Since the last meeting of the WHO Expert Committee on Problems Related to Alcohol Consumption WHO has undertaken a range of major initiatives to support Member States and reinforce the evidence on which policies work to develop global and regional information systems and to promote effective policies in health-care settings. These initiatives provide the background for the continuing role of WHO in supporting Member States to reduce the harm done by alcohol. In resolution WHA58.26 the Fifty-eighth World Health Assembly in 2005 requested the Director-General to report to the Sixtieth World Health Assembly on evidence-based strategies and interventions to reduce alcohol-related harm including a comprehensive assessment of public-health problems caused by harmful use of alcohol and to draw up recommendations for effective policies and interventions to reduce alcohol-related harm . To this end a WHO Expert Committee on Problems Related to Alcohol Consumption was convened with the main objectives of reviewing a range of public health problems attributable to alcohol consumption as well as scientific and empirical evidence of effectiveness of different policy options and providing technical recommendations on effective policies and interventions to reduce alcohol-related harm.
Since the last meeting of the WHO Expert Committee on Problems Related to Alcohol Consumption WHO has undertaken a range of major initiatives to support Member States and reinforce the evidence on which policies work to develop global and regional information systems and to promote effective policies in health-care settings. These initiatives provide the background for the continuing role of WHO in supporting Member States to reduce the harm done by alcohol. In resolution WHA58.26 the Fifty-eighth World Health Assembly in 2005 requested the Director-General to report to the Sixtieth World Health Assembly on evidence-based strategies and interventions to reduce alcohol-related harm including a comprehensive assessment of public-health problems caused by harmful use of alcohol and to draw up recommendations for effective policies and interventions to reduce alcohol-related harm . To this end a WHO Expert Committee on Problems Related to Alcohol Consumption was convened with the main objectives of reviewing a range of public health problems attributable to alcohol consumption as well as scientific and empirical evidence of effectiveness of different policy options and providing technical recommendations on effective policies and interventions to reduce alcohol-related harm.
This report makes recommendations on new therapeutic regimens for visceral and cutaneous leishmaniasis, on the use of rapid diagnostic tests, details on the management of Leishmania-HIV coinfection and consideration of social factors and climate change as risk factors for increased spread. Recommendations for research include the furtherance of epidemiological knowledge of the disease and clinical studies to address the lack of an evidence-based therapeutic regimen for cutaneous and mucocutaneous leishmaniases and post-kala-azar dermal leishmaniasis (PKDL). This report not only provides clear guidance on implementation but should also raise awareness about the global burden of leishmaniasis and its neglect. It puts forward directions for formulation of national control programs and elaborates the strategic approaches in the fight against Leishmaniases. The committee's work reflects the latest scientific and other relevant developments in the field of leishmaniasis that can be considered by member states when setting national programs and making public health decisions.
The WHO Expert Committee on Drug Dependence (ECDD) is responsible for assessing psychoactive substances for possible control under the international drug control conventions. The ECDD reviews the therapeutic usefulness, the liability for abuse and dependence, and the public health and social harm potential of each substance under review. After the ECDD advises the Director-General of WHO as to whether to schedule or to amend the scheduling status of a substance, the Director-General will, as appropriate, communicate the recommendations to the United Nations Secretary-General. The Secretary-General communicates the advice to the Commission on Narcotic Drugs (CND), as appropriate. This report presents the recommendations of the thirty-seventh meeting of the WHO Expert Committee on Drug Dependence. The report summarizes the review of nine substances and the ECDD's recommendations for the scheduling of seven substances. The report also provides updates on ketamine and cannabis, as requested by resolutions of the Commission on Narcotic Drugs. It contains updates on the work of international bodies concerned with controlled substances, as well as summaries of the follow-up discussions on recommendations made at the previous ECDD meeting, and on the discussions on criteria for assessing new psychoactive substances and on terminology.
The World Health Organization (WHO) Expert Committee on Specifications for Pharmaceutical Preparations advises the Director-General of WHO in the area of medicines quality assurance. It provides independent expert recommendations and guidance to ensure that medicines meet standards of quality safety and efficacy in all WHO Member States. Its advice is developed through a broad consensus-building process and covers all areas of quality assurance of medicines from their development to their distribution to patients. In the area of quality control the Expert Committee reviewed new and revised specifications and general texts for inclusion in The International Pharmacopoeia and received the annual report of the European Directorate for the Quality of Medicines & HealthCare (EDQM) the custodian centre for International Chemical Reference Substances (ICRS). The Committee adopted a number of monographs general texts and ICRS. It noted the report on Phase 5 of the External Quality Assurance Assessment Scheme (EQAAS) and on new approaches to ensure sustainability of this scheme through user fees. The Committee further received a concept paper on the benefits of good pharmacopoeial practices (GPhP) and was informed of progress achieved with developing a comprehensive document on GPhP through discussions at consecutive international meetings of world pharmacopoeias. In the various quality assurance-related areas the Expert Committee was presented with a number of new and revised guidelines related to good manufacturing practices (GMP) distribution and trade of pharmaceuticals and regulatory practice. It adopted eight guidelines and 16 technical supplements as listed below including a new guidance text on good review practice prepared under the leadership of the Asian-Pacific Economic Cooperation Regulatory Harmonization Steering Committee. The Committee took note of ongoing work to promote collaboration and information exchange through the good regulatory practice project and welcomed the development of a comprehensive set of guidelines for all national regulatory authorities through this project. The report includes the following annexes which are recommended as new WHO guidelines: . Annex 1. Procedure of the development of monographs for inclusion in The International Pharmacopoeia (revision); . Annex 2. Updating mechanism for the section on radiopharmaceuticals in The International Pharmacopoeia (revision); . Annex 3. Supplementary guidelines on good manufacturing practices: validation; Appendix 7: non-sterile process validation (revision); . Annex 4. General guidance for inspectors on hold-time studies (new); . Annex 6. Recommendations for quality requirements when plant-derived artemisinin is used as a starting material in the production of antimalarial active pharmaceutical ingredients (revision); . Annex 7. Guidelines on registration requirements to establish interchangeability (revision); . Annex 8. Guidance on the selection of comparator pharmaceutical products for equivalence assessment of interchangeable multisource (generic) products (revision); . Annex 9: Good review practices guidelines for regulatory authorities (new). In addition 16 technical supplements to the WHO model guidance for the storage and transport of time- and temperature-sensitive pharmaceutical products were adopted for publication in a format which is appropriate to the large volume of this guidance (Annex 5). The newly adopted monographs were adopted for inclusion in The International Pharmacopoeia. Following the implementation of the revised general monograph on parenteral preparations the Committee adopted the proposed endotoxin limits for 11 parenteral dosage form monographs lacking such specification together with related updates to relevant monographs. The Committee adopted 12 ICRS newly characterized by the custodian centre EDQM. The Committee further adopted the workplan for new monographs to be included in The International Pharmacopoeia.
Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).
Report of the WHO Expert Committee, 2013 (including the 18th WHO Model List of Essential Medicines and the 4th WHO Model List of Essential Medicines for Children).
The 19th Meeting of the WHO Expert Committee on the Selection and Use of Essential Medicine took place in Geneva, Switzerland, from 8 to 12 April 2013"--P. vii.
This volume contains monographs prepared at the fifty-sixth meeting of the Joint FAO/WHO Expert Committee on Food Additives (JECFA). Five mycotoxins or groups of mycotoxins that contaminate food commodities were evaluated at the meeting: aflatoxin M1, fumonisins B1, B2, and B3, ochratoxin A, deoxynivalenol, and T -2 and HT -2 toxins. The monographs in this volume summarize the data that were reviewed on these contaminants, including information on metabolism and toxicity, epidemiology, analytical methods for their measurement in food commodities, sampling protocols, effects of processing, levels and patterns of contamination of food commodities, food consumption, and prevention and control. Based upon this information the Committee assessed the risks associated with intake of these mycotoxins.
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 B-glucanase cellulase and xylanase from Rasamsonia emersonii; mixed B-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). Specifications for the following food additives were revised or withdrawn: advantame; annatto extracts (solvent-extracted bixin and solvent-extracted norbixin); food additives containing aluminium and/or silicon (aluminium silicate; calcium aluminium silicate; calcium silicate; silicon dioxide amorphous; sodium aluminium silicate); and glycerol ester of gum rosin. Annexed to the report are tables or text summarizing the toxicological and dietary exposure information and information on specifications as well as the Committee’s recommendations on the food additives and contaminants considered at this meeting.
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