VICH/99/036

October 2024

STATUS OF VICH GUIDELINES & VICH WORKPLAN

1/ Draft and Adopted VICH Guidelines

Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:
GL1 Validation Validation of analytical Quality Step 7 Mar. 1997 Aug.1997 Oct. 1998 Oct. 98 Oct. 1999
definitions procedures: definition and
terminology
GL2 Validation Validation of analytical Quality Step 7 Mar. 1997 Aug.1997 Oct. 1998 Oct. 98 Oct. 1999
methodology procedures : methodology
GL3 Stability 1 Stability testing of new drug Quality Step 9 Sep. 1997 Feb. 1998 Mar. 1999 May 1999 May 2000
substances and products
GL4 Stability 2 Stability testing for new dosage Quality Step 7 Sep. 1997 Feb. 1998 Mar. 1999 May 1999 May 2000
forms
GL5 Stability 3 Stability testing : photostability Quality Step 7 Sep. 1997 Feb. 1998 Mar. 1999 May 1999 May 2000
testing of new drug substances
and products
GL6 Ecotox Phase I Environmental impact assessments Ecotoxicity Step 7 Sep. 1998 Oct. 1998 Nov. 1999 June 2000 Jul. 2001 (to
(EIAs) for veterinary medicinal be
product (VMPs) Phase 1 implemented
in Japan
upon
completion
of phase 2)
GL7 Anthelmintics Efficacy of anthelmintics: general Anthelmintics Step 7 Aug. 1998 Oct. 1998 Nov. 1999 Nov. 1999 Dec.2000 –
General requirements June 2001
GL8 Stability premixes Stability testing for medicated Quality Step 7 Jul. 1998 Oct. 1998 Nov. 1999 Nov. 1999 Dec.2000 –
premixes June 2001
GL9 GCP Go o d C l i n i c a l P r a c t i c e s GCP Step 7 Sep. 1998 Oct. 1998 Nov. 1999 June 2000 Jul. 2001
GL10 Impurities Impurities in new veterinary drug Quality Step 9 Oct. 1998 Oct. 1998 Nov. 1999 Nov. 1999 Dec.2000 –
substances substances June 2001
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL11 Impurities Impurities in new veterinary Quality Step 9 Oct. 1998 Oct. 1998 Nov. 1999 Nov. 1999 Dec.2000 –
products medicinal products June 2001
GL 12 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Nov. 1998 Feb. 1999 Nov. 1999 Nov. 1999 Dec.2000 –
bovine recommendations for bovines June 2001
GL13 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Nov. 1998 Feb. 1999 Nov. 1999 Nov. 1999 Dec.2000 –
ovine recommendations for ovines June 2001
GL14 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Nov. 1998 Feb. 1999 Nov. 1999 Nov. 1999 Dec.2000 –
caprine recommendations for caprines June 2001
GL15 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Mar. 1999 Nov. 1999 Feb. 2001 Jun. 2001 Jul. 2002
equine recommendations for equines
GL16 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Mar. 1999 Nov. 1999 Feb. 2001 Jun. 2001 Jul. 2002
porcine recommendations for porcines
GL17 Stability: Stability testing of new Quality Step 7 Apr. 1999 July 1999 Mar. 2000 Jun. 2000 Jul. 2001
Biotechnologicals/ biotechnological/biological
biologicals products
GL18 Impurities: Impurities: residual solvents in Quality Step 7 Apr. 1999 July 1999 Mar. 2000 Jun. 2000 Jul. 2001
Residual Solvents new veterinary medicinal
products, active substances and
excipients
GL19 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Nov. 1999 Nov. 1999 Feb. 2001 Jun. 2001 Jul. 2002
canine recommendations for canine
GL20 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Feb. 2000 Jun. 2000 Feb. 2001 Jun. 2001 Jul. 2002
feline recommendations for feline
GL21 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 7 Feb. 2000 Jun. 2000 Feb. 2001 Jun. 2001 Jul. 2002
poultry recommendations for poultry
GL22 Safety Studies to evaluate the safety of residues of Safety Step 7 Apr. 2000 Jun. 2000 May 2001 Jun. 2001 Aug. 2002
reproduction veterinary drugs in human food:
reproduction studies
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL23 Safety Studies to evaluate the safety of residues of Safety Step 7 Apr. 2000 Jun. 2000 May 2001 Jun. 2001 Aug. 2002
genotoxicity veterinary drugs in human food: 2001 (to be
genotoxicity testing implemented
in Japan
upon
completion
of phase 2)
GL24 Pharmacovigilance Pharmacovigilance of veterinary Pharmacovigil Step 7 Apr. 2000 (Jun. 2000) (May 2001) Oct 2007 December
medicinal products: management ance Re-signed 2015
of Adverse Event Reports (AERs) Nov 2005 Sept. 2007

GL25 Biologicals Testing of residual formaldehyde Biologicals Step 7 Jul. 2000 Nov. 2000 Feb. 2002 Apr. 2002 May 2003
GL26 Biologicals Testing of residual moisture Biologicals Step 7 Jul. 2000 Nov. 2000 Feb. 2002 Apr. 2002 May 2003
GL27 Antimicrobial Guidance on pre-approval information for Antimicrobial Step 7 May 2001 Jun. 2001 Aug. 2003 Oct. 2003 15 December
Resistance registration of new veterinary medicinal Resistance 2004
products for food producing animals with
respect to antimicrobial resistance
GL28 Safety Studies to evaluate the safety of residues of Safety Step 9 May 2001 Jun. 2001 Aug. 2002 Oct. 2002 Oct. 2003
carcinogenicity veterinary drug in human food:
carcinogenicity testing
GL29 Pharmacovigilance Pharmacovigilance of Veterinary Medicinal Pharmacovigil Step 7 May 2001 Jun. 2001 May 2006 June 2006 June 2007
: PSU Products: Management of Periodic ance
Summary Update Reports (PSUs)
GL30 Pharmacovigilance Pharmacovigilance of Veterinary Medicinal Pharmacovigil Step 7 May 2006 June 2006 (Sept. 2007) June 2010 December
: list of terms Products: Controlled List of Terms ance Re-signed 2015
June 2010
GL31 Safety: Repeat- Studies to evaluate the safety of residues of Safety Step 7 Dec. 2001 Apr. 2002 Oct. 2002 Oct. 2002 Oct. 2003
dose toxicity test veterinary drugs in human food: Repeat-
dose toxicity testing
GL32 Safety: Studies to evaluate the safety of residues of Safety Step 7 Dec. 2001 Apr. 2002 Oct. 2002 Oct. 2002 Oct. 2003
Developmental veterinary drugs in human food:
toxicity test Developmental toxicity testing (Exc. EU)

GL33 Safety: General Studies to evaluate the safety of residues of Safety Step 9 Dec. 2001 Apr. 2002 Oct. 2002 Oct. 2002 Oct. 2003
approach to testing veterinary drugs in human food: General
approach to testing
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL34 Biologicals: Test for the detection of Mycoplasma Biologicals Step 7 Dec. 2001 (Sept. 2007) Jan. 2013 Feb. 2013 Feb. 2014
Mycoplasma contamination Re-signed
Nov. 2011
GL35 Pharmacovigilance: Pharmacovigilance: Electronic Standards Pharmacovigil Step 7 (May 2002) (Sept. 2007) Feb. 2013 Feb. 2013 December
ESTD for Transfer of Data ance Re-signed Re-signed 2015
June 2010 June 2010
GL36 Safety: microbiological Studies to evaluate the safety of residues of Safety Step 7 May 2002 by May 2003 March 2004 May 2004 May 2005
ADI veterinary drugs in human food: General Task Force
Approach to establish a microbiological
ADI
GL37 Safety: repeat dose Studies to evaluate the safety of residues of Safety Step 7 May 2002 by May 2003 March 2004 May 2004 May 2005
chronic toxicity veterinary drugs in human food: Repeat- Task Force
dose Chronic Toxicity Testing
GL38 Ecotoxicity Phase II Environmental Impact Assessment (EIAs) Ecotoxicity Step 7 July 2003 Oct. 2003 Sept. 2004 Oct. 2004 Oct. 2005
for Veterinary Medicinal Products (VMPs)
– Phase II
GL39 Quality: specifications Test Procedures and Acceptance Criteria Quality Step 7 July 2004 August 2004 Sept. 2005 Nov. 2005 Nov. 2006
for new Veterinary Drug Substances and
New medicinal Products: Chemical
Substances
GL40 Quality: specifications Test Procedures and Acceptance Criteria Quality Step 7 July 2004 August 2004 Sept. 2005 Nov. 2005 Nov. 2006
for new Biotechnological/Biological
Veterinary Medicinal Products
GL41 TAS: reversion to Examination of live Veterinary Vaccines in TAS Step 7 Sept. 2004 Oct. 2004 June 2007 July 2007 July 2008
virulence Target Animals for Absence of Reversion
to Virulence
GL42 Pharmacovigilance: Pharmacovigilance: Data Elements for Pharmacovigil Step 7 Oct. 2005 Nov. 2005 Sept. 2007 Oct 2007 December
Data elements Submission of Adverse Events Reports ance Re-signed Re-signed 2015
June 2010 June 2010
GL43 TAS: Pharmaceuticals Target Animal Safety for Pharmaceuticals TAS Step 7 Sept. 2006 Dec. 2006 June 2009 July 2009 July 2010

GL44 TAS: Biologicals Target Animal Safety for Veterinary live TAS Step 7 June 2007 August 2007 June 2009 July 2009 July 2010
and inactivated Vaccines
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL45 Quality: Bracketing and Bracketing and Matrixing Designs for Quality Step 7 Nov. 2007 Feb. 2008 Feb. 2010 April 2010 April 2011
Matrixing Stability Testing of new Veterinary Drug
Substances and Medicinal Products

GL 46 MRK: Nature of Studies to evaluate the Metabolism and MRK Step 7 July 2009 Nov. 2009 Dec 2010 Feb. 2011 Feb. 2012
Residues Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Metabolism
Study to determine the Quantity and
Identify the Nature of Residues
GL 47 MRK: Comparative Studies to evaluate the Metabolism and MRK Step 7 July 2009 Nov. 2009 Dec 2010 Feb. 2011 Feb. 2012
Metabolism Studies Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Comparative
Metabolism Studies in Laboratory Animals
GL 48 MRK: Marker Residue Studies to evaluate the Metabolism and MRK Step 7 July 2009 Nov. 2009 Dec 2010 Feb. 2011 Feb. 2012
Depletion Studies Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Marker Residue
Depletion Studies to establish Product
Withdrawal Periods
GL 49 MRK: Method used in Guidelines for the Validation of Analytical MRK Step 7 July 2009 Nov. 2009 Dec 2010 Feb. 2011 Feb. 2012
Residue Depletion Methods used in Residue Depletion Studies
Studies
GL 50 Biologicals: TABST Harmonisation of criteria to waive target Biologicals Step 7 Sept. 2011 Nov. 2011 Feb. 2013 Feb. 2013 Feb. 2014
animal batch safety testing (TABST) for
inactivated vaccines for veterinary use
GL51 Quality: Stability data Statistical evaluation of stability data Quality Step 7 Nov. 2011 Nov. 2011 Feb. 2013 Feb. 2013 Feb. 2014

GL52 Bioequivalence: Blood Blood Level Bioequivalence Study Bioequivalenc Step 7 Oct. 2013 Nov. 2013 June 2015 Aug. 2015 Aug. 2016
level e

GL53 Electronic File Format Electronic exchange of documents: File EFF Step 7 Nov. 2013 Jan. 2014 Jan. 2015 Feb. 2015 Feb. 2016
format requirements
GL54 S a f e t y : Acute Studies to Evaluate the Safety of Residues Safety Step 7 Dec. 2014 Feb 2015 Sept 2016 Nov. 2016 Nov. 2017
Reference Dose (ARfD) of Veterinary Drugs in Human Food:
General Approach to Establish an Acute
Reference Dose (ARfD)
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:
Oct 2015
GL 55 B i o l o g i c a l s : TABST Harmonisation of criteria to waive target Biologicals Step 7 Sept. 2015 Re-signed in April 2017 May 2017 May 2018
Live vaccines animal batch safety testing for live vaccines Feb 2016
GL 56 MRK: Residues in Studies to evaluate the Metabolism and MRK Step 7 Oct. 2016 Jan. 2017 June 2018 June 2018 June 2019
Honey Residue Kinetics of Veterinary Drugs in
Food-producing Species: Study Design
Recommendations for Residue Studies in
Honey for establishing MRLs and
Withdrawal Periods
GL 57 MRK: Residues in Studies to evaluate the Metabolism and MRK Step 7 Nov. 2017 Dec. 2017 February February 2019 February 2020
Fish Residue Kinetics of veterinary drugs in 2019
food-producing species: Marker residue
depletion studies to establish product
withdrawal periods in aquatic species
GL 58 S t a b i l i t y : Climatic Stability Testing of New Veterinary Drug Quality Step 7 June 2018 June 2018 October November 2019 November 2020
Zones III and IV Substances and Medicinal Products in 2019
Climatic Zones III and IV
GL 59 B i o l o g i c a l s : LABST Harmonisation of criteria to waive Biologicals Step 7 June 2019 Oct. 19 October November 2020 November 2021
Veterinary vaccines laboratory animal batch safety testing for 2020
vaccines for veterinary use
GL 60 Q u a l i t y : GM P f o r Good Manufacturing Practice for Active Quality Step 4 August 2023 Sept. 23
API Pharmaceutical Ingredients used in
Veterinary Medicinal Products
GL 61 Quality: Pharmaceutical Development for Quality Step 4 January 24 February 24
Pharmaceutical veterinary medicinal products
Development

2/ VICH Revised Guidelines at Step 9

GL3 Stability 1 Stability testing of new drug Quality Step 7 April 2005 May 2005 Dec. 2006 Jan 2007 Jan 2008
substances and products

GL10 Impurities substances Impurities in new veterinary drug Quality Step 7 April 2005 May 2005 Dec. 2006 Jan 2007 Jan 2008
substances
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL11 Impurities products Impurities in new veterinary Quality Step 7 April 2005 May 2005 Dec. 2006 Jan 2007 Jan 2008
medicinal products

GL18 Impurities: Impurities: residual solvents in Quality Step 7 Feb. 2010 April 2010 July 2011 June 2012
Residual Solvents new veterinary medicinal
products, active substances and
excipients
GL18 Impurities: Impurities: residual solvents in Quality Step 7 Oct 21 Nov 21 March 23 April 2023 April 2024
Residual Solvents new veterinary medicinal
Rev 2 products, active substances and
excipients
GL23 Safety: Studies to evaluate the safety of residues of Safety Step 7 October 2012 Dec 2012 August 2014 Sept. 2014 Oct. 2015
genotoxicity veterinary drug in human food:
genotoxicity testing
GL28 Safety: Carcinogenicity Studies to evaluate the safety of residues of Safety Step 7 May 2004 March 2005 March 2005 March 2006
veterinary drug in human food: (part only)
carcinogenicity testing
GL33 Safety: General Studies to evaluate the safety of residues of Safety Step 7 Feb 2009 Feb 2010
approach to testing veterinary drugs in human food: General
Rev 2 approach to testing
GL35 Pharmacovigilance: Pharmacovigilance: Electronic Standards Pharmacovigil Step 7 Feb 2023 March 2023 March 2024
ESTD for Transfer of Data ance
Rev 1
GL36 Safety: microbiological Studies to evaluate the safety of residues of Microbiologic Step 7 January 2011 February April 2012 May 2012 June 2013
ADI veterinary drugs in human food: General al ADI 2011 (at the
Approach to establish a microbiological 25th SC)
ADI
GL36 Safety: microbiological Studies to evaluate the safety of residues of Microbiologic Step 7 February August 2019
ADI veterinary drugs in human food: General al ADI 2019
Approach to establish a microbiological
Rev 2 ADI

GL42 Pharmacovigilance: Pharmacovigilance: Data Elements for Pharmacovigil Step 7 Feb 2023 March 2023 March 2024
Data elements Submission of Adverse Events Reports ance
Rev 1
GL 48 MRK: Marker Residue Studies to evaluate the Metabolism and MRK Step 7 Sept 2014 Jan 2015 Jan 2016
Depletion Studies Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Marker Residue
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:
Depletion Studies to establish Product
Withdrawal Periods
GL 49 MRK: Method used in Guidelines for the Validation of Analytical MRK Step 7 Sept 2014 Jan 2015 Jan 2016
Residue Depletion Methods used in Residue Depletion Studies
Rev 1 Studies
GL 50 Biologicals: TABST Harmonization of criteria to waive target Biologicals Step 7 Feb. 2016 April 17 May 2017 May 2018
animal batch safety testing (TABST) for
Rev 1 inactivated vaccines for veterinary use

3/ VICH Guidelines under Revision - Step 9

GL7 Anthelmintics Efficacy of anthelmintics: general Anthelmintics Step 4 March 22 May 22 Sept 24
General requirements
GL8 Stability premixes Stability testing for medicated Quality Step 1
premixes
GL 12 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
bovine recommendations for bovines
GL13 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
ovine recommendations for ovines
GL14 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
caprine recommendations for caprines
GL15 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
equine recommendations for equines
GL16 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
porcine recommendations for porcines
GL19 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
canine recommendations for canine
GL20 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
feline recommendations for feline
GL21 Anthelmintics Efficacy of anthelmintics: specific Anthelmintics Step 4 March 22 May 22 Sept 24
poultry recommendations for poultry
 Step 3 (SC
Expert Step 5 Step 6
Step 2 (EWG approval of
Working Step (EWG (SC Implementa
Re Topic TITLE OF GUIDELINES consensus) release for
Group in Status consensus) approval) tion date
Signed on: consultation)
charge signed on: signed on:
Signed on:

GL22 Safety Studies to evaluate the safety of residues of Safety Step 4 December 23 January 24
reproduction veterinary drugs in human food:
Rev 1 reproduction studies
GL23 Safety: Studies to evaluate the safety of residues of Safety Step 2 April 24 May 24
genotoxicity veterinary drugs in human food:
Rev 2 genotoxicity testing
GL24 Pharmacovigilance Pharmacovigilance of veterinary Pharmacovigil Minor ON HOLD
medicinal products: management ance revision
of Adverse Event Reports (AERs)
GL29 Pharmacovigilance Pharmacovigilance of Veterinary Medicinal Pharmacovigil Minor ON HOLD
: PSU Products: Management of Periodic ance revision
Summary Update Reports (PSUs)
GL 47 MRK: Comparative Studies to evaluate the Metabolism and MRK Step17
Metabolism Studies Residue Kinetics of Veterinary Drugs in
Food-producing Animals: Comparative
Metabolism Studies in Laboratory Animals
GL 49 MRK: Method used in Guidelines for the Validation of Analytical MRK Step 1
Residue Depletion Methods used in Residue Depletion Studies
Rev 2 Studies