VICH - Topics

Quality

Topic : Analytical validation
	Text of the guidelines
		Validation of analytical procedures : Definition and Terminology VICH GL1 (Validation definitions) – EWG consensus signed in 1997 Implemented in October 1999 Validation of analytical procedures : Methodology VICH GL2 (Validation methods) – EWG consensus signed in 1997 Implemented in October 1999

Quality

Safety

Ecotoxicity

Good Clinical Practice (GCP)

Anthelmintics

Pharmacovigilance

Biologicals quality monitoring

Antimicrobial resistance

Target Animal Safety

Metabolism and Residue Kinetics

Topic : Impurities
	Text of the guidelines
		Impurities in New Veterinary Drug Subtances VICH GL10 (impurities New Substances) - EWG consensus signed in 1998 Implemented in December 2000 - June 2001 Impurities in New Veterinary Drug Substances (Revision) VICH GL 10 (R) (Quality) – For implementation in January 2008 Impurities in New Veterinary Medicinal products VICH GL11 (impurities New VMPs) EWG consensus signed in 1998 Implemented in December 2000 - June 2001 Impurities in New Veterinary Medicinal Products (Revision) VICH GL 11 (R) (Quality) – For implementation in January 2008 Impurities: Residual Solvents in new veterinary medicinal products, active substances and excipients VICH GL18 (impurities: Residual Solvents) EWG consensus signed in 1999 Implemented in July 2001
Topic : Stability
	Text of the guidelines
		Stability testing of new drugs substances and products VICH GL3 (Stability drugs) – EWG consensus signed in 1997 Implemented in May 2000 Stability Testing of New Veterinary Drug Substances and Medicinal Products (Revision) VICH GL3(R) (Quality) – For implementation in January 2008 Stability Testing: Requirements for New Dosage Forms Annex to the VICH guidelines on Stability Testing for New Drugs and Products VICH GL4 (Stability products) – EWG consensus signed in 1997 - Implemented in May 2000 Stability Testing: Photostability Testing of New Drug Substances and Products VICH GL5 (Photostability) – EWG consensus signed in 1997 Implemented in May 2000 Stability Testing for Medicated Premixes VICH GL8 (Stability premixes) EWG consensus signed in 1998 Implemented in December 2000 - June 2001 Stability testing of new biotechnological/biological veterinary medicinal products VICH GL17 (Stability: biotechnologicals/biologicals) EWG consensus signed in 1999 Implemented in July 2001
Topic : Specifications
	Text of the guidelines
		Test Procedures and Acceptance Criteria for New Veterinary Drug Substances and New Medicinal Products: Chemical Substances VICH GL39 (Quality) EWG consensus signed in 2004 Implemented in November 2006 Test Procedures and Acceptance Criteria for New Biotechnological/Biological Veterinary Medicinal Products VICH GL40 (Quality) EWG consensus signed in 2004 - Implemented in November 2006

Safety


Topic : General Approach to testing
	Text of the guidelines
		Studies to evaluate the safety of veterinary drug residues in human food: General approach to testing VICH GL33 (Safety General Approach) EWG consensus signed in 2001 – Implemented in October 2003 Studies to evaluate the safety of residues of veterinary drugs in human food: General approach to establish a microbiological ADI VICH GL36 (Safety: General Approach) EWG consensus signed in 2002 - Implemented in May 2005
Topic : Genotoxicity
	Text of guidelines
		Studies to evaluate the safety of veterinary drug residues in human food: Genotoxicity testing VICH GL23 (Safety Genotoxicity) EWG consensus signed in 2000 Implemented in August 2002 (to be implemented in Japan when the guideline on the General Approach to Testing is finalised)
Topic : Reproduction toxicity
	Text of guidelines
		Studies to evaluate the safety of veterinary drug residues in human food: Reproduction testing VICH GL22 (Safety Reproduction) EWG consensus signed in 2000 Implemented in August 2002 Studies to evaluate the safety of residues of veterinary drugs in human food: Developmental toxicity testing VICH GL32 (Safety Developmental toxicity) EWG consensus signed in 2001 Implemented in October 2003 (Exc. EU)
Topic : Repeated dose toxicity
	Text of guidelines
		Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat dose toxicity testing VICH GL31 (Safety Repeat dose) EWG consensus signed in 2001 Implemented in October 2003 Studies to evaluate the safety of residues of veterinary drugs in human food: Repeat-dose (chronic) toxicity testing VICH GL37 (Safety: Repeat-dose chronic toxicity) EWG consensus signed in 2002 Implemented in May 2005
Topic : Carcinogenicity
	Text of guidelines
		Studies to evaluate the safety of veterinary drug residues in human food: carcinogenicity testing VICH GL28 (Safety Carcinogenicity) EWG consensus signed in 2001 Implemented in October 2003

Ecotoxicity

Topic
	Text of the guidelines
		Environmental Impact Assessment (EIAs) for veterinary medicinal products (VMPs) - Phase 1 VICH GL6 (Ecotoxicity - Phase 1) - EWG consensus signed in 1998 Implemented in July 2001 (to be implemented in Japan upon completion of phase 2) Environmental Impact Assessment (EIAs) for Veterinary Medicinal Products (VMPs) - Phase II VICH GL38 (Ecotoxicity Phase II) EWG consensus signed in 2003 Implemented in October 2005

Good Clinical Practice (GCP)

Topic
	Text of the guidelines
		Good Clinical Practices VICH GL9 (GCP) - EWG consensus signed in 1998 Implemented in July 2001

Anthelmintics

Topics
	Text of the guidelines
		Efficacy of Anthelmintics : General Requirements VICH GL7 (Anthelmintics General) – EWG consensus signed in 1998 Implemented in December 2000 – June 2001 Efficacy of Anthelmintics : Specific Recommendations for Bovines VICH GL12 (Anthelmintics : Bovines) EWG consensus signed in 1998 Implemented in December 2000 – June 2001 Efficacy of Anthelmintics : Specific Recommendations for Ovines VICH GL13 (Anthelmintics : Ovines) EWG consensus signed in 1998 Implemented in December 2000 – June 2001 Efficacy of Anthelmintics : Specific Recommendations for Caprines VICH GL14 (Anthelmintics : Caprines) EWG consensus signed in 1998 Implemented in December 2000 – June 2001 Efficacy of Anthelmintics : Specific Recommendations for Equine VICH GL15 (Anthelmintics : Equine) EWG consensus signed in 1999 Implemented in July 2002 Efficacy of Anthelmintics : Specific Recommendations for Porcine VICH GL16 (Anthelmintics : Swine) EWG consensus signed in 1999 Implemented in July 2002 Efficacy of Anthelmintics : Specific Recommendations for Canine VICH GL19 (Anthelmintics : Canine) EWG consensus signed in 1999 Implemented in July 2002 Efficacy of Anthelmintics : Specific Recommendations for Feline VICH GL20 (Anthelmintics : Feline) EWG consensus signed in 2000 Implemented in July 2002 Efficacy of Anthelmintics : Specific Recommendations for Poultry VICH GL21 (Anthelmintics : Poultry) EWG consensus signed in 2000 Implemented in July 2002

Pharmacovigilance

Topic
	Text of the guidelines
		Pharmacovigilance of veterinary medicinal products: management of adverse event reports (AERs) VICH GL24 (Pharmacovigilance) - October 2007 - For implementation to be determined Pending adoption of GL 30 and GL 35 - Regulatory Authorities may consider implementation at an earlier stage as appropriate Pharmacovigilance of Veterinary Medicinal Products - Management of Periodic Summary Update Reports VICH GL29 (Pharmacovigilance) EWG consensus signed in 2001 - For implementation by June 2007 Pharmacovigilance of veterinary medicinal products: Controlled list of terms (& Signatures at Step 5) GL30 (Pharmacovigilance) - Recommended for adoption at step 6 in October 2007 Pharmacovigilance of Veterinary Medicinal Products: Electronic standards for transfer of data (& Signatures at Step 3) VICH GL35 (Pharmcovigilance) - Recommended for consultation at step 4 in October 2007 Pharmacovigilance of Veterinary Medicinal Products - Data Elements for Submission of Adverse Event Reports VICH GL42 (Pharmacovigilance) - October 2007 - For implementation to be determined Pending adoption of GL 30 and GL 35

Biologicals quality monitoring

Topic
	Text of the guidelines
		Testing of residual formaldehyde VICH GL25 (Biologicals: Formaldehyde) EWG consensus signed in 2000 Implemented in May 2003 Testing of residual moisture VICH GL26 (Biologicals: Moisture) EWG consensus signed in 2000 Implemented in May 2003 Testing for the detection of Mycoplasma contamination VICH Draft GL34 (Biologicals: Mycoplasma) April 2002 - For a 12-month public consultation at step 3 - Draft 1

Antimicrobial resistance

Topic
	Text of the guidelines
		Pre-approval information for registration of new veterinary medicinal products for food producing animals with respect to antimicrobial resistance VICH GL27 (Antimicrobial Resistance: pre-approval) EWG consensus signed in 2001 Implemented in 2004

Target Animal Safety

Topic
	Text of the guidelines
		Target Animal Safety - Examination of Live Veterinary Vaccines in Target Animals for Absence of Reversion to Virulence VICH GL41 draft 1 – EWG consensus signed in 2004 - Recommended for adoption at step 3 in May 2006 Target Animal Safety for Pharmaceuticals VICH GL43 (TAS Pharmaceuticals) – July 2008 - For implementation in July 2009 Target Animal Safety for Veterinary Live and Inactivated Vaccines VICH GL44 (TAS Biologicals) - July 2008 - For implementation in July 2009

Metabolism and Residue Kinetics

		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 VICH GL46 (MRK) - Released for adoption at step 3 in September 2009 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Comparative metabolism studies in laboratory animals VICH GL47 (MRK) - Released for adoption at step 3 in September 2009 Studies to evaluate the metabolism and residue kinetics of veterinary drugs in food-producing animals: Marker residue depletion studies to establish product withdrawal periods VICH GL48 (MRK) - Released for adoption at step 3 in September 2009 - To be further dicussed at 23rd VICH SC meeting in November 2009 as IFAH-Europe is unable to sign Guidelines for the validation of analytical methods used in residue depletion studies VICH GL49 (MRK) - Released for adoption at step 3 in September 2009