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Clinical Pharmacology: Advances and Applications, 2025:17 29–47
Preferred product characteristics and clinical development considerations
Malaria vaccines: the 60‑year journey of hope and final success—lessons learned and future prospects
Tropical Medicine and Health (2023) 51:29
The aim of this protocol is to support the conduct of entomological comparative efficacy assessments for vector control products and the associated non-inferiority analysis. This evidence is used to inform discussions within the guidelines development context as to whether a new vector control prod
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uct should be considered as covered by one or more existing WHO recommendations or not. Alternatively, the evidence may inform the extension of an existing WHO recommendation or the development of a new one, provided that non-inferiority is demonstrated
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Vector control, alongside case management, remains the most effective approach to controlling and eliminating malaria. Key interventions, such as indoor residual spraying (IRS) and long-lasting insecticidal nets (LLINs), have significantly reduced malaria transmission in many African countries. This
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has enabled some countries to transition from the control phase to the elimination phase.
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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
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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.
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Malaria Journal (2021) 20:190
SuperBetter Children is a health and wellbeing curriculum designed to be integrated into school programmes or offered as an extracurricular activity.
This training module on malaria case management has been developed to support the staff involved in malaria control and elimination programmes in the effective organization of malaria diagnosis and case management services
Offering additional pre-exposure prophylaxis (PrEP) choices has the potential to increase uptake and effective use of PrEP, and of HIV prevention overall, as it allows people to choose a method that they prefer.
In this guideline, WHO recommends an offering long-acting injectable lenacapavir (LEN
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) as an additional HIV prevention choice, as part of combination HIV prevention approaches. LEN, administered twice a year as PrEP, has been shown to be highly effective at reducing the risk of HIV acquisition. In this guideline, WHO also recommends using HIV rapid diagnostic tests (RDTs) for individuals initiating or continuing long-acting injectable PrEP, such as LEN and long acting injectable cabotegravir (CAB-LA). Flexible HIV testing approaches are essential for ensuring that testing does not become a barrier to accessing or continuing PrEP, including long-acting injectable options.
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Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex B
This policy brief presents a summary of current evidence on vulnerability to TB and proposes interventions for equitable, person-centred, and human rights-based TB prevention and care. It aligns with WHO policies and guidance on TB prevention and screening, management of TB and comorbidities, access
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to health care, universal health coverage, determinants of TB, TB-associated impairment and disability, social protection, as well as ethics, equity and human rights.
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This operational guidance provides a structured approach to support countries in sustaining priority services for HIV, viral hepatitis and sexually transmitted infections in the context of reduced external funding. The guidance is intended for national governments, public health programmes, communit
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y-led organizations, civil society, technical partners and donors working to safeguard priority services, support phased adaptation, protect health outcomes and preserve hard-won gains.
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WHO guidelines for clinical management of arboviral diseases: dengue, chikungunya, Zika and yellow fever
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The new WHO guidelines provide clinical management recommendations for four of the most widespread arboviruses affecting humans: dengue, chikungunya, Zika, and yellow fever.
An integrated approach is vital, as these four diseases often present with similar symptoms, especially in the early stages
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of infection, and multiple arboviruses may circulate simultaneously in certain regions. This makes clinical differentiation challenging, particularly where diagnostic testing is not readily available.
This guideline is available in online format on the MAGICapp platform
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Access to safe, effective and quality-assured health products and technologies is crucial for achieving universal health coverage and primary health care goals. The continued growth of the aging population; increasing burden of noncommunicable diseases; growing burden of mental health issues; climat
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e change; shifting patterns of vector borne diseases, fungal disease and waterborne diseases; antimicrobial resistance; and new infectious hazards create an ongoing need for equitable access to safe, effective and quality-assured health products and technologies, and renewed investments in research and development for innovative health products and technologies.
The coronavirus pandemic exposed the inequalities in access to health products, highlighting the need for longer-term strategies to strengthen access to health products and technologies outside of and in emergency situations. While technological and scientific advances present an opportunity to increase access to health products and technologies, the risk of increasing inequality due to higher prices for new health products and technologies; the persisting problem of substandard and falsified medical products; a lack of skilled workforce in many low- and middle-income countries; and a lack of data for decisionmaking and for measuring progress present significant challenges.
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The World Health Organization recently redefined leprosy elimination as a phased process, with the first milestone being the
interruption of transmission, achieved when no new child cases (defined as younger than 15 years) are reported for five consecutive years.
In Pakistan, the well-functioning
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leprosy programme, with effective case management, context-specific active case-finding strategies and
a robust data management system, has contributed to a decrease in new cases. Between 2001 and 2023, new adult cases dropped by 75%
(from 878 cases to 220 cases annually) and child cases by 83% (from 93 to 16). To support the country’s goal of no new child cases by 2030
and ultimately eliminate the disease, the nongovernmental organizations Marie Adelaide Leprosy Centre and Aid to Leprosy Patients, with
support from the German Leprosy and Tuberculosis Relief Association, have developed a zero leprosy roadmap. As part of this roadmap,
the leprosy elimination strategy emphasizes improving active case-finding and providing post-exposure prophylaxis for contacts of leprosy
cases, who are at the highest risk
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This document on logistics management information systems (LMIS) was developed to address the increasing need for harmonization and standardization of core indicators for managing medicines and health products for neglected tropical diseases (NTDs) at country level (i.e. for last-mile logistics). It
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thereby responds to requests from Members States, pharmaceutical groups, financial donors and implementing partners for guidance from the World Health Organization (WHO) for a transparent, standardized reporting mechanism and key indicators for in-country logistics. More importantly, this document will also guide the last-mile logistics process and is relevant for the health workforce working at different levels of national health information systems. It can be adapted and used for any health products depending on the needs of the country or health programmes.
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Noncommunicable diseases (NCDs) (e.g., cardiovascular diseases, cancers, diabetes, and chronic respiratory diseases) and mental health conditions (e.g., Alzheimer’s disease and related dementias, depression, anxiety, autism spectrum disorders) are the world’s leading cause of preventable illness
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, disability, and death. This report examines the dangers posed by current and rising rates of noncommunicable diseases and mental health conditions (NMHs) in South America, beyond their health risks, by demonstrating their considerable negative impact on economic growth. An analytical model was developed that projects the macroeconomic effects of NMHs over the period 2020–2050 in ten South American countries: Argentina, Bolivia (Plurinational State of), Brazil, Chile, Colombia, Ecuador, Paraguay, Peru, Uruguay, and Venezuela. The results showed that the macroeconomic impact of NMHs in South America indicates significant economic shortfalls resulting from NMHs. Overall, the total GDP loss due to NMHs in South America amounts to USD 7.3 trillion (2022 international USD) over the period 2020–2050
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To contribute to the availability of basic knowledge and skills for the provision of palliative care in
the African region, the African Palliative Care Association (APCA) has developed a competencybased core curriculum framework for use in introductory training on palliative care. The curriculum
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is based on the APCA Standards for Providing Quality Palliative Care Across Africa to ensure that care providers are trained to the appropriate competence for their cadre and level of skill. This curriculum therefore aims to facilitate the development of the best basic skills and attitudes required for the delivery of palliative care services that meet the desired standards of palliative care. The curriculum incorporates theoretical, practical, mentorship and supervision components that are critical to the effective application of knowledge in practice.
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The African Palliative Care Association is pleased to publish the first edition of Palliative Care Standards for Africa. The development of these standards was achieved through wide consultation with service beneficiaries and providers, and they have been developed to suit different levels of
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service delivery, from primary to tertiary. These standards are underpinned by the World Health Organization’s definition of palliative care, and recognise that scaling up palliative care requires a public health approach with four pillars: policy, education, drug availability and implementation. In addition, the increasing need to establish specific indicators of quality and effectiveness for palliative care has been a big driving force behind these comprehensive standards. It is APCA’s wish that they will provide a framework for the development of evaluation
and performance indicators that can facilitate programme improvement and development. The standards are designed to allow the development or improvement of palliative care across the different services levels, within the organisational capacity of various service providers. They describe a relationship between primary, intermediary and tertiary level service providers, with expectations for all providers articulated through detailed criteria for each standard. It is therefore expected that these standards will influence the planning and delivery of palliative care services at all levels of health care service delivery.
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