Re
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Topic
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TITLE OF GUIDELINES
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In charge
 Expert Working Group in charge |
Step
Status
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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 |
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| 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
bovine |
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
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Pharmacovigilance |
Pharmacovigilance of
veterinary medicinal products: management of Adverse Event Reports (AERs) |
Pharmacovigilance |
Step 5 |
Apr. 00 |
Jun. 00
Re-signed Nov 05 |
May 01
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Oct. 07 |
Pending adoption of GL 30 and GL 35 - Regulatory Authorities may consider implementation at an earlier stage as appropriate To be determined |
| 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 5
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May 06
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June 06
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Sept. 07
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| 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 3 |
Dec. 01 |
(Apr.
02)
Sept. 07 |
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| GL35 |
Pharmacovigilance : ESTD |
Pharmacovigilance : Electronic Standards for Transfer of Data |
Pharmacovigilance
|
Step 3 |
(May 02) |
Sept. 07 |
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| 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
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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 5 |
Oct. 05 |
Nov. 05 |
Sept. 07 |
Oct.07 |
Pending adoption of GL 30 and GL 35 To be determined |
| 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
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Quality: Bracketing and Matrixing
|
Bracketing and Matrixing Designs for Stability Testing of new Veterinary Drug Substances and Medicinal Products |
Quality |
Step 4 |
Nov. 2007 |
Feb. 2008 |
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| GL46 |
MRK:
Nature of Residues
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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
4
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July
09 |
Nov.
09 |
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| GL47 |
MRK:
Comparative Metabolism Studies
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Studies
to evaluate the metabolism and residue kinetics of
veterinary drugs in food-producing animals: Comparative
metabolism studies in laboratory animals |
MRK |
Step
4
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July
09 |
Nov.
09 |
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| GL48 |
MRK:
Marker Residue Depletion Studies
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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
4
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July
09 |
Nov.
09 |
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| GL49 |
MRK:
Method used in Residue Depletion Studies
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Guidelines
for the validation of analytical methods used in residue
depletion studies |
MRK |
Step
4
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July
09 |
Nov.
09 |
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