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WHO Expert Committee on Biological Standardization: seventieth report 1024.1 [Pehme köide]

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This report presents the recommendations of a WHO Expert Committee commissioned to coordinate activities leading to the adoption of international recommendations for the production and control of vaccines and other biological substances and the establishment of international biological reference materials. Following a brief introduction the report summarizes a number of general issues brought to the attention of the Committee. The next part of the report of particular relevance to manufacturers and national regulatory authorities outlines the discussions held on the development and adoption of new and revised WHO Recommendation Guidelines and guidance documents. Following these discussions WHO Guidelines on the quality, safety, and efficacy of respiratory syncytial virus vaccines; and an Amendment document to the WHO Recommendations to assure the quality, safety, and efficacy of poliomyelitis vaccines (inactivated) were adopted on the recommendation of the Committee. Subsequent sections of the report provide information on the current status, proposed development, and establishment of international reference materials in the areas of: antibiotics; biotherapeutics other than blood products; blood products and related substances; cellular and gene therapies; in vitro diagnostics; and vaccines and related substances.
Abbreviations xiii
1 Introduction
1(2)
2 General
3(24)
2.1 Current directions
3(4)
2.1.1 Strategic directions in the regulation of medicines and other health technologies: WHO priorities
3(1)
2.1.2 Vaccines and biotherapeutics: recent and planned activities in biological standardization
4(2)
2.1.3 Blood products and in vitro diagnostics: recent and planned activities in biological standardization
6(1)
2.2 Reports
7(2)
2.2.1 Report from the WHO Blood Regulators Network
7(2)
2.3 Feedback from custodian laboratories
9(4)
2.3.1 Developments and scientific issues identified by custodians of WHO biological reference preparations
9(4)
2.4 Cross-cutting activities of other WHO committees and groups
13(14)
2.4.1 Update from the WHO Expert Committee on Specifications for Pharmaceutical Preparations
13(2)
2.4.3 Update on the WHO R&D Blueprint for action to prevent epidemics
15(1)
2.4.4 Update on the activities of the Coalition for Epidemic Preparedness Innovations
15(1)
2.4.5 Update on the WHO pilot procedure for the prequalification of biotherapeutic products and SBPs
16(2)
2.4.6 Update on the WHO Model List of Essential Medicines
18(1)
2.4.7 Update on WHO regulatory systems strengthening activities
19(1)
2.4.8 Update from the WHO Product Development for Vaccines Advisory Committee
20(2)
2.4.9 Report of the October meeting of the Strategic Advisory Group of Experts on Immunization
22(1)
2.4.10 Report of progress made in integrating blood products into the WHO Global Benchmarking Tool
23(1)
2.4.11 Update on the WHO snakebite envenoming strategy
24(1)
2.4.12 Development of reference materials for Plasmodium vivax antigen
25(2)
3 International Recommendations, Guidelines and other matters related to the manufacture, quality control and evaluation of biological substances
27(50)
3.1 General
27(1)
3.1.1 Assessment of commutability in international collaborative studies
27(1)
3.2 Biotherapeutics other than blood products
28(49)
3.2.1 Revision of the WHO Guidelines on evaluation of similar biotherapeutic products (SBPs)
28(1)
3.2.2 Update on the standardization of similar biotherapeutic products
29(45)
8.2.7 Proposed First WHO International Standard for Aspergillus fumigatus DNA for NAT-based assays
74(1)
8.2.8 Proposed First WHO International Standard for cell-associated HIV nucleic acid and First WHO International Reference Panel for cell-associated HIV nucleic acid
74(1)
8.2.9 Update on the stability of the First WHO International Reference Panel for Ebola virus VP40 antigen
75(2)
9 International reference materials - vaccines and related substances
77(10)
9.1 WHO International Standards and Reference Reagents - vaccines and related substances
77(4)
9.1.1 First WHO International Standard for EV71 inactivated vaccine, First WHO International Reference Reagent for EV71 genotype C4 inactivated vaccine and First WHO International Reference Reagent for EV71 genotype B4 inactivated vaccine
77(1)
9.1.2 Third WHO International Standard for tetanus toxoid for use in flocculation test
78(1)
9.1.3 Extension of use of the First WHO International Standard for antiserum to respiratory syncytial virus
79(1)
9.1.4 First WHO international standards for meningococcal serogroups Wand Y polysaccharide
80(1)
9.2 Proposed new projects and updates - vaccines and related substances
81(6)
9.2.1 Proposed First WHO International Reference Reagent for tetanus antitoxin for the flocculation test
81(1)
9.2.2 Proposed First WHO International Standard for anti-Rift Valley fever virus immunoglobulin
82(1)
9.2.3 Proposed First WHO International Reference Reagent for recombinant pertussis toxoid
83(1)
9.2.4 Proposed Second WHO international reference reagents for MAPREC analysis and NGS of poliovirus types 1, 2 and 3 (Sabin)
84(1)
9.2.5 Update on work towards the First WHO International Standard for antibody to the influenza virus haemagglutinin stem domain
85(2)
Annex 1 WHO Recommendations, Guidelines and other documents related to the manufacture, quality control and evaluation of biological substances used in medicine 87(6)
Annex 2 Guidelines on the quality, safety and efficacy of respiratory syncytial virus vaccines 93(108)
Annex 3 Recommendations to assure the quality, safety and efficacy of poliomyelitis vaccines (inactivated) 201(22)
Annex 4 Biological substances: WHO International Standards, Reference Reagents and Reference Panels 223