) April 1, 2016 (Fall, 2017)

Sodium Starch Glycolate Nov. 10, 2003 Jun. 2004 ― ― Jul. 1, 2005 ― ― _ ― ―

Rev. 1 May 11, 2005 _ Sep. 28, 2007 2006.06.01 _ Oct. 1, 2007 2006.08.01 _ Oct. 1, 2007 2006.08.01

Rev. 3 Jun. 27, 2013 Nov. 2013 (Mar, 2016) 2014.02.28 Jan. 1, 2015 (Apr, 2016) 2014.12.01 Jan. 1, 2015 (Apr, 2016)

Starch, Corn Oct. 24, 2001 Nov. 2001 Dec. 28, 2004 2005.03.01 Jan. 1, 2003 Jan. 1, 2005 2005.03.01 _ Jan. 1, 2005 2005.03.01

Rev. 1 Feb. 18, 2004 Mar. 2004 Mar. 31, 2006 2008.02.01 April 1, 2005 Apr. 1, 2006 2008.08.01 _ Apr. 1, 2006 2008.08.01

Rev. 2 Oct. 29, 2007 Nov. 2007 Sep. 30, 2009 2010.04.01 Jan. 1, 2009 Oct. 1, 2009 2010.10.01 _ Oct. 1, 2009 2010.10.01

Rev. 3 Jun. 6, 2012 Nov. 2012 Feb. 28, 2014 2013.04.26 Jan. 1, 2014 Feb. 28, 2014 2014.05.01 Jan. 1, 2014 Feb. 28, 2014

Starch, Potato Oct. 24, 2001 Nov. 2001 Dec. 28, 2004 2005.03.01 Jan. 1, 2003 Jan. 1, 2005 2005.03.01 _ Jan. 1, 2005 2005.03.01

Rev. 1 Oct. 29, 2007 Nov. 2007 Sep. 30, 2009 2010.04.01 Jan. 1, 2009 Oct. 1, 2009 2010.10.01 _ Oct. 1, 2009 2010.10.01

Rev. 2 Jun. 15, 2011 Nov. 2012 Mar. 24, 2011 2011.11.23 Jan. 1, 2014 Apr. 1, 2011 2012.12.01 Jan. 1, 2014 Apr. 1, 2011 2012.12.01

Starch, Rice Oct. 25, 2006 Nov. 2006 Sep. 30, 2009 2010.04.01 Jan. 1, 2008 Oct. 1, 2009 2010.10.01 _ Oct. 1, 2009 2010.10.01

Rev. 1 Nov. 6, 2013 Mar. 2014 (Mar, 2016) 2014.09.26 April 1, 2015 (Apr, 2016) (Aug. 1, 2015) April 1, 2015 (Apr, 2016)

Starch, Wheat Oct. 24, 2001 Nov. 2001 Dec. 28, 2004 2005.03.01 Jan. 1, 2003 Jan. 1, 2005 2005.03.01 _ Jan. 1, 2005 2005.03.01

Rev. 1 Oct. 29, 2007 Nov. 2007 Sep. 30, 2009 2010.04.01 Jan. 1, 2009 Oct. 1, 2009 2010.10.01 _ Oct. 1, 2009 2010.10.01

Rev. 2 Jun. 15, 2011 Nov. 2012 Mar. 24, 2011 2011.11.23 Jan. 1, 2014 Apr. 1, 2011 2012.12.01 Jan. 1, 2014 Apr. 1, 2011 2012.12.01

Stearic Acid Jun. 3, 2008 Jun. 2008 Feb. 28, 2014 2011.04.29 Jul. 1, 2009 Feb. 28, 2014 2012.05.01 _ Feb. 28, 2014 2012.05.01

Rev. 1 Nov. 6, 2013 Mar. 2014 Feb. 28, 2014 N/A April 1, 2015 Feb. 28, 2014 N/A April 1, 2015 Feb. 28, 2014

Rev. 1, Corr. 1 Nov. 13, 2014 _ ― 2015.04.24 _ ― (May 1, 2016) _ ―

Revision: Sign-off cover sheet July 1, 2015 (Fall, 2017) (Fall, 2017) (Fall, 2017)

Sucrose Oct. 30, 2007 Nov. 2007 Sep. 27, 2012 Postponed Jan. 1, 2009 Oct. 1, 2012 TBD _ Oct. 1, 2012 TBD

Revision: Sign-off cover sheet June 27, 2013 _ ― 2013.09.27 _ ― 2014.08.01 Jan. 1, 2015 ―

Talc Nov. 10, 2003 Mar. 2004 ― 2005.09.01 April 1, 2005 ― 2005.09.01 _ ― 2005.09.01

Rev. 1 Jun. 3, 2008 _ Mar. 24, 2011 2011.02.01 _ Apr. 1, 2011 2011.08.01 _ Apr. 1, 2011 2011.08.01