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Guidelines ICH
- Q5A : Viral Safety Evaluation
Implementation (Step 5):
EU: Adopted by CPMP, April 97, issued as CPMP/ICH/295/95
MHLW
: Adopted, PMSB/ELD, Notification n° 329, 22 February 2000
FDA: Published in the Federal Register, Vol. 63, No. 185, September 24, 1998, page 51074
Q5B : Genetic Stability
Implementation (Step 5):
EU: Adopted by CPMP, December 95, issued as CPMP/ICH/139/95
MHLW: Adopted January 98, PMSB/ELD Notification No.3
FDA
: Published in the Federal Register, Vol. 61, February 23, 1996, page 7006
Q5C
: Stability of Products
Implementation (Step 5):
EU: Adopted by CPMP, December 95, issued as CPMP/ICH/138/95
MHLW: Adopted January 98, PMSB/ELD Notification No.6
FDA: Published in the Federal Register, Vol. 61, July 10, 1996, page 36466
Q5D : Cell Substrates
Implementation (Step 5):
EU: Adopted by CPMP, September 98, issued as CPMP/ICH/294/95
MHLW: Adopted July 14, 2000, PMSB/ELD, Notification No. 873
FDA: Published in the Federal Register, Vol. 63, No. 182, September 21, 1998, pages 50244-49
Guidelines CEDER
- Q5A : Viral Safety Evaluation
- Q5B : Genetic Stability
- Q5C : Stability of Products
- Q5D : Cell Substrates
Guidelines EUDRALEX
Qualité
- 3AQ1A : Development Pharmaceutics and Process Validation
- 3AQ2A : Manufacture of the Finished Dosage Form
- 3AQ3A : Limitations to the use of Ethylene Oxide in the Manufacture of Medicinal Products
- 3AQ4A : The use of Ionizing Radiation in the Manufacture of Medicinal Products.
- 3AQ5A : Chemistry of Active Substances
- 3AQ6A : Requirements in Relation to Active Substances
- 3AQ7A : European Drug Master File Procedure for Active Substances
- 3AQ8A : Impurities in new Active Substances
- 3AQ9A Excipients in the Dossier for Application for Marketing Authorization of a Medicinal
Product.
- 3AQ10A Plastic Primary Packaging Materials.
- 3AQ11A Specifications and Control Tests on the Finished Product.
- 3AQ12A Impurities in New Medicinal Products
- 3AQ13A Validation of Analytical Procedures: Methodology
- 3AQ14A Validation of Analytical Procedures: Definition and Terminology.
- 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
- 3AQ19A Quality of Prolonged Release Oral Solid Dosage Forms.
- 3AQ20A Radiopharmaceuticals.
- 3AQ21A Radiopharmaceuticals Based on Monoclonal Antibodies.
- 3AQ22A Quality of Herbal Remedies
Biotechnologie
- 3AB1A Production and Quality Control of Medicinal Products Derived by Recombinant dna
Technology.
- 3AB2A Quality of Biotechnological Products: Analysis of the Expression Construct in Cells
Used for Production of R-dna Derived Protein Products.
- 3AB3A Production and Quality Control of Cytokine Products Derived by Biotechnological
Process.
- 3AB4A Production and Quality Control of Monoclonal Antibodies
- 3AB5A Quality of Biotechnological Products: Stability Testing of Biotechnological/Biological
Products
- 3AB6A Gene Therapy Product Quality Aspects in the Production of Vectors and Genetically
Modified Somatic Cells.
- 3AB7A Use of Transgenic Animals in the Manufacture of Biological Medicinal Products for
Human use.
- 3AB8A Virus Validation Studies: The Design, Contribution and Interpretation of Studies
validating the Inactivation and Removal of Viruses
- 3AB9A Validation of Virus Removal/Inactivation Procedures: Choice of Viruses.
- 3AB10A Minimizing the Risk of Transmitting Agents Causing Spongiform Encephalopathy via
Medicinal Products.
- 3AB11A Tests on Samples of Biological Origin.
- 3AB12A Plasma Derived Medicinal Products
- 3AB13A Plasma Pool Testing.
- 3AB14A Harmonization of Requirements for Influenza Vaccines.
- 3AB15A Allergen Products.
- 3AB16A Assessing the Efficacy and Safety of Human Plasma derived Factor VIII:C and Factor
IX:C Products in Clinical Trials in Haemophiliacs before and after Authorisation
- 3AB17A Assessing the Efficacy and Safety of Normal Intravenous and Immunoglobulin
Products for Marketing Authorisations
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