This document provides a generic model that can be used for risk assessment of exposure to insecticide products applied as indoor residual sprays. It aims to harmonize the risk assessment of such insecticides for public health use in order to generate comparable data for their registering and labell...ing by national regulatory authorities. The assessment considers both adults and children (all age groups) as well as people in the following specific categories:
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides.
more
The main objectives of these guidelines are to:
1. contribute to the quality assurance of medicinal plant materials used as the source for herbal medicines to improve the quality, safety and efficacy of finished herbal products;
2. guide the formulation of national and/or regional GACP guideli...nes and GACP monographs for medicinal plants and related standard operating procedures; and
3. encourage and support the sustainable cultivation and collection of medicinal plants of good quality in ways that respect and support the conservation of medicinal plants and the environment in general.
These guidelines concern the cultivation and collection of medicinal plants and include certain post-harvest operations.
more
WHO recently conducted a survey to assess the availability and cost of a national tracer list of essential medicines in the outpatient sector in Ukraine using a new collection tool – the WHO Essential Medicines and Health Products Price and Availability Monitoring Mobile Application. This tool fac...ilitates rapid and inexpensive data collection at the facility level.
more
Self-care interventions are evidence-based, quality drugs, devices, diagnostics and/or digital products which can be provided fully or partially outside of formal health services and can be used with or without the direct supervision of health care personnel.
Where HPV tests are available as part o...f the national programme, HPV self-sampling offers an additional option to improve cervical cancer screening coverage.
Self-sampling can help reach a global target of 70% coverage of screening by 2030. Women may feel more comfortable taking their own samples, rather than going to see a health worker for cervical cancer screening.
more
This WHO information note provides an updated list of recommended criteria for selecting RDTs for malaria, and highlights the performance of RDTs evaluated by the WHO malaria RDT product testing programme. It also provides an overview of additional considerations in the procurement of rapid tests.
For thousands of years, humans have been using wildlife for commercial and subsistence purposes. Wildlife trade takes place at local, national and international levels, with different forms of wildlife, such as live animals, partly processed products and finished products. Wildlife is a vital source... of safe and nutritious food, clothing, medicine, and other products, in addition to having religious and cultural value. Wildlife trade also contributes to livelihoods, income generation and overall economic development.
However, wildlife trade can have detrimental effects on species conservation, depleting natural resources, impoverishing biodiversity and degrading ecosystems (Morton et al., 2021). Wildlife trade, whether legal or illegal, regulated or unregulated, can pose threats to animal health and welfare. It also presents opportunities for zoonotic pathogens to spill over between wildlife and domestic animals, and for diseases to emerge with serious consequences for public or animal health and profound economic impacts (IPBES, 2020; Swift et al., 2007; Smith et al., 2009; Gortazar et al., 2014; Stephen, 2021; Stephen et al., 2022; FAO, 2020). The risk of pathogen spillover and disease emergence is amplified with increased interaction between humans, wildlife and domestic animals. The risk of pathogen spillover has also been exacerbated by climate change, intensified agriculture and livestock production, deforestation, and other land-use changes. Wildlife trade is also a risk to ecosystem biodiversity via the introduction of invasive species (Wikramanayake et al., 2021). Therefore, increased effort must be put into understanding the potential consequences of the wildlife trade, mapping and analysing the adjacent risks, and implementing strategies to manage those risks. Reducing wildlife-trade risks not only helps to limit disease but also minimises the negative effects of invasive species. Between 1960 and 2021, invasive alien species caused estimated cumulative damage of around 116 billion euros across 39 countries in the European Union alone, despite strict import regulations (Haubrock et al., 2021). The effect of invasive species is extremely apparent.
more
This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
more
Long-lasting insecticidal nets (LNs) constitute a core vector control intervention against malaria. A number of new LN products are under development and will require assessment of risks to humans. This document provides an updated generic model that can be used for the risk assessment of exposure t...o insecticides of individuals sleeping under LNs and during the washing of nets.
In an Annex, exposures and health risks are described for the conventional treatment or retreatment of nets (ITNs) with an insecticide considering that such practices may still be used in evaluation of ITNs and their use. The generic model does not include the risks associated with the manufacturing of LNs in a factory environment.
more
Following review of evidence and advice from the Technical Advisory Group (TAG) on Tuberculosis (TB) Diagnostics and Laboratory Strengthening, the World Health Organization (WHO) announces that current WHO recommendations for the use of interferon-gamma release assays (IGRA) are also valid for Beij...ing Wantai’s TB-IGRA and Qiagen QuantiFERON-TB Gold Plus products. This expands the range of tests available to detect TB infection. Full details are provided in this WHO policy statement.
more
This document provides up-to-date guidance on laboratory studies as well as smallscale (semi-field) and large-scale field trials to assess the efficacy and determine field application rates of new molluscicide products for control of schistosomiasis.
This publication is a companion document to the NDVP National Deployment and Vaccination Plans guidance, which provides a framework for countries to develop their national strategies. As countries face challenges with erratic vaccine supplies, use of multiple vaccine products with different charact...eristics, and the size of populations and their diversity, this document provides operational guidance and information to support planners and immunization programme managers at the national and sub-national levels on microplanning for COVID-19 vaccination implementation.
This Guide is available in English, French, Arabic, chinese, Portuguese, Spanish, Russian
more
Many vaccines and drugs hold the promise of reducing mortality and morbidity among pregnant women and infants living in low- and middle-income countries (LMICs). However, sufficient information on the safety of drugs and vaccines in pregnant women is rarely available at the time of product licensure... or approval. To account for this, active safety surveillance efforts are needed during the post-licensure and post-approval
phase to assess the safety of drugs and vaccines in pregnant women and their offspring. Pregnancy exposure registries (PER) are used to monitor the safety of vaccines and drugs. PERs are observational studies that systematically collect health information on exposure to medical products such as drugs and vaccines during pregnancy. This review demonstrates that a number of resources presently exist in LMICs that perform active safety surveillance in pregnant populations. These results indicate such systems employ a wide variety of approaches, each with their own set of strengths and challenges, as summarized in the final section of the report.
more
There is an urgent need for safer, simpler, more efficacious and accessible treatment regimens for all forms of TB. The development of Target Product Profiles for TB treatment regimens (referred to as Target Regimen Profiles or TRPs) seeks to guide the drug development process towards important regi...men characteristics corresponding to the needs of end-users.
more
28 May 2021
Contact tracing is a key component of a public health response to infectious disease outbreaks. The purpose of this guidance is to reinforce the place of community engagement and participation in the contact tracing process. The guidance and related products articulate best practice pri...nciples for community engagement and how they can be operationalized as part of any community-centred contact tracing strategy. The material provided can stand on its own or be used to complement other documents that support strategies, implementation plans or training and capacity building modules.
more
This interagency report provides recommendations for assuring quality of medicines during key activities of country-level procurement agencies, namely prequalification of pharmaceutical products and manufacturers; purchase of pharmaceutical products; storage of pharmaceutical products; and distribut...ion of pharmaceutical products.
more
Diabetes is a serious, chronic disease that occurs either when the pancreas does not produce enough insulin (a hormone that regulates blood sugar, or glucose), or when the body cannot effectively use the insulin it produces. Diabetes is an important public health problem, one of four priority noncom...municable diseases (NCDs) targeted for action by world leaders. Both the number of cases and the prevalence of diabetes have been steadily increasing over the past few decades.
more
The pre-clinical pipeline shows more innovation and diversity, with 252 agents being developed to treat WHO priority pathogens.
However, these products are in the very early stages of development and still need to be proven effective and safe. The optimistic scenario, the report indicates, is for... the first two to five products to become available in about 10 years.
more
The purpose of the guideline is to provide information to stakeholders on the necessary requirements for a complete prequalification dossier for insecticide-treated nets (ITNs). Its aim is to establish the baseline for dossier requirements which are necessary to assess ITN products for the purposes ...of prequalification, describe the data requirements for fulfilling each dossier module, and to provide standardized information for applicants and testing facilities generating data for ITN prequalification dossiers. The document is supported by implementation guidance documents which provide specific information and considerations for how applicants may approach the generation of supporting information and compilation of a complete product dossier.
more
Buruli ulcer is caused by Mycobacterium and belongs to the family of bacteria that causes tuberculosis and leprosy. Although the causative organism of Buruli ulcer is an environmental bacterium, the mode of transmission to humans remains unknown. The organism produces a unique toxin – mycolactone ...– that causes the damage to the skin. Early diagnosis and treatment are crucial to minimizing morbidity, costs and prevent long-term disability.
more