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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he statistics in this report are from the Emergency Events Database (EM-DAT) maintained by the Centre for Research on the Epidemiology of Disasters (CRED) which records disasters which have killed ten or more people; affected 100 or more people; resulted in a declared state of emergency; or a call f...or international assistance.
In the period 2000 to 2019, there were 7,348 major recorded disaster events claiming 1.23 million lives, affecting 4.2 billion people (many on more than one occasion) resulting in approximately US$2.97 trillion in global economic losses.
This is a sharp increase over the previous twenty years. Between 1980 and 1999, 4,212 disasters were linked to natural hazards worldwide claiming approximately 1.19 million lives and affecting 3.25 billion people resulting in approximately US$1.63 trillion in economic losses.
Much of the difference is explained by a rise in climate-related disasters including extreme weather events: from 3,656 climate-related events (1980-1999) to 6,681 climate-related disasters in the period 2000-2019.
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23 March 2021
The meeting addressed the last key area, that is, determining the best method or combination of diagnostic methods for a control programme for S. stercoralis infections in humans.
Dr Montresor’s presentation highlighted that while there is currently no “gold standard” for the... diagnosis of S. stercoralis, there is a felt urgency to optimize diagnostic regimens that are currently available, and in the context of population-based testing (as opposed to individual focused diagnostics in clinical settings).
In other words, the diagnostic test(s) should have good accuracy, but we should remember that in public health we do not aim at individual diagnosis: rather, we need a tool that should help to estimate the prevalence in a population.
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The United Nations Commission on Life-Saving Commodities (UNCLSC, 2012) defined 13 health products to end preventable deaths of woman and children. One of those 13 products is the neonatal resuscitator, is indispensable medical device to save newborns from asphyxia at birth. For the efficient use of... neonatal resuscitation, training of healthcare professionals using neonatal resuscitation manikins is the most effective approach. Critical lifesaving trainings calls for the need of neonatal resuscitation manikins with the right features.
The purpose of the WHO Neonatal resuscitation manikin: technical specifications is to provide a minimum standard baseline to meet the increasing demand to procure good quality, affordable, accessible, and appropriate neonatal resuscitation manikins. Towards the development of this baseline, this document includes compilation of available scientific evidence from technical literature, international publications, expert reviews, and an industry survey which was conducted by WHO medical devices team.
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This document provides an overview of key considerations for the provision of the HIV continuum of care in the context of displaced people from Ukraine in the EU/EEA. This document has two aims: firstly, to outline what is known of the Ukrainian HIV epidemic, and secondly, to use the HIV continuum o...f care as a framework to set out suggestions based on published evidence and expert opinion on the management of the HIV continuum of care, with special consideration for people living with HIV from Ukraine. The document will also address the needs of those at risk of acquiring HIV. The main findings of this document were presented during an ECDC webinar, ‘Key considerations on the continuum of HIV care for refugees from Ukraine,’ hosted on 19 May 2022.
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Las guías para la prevención de Infecciones del Sitio Quirúrgico (ISQ) resumen las medidas basadas en la evidencia que han demostrado disminuir su incidencia y mejorar la calidad asistencial de los pacientes sometidos a cirugía. La última revisión local fue realizada en el año 2009, en el mar...co del consenso intersociedades INE - SADI - ADECI.
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Nat Commun 9, 5370 (2018). https://doi.org/10.1038/s41467-018-07804-8. Mycobacterium ulcerans is the causative agent of Buruli ulcer, a neglected tropical skin disease that is most commonly found in children from West and Central Africa. Despite the severity of the infection, therapeutic options are... limited to antibiotics with severe side effects. Here, we show that M. ulcerans is susceptible to the anti-tubercular drug Q203 and related compounds targeting the respiratory cytochrome bc1:aa3. While the cytochrome bc1:aa3 is the primary terminal oxidase in Mycobacterium tuberculosis, the presence of an alternate bd-type terminal oxidase limits the bactericidal and sterilizing potency of Q203 against this bacterium. M. ulcerans strains found in Buruli ulcer patients from Africa and Australia lost all alternate terminal electron acceptors and rely exclusively on the cytochrome bc1:aa3 to respire. As a result, Q203 is bactericidal at low dose against M. ulcerans replicating in vitro and in mice, making the drug a promising candidate for Buruli ulcer treatment.
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Epidemiology
Chagas disease (American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi, and transmitted to humans by infected triatomine bugs, and less commonly by transfusion, organ transplant, from mother to infant, and in rare instances, by ingestion of contaminated food or... drink.1-4 The hematophagous triatomine vectors defecate during or immediately after feeding on a person. The parasite is present in large numbers in the feces of infected bugs, and enters the human body through the bite wound, or through the intact conjunctiva or other mucous membrane.
Vector-borne transmission occurs only in the Americas, where an estimated 8 to 10 million people have Chagas disease.5 Historically, transmission occurred largely in rural areas in Latin America, where houses built of mud brick are vulnerable to colonization by the triatomine vectors.4 In such areas, Chagas disease usually is acquired in childhood. In the last several decades, successful vector control programs have substantially decreased transmission rates in much of Latin America, and large-scale migration has brought infected individuals to cities both within and outside of Latin America.
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Chagas disease (American trypanosomiasis) is caused by the protozoan parasite Trypanosoma cruzi, and transmitted to humans by infected triatomine bugs, and less commonly by transfusion, organ transplant, from mother to infant, and in rare instances, by ingestion of contaminated food or drink.1-4 The... hematophagous triatomine vectors defecate during or immediately after feeding on a person. The parasite is present in large numbers in the feces of infected bugs, and enters the human body through the bite wound, or through the intact conjunctiva or other mucous membrane.
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PLoS Negl Trop Dis 14(1): e0007999. January 30, 2020 is the first-ever World Neglected Tropical Diseases Day (World NTD Day), a day when we celebrate the achievements made towards control of the world’s NTDs, yet recognize the daunting challenges we face in the control and elimination of these con...ditions.
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Following the publication of Guidelines on certification of elimination of human onchocerciasis in 2001 by the World Health Organization (WHO), these are the first evidence-based guidelines developed by NTD Department according to the international standards. They provide a set of recommendations th...at would guide national programme managers in collaboration with their respective oversight committees on when to stop mass drug administration (MDA) and conduct post-treatment surveillance (PTS) activities for a minimum period of 3 to 5 year before confirming the interruption of transmission of Onchocerca volvulus parasite and hence its elimination. They also include steps to undertake for verification of elimination of transmission of the parasite in the whole endemic country by the International Verification Team (IVT) prior to the official acknowledgement by WHO Director General.
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The availability of controlled medicines is crucial for patients requiring palliative care, pain relief and symptom management. Many individuals worldwide, especially in low- and middle-income countries, continue to experience limited access to these essential medicines. Enhancing access to controll...ed medicines is paramount in promoting universal health coverage. This report offers a detailed situational analysis of policies and programmes aimed at improving access to affordable, high-quality controlled medicines for pain management in the WHO South-East Asia Region. The report identifies the existing barriers, challenges and possible solutions to facilitate access to such medicines across all Member States.
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There is increasing interest in understanding the role of air pollution as one of the greatest threats to human health worldwide. Nine of 10 individuals breathe air with polluted compounds that have a great impact on lung tissue. The nature of the relationship is complex, and new or updated data are... constantly being reported in the literature. The goal of our review was to summarize the most important air pollutants and their impact on the main respiratory diseases (chronic obstructive pulmonary disease, asthma, lung cancer, idiopathic pulmonary fibrosis, respiratory infections, bronchiectasis, tuberculosis) to reduce both short- and the long-term exposure consequences. We considered the most important air pollutants, including sulfur dioxide, nitrogen dioxide, carbon monoxide, volatile organic compounds, ozone, particulate matter and biomass smoke, and observed their impact on pulmonary pathologies. We focused on respiratory pathologies, because air pollution potentiates the increase in respiratory diseases, and the evidence that air pollutants have a detrimental effect is growing. It is imperative to constantly improve policy initiatives on air quality in both high- and low-income countries.
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Severe Acute Malnutrition (SAM) is one of the greatest child survival challenges in the world today and
reportedly affects more than 16.2 million children each year1. High impact, proven treatment interventions exist
yet sadly approximately only 3.2 million children with SAM have access to treatme...nt each year2. Thus, there
is a need to scale up interventions to improve coverage and access across high burden countries. While efforts
are currently underway to expand services in many countries, obstacles remain.
One critical barrier to expanding SAM treatment services is the acceptance, accessibility and utilisation of
ready-to-use therapeutic food (RUTF). In some countries and contexts, RUTF is still not fully accepted by
community members; while other countries face problems with procurement, storage and supply chain
management which impact on availability and use3. Reports from Ghana and Zambia highlighted that stock-
outs and logistical challenges are often noted as key contributors to high default rates in outpatient treatment
centres4.
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The Guidelines for the Diagnosis, Treatment and Prevention of Leprosy provide state-of-the-art knowledge and evidence on leprosy diagnosis, treatment and prevention based on a public health approach in endemic countries. The target audience of this document includes policy-makers in leprosy or infec...tious diseases in the ministries of health (especially but not limited to endemic countries), nongovernmental organizations, clinicians, pharmaceutical companies, donors and affected persons
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Las directrices actualizadas del mhGAP, la retroalimentación de
información y la evaluación de la versión 1.0 de la GI-mhGAP
por los usuarios han permitido la revisión y elaboración de esta
versión actualizada de la guía. En el año 2015, se llevó a cabo y
se publicó una actualización... completa de las directrices mhGAP
conforme a la metodología de la OMS para la formulación de
directrices, que incluyó el proceso de análisis de datos científicos
y la síntesis y formulación de recomendaciones mediante la
participación de un grupo de expertos internacionales e
instituciones con experiencia apropiada: médicos clínicos,
investigadores, directores de programa, formuladores de
políticas y usuarios de los servicios. Se pueden encontrar detalles
de los métodos y las recomendaciones actualizadas en el centro
de datos de investigación del mhGAP: http://www.who.int/
mental_health/mhgap/evidence/es/.
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Abusos de grupos armados contra civiles colombianos y venezolanos en el noreste de Colombia.
Este informe se basa en una investigación realizada en el Catatumbo en abril de 2019. Entrevistamos a más de 80 personas, incluidas víctimas de abusos, sus familiares, líderes sociales, representantes e...clesiásticos, funcionarios de derechos humanos, autoridades locales, funcionarios judiciales y miembros de organizaciones humanitarias y de derechos humanos que trabajan en la zona. Algunas entrevistas se realizaron en Cúcuta, la capital del departamento de Norte de Santander, y otras telefónicamente. También tuvimos acceso a informes y estadísticas oficiales, publicaciones de organizaciones no gubernamentales e internacionales, y testimonios tomados por funcionarios públicos a casi 500 víctimas de abusos cometidos en el contexto del conflicto armado.
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Constituting the second part of the World Drug Report 2022, the present booklet contains an overview of the global demand for and supply of drugs.
The first chapter of the booklet begins with the latest estimates of the number of people who use drugs, the distribution of those users by type of drug...s, age and sex, and recent trends in the use of drugs. The chapter also reviews the impact of the coronavirus disease (COVID-19) pandemic on drug use patterns and service provision. Other issues examined in the chapter are the health consequences of drug use, including the number of people in treatment for drug use disorders and the extent of drug injecting and of HIV and hepatitis C among people who inject drugs. The chapter concludes with a review of the extent to which strategies, policies and interventions are in place to respond to the drug use problem.
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Constituting the fourth part of the World Drug Report 2022, this booklet focuses on the market dynamics of various stimulants – cocaine, amphetamines and “ecstasy” – and of NPS.
The first chapter contains an analysis of the global market for cocaine, starting with a review of cocaine supply..., including trends in the cultivation of coca bush and in the manufacture of and trafficking in cocaine at the global level and in the various regions. An analysis of different eradication strategies is included, as well as of the role of women in the cocaine supply chain. The chapter also presents the latest estimates of and trends in cocaine use, including a brief introduction to the various cocaine consumer products. Finally, it reviews the trends in the use of cocaine and the impact of the coronavirus disease (COVID-19) pandemic in different regions
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In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food safety comm...unity to play its part and re-established the ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) ). The objectives of the Task Force were
to revise the current Codex Code of Practice to Minimise and Contain Antimicrobial Resistance and to develop new guidance on surveillance programmes relevant to foodborne AMR.
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