World Health Organization Technical Report Series

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...

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...

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...

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...

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...

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...

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: Release procedure for International Chemical Reference Substances; WHO guidelines on quality risk management; WHO guidelines on variations to a prequalified product; and the Collaborative procedure between the World Health Organization Prequalification of Medicines Programme and national medicines regulatory authorities in the assessment and accelerated national registration of WHO-prequalified pharmaceutical products...

This report reviews the connections between environmental change, modern agricultural practices and the occurrence of infectious diseases - especially those of poverty; proposes a multi-criteria decision analysis approach to determining the key research priorities; and explores the benefits and limitations of a more systems-based approach to conceptualizing and investigating the problem. The report is the output of the Thematic Reference Group on Environment, Agriculture and Infectious Diseases of Poverty (TRG 4), part of an independent think tank of international experts, established and funded by the Special Programme for Research and Training in Tropical Diseases (TDR) to identify key research priorities through review of research evidence and input from stakeholder consultations...

This report presents the recommendations of a WHO Expert Committee responsible for reviewing information on psychoactive substances to assess the need for their international control. The report contains a summary of the Committee's evaluations of gamma-hydroxybutyric acid (GHB) and ketamine. GHB was recommended to be rescheduled from Schedule IV to Schedule II of the Convention on Psychotropic Substances. The report also discusses the nine substances that were pre-reviewed: dextromethorphan, tapentadol, N-benzylpiperazine (BZP), 1-(3-trifluoromethylphenyl) piperazine (TFMPP), 1-(3-chlorophenyl)piperazine (mCPP), 1-(4-methoxyphenyl)piperazine (MeOPP), 1-(3,4-methylenedioxybenzyl)piperazine (MDBP), gamma-butyrolactone (GBL), and 1,4-butanediol (1,4-BD)...

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, including flavouring agents, 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, including flavouring agents. A summary follows of the Committee's evaluations of technical, toxicological and dietary exposure data for five food additives (magnesium dihydrogen diphosphate; mineral oil (medium and low viscosity) classes II and III; 3-phytase from Aspergillus niger expressed in Aspergillus niger; serine protease (chymotrypsin) from Nocardiopsis prasina expressed in Bacillus licheniformis; and serine protease (trypsin) from Fusarium oxysporum expressed in Fusarium venenatum) and 16 groups of flavouring agents (aliphatic and aromatic amines and amides; aliphatic and aromatic ethers; aliphatic hydrocarbons, alcohols, aldehydes, ketones, carboxylic acids and related esters, sulfides, disulfides and ethers containing furan substitution; aliphatic linear alpha,beta-unsaturated aldehydes, acids and related alcohols, acetals and esters; amino acids and related substances; epoxides; furfuryl alcohol and related substances; linear and branched-chain aliphatic, unsaturated, unconjugated alcohols, aldehydes, acids and related esters; miscellaneous nitrogen-containing substances; phenol and phenol derivatives; pyrazine derivatives; pyridine, pyrrole and quinoline derivatives; saturated aliphatic acyclic branched-chain primary alcohols, aldehydes and acids; simple aliphatic and aromatic sulfides and thiols; sulfur-containing heterocyclic compounds; and sulfur-substituted furan derivatives)...

This report provides a review and analysis of the research landscape for three diseases - Chagas disease, human African trypanosomiasis and leishmaniasis - that disproportionately afflict poor and remote populations with limited access to health services. It represents the work of the disease reference group on Chagas Disease, Human African Trypanosomiasis and Leishmaniasis (DRG3) which was established to identify key research priorities through review of research evidence and input from stakeholders' consultations...

This report provides a review and analysis of the research landscape for zoonoses and marginalized infections which affect poor populations, and a list of research priorities to support disease control. The work is the output of the Disease Reference Group on Zoonoses and Marginalized Infectious Diseases of Poverty (DRG6), which is part of an independent think tank of international experts, established and funded by the Special Programme for Research and Training in Tropical Diseases (TDR), to identify key research priorities through review of research evidence and input from stakeholder consultations...

Over a billion people in sub-Saharan Africa, Asia and the Americas are infected with one or more helminth species, causing morbidity that helps maintain the vicious cycle of poverty, decreased productivity, and inadequate socioeconomic development. This report presents an evaluation of current research and challenges in controlling the helminthiases of public health importance, including onchocerciasis, lymphatic filariasis, soil-transmitted helminthiases, schistosomiasis, food-borne trematodiases and taeniasis/cysticercosis...

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, with a view to recommending acceptable daily intakes (ADIs) and to preparing specifications for identity and purity. The Committee also evaluated the risk posed by two food contaminants, with the aim of deriving tolerable intakes where appropriate and advising on risk management options for the purpose of public health protection. 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 and contaminants...

This report represents the conclusions of a Joint FAO/WHO Expert Committee convened to evaluate the safety of various food additives, with a view to recommending acceptable daily intakes (ADIs) 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 and assessment of intake of food additives. A summary follows of the Committee's evaluations of technical, toxicological and intake data for certain food additives: branching glycosyltransferase from Rhodothermus obamensis expressed in Bacillus subtilis, cassia gum, cyclamic acid and its salts (dietary exposure assessment), cyclotetraglucose and cyclotetraglucose syrup, ferrous ammonium phosphate, glycerol ester of gum rosin, glycerol ester of tall oil rosin, lycopene from all sources, lycopene extract from tomato, mineral oil (low and medium viscosity) class II and class III, octenyl succinic acid modified gum arabic, sodium hydrogen sulfate and sucrose oligoesters type I and type II...

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 standards and guidelines were adopted and recommended for use: the current list of available International Chemical Reference Substances and International Infrared Reference Spectra; guidelines on stability testing of active pharmaceutical ingredients and finished pharmaceutical products; procedure for prequalification of pharmaceutical products; and the procedure for assessing the acceptability, in principle, of active pharmaceutical ingredients for use in pharmaceutical products...

OBJECTIVE: To review evaluations of interventions in developing countries targeting three groups most at risk of becoming infected with HIV: young sex workers, young injecting drug users and young men who have sex with men. METHODS: A systematic literature review was undertaken to identify programmes in developing countries targeting young people in the three selected groups most at risk from HIV. We also identified programmes directed at young people in developed countries as well as programmes in developing countries that targeted these three population groups but that did not differentiate between young people and adults...

OBJECTIVE: To identify successful HIV/AIDS prevention interventions targeting youths and delivered in geographically bounded communities (for example, rural villages, urban settlements or neighbourhoods) in developing countries. METHODS: A systematic review and synthesis of studies evaluating interventions that were published between January 1990 and December 2004 was conducted. Using predetermined criteria, all interventions were summarized into multiple tables to facilitate comparison...

OBJECTIVE: This chapter reviews the evidence base for interventions that aim to increase young people's use of health services in developing countries. METHODS: We identified published and unpublished studies and reports from developing countries that provided information about interventions designed to increase young people's use of health services. The studies were classified into six different types based on whether they included some or all of the following characteristics: training for service providers and clinic staff; making efforts to improve the quality of the facilities; implementing community activities to generate demand and support for the services; and involving other sectors, notably schools and the media...

OBJECTIVES: To design a method for assessing the strength of evidence on the effectiveness of different interventions to prevent the spread of HIV that will be the basis for the reviews in this series. METHODS: The literature on the evaluation of public health interventions was reviewed, and a method was developed in consultation with colleagues involved in this series of reviews and others. FINDINGS: The method involves the following steps...