This publication describes the first WHO public-benefit Target Product Profiles (TPPs) for snakebite antivenoms. It focuses on antivenoms for treatment of snakebite envenoming in sub-Saharan Africa. Four TPPs are described in the document:
Broad spectrum Pan-African polyvalent antivenoms: products ...that are intended for widespread utility throughout sub-Saharan Africa for treatment of envenoming irrespective of the species of snake causing a bite. Monovalent antivenoms for specific use cases: for products for a single species (or genus) of snake (e.g., boomslangs or carpet viper antivenoms).
Syndromic Pan-African polyvalent antivenoms for neurotoxic envenoming: products that are intended for treatment of envenoming by species whose venoms are neurotoxic. Syndromic Pan-African polyvalent antivenoms for non-neurotoxic envenoming: products for snakebite envenoming where the effects are largely haemorrhagic, necrotic or procoagulant.
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Last revised 2015.
Original Word document on: http://www.epnetwork.org/Resources/Standard%20Operating%20Procedure/Gantt%20Chart_Form.doc
In September, 2018, the first international Medicine Quality and Public Health Conference was held at Oxford University, UK, to discuss opportunities and solutions to ensure that all people have access to affordable and quality-assured medical products. Delegates developed the short Oxford Statement..., calling for investment, policy change, and action to eliminate substandard and falsified medical products. The statement was born out of discussion between governments, national and international agencies, non-governmental organisations, professional associations, and academic institutions who together examined the latest evidence on the epidemiology and public health implications of substandard and falsified medical products.
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This 3rd edition of Guidelines for medicine donations has been developed by the World Health Organization (WHO) in cooperation with major international agencies active in humanitarian relief and development assistance. The guidelines are intended to improve the quality of medicine donations in inter...national development assistance and emergency aid. Good medicine donation practice is of interest to both donors and recipients...
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WHO today published the new edition of its Model Lists of Essential Medicines and Essential Medicines for Children, which include new treatments for various cancers, insulin analogues and new oral medicines for diabetes, new medicines to assist people who want to stop smoking, and new antimicrobials... to treat serious bacterial and fungal infections.
The listings aim to address global health priorities, identifying the medicines that provide the greatest benefits, and which should be available and affordable for all. However, high prices for both new, patented medicines and older medicines, like insulin, continue to keep some essential medicines out of reach for many patients.
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Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The development of this target product profile (TPP) was led by the WHO Department of Control of Neglected Tropical Diseases (NTD) following standard WHO guidance for TPP development. In order to identify and prioritize diagnostic needs, a WHO NTD Diagnostics Technical Advisory Group (DTAG) was form...ed, and different subgroups were created to advise on specific NTDs, including a subgroup working on the human African trypanosomiasis (HAT) diagnostic innovation needs. This group of independent experts included leading scientists, public health officials and endemic-country end-user representatives. Standard WHO Declaration of Interest procedures were followed. A landscape analysis of the available products and of the development pipeline was conducted, and the salient areas with unmet needs were identified.
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Soil-transmitted helminths are a group of intestinal worms that include Ascaris lumbricoides (giant roundworm), Trichuris trichiura (whipworm), and Ancylostoma spp. (A. duodenale, A. ceylanicum) and Necator americanus (hookworms). Despite the clear biological differences among the different species,... their transmission is characterized by the same sequence of events: (i) infected individuals excrete worm eggs through their stool in soil; (ii) under optimal conditions of moisture and temperature the excreted eggs develop into infectious stages; and (iii) finally, infection occurs through oral uptake (Ascaris, Ancylostoma and Trichuris) or skin penetration (Ancylostoma and Necator) of these infectious stages (embryonated eggs and third stage larvae) that reside in the soil and/or in the environment (referring to their common name).
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Development of one or more vaccines for Neisseria gonorrhoeae is an important objective for sexual and reproductive health worldwide, and for the fight against antimicrobial resistance.
WHO preferred product characteristics (PPCs) provide strategic guidance as to WHO’s preferences for new vacci...nes in priority disease areas. PPCs are intended to encourage innovation and development of vaccines for use in settings most relevant to the global unmet public health need.
Gonococcal vaccine PPCs describe global public health goals for gonococcal vaccines and preferred parameters pertaining to vaccine indications and target populations, safety and efficacy considerations, and immunization strategies.
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