Session V: Regulatory & quality assurance aspects
Update on prequalification of ARVs and regional harmonisation of medicine registration
Deusdedit K. Mubangizi
Group Lead, Inspections, WHO-PQT E-mail: mubangizid@who.int
Acknowledgements:
• Matthias Stahl
• Milan Smid
• Antony Fake
...• Jacqueline Sawyer
• Iveta Streipa
D-Building – UNAIDS
Kofi A. Annan Meeting Room
Wednesday, 9 March 2016 11:15 – 11:30
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The Global Programme on Tuberculosis & Lung Health of the World Health Organization (WHO/GTB) is now combining all current recommendations into one overall set of consolidated guidelines on TB. The guidelines contain recommendations pertaining to all areas related to the programmatic management of T...B (e.g. screening, preventive treatment, diagnostics, patient support, and the treatment of drug-susceptible TB and DR-TB). The consolidated guidelines contain modules specific to each programmatic area.
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Chinese Medicine, (2016) 11:37
Medicinal plants are globally valuable sources of herbal products, and they are disappearing at a high speed. This article reviews global trends, developments and prospects for the strategies and methodologies concerning the conservation and sustainable use of me...dicinal plant resources to provide a reliable reference for the conservation and sustainable use of medicinal plants. We emphasized that both conservation strategies (e.g. in situ and ex situ conservation and cultivation practices) and resource management (e.g. good agricultural practices and sustainable use solutions) should be adequately taken into account for the sustainable use of medicinal plant resources. We recommend that biotechnical approaches (e.g. tissue culture, micropropagation, synthetic seed technology, and molecular marker-based approaches) should be applied to improve yield and modify the potency of medicinal plants.
https://doi.org/10.1186/s13020-016-0108-7
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This document puts forward the joint position and vision of an expert, global, multistakeholder working group on implementing Kangaroo Mother Care (KMC) for all preterm or low birth weight (LBW) infants as the foundation for small and/or sick newborn care within maternal, newborn, and child health p...rogrammes, and spur collaborative global action. The document summarizes the background information, evidence, and rationale for making KMC available to every preterm or LBW newborn and seeks to galvanize the international maternal, newborn, and child health community and families to come together to support the implementation of KMC for all preterm or LBW infants to improve their and their mothers and families health and well-being.
This position paper is intended to be used by policy-makers (i.e. those responsible for national policy, guideline development and budget allocation), development partners, programme managers, health workforce leadership, practising clinicians, civil society leadership (e.g. parent and professional organizations) and researchers/research organizations involved in KMC implementation research.
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Frequently asked questions (FAQs)
This document highlights COVID-19 specific considerations in relation to camp and camp-like settings, and is intended to assist in guiding operations where camp/site management5 is being implemented. Although the guidance - structured around questions from the fiel...d - is intended for camp/site managers, UNHCR senior managers/ heads of ooffices, field coordinators and other staff (e.g. programme, protection) should be aware of the guidance and the operational implications in order to provide appropriate support, including to partners implementing camp/site management programmes.
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This book is a practical manual of mental health care for community health workers, primary care nurses, social workers and primary care doctors, particularly in developing countries.Helpful features include: over 50 illustrations and case studies, jargon-free explanations and descriptions, flow-cha...rts on common clinical problems, and a practical guide to the use of psychiatric medicines and simple psychological treatments.
Chapters 1, 9 and 10 can be found on the e-TALC CD-ROM number 2 (April 2003). See www.talcuk.org for details Links to Chapters 2 and 3 above. Printed copies of this book can also be obtained from the Royal College of Psychiatrists www.rcpsych.ac.uk/wnitp
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This country cooperation strategy (CCS) outlines how the World Health Organization (WHO) will work with the Lao People’s Democratic Republic over the next five years (2024–2028), supporting the implementation of the five-year health sector development plans and the Health Sector Reform Strategy ...2021–2030 to attain the Sustainable Development Goals (SDGs) by 2030.
The Lao People’s Democratic Republic experienced substantial economic growth in the 30 years prior to the coronavirus disease (COVID-19) pandemic, contributing to reduced poverty and significant progress toward the SDGs. However, the COVID-19 pandemic brought this development to a halt. It was anticipated that the COVID-19 recovery and the tremendous population growth in recent years would provide opportunities for a shift toward more sustainable and inclusive development in the years ahead. In 2023, however, the contrary was the case. Rural residents, including many ethnic minorities, continued to face marginalization because of limited access to education, health care and economic opportunities.
Despite the challenges of COVID-19 and other disease outbreaks, the country has made significant improvements in health. Nonetheless, progress has been uneven and not everyone has benefited from these achievements. In the mountainous region, many people lack access to quality health care because of the unequal distribution of well-trained health-care workers. Preventable deaths due to poor-quality health care for children and newborns, infants and mothers remain a concern, as do communicable diseases such as sexually transmitted infections and tuberculosis. The increasing burden of noncommunicable diseases and the health impact of worsening climate change further heighten the need for strengthened and resilient health systems, which are at risk due to an underfunded health sector and weak economy.
This CCS aims to address remaining and future challenges as well as health needs while creating an impact that is sustainable. It identifies three strategic priorities and nine deliverables (Table 1) to support the attainment of the national vision of Health for all by all, as articulated in the 9th Health Sector Development Plan 2021–2025. It contributes to the country’s goals to achieve universal health coverage, graduate from least developed country status by 2026 and attain SDGs by 2030.
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The primary role of Benin’s Department of Pharmacy and Medicines (DPMED) is to develop and apply the national pharmaceutical policy. The main objective of this policy is to ensure the availability and accessibility of quality medicines for the population. To fulfill its mandate, DPMED aims to stre...ngthen its regulatory capacity, including the issuance of licenses to pharmaceutical establishments and the registration of pharmaceutical products. Benin’s current registration system shares core concerns that are common to most developing countries, notably the capacity to evaluate and monitor the security, efficacy, and quality of medicines and other health products. It is currently characterized by 1) poor or inadequate traceability of records or regulations (example: a product’s marketing authorization [MA] is often hard to find); 2) lack of evidence used in the regulatory decision-making process (reasons behind special import authorization, i.e., products without valid MAs); 3) inconsistent and unsecured archiving system; 4) limited human resources; and 5) an inefficient information management system
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Maternal, Infant and Young Child Nutrition Strategic Actions:
1 Endorse and disseminate key policies and regulations
2 Improve maternal nutrition
3 Protect, promote, and support optimal infant and young child feeding practices
4 Support optimal infant and young child feeding in ...difficult circumstances
5 Ensure intra-sectoral integration (Health and Nutrition)
6 Improve intersectoral integration (food security and livelihood, WASH, protection, education and shelter)
7 Support capacity building and service strengthening
8 Initiate advocacy and social behavioural change communication
9 Sustain research, information, monitoring and evaluation
10 Mobilise resources and support
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sur la base des orientations actuelles de l’OMS, 31 may 2021. Aide mémoire
This aide-mémoire presents information on use and procurement of masks for community outreach interventions, with a focus on those for malaria, neglected tropical diseases, tuberculosis, HIV/AIDS and vaccine-preventable ...diseases. It details requirements for the different types of professionals involved (e.g. health workers, social mobilizers, data collectors, logisticians, insecticide spraying personnel, etc.), based on their level of risk of potential exposure to SARS-CoV-2.
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Biodiversity and healthy natural ecosystems, including protected areas in and around cities, provide ecosystem benefits and services that support human health, including reducing flood risk, filtering air pollutants, and providing a reliable supply of clean drinking water. These services help to red...uce the incidence of infectious diseases and respiratory disorders, and assist with adaptation to climate change. Access to nature offers many other direct health benefits, including opportunities for physical activity, reduction of developmental disorders and improved mental health.
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El Programa Nacional de Chagas ha definido la utilización de dos medicamentos para el tratamiento de la Enfermedad de Chagas Crónico Reciente Infantil (en niños de 9 meses a menor de 15 años); el benznidazol (BNZ) que será utilizado como medicamento de primera elección en todos los casos con d...iagnóstico serológico positivo confirmado y el nifurtimox (NFT) que será utilizado como segunda alternativa en aquellos casos que hubieran presentado reacciones adversas graves al benznidazol, e indiquen un cambio de conducta.
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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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Forests, trees and green spaces, hereinafter ‘forests and trees’ for short, provide multiple goods and services that contribute to human health. These include medicines, nutritious foods and other non-wood forest products (NWFPs). Globally, at least 3.5 billion people use NWFPs, including medici...nal plants, which are particularly important for vulnerable groups and Indigenous Peoples and local communities (IPLCs).
During periods of crises, such as the COVID-19 pandemic, demand for forest products typically increases amongst these groups. Forests and trees also contribute to better health by playing a role in climate change
mitigation and adaptation, contributing to regulating the carbon cycle, but also moderating the micro-climate, filtering pollutants from the air and protecting settlements against the effects of extreme events such as droughts and flash floods.
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Six months after its launch on 24 April, the Access to COVID-19 Tools (ACT) Accelerator has already delivered concrete results in speeding up the development of new therapeutics, diagnostics, and vaccines. Now mid-way through the scale-up phase, the tools we need to fundamentally change the course o...f this pandemic are within reach. But to deliver the full impact of the ACT-Accelerator – and ultimately an exit to this global crisis – these tools need to be available everywhere. On behalf of the ACT-Accelerator Pillar lead agencies – CEPI, Gavi, the Global Fund, FIND, Unitaid, Wellcome Trust, the World Bank, and the World Health Organization, as well as the Bill & Melinda Gates Foundation – I am pleased to share this document setting out the near-term priorities, deliverables and financing requirements of the ACT-Accelerator Pillars and Health Systems Connector. Urgent action to address these financing requirements will boost the impact of the ACTAccelerator achievements to date, fast-track the development and deployment of additional game-changing tools, and mitigate the risk of a widening gap in access to COVID-19 tools between low- and high-income countries. Delivering on this promise requires strong political leadership, financial investment, and incountry capacity building. COVID-19 cannot be beaten by any one country acting alone. We must ACT now, and ACT together to end the COVID-19 crisis.
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The importance of robust mortality surveillance systems cannot be overstated in an era marked by increasing global health challenges where health threats loom large and population dynamics continue to evolve. Accurate and timely mortality data is essential for identifying trends and detecting emergi...ng health threats, evaluating the impact of interventions, and guiding evidence-based policy decisions.
This framework outlines a holistic approach to strengthening routine mortality surveillance systems, considering the unique contextual factors and challenges faced by African countries. It emphasizes the importance of establishing efficient data collection mechanisms, enhancing data quality and completeness, and promoting data sharing and collaboration among stakeholders.
Moreover, the framework recognizes the pivotal role of technology in the integration of data from fragmented mortality data sources. It highlights the potential of innovative data capture methods, advanced analytics, and real-time reporting systems to enhance mortality data’s accuracy, efficiency, and timeliness.
The continental framework for mortality surveillance aligns with Africa CDC’s mission and strategic goal by serving as a fundamental component in strengthening public health systems, enhancing disease surveillance capacities and capabilities, informing evidence-based policies and interventions, and promoting collaboration and coordination among African countries to address health challenges and improve health outcomes on the continent.
The successful implementation of this framework requires collective commitment and concerted efforts from governments, health institutions, and the international community. We hope this document will serve as a catalyst for transformative change, enabling countries to build resilient mortality surveillance systems that protect public health, save lives, and contribute to evidence-based decision-making.
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This policy brief has been developed in response to the contemporary challenge of antibiotic resistance (ABR). ABR poses a formidable threat to global health and sustainable development. It is now increasingly recognized that the systematic neglect of cultural factors is one of the biggest obs...tacles to achieving better health outcomes and better standards of living worldwide. Using a cultural contexts of health approach, the policy brief explores the centrality of culture to the challenge of ABR. The brief examines how the prescription and use of antibacterial medicines, the transmission of resistance, and the regulation and funding of research are influenced by cultural, social and commercial, as well as biological and technological factors. The brief moves beyond the ready equation of culture with individual behaviours and demonstrates how culture serve as an enabler of health and provide new possibilities for change.
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The 2019-2023 Strategy for UNU-IIGH, developed in
2018, built on UNU-IIGH’s strategic advantage and
position vis-à-vis the UN and global health ecosystem.
The Strategy set a goal to advance evidencebased policy on key issues related to sustainable
development and health and shifted the Instit...ute’s
body of work from investigator-driven global health
projects to three priority-driven, policy-relevant pillars
of work, each reflecting UNU-IIGH’s unique value
position.
When the COVID-19 pandemic hit in 2020, the
Institute adapted and reprioritised its areas of work
while continuing to deliver on the main strategic
objectives of translating evidence to policy, generating
policy-relevant analyses on gender and health, and
strengthening capacity for local decision making
especially in the Global South.
The new strategic plan encompasses four work packages:
1. Gender Equality and Intersectionality: through this work, we will aim to improve the quality of health care through a human-centred approach, by ensuring the health system is responsive to the needs of structurally excluded individuals and communities; and by advancing a positive and enabling environment for the frontline health workforce—e.g. addressing the experience of gender-based violence.
2. Power and Accountability: through this work, we will catalyse equitable shifts in power and address key accountability deficits that prevent the equitable and effective functioning of the global health system and prevent adequate responsiveness to the needs of states and populations in the Global South.
3. Digital Health Governance: through this work, we will address the colonial legacies and power asymmetries that negatively impact robust digital health governance, identify ways to strengthen health data governance with a particular focus on SRHR and promote diversity in technology design and development.
4. Climate Justice and Determinants of Health: through this work we will leverage UNU-IIGH's position within the UN and network of UNU institutes, network experts, practitioners, policy-makers, and academics to advance evidence-based policy on the different dimensions of the climate emergency and its impact on health.
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Safe disposal of children’s feces is as essential as the safe disposal of adults’ feces. Th is brief provides an overview of the available data on child feces disposal in Burkina Faso and concludes with ideas to strengthen safe disposal practices, based on emerging good practice. Th e Joint Mon...itoring Programme for Water Supply and Sanitation (JMP) tracks progress toward the Millennium Development Goal 7 target to halve, by 2015, the proportion of people without sustainable access to safe drinking water and basic sanitation. Th e JMP standardized defi nition for an improved sanitation facility is one that hygienically separates human excreta from human contact.
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This toolkit was developed by the Centers for Disease Control and Prevention (CDC) Division for Heart Disease and Stroke Prevention (DHDSP) to provide healthcare organizations, including those in resource-constrained settings, with the information and resources to implement the HMP and improve hyper...tension control among their patients. CDC DHDSP developed an online toolkit that consists of interactive e-learning modules that are designed to guide learners through the key features of the ten HMP components and prepare them for implementation at their health system. The online e-learning modules are accompanied by a PDF toolkit document that can be used as an additional resource for users.
The purposes of this toolkit and the associated online e-learning modules are to provide healthcare organizations:
An overview of the HMP, its ten core components, and suggestions for implementing the HMP in clinical settings.
Guidance to staff, administrators, and other healthcare professionals on how to implement and adapt the HMP for their unique clinical setting.
The online e-learning modules you can find here:
https://www.cdc.gov/dhdsp/pubs/toolkits/hmp-toolkit/index.htm
accessed 29.07.2021
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