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World Health Organization Technical Report Series

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https://www.readbyqxmd.com/read/27514184/who-expert-committee-on-specifications-for-pharmaceutical-preparations-fiftieth-report
#1
(no author information available yet)
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Good pharmacopoeial practices; FIP-WHO technical guidelines: points to consider in the provision by health-care professionals of children-specific preparations that are not available as authorized products; Guidance on good manufacturing practices for biological products; Guidance on good manufacturing practices: inspection report, including Appendix 1: Model inspection report; Guidance on good data and record management practices; Good trade and distribution practices for starting materials; Guidelines on the conduct of surveys of the quality of medicines; Collaborative procedure between the World Health Organization (WHO) prequalification team and national regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products and vaccines; Guidance for organizations performing in vivo bioequivalence studies; and World Health Organization (WHO) general guidance on variations to multisource pharmaceutical products...
2016: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/27514183/evaluation-of-certain-food-additives-and-contaminants-eightieth-report-of-the-joint-fao-who-expert-committee-on-food-additives
#2
(no author information available yet)
This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives and contaminants and to prepare specifications for identity and purity. The first part of the report contains a brief description of general considerations addressed at the meeting, including updates on matters of interest to the work of the Committee. A summary follows of the Committee's evaluations of technical, toxicological and/or dietary exposure data for seven food additives (benzoates; lipase from Fusarium heterosporum expressed in Ogataea polymorpha; magnesium stearate; maltotetraohydrolase from Pseudomonas stutzeri expressed in Bacillus licheniformis; mixed β-glucanase, cellulase and xylanase from Rasamsonia emersonii; mixed β-glucanase and xylanase from Disporotrichum dimorphosporum; polyvinyl alcohol (PVA)- polyethylene glycol (PEG) graft copolymer) and two groups of contaminants (non-dioxin-like polychlorinated biphenyls and pyrrolizidine alkaloids)...
2016: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/27509597/evaluation-of-certain-veterinary-drug-residues-in-food-eighty-first-report-of-the-joint-fao-who-expert-committee-on-food-additives
#3
(no author information available yet)
This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues in food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including MRLs for generic fish species, acute reference doses (ARfDs) for veterinary drugs, an approach for dietary exposure assessment of compounds used for multiple purposes (i...
2016: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/27183787/the-selection-and-use-of-essential-medicines
#4
(no author information available yet)
This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. It contains a summary of the Committee's considerations and justifications for additions and changes to the Model Lists, including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (19th edition) and the WHO Model List of Essential Medicines for Children (5th edition). In addition there is a list of all the items on the Model Lists sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/26714369/who-expert-committee-on-biological-standardization-sixty-fifth-report
#5
(no author information available yet)
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 Recommendations, Guidelines and guidance documents...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/26353746/who-study-group-on-tobacco-product-regulation-report-on-the-scientific-basis-of-tobacco-product-regulations-fifth-report-of-a-who-study-group
#6
(no author information available yet)
This report presents the conclusions reached and recommendations made by the members of the WHO Study Group on Tobacco Product Regulation (TobReg) at its seventh meeting, in December 2013, during which it reviewed background papers specially commissioned for the meeting, which dealt, respectively, with the following four themes: Novel tobacco products, including potential reduced exposure products Smokeless tobacco products: research needs and regulatory recommendations Reduced ignition propensity cigarettes: research needs and regulatory recommendations Non-exhaustive priority list of toxic contents and emissions of tobacco products...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/26118220/evaluation-of-certain-food-additives
#7
(no author information available yet)
This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, including flavouring agents, and to prepare specifications for identity and purity. The first part of the report contains a general discussion of the principles governing the toxicological evaluation of and assessment of dietary exposure to food additives, including flavouring agents. A summary follows of the Committee's evaluations of technical, toxicological and dietary exposure data for eight food additives (Benzoe tonkinensis; carrageenan; citric and fatty acid esters of glycerol; gardenia yellow; lutein esters from Tagetes erecta; octenyl succinic acid-modified gum arabic; octenyl succinic acid-modified starch; paprika extract; and pectin) and eight groups of flavouring agents (aliphatic and alicyclic hydrocarbons; aliphatic and aromatic ethers; ionones and structurally related substances; miscellaneous nitrogen-containing substances; monocyclic and bicyclic secondary alcohols, ketones and related esters; phenol and phenol derivatives; phenyl-substituted aliphatic alcohols and related aldehydes and esters; and sulfur-containing heterocyclic compounds)...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/26118121/who-expert-committee-on-specifications-for-pharmaceutical-preparations-forty-ninth-report
#8
(no author information available yet)
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use. Revised procedure for the development of monographs and other texts for The International Pharmacopoeia; Revised updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia; Revision of the supplementary guidelines on good manufacturing practices: validation, Appendix 7: non-sterile process validation; General guidance for inspectors on hold-time studies; 16 technical supplements to Model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products; Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients; Multisource (generic) pharmaceutical products: guidelines on registration requirements to establish interchangeability: revision; Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products: revision; and Good review practices: guidelines for national and regional regulatory authorities...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/26062388/who-expert-committee-on-drug-dependence-thirty-sixth-report
#9
(no author information available yet)
This report presents the recommendations of the thirty-sixth WHO Expert Committee on Drug Dependence (ECDD). The ECDD is responsible for the assessment of therapeutic usefulness, the liability to abuse and dependence and the public health and social harm of each substance under review. After receiving the advice from the Expert Committee to schedule or to amend the scheduling status of a substance, the Director-General of WHO will as appropriate, communicate the recommendations to the United Nations. The report summarizes the review of 26 substances and the Committee's recommendations for scheduling under the international drug control conventions...
2015: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/25591324/evaluation-of-certain-veterinary-drug-residues-in-food-seventy-eighth-report-of-the-joint-fao-who-expert-committee-on-food-additives
#10
(no author information available yet)
This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of residues of certain veterinary drugs in food and to recommend maximum levels for such residues of food. The first part of the report considers general principles regarding the evaluation of residues of veterinary drugs within the terms of reference of the Joint FAO/WHO Expert Committee on Food Additives (JECFA), including extrapolation of maximum residue limits (MRLs) to minor species, MRLs for veterinary drug residues in honey, MRLs relating to fish and fish species, dietary exposure assessment methodologies, the decision-tree approach to the evaluation of residues of veterinary drugs and guidance for JECFA experts...
2014: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/25167682/who-expert-committee-on-biological-standardization
#11
(no author information available yet)
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 of revised WHO Guidelines...
2014: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/25080778/the-selection-and-use-of-essential-medicines
#12
(no author information available yet)
This report presents the recommendations of the WHO Expert Committee responsible for updating the WHO Model Lists of Essential Medicines. It contains a summary of the Committee's considerations and justifications for additions and changes to the Model Lists, including its recommendations. Annexes to the main report include the revised version of the WHO Model List of Essential Medicines (18th edition) and the WHO Model List of Essential Medicines for Children (4th edition). In addition there is a list of all the items on the Model Lists sorted according to their Anatomical Therapeutic Chemical (ATC) classification codes...
2014: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24964711/who-expert-committee-on-specifications-for-pharmaceutical-preparations
#13
(no author information available yet)
The Expert Committee on Specifications for Pharmaceutical Preparations works towards clear, independent and practical standards and guidelines for the quality assurance of medicines. Standards are developed by the Committee through worldwide consultation and an international consensus-building process. The following new guidelines were adopted and recommended for use, in addition to 20 monographs and general texts for inclusion in The International Pharmacopoeia and 11 new International Chemical Reference Substances...
2014: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24669583/who-expert-committee-on-biological-standardization-sixty-third-report
#14
(no author information available yet)
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 biologicals, 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 of revised WHO Recommendations and Guidelines for a number of vaccines, blood products and related substances...
2014: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24779311/evaluation-of-certain-food-additives-and-contaminants
#15
(no author information available yet)
This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives and a food contaminant with a view to concluding as to safety concerns and to preparing specifications for identity and purity. The first part of the report contains a general discussion of the principles governing the toxicological evaluation of and assessment of dietary exposure to food additives. A summary follows of the Committee's evaluations of technical, toxicological and dietary exposure data for seven food additives (advantame; glucoamylase from Trichoderma reesei expressed in Trichoderma reesei; glycerol ester of gum rosin; glycerol ester of tall oil rosin; glycerol ester of wood rosin; nisin; and octenyl succinic acid modified gum arabic) and an assessment of dietary exposure to cadmium from cocoa and cocoa products...
2013: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24552089/control-and-surveillance-of-human-african-trypanosomiasis
#16
(no author information available yet)
In the 1960s, it appeared that human African trypanosomiasis (HAT) could be effectively controlled, but by the beginning of the twenty-first century several decades of neglect had led to alarming numbers of reported new cases, with an estimated 300 000 people infected. The World Health Organization (WHO) responded with a series of initiatives aimed at bringing HAT under control again. Since 2001, the pharmaceutical companies that produce drugs for HAT have committed themselves to providing them free of charge to WHO for distribution for the treatment of patients...
2013: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24340794/who-expert-committee-on-biological-standardization
#17
(no author information available yet)
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 biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices...
2013: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24340690/who-expert-committee-on-biological-standardization
#18
(no author information available yet)
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 biologicals and the establishment of international biological reference materials. The report starts with a discussion of general issues brought to the attention of the Committee and provides information on the status and development of reference materials for various antibodies, antigens, blood products and related substances, cytokines, growth factors, endocrinological substances and in vitro diagnostic devices...
2013: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24340361/who-expert-committee-on-biological-standardization
#19
(no author information available yet)
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 biologicals 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, sets out revised WHO Guidelines on the quality, safety and efficacy of candidate dengue tetravalent vaccines (live, attenuated), along with revised WHO Recommendations in relation to the production and quality control of bacille Calmette-Guérin (BCG) vaccines and of acellular pertussis vaccines...
2013: World Health Organization Technical Report Series
https://www.readbyqxmd.com/read/24069724/who-expert-consultation-on-rabies-second-report
#20
(no author information available yet)
Although there is debate about the estimated health burden of rabies, the estimates of direct mortality and the DALYs due to rabies are among the highest of the neglected tropical diseases. Poor surveillance, underreporting in many developing countries, frequent misdiagnosis of rabies, and an absence of coordination among all the sectors involved are likely to lead to underestimation of the scale of the disease It is clear, however, that rabies disproportionately affects poor rural communities, and particularly children...
2013: World Health Organization Technical Report Series
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