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Guidelines ICH
- Q1A : Stability Testing of New Drug Substances and Products.
This guideline is now being revised under topic code Q1A(R).
Q1A(R) :Stability Testing of New Drugs and Products (Revised guideline
Implementation
EU:
Adopted by CPMP, November 2000, issued as CPMP/ICH/2736/99
MHLW: Adopted May 1, 2001, PMSB/ELD, Notification No. 565
FDA:
Published in the Federal Register, Vol. 66, No 216, November 7, 2001, pages 56332 to 56333
Q1B: Photostability Testing
Implementation (Step 5):
EU: Adopted by CPMP, December 96, issued as CPMP/ICH/279/95
MHLW: Adopted May 97, PAB/PCD Notification No.422
FDA:
Published in the Federal Register, Vol. 62, No. 95, May 16, 1997, pages 27115-27122.
- Q1C :
Stability Testing for New Dosage Forms
Implementation
EU: Adopted by CPMP, December 96, issued as CPMP/ICH/280/95
MHLW: Adopted May 97, PAB/PCD Notification No.425
FDA: Published in the Federal Register, Vol. 62, No. 90, May 9, 1997, pages 25634-25635
- Q1D: Bracketing and Matrixing Designs for Stability Testing of Drug
Substances and Drug Products
Implementation (Step 5):
EU: Adopted by CPMP, Februar 2002, CPMP/ICH/4104/00
MHLW: To be Notified
FDA
: To be Notified
- Q1E : Evaluation of Stability Data
Consultation (Step 3):
EU
: Released for consultation, February 2002, CPMP/ICH/420/02
MHLW: Released for consultation on 21th May 2002 - ELD/PFSB N° 0520002 - Comment period until 16th August 2002
FDA
: Published in the Federal Register on June 14, 2002, vol. 67, n.115, p. 40949-40950
- Q1F : Text on Validations of Analytical Procedures
Implementation (Step 5):
EU: Adopted by CPMP, November 94, issued as CPMP/ICH/381/95
MHLW: Adopted July 95, PAB/PCD Notification No.755
FDA
: Published in the Federal Register, Vol. 60, March 1, 1995, pages 11260
- Q3A : Impurities in New Drug Products :
This Guideline is now being revised under topic code Q3B(R)
- Q3B(R) :
Impurities in New Drug Products (Revised Guideline)
Consultation (Step 3):
EU: Released for consultation, November 1999, issued as CPMP/ICH/2738/99,
deadline for comments on May 2000.
MHLW: Released for consultation, PAB/PCD Notification n° 1829, 17 December 1999, deadline for comments on 31 March 2000.
FDA
: Published in the Federal Register, Vol. 65, No 139, Wednesday, July 19, 2000, p. 44791 to 44797
Guidelines Eudralex
- 3AQ15A : Stability Testing of new Active Substances and Medicinal Products
- 3AQ16A : Stability Testing on Active Ingredients and Finished Products
- 3AQ17A : Stability Testing: Requirements for New Dosage Forms
- 3AQ18A : Photostability Testing of New Active Substances and Medicinal Products
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