It is estimated that around 2 billion people worldwide do not have access to essential medicines. Access to medicines in the Eastern Mediterranean Region varies among countries, depending on their income level and allocation of domestic resources to medicine and vaccine procurement. Access to safe a...nd effective antibiotics remains a major challenge, especially for low- and middleincome countries. Barriers to access include high prices for new products, weak regulatory systems, substandard and falsified antibiotics, shortages of essential antimicrobials and inefficient procurement and supply management systems.
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These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situation. Level 1 indicators measure the existence and ...performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
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Member States have requested WHO policy guidance on how to facilitate the implementation of national AMS activities in an integrated and programmatic approach. This policy guidance responds to that demand from Member States and is anchored in public health guiding principles in the human health sect...or. It aims to provide a set of evidence-based and pragmatic recommendations to drive comprehensive and integrated AMS activities under the purview of a central national coordination unit, National AMR steering or coordinating committees or other equivalent national authorities.
Available in English, French, Spanish, Russian, Arabic, Chinese
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interim guidance, 14 June 2021
This document is intended for national authorities and decision makers in countries that have introduced large scale public health and social measures. It offers guidance for adjusting public health and social measures, while managing the risk of a resurgence of cases....
Available in English, Arabic, Chinese, French, Russian and Spanish
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The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
Guidelines for the registration of microbial, botanical and semiochemical pest control agents for plant protection and public health uses.
These guidelines are intended to guide pesticide regulatory authorities in the registration of microbial, botanical, and semiochemical pest control agents for p...lant protection and public health uses.
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A survey was conducted in countries in all six WHO regions and focused on the building blocks that are considered prerequisites to combat antimicrobial resistance: a comprehensive national plan, laboratory capacity to undertake surveillance for resistant microorganisms, access to safe, effective ant...imicrobial medicines, control of the misuse of these medicines, awareness and understanding among the general public and effective infection prevention and control programmes.
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This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used i...n the context of COVID-19. This includes WHO Priority Medical Devices, specifically: surgical masks, non-surgical masks, gloves, googles, face shields, gowns and N95 masks. It is intended for procurement agencies, occupational health departments, infection prevention and control departments or focal points, health facility administrators, biomedical and materials engineering, PPE manufacturers and public health authorities at both national and facility levels.
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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.
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Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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The Operational guide: use of referral laboratories for the analysis of foodborne hazards in the Pacific aims to strengthen the food analysis capacity of Pacific Island countries and areas by identifying national and reference laboratories capable of testing for priority foodborne hazards. The Pacif...ic Island countries and areas are often vulnerable to food safety incidents and emergencies due to their geographical distribution and dependence on food imports. The guide outlines key considerations for selecting referral laboratories and submitting samples to them, enabling continuous improvement of food safety systems and providing safe food for all. The target audiences are health and food safety authorities.
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Despite the considerable improvement in global health, millions of people still lack access to quality health services, including access to effective antimicrobial medicines, or are impoverished as a result of health spending. At the same time, antimicrobial resistance – a consequence of overuse a...nd misuse of antimicrobials – is increasingly a barrier to accessing effective care. The declining effectiveness of antibiotics is driven by multiple factors, many of which can be addressed through well functioning primary health care. However, primary health care has not always had much attention in national health sector responses to
antimicrobial resistance, which often focus on tertiary care, laboratory detection and surveillance. The three pillars of primary health care (community engagement, front-line health services including primary care and essential public health, and multisectoral action on wider health determinants) are central not just to Universal Health Coverage and the Sustainable Development Goals, but also to an effective response to antimicrobial resistance.
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Cryptococcal disease is one of the most common opportunistic infections among people living with advanced HIV disease and is a major contributor to severe illness, morbidity, and mortality, particularly in sub-Saharan Africa.
These guidelines update the recommendations that were first released i...n 2018 on diagnosing, preventing, and managing cryptococcal disease. In response to important new evidence that became available in 2021, these new guidelines strongly recommend a single high dose of liposomal amphotericin B as part of the preferred induction regimen for the treatment of cryptococcal meningitis in people living with HIV. This simplified regimen - a single high dose of liposomal amphotericin B paired with other standard medicines (flucytosine and fluconazole) - is as effective as the previous WHO standard of care, with the benefits of lower toxicity and fewer monitoring demands.
The objective of these guidelines is to provide updated, evidence-informed recommendations for treating adults, adolescents and children living with HIV who have cryptococcal disease. These guidelines are aimed at HIV programme managers, policymakers, national treatment advisory boards, implementing partners and health-care professionals providing care for people living with HIV in resource-limited settings with a high burden of cryptococcal disease.
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Contact tracing for COVID-19 is the process of identifying, assessing, and managing people who have been exposed to someone who has been infected with the SARS-CoV-2 virus, while quarantine is the separation of contacts from other people after exposure to a probable or confirmed case of SARS-CoV-2 i...nfection. In the context of growing global population immunity from COVID-19 vaccination and past SARS-CoV-2 infection, WHO recommends that identification, contact, quarantine and follow-up should be prioritized for individuals at high risk who have been in contact with a confirmed or probable case of SARS-CoV-2 infection, rather than targeting all contacts. This updated guidance also introduces shorter recommended quarantine periods, including the ability to further shorten quarantine through the use of testing. National and local health authorities should use risk-based approaches to contact tracing and quarantine that include reviewing and adjusting to their local circumstances and disease epidemiology, population immunity, their health system’s capacities, and risk tolerance.
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Policy brief, 24 July 2020
The COVID-19 pandemic has affected older people disproportionately, especially those living in long-term care facilities. In many countries, evidence shows that more than 40% of COVID-19 related deaths have been linked to long-term care facilities, with figures being as h...igh as 80% in some high-income countries. Concerted action is needed to mitigate the impact across all aspects of long-term care, including home- and community-based care, given that most users and providers of care are those who are vulnerable to severe COVID-19.
This policy brief provides 11 policy objectives and key action points to prevent and manage COVID-19 across long-term care. Its intended audience is policy makers and authorities (national, subnational and local) involved in the COVID-19 pandemic. The brief builds on currently available evidence on the measures taken to prevent, prepare for and respond to the COVID‑19 pandemic across long-term care services including care providers
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Africa’s health sector is facing an unprecedented financing crisis, driven by a sharp decline of 70% in Official Development Assistance (ODA) from 2021 to 2025 and deep-rooted structural vulnerabilities. This collapse is placing immense pressure on Africa’s already fragile health systems as ODA ...is seen as the backbone of critical health programs: pandemic preparedness, maternal and child health services, disease control programs are all at
risk, threatening Sustainable Development Goal 3 and Universal Health Coverage. Compounding this is Africa’s spiraling debt, with countries expected to service USD 81 billion by 2025—surpassing anticipated external financing inflows—further eroding fiscal space for health investments. Level of domestic resources is low. TThe Abuja Declaration of 2001, a pivotal commitment made by African Union (AU) member states, aimed to reverse this trend by pledging to allocate at least 15% of national budgets to the health sector. However, more than two decades later, only three countries—Rwanda, Botswana, and Cabo Verde—have
consistently met or exceeded this target (WHO, 2023). In contrast, over 30 AU member states remain well below the 10% benchmark, with some allocating as little as 5–7% of their national budgets to health.
In addition, only 16 (29%) of African countries currently have updated versions of National Health Development Plan (NHDP) supported by a National Health Financing Plan (NHFP). These two documents play a critical role in driving internal resource mobilisation. At the same time, public health emergencies are surging, rising 41%—from 152 in 2022 to
213 in 2024—exposing severe under-resourcing of health infrastructure and workforce. Recurring outbreaks (Mpox, Ebola, cholera, measles, Marburg…) alongside effects of climate change and humanitarian crises in Eastern DRC, the Sahel, and Sudan, are overwhelming systems stretched by chronic underfunding. The situation is worsened by Africa’s heavy dependency with over 90% of vaccines, medicines, and diagnostics being externally sourced—leaving countries vulnerable to global supply chain shocks. Health worker shortages persist, with only 2.3 professionals
per 1,000 people (below the WHO’s recommended 4.45), and fewer than 30% of systems are digitized, undermining disease surveillance and early warning. Without decisive action, Africa CDC projects the continent could reverse two decades of health progress, face 2 to 4 million additional preventable deaths annually, and a heightened risk of a pandemic emerging from within. Furthermore, 39 million more
Africans could be pushed into poverty by 2030 due to intertwined health and economic shocks. This is not just a sectoral crisis—it is an existential threat to Africa’s political, social, and economic resilience, and global stability. In response, African leaders, under Africa CDC’s stewardship, are advancing a comprehensive three-pillar strategy centered on domestic resource mobilization, innovative financing, and blended finance.
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