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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Results and Lessons Learned from CapacityPlus 2009-2015
La documentation et la diffusion de cette directive, des éléments de preuves et leçons émergentes seront essentielles pour mettre en œuvre les réponses les plus appropriées et efficaces face à cette pandémie.
Significant progress has been made in the eradication of three priority diseases in the African Region, as a result of extensive collaboration between the Regional Office, WHO country offices and countries. For example, in August 2020, the region was certified free of wild poliovirus. In the area of... neglected tropical diseases, Guinea worm disease is on the verge of eradication, and 12 member states are within reach of being certified as having eradicated yaws by the end of this year.
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The information provided here can be used to understand the current situation, increase attention to preterm births in Rwanda and to inform dialogue and action among stakeholders. Data can be used to identify the most important risk factors to target and gaps in care in order to identify and impleme...nt solutions for improved outcomes.
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The growing understanding of how sequence information can contribute to improved public health is driving global investments in sequencing facilities and programmes. The falling cost and complexity of generating GSD provides opportunities for expanding sequencing capacity; however, challenges to wid...espread implementation remain. This document provides policy-makers and stakeholders with guidance on how to maximize the public health benefit of SARS-CoV-2 genomic sequencing activities in the short and long term as the pandemic continues to unfold. Practical considerations for the implementation of a virus genomic sequencing programme and an overview of the public health objectives of genomic sequencing are covered. This guidance focuses on SARS-CoV-2 but is applicable to other pathogens of public health concern.
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Le plan stratégique du Centre des Opérations d'Urgence Sanitaire du Sénégal 2016-2018 s'inscrit dans la vision des authorités politiques, et en premier lieu dans le deuxième pilier du Plan Sénégal Émergent, visent à renforcer le capital humain, la protection sociale et le développement du...rable.
Les crises sanitaires étant susceptibles d'ébranler les efforts du Sénégal vers l'émergence, leur maîtrise est du la toute première importance.
Ce plan stratégique est par ailleurs aligné au Plan national de Dévloppement Sanitaire et contribue à fournir un cadre pécis d'action dans son rôle de renforcement du système de gestion des urgences et catastrophes sanitaires d'ampleur nationale.
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The document contains preliminary report on all aspects of WHO’s response in the Ebola outbreak. WHO Member States will discuss the report at the sixty-eighth World Health Assembly.
New data from the WHO reveal that an estimated 2.2 billion cases of malaria and 12.7 million deaths have been averted since 2000, but the disease remains a serious global health threat, particularly in the WHO African Region. According to WHO’s latest World malaria report, there were an estimated ...263 million cases and 597 000 malaria deaths worldwide in 2023. This represents about 11 million more cases in 2023 compared to 2022, and nearly the same number of deaths. Approximately 95% of the deaths occurred in the WHO African Region, where many at risk still lack access to the services they need to prevent, detect and treat the disease.
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To meet our Strategy objectives and get within reach
of the 2030 SDG 3 target related to the three diseases,
the Global Fund needs to raise US$18 billion for the
Eighth Replenishment. That sum is essential to drive the
required pace of progress in the fight against HIV, TB
and malaria, and to m...aintain the necessary investments
in health and community systems.
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The role of evidence in the journey towards universal health coverage is paramount. Financial risk protection monitoring, the major focus of this report, informs where the WHO African Region stands in reducing the financial hardship people face due to health expenses. This report details the status ...of financial risk protection and related trends, the drivers of out-of-pocket (OOP) payments and the impact of the COVID-19 pandemic on financial risk protection. As such, it provides evidence coutries can draw on to develop health financing systems and reforms that mitigate financial barriers to accessing health services. Through analysis of country data, cross-country learning and drawing on the published literature, this report proposes recommendations that countries may adapt to their contexts.
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Over the past decade, countries in the African region experienced slow progress in mobilizing resources for health while facing continued challenges. In their revised estimates published in 2017, Stenberg et al., developed two costs scenarios, termed progress and ambitious, aimed at strengthening co...mprehensive health service delivery to achieve SDG 3 and universal health coverage in low-income and middle-income countries (Stenberg et al., 2017). Out of the 47 countries in the WHO African region only eight, on average, met the recommended threshold of spending a minimum of US$ 249 per capita on health during the period from 2012 to 2020. In 2020, this achievement was observed in only five countries while the remaining countries spent less than US$ 249 per capita, with health expenditures ranging from US$ 16.4 to US$ 236.6, highlighting significant disparities across the region.
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Achieving financial risk protection for the whole population requires significant financing for health. Health systems in low- and middle-income countries (LMIC) are plagued with persistent underfunding, and recent reductions in official development assistance have been registered. To create fiscal
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space for health, the pursuit of efficiency gains and exploring innovative health financing for health seem attractive. This paper sought to synthesize available evidence on the nature of innovative health financing instruments, mechanisms and policies implemented in Africa. We further reviewed the factors that hinder or facilitate implementation, the lessons learnt on the structure, the development process and the implementation.
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This paper examines the implications of the IMF’s April 2024 macro-fiscal forecast updates on government health expenditure (GHE) across 170 economies through 2029, covering nearly all years remaining to achieve the Sustainable Development Goals (SDGs). The findings reveal wide disparities in gove...rnments' capacities to increase health spending, with differences not only observed across income groups but also within them. Primary concerns focus to two groups of low- and lower middleincome
countries: the first group is projected to experience a contraction in real per capita GHE from 2019 and 2029, threatening to reverse progress toward the health SDG targets, while the other group faces stagnation in real per capita GHE, greatly limiting advancement. The insights presented are crucial for health policymakers and their external partners to respond to evolving macro-fiscal circumstances and stabilize investment growth in health. While increasing the priority of health in spending is a key policy option, it will not be sufficient on its own. Effective responses also
require improving spending efficiency and addressing broader fiscal challenges. Without decisive action, many countries have little chance of achieving the health SDGs.
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Conditioned domestic financing policy, referring to the domestic financing of health projects, programs, and national responses conditioned by global health funding agencies and recipient country governments, is one mechanism to promote sustainability and country ownership. We aim to understand how ...the concept is defined and operationalized by agencies and how such policies relate to overall health spending patterns.
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This WHO laboratory manual provides the most up to date methods and procedures for the laboratory identification of yellow fever virus infection in humans. It provides guidance on the establishment and maintenance of an effective laboratory providing routine surveillance testing for yellow fever, wh...ich operates within the WHO coordinated Global Yellow Fever Laboratory Network (GYFLaN) capable of providing confirmation of yellow fever infection reliably and timely. This second edition supersedes the first edition of the 2004 WHO manual for the monitoring of yellow fever virus infection.
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BMJ Global Health 2022;7:e008007. doi:10.1136/ bmjgh-2021-00800