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.
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The scope of this PPC document is to serve as a guide to address the unmet public health need for a PPE system that protects the HW-F in tropical climate
s while caring for patients and providing heavy duty essential health services.
The characteristics described in this guidance are targeted fo...r PPE used in
health clinics, hospitals and communities in low resource settings where there is lack of advanced environmental controls and equipment. The purpose is to ensure harmonization in PPE design and its use to avoid confusion and exacerbating the risk of infections in HW-F. The principles of this PPC document can also be considered in risk reduction strategies
in other healthcare settings.
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Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. The PPC published here describes the characteristics of new types of insecticide-treated nets (ITNs) to control malaria transmission in areas with insecticide-resist...ant mosquito populations. The document was developed to address the public health need caused by the evolution and spread of insecticide resistance, particularly to pyrethroids. Such resistance threatens the effectiveness of the current standard of malaria vector control in many countries, namely pyrethroid-only long-lasting insecticidal nets (LLINs).
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“Preferred product characteristics” (PPCs) are key tools to incentivize and guide the development of urgently needed health products. Some of the vector control interventions deployed in complex emergencies and in response to natural disasters – namely insecticide-treated nets (ITNs) and indoo...r residual spraying (IRS) – have already met identified public health needs in more stable settings; other tools such as insecticide-treated tarpaulins have been specifically designed for this use case. Given the diverse mix of existing and potential new interventions and the considerable gaps in the associated evidence base, this PPC aims to clearly articulate the unmet public health needs for tools designed to control malaria transmission in complex emergencies and in response to natural disasters.
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The purpose of this TPP is to communicate the minimum and ideal characteristics desired to meet the need for discriminating low levels of risk for transmission, i.e. targeted prevalence thresholds in the surveyed areas. An in vitro diagnostic test is needed for the detection of analyte(s) specific t...o Wuchereria bancrofti, Brugia malayi, and Brugia timori to aid in the surveillance of defined geographic areas as to whether infection and/or transmission potential has increased (recrudescence) or decreased (elimination of transmission).
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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 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
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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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On 15–16 December 2020, WHO and the Medicines for Malaria Venture co-convened a technical consultation to consider the preferred product characteristics (PPCs) for drugs used in malaria chemoprevention. The main goal of the technical consultation was to agree on the most important PPCs for drugs t...o protect populations from malaria (chemoprevention), while considering relevant measures of efficacy and the safety data needed to support WHO policy recommendations.
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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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The development of this target product profile (TPP) was led by the WHO Department of Control of Ne-
glected 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... formed, 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 in-
dependent experts included leading scientists, public health officials and endemic-country end-user rep-
resentatives. 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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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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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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Introduction
In 2017, development assistance for health (DAH) comprised 5.3% of total health spending in lowincome countries. Despite the key role DAH plays in global health-spending, little is known about the characteristics of assistance that may be associated with committed assistance that is a...ctually disbursed. In this analysis, we examine associations between these characteristics and disbursement of committed assistance.
Methods
We extracted data from the Creditor Reporting System of the Organization for Economic Co-operation and Development, Institute for Health Metrics and Evaluation, and the WHO National Health Accounts database. Factors examined were off-budget assistance, administrative assistance, publicly sourced assistance and assistance to health systems strengthening. Recipient-country characteristics examined were perceived level of corruption, civil fragility and gross domestic product per capita (GDPpc). We used linear regression methods for panel of data to assess the proportion of committed aid that was disbursed for a given country-year, for each data source.
Results
Factors that were associated with a higher disbursement rates include off-budget aid (p<0.001), lower administrative expenses (p<0.01), lower perceived corruption in recipient country (p<0.001), lower fragility in recipient country (p<0.05) and higher GDPpc (p<0.05).
Conclusion
Substantial gaps remain between commitments and disbursements. Characteristics of assistance (administrative, publicly sourced) and indicators of government transparency and fragility are also important drivers associated with disbursement of DAH. There remains a continued need for better aid flow reporting standards and clarity around aid types for better measurement of DAH.
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Food inspection is crucial for ensuring food safety, using risk-based approaches to target high-risk products and businesses. This guidance aids national authorities in designing and implementing risk-based systems, offering step-by-step instructions, examples, and tools for prioritization and inspe...ction frequency estimation. It emphasizes adapting to individual country needs and recognizing variations in food risks and production chain characteristics. The document underscores resource-efficient, risk-based food inspection systems, prioritizing high-risk products and businesses to prevent safety incidents proactively. It suggests designing models based on relevant information and periodically adjusting them for continuous improvement.
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