Summary Table of VICH guidelines


Summary Table of VICH guidelines
Official texts of final guidelines
Official texts of draft guidelines
VICH Guidelines by Category
Documents in consultation


Re

Topic

TITLE OF GUIDELINES

In charge
Expert Working Group in charge
Step
Status


Step2
EWG consensus
Signed on:
Step3
SC approval of release for consultation
Signed on:
Step5
EWG consensus
Signed on:
Step6
SC approval
Signed on:
Impl.
date
                   
GL1 Validation 
definitions
Validation of analytical procedures: definition and terminology Quality Step 7 Mar. 97 Aug.97 Oct. 98 Oct. 98 Oct. 99
GL2 Validation
methodology
Validation of analytical procedures : methodology Quality Step 7 Mar. 97 Aug.97 Oct. 98 Oct. 98 Oct. 99
GL3 Stability 1 Stability testing of new drug substances and products Quality Step 9 Sep. 97 Feb. 98 Mar. 99 May 99 May 00
GL4 Stability 2 Stability testing for new dosage forms Quality Step 7 Sep. 97 Feb. 98 Mar. 99 May 99 May 00
GL5 Stability 3 Stability testing : photostability testing of new drug substances and products Quality Step 7 Sep. 97 Feb. 98 Mar. 99 May 99 May 00
GL6

Ecotox
Phase I

Environmental impact assessments (EIAs) for veterinary medicinal product (VMPs) Phase 1 Ecotoxicity Step 7 Sep. 98 Oct. 98 Nov. 99 June 00 to be implemented in Japan upon completion of phase 2 - Jul. 01
GL7 Anthelmintics
General
Efficacy of anthelmintics: general requirements Anthelmintics Step 7 Aug. 98 Oct. 98 Nov. 99 Nov. 99 Dec.00
June 01
GL8 Stability
premixes
Stability testing for medicated premixes Quality Step 7 Jul. 98 Oct. 98 Nov. 99 Nov. 99 Dec.00
June 01
GL9 GCP Good Clinical Practices GCP Step 7 Sep. 98 Oct. 98 Nov. 99 June 00 Jul. 01
GL10 Impurities
substances
Impurities in new veterinary drug substances Quality Step 9 Oct. 98 Oct. 98 Nov. 99 Nov. 99 Dec.00
June 01
GL11 Impurities
products
Impurities in new veterinary medicinal products Quality Step 9 Oct. 98 Oct. 98 Nov. 99 Nov. 99 Dec.00
June 01
GL12 Anthelmintics
bovine
Efficacy of anthelmintics: specific recommendations for bovines Anthelmintics Step 7 Nov. 98 Feb. 99 Nov. 99 Nov. 99 Dec.00
June 01
GL13 Anthelmintics
ovine
Efficacy of anthelmintics: specific recommendations for ovines Anthelmintics Step 7 Nov. 98 Feb. 99 Nov. 99 Nov. 99 Dec.00
June 01
GL14 Anthelmintics
caprine
Efficacy of anthelmintics: specific recommendations for caprines Anthelmintics Step 7 Nov. 98 Feb. 99 Nov. 99 Nov. 99 Dec.00
June 01
GL15 Anthelmintics
equine
Efficacy of anthelmintics: specific recommendations for equines Anthelmintics Step 7 Mar. 99 Nov. 99 Feb. 01 Jun. 01 Jul. 02
GL16 Anthelmintics
porcine
Efficacy of anthelmintics: specific recommendations for porcines Anthelmintics Step 7 Mar. 99 Nov. 99 Feb. 01 Jun. 01 Jul. 02
GL17 Stability:
Biotechnologicals / biologicals
Stability testing of new biotechnological / biological products Quality Step 7 Apr. 99 July 99 Mar. 00 Jun. 00 Jul. 01
GL18 Impurities:
Residual Solvents
Impurities: residual solvents in new veterinary medicinal products, active substances and excipients Quality Step 7 Apr. 99 July 99 Mar. 00 Jun. 00 Jul. 01
GL19 Anthelmintics
canine
Efficacy of anthelmintics: specific recommendations for canine Anthelmintics Step 7 Nov. 99 Nov. 99 Feb. 01 Jun. 01 Jul. 02
GL20 Anthelmintics
feline
Efficacy of anthelmintics: specific recommendations for feline Anthelmintics Step 7 Feb. 00 Jun. 00 Feb. 01 Jun. 01 Jul. 02
GL21 Anthelmintics
poultry
Efficacy of anthelmintics: specific recommendations for poultry Anthelmintics Step 7 Feb. 00 Jun. 00 Feb. 01 Jun. 01 Jul. 02
GL22 Safety
reproduction
Studies to evaluate the safety of residues of veterinary drug in human food: reproduction studies Safety Step 7 Apr. 00 Jun. 00 May 01 Jun. 01 Aug. 02

GL23

Safety
genotoxicity

Studies to evaluate the safety of residues of veterinary drug in human food: genotoxicity testing

Safety

Step 7

Apr. 00

Jun. 00

May 01

Jun. 01

to be implemented in Japan upon completion of phase 2 - Aug. 02
01
GL24 Pharmacovigilance Pharmacovigilance of veterinary medicinal products: management of Adverse Event Reports (AERs) Pharmacovigilance Step 7 Apr. 00 Jun. 00
Re-signed Nov 05

May 01

Oct. 07 December 2015
GL25 Biologicals Testing of residual formaldehyde Biologicals Step 7 Jul. 00 Nov. 00 Feb. 02 Apr. 02 May 03
GL26 Biologicals Testing of residual moisture Biologicals Step 7 Jul. 00 Nov. 00 Feb. 02 Apr. 02 May 03
GL27 Antimicrobial
Resistance
Guidance on pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance Antimicrobial Resistance Step 7 May 01 Jun. 01 Aug. 03 Oct. 03 15 Dec. 04
GL28 Safety
carcinogenicity
Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing Safety Step 7 May 01 Jun. 01 Aug. 02 Oct. 02 Oct. 03
GL29 Pharmacovigilance
PSU
Pharmacovigilance of Veterinary Medicinal Products:  Management of Periodic Summary Update Reports (PSUs) Pharmacovigilance Step 7 May 01 Jun. 01 May 06 June 06 June 07
GL30 Pharmacovigilance list of terms Pharmacovigilance of Veterinary Medicinal Products : controlled list of terms Pharmacovigilance Step 7
May 06
June 06
Sept. 07
Re-signed June 10
 June 10

December 2015

GL31 Safety:
Repeat-dose
toxicity test
Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose toxicity testing Safety Step 7 Dec. 01 Apr. 02 Oct. 02 Oct. 02 Oct. 03
GL32 Safety:
Developmental
toxicity
test
Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing Safety Step 7 Dec. 01 Apr. 02 Oct. 02 Oct. 02

Oct. 03
(Exc. EU)

GL33 Safety:
General approach
to testing
Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing Safety Step 7 Dec. 01 Apr. 02 Oct. 02 Oct. 02 Oct. 03
GL34 Biologicals:
Mycoplasma
Test for the detection of Mycoplasma contamination Biologicals Step 4 Sept. 11 Sept. 07
Re-signed
Nov. 11
Jan. 13 Feb. 13 February 2014
GL35 Pharmacovigilance : ESTD Pharmacovigilance : Electronic Standards for Transfer of Data Pharmacovigilance
Step 7 (May 02)
Re-signed
June 10
Sept. 07
Re-signed
June 10
Feb. 13 Feb. 13 December 2015
GL36 Safety:
microbiological ADI
Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to establish a microbiological ADI Safety Step 7 May 02
by Task Force
May 03 March 04 May 04 May 05
GL37 Safety:
repeat dose chronic
toxicity
Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose Chronic Toxicity Testing Safety Step 7 May 02
by Task Force
May 03 March 04 May 04 May 05
GL38 Ecotoxicity
Phase II
Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) – Phase II Ecotoxicity Step 7 July 03 Oct. 03 Sept. 04 Oct. 04 Oct. 05
GL39 Quality:
specifications
Test Procedures and Acceptance Criteria for new Veterinary Drug Substances and New medicinal Products: Chemical Substances Quality Step 7 July 04 Aug. 04

Sept. 05

Nov. 05 Nov. 06
GL40 Quality:
specifications
Test Procedures and Acceptance Criteria for new Biotechnological/Biological Veterinary Medicinal Products Quality Step 7 July 04 Aug. 04

Sept. 05

Nov. 05 Nov. 06
GL41 TAS:
reversion to virulence
Examination of live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence TAS Step 7 Sept. 04 Oct. 04 June 07 July 07 July 08
GL42 Pharmacovigilance:
Data elements
Pharmacovigilance:  Data Elements for Submission of Adverse Events Reports Pharmacovigilance Step 7 Oct. 05 Nov. 05 Sept. 07
Re-signed
June 10
Oct.07
Re-signed
June 10
December 2015
GL43

TAS: Pharmaceuticals

Target Animal Safety for Pharmaceuticals

TAS Step 7 Sept. 06 Dec. 06 June 08 July 08 July 09
GL44 TAS: Biologicals

Target Animal Safety for Veterinary live and inactivated Vaccines

TAS Step 7 June 2007

Aug. 07

June 08 July 08 July 09
GL45

Quality: Bracketing and Matrixing

Bracketing and Matrixing Designs for Stability Testing of new Veterinary Drug Substances and Medicinal Products

Quality

Step 7 Nov. 2007

Feb. 2008

Jan. 10 April 2010 April 2011
GL46

MRK: Nature of Residues

Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Metabolism study to determine the quantity and identify the nature of residues MRK Step 7

 

July 09 Nov. 09 Oct. 10 Feb. 2011 February 2012
GL47

MRK: Comparative Metabolism Studies

Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals MRK Step 7

 

July 09 Nov. 09 Oct. 10 Feb. 2011 February 2012
GL48

MRK: Marker Residue Depletion Studies

Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods MRK Step 7

 

July 09 Nov. 09 Oct. 10 Feb. 2011 February 2012
GL49

MRK: Method used in Residue Depletion Studies

Guidelines for the validation of analytical methods used in residue depletion studies MRK Step 7

 

July 09 Nov. 09 Oct. 10 Feb. 2011 February 2012
GL50 Biologicals: TABST Harmonization of criteria to waive TABST for inactivated vaccines for veterinary use TABST Step 4 Sept. 11 Nov. 11 Feb. 13 Feb. 13 February 2014
GL51 Quality Statistical evaluation of stability data Quality Step 4 Nov. 11 Nov. 11 Feb. 13 Feb. 13 February 2014
GL52 Bioequivalence: Blood level Blood level bioequivalence study Bioequivlance Step 4 Oct. 13 Nov. 13      
GL53 Electronic File Format Electronic Exchange of documents: File format requirements EFF Step 2 Nov. 13        

VICH Revised Guidelines

Re

Topic

TITLE OF GUIDELINES

In charge
Expert Working Group in charge
Status

Step2
EWG consensus
Signed on:
Step3
SC approval of release for consultation
Signed on:
Step5
EWG consensus
Signed on:
Step6
SC approval
Signed on:
Impl.
date
                   
GL3 Stability 1 Stability testing of new drug substances and products Quality Step 7 April 05 May 05 Dec. 06 Jan. 07 Jan. 08
GL10 Impurities
substances
Impurities in new veterinary drug substances Quality Step 7 April 05 May 05 Dec. 06 Jan. 07 Jan. 08
GL11 Impurities
products
Impurities in new veterinary medicinal products Quality Step 7 April 05 May 05 Dec. 06 Jan. 07 Jan. 08

GL18

Impurities : Residual Solvents

Impurities : residual solvents in new veterinary medicinal products, active substances and excipients

Quality

Step 7

Jan. 2010 April 2010   July 2011 June 2012
GL28 Safety:
Carcinogenicity
Studies to evaluate the safety of residues of veterinary drug in human food: carcinogenicity testing Safety Step 7   May 04
Part only
March 05 March 05 March 06

GL33 Rev 2

Safety : General approach to testing
Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to testing Safety
Step 7
      Feb. 09
Feb. 2010
GL36 Safety: microbiological ADI Studies to evaluate the safety of residues of veterinary drugs in human food: General Approach to establish a microbiological ADI Safety Step 9 Jan. 11 Feb. 11 (at the 25th SC) April 12 June 12 June 13

VICH Guidelines under Revision

Re

Topic

TITLE OF GUIDELINES

In charge
Expert Working Group in charge
Status

Step2
EWG consensus
Signed on:
Step3
SC approval of release for consultation
Signed on:
Step5
Step6
SC approval
Signed on:
Impl.
date

GL23

Safety: genotoxicity

Studies to evaluate the safety of residues of veterinary drug in human food: genotoxicity testing

Safety

Step 9

Oct. 12 Dec. 12