This guideline provides advice in regards to applications for Marketing Authorisations for antimicrobial veterinary medicinal products (VMPs) on the data required and the methodology to be used for performing an assessment of the risk to public health from antimicrobial resistance (AMR) due to use o...f the product. The scope of the guidance extends to VMPs intended for food producing species and to the transmission of AMR by the foodborne route or through direct contact with treated animals.
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Geneva, 22 May 2023 – Gavi, the Vaccine Alliance today published a roadmap* outlining critical actions needed to ensure supply of oral cholera vaccine (OCV) is able to meet growing demand from countries. Released against a backdrop of a recent wave of cholera outbreaks around the world, the roadma...p forecasts the short-, mid- and long-term outlook for global cholera vaccine supply. Developed in consultation with a range of key Alliance partners, including WHO, UNICEF, the Global Taskforce for Cholera Control (GTFCC), and the Bill and Melinda Gates Foundation (BMGF), it describes how these organizations, manufacturers and countries can work together towards ensuring global OCV supply can support largescale preventive vaccination by 2026.
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Building laboratory testing capacity
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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Welcome to the online course on the basics of tobacco product regulation. Although tobacco use is a major public health problem, tobacco products are one of the few openly available consumer products that are virtually unregulated in many countries for contents, emissions and design features. In rec...ent years, health authorities have become increasingly interested in the potential of tobacco product regulation to reduce the morbidity and mortality associated with tobacco use. However, barriers to implementing appropriate regulation include limited understanding of common approaches or best practices, and a lack of adequate resources and/or technical capacity. Duration app. 3 hours
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Lateral-flow rapid diagnostic tests (RDTs) continue to play a vital role in global health in the management and diagnosis of infectious diseases, including malaria, HIV and COVID-19. Visually interpreted RDTs, more than any other class of diagnostics, fulfil WHO’s ASSURED criteria,1 enabling their... use at the lowest levels of health care and in self-testing.2 Their utility is, however, compromised every time a test is incorrectly performed or interpreted or its result is not available in a timely manner for clinical decisionmaking and surveillance.
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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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Localized cutaneous leishmaniasis and its evolving forms (diffuse cutaneous leishmaniasis, mucosal leishmaniasis and cutaneous leishmaniasis recidivans), together with the sequela of visceral leishmaniasis (post-kala-azar dermal leishmaniasis), account for about one million cases of dermal leishmani...ases per year worldwide. Although not lethal, the dermal leishmaniases cause chronic, disfiguring skin lesions which are an important cause of morbidity and stigma.
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In 2007, the Sixtieth World Health Assembly adopted resolution WHA60.13 on control of leishmaniasis, urging Member States, among other actions:
to strengthen prevention, active detection and treatment of cases of both cutaneous and visceral leishmaniasis in order to decrease the disease burde...n; and
to strengthen the capacity of peripheral health centres to deliver primary and secondary care, so that they provide appropriate affordable diagnosis and treatment and act as sentinel surveillance sites.
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Health ministries currently lack effective tools for monitoring and evaluation of schistosomiasis control programmes. Egg detection can be used, but the cost, challenges of obtaining samples, and the need for trained personnel and equipment limit the frequency of monitoring. The purpose of this TPP ...is to guide the development of new diagnostic tools to reliably measure when prevalence is above or below a cut-off of 10% in school-aged children. Communities remaining above 10% require annual MDA, while communities below 10% can reduce MDA frequency as long as < 10% prevalence can be maintained. However, the lack of a reliable test has hindered the development of maintenance strategies. The test is also needed to track changes of prevalence > 10% to ensure that annual MDA is reducing overall prevalence.
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This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
In 2007, the Sixtieth World Health Assembly adopted resolution WHA60.13 on control of leishmaniasis, urging Member States, among other actions: to strengthen prevention, active detection and treatment of cases of both cutaneous and visceral leishmaniasis in order to decrease the disease burden; and ...to strengthen the capacity of peripheral health centres to deliver primary and secondary care, so that they provide appropriate affordable diagnosis and treatment and act as sentinel surveillance sites.
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