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 Ideal Clinic manual has been developed to assist managers at various levels of healthcare service provision to correctly interpret and understand the requirement for achieving the elements as depicted in the Ideal Clinic framework/dashboard. It can therefore be regarded as a reference document w...hich guides the managers to determine the status of Ideal Clinic framework/dashboard elements in a facility.
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NATIONAL TUBERCULOSIS AND LEPROSY PROGRAMME
A healthcare worker manual. 2nd edition
The development of this National Manual for the Management of HIV-related Opportunistic Infections and Conditions for use by health care workers at the frontline of our fight against HIV/AIDS is intended to improve their understanding of the causes, preventio...n and appropriate management of opportunistic infections and conditions in adults and adolescents (OIs in children is covered effectively in the Integrated Management of Childhood Illnesses – IMCI – materials). It is also intended to be a practical guide at the clinic level, so as to improve quality of life, treatment outcomes and survival of PLHA. Crucially, this manual uses a “symptom-based” approach to support health care workers at the most basic primary level to be able to effectively initiate the care of PLHA with OIs and refer patients as appropriate (effective triage of patients at the primary care level). The result of this will be to move the management of OIs closer to the patient while ensuring that referral links with higher-level facilities and care is cultivated.
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Antimicrobial resistance (AMR) is a global public health crisis that resulted in 1.14 million deaths in 2021. According to the Institute for Health Metrics and Evaluation estimates, 96 416 of these deaths occurred in the World Health Organization (WHO) Eastern Mediterranean Region. All 22 countr...ies/territories in the Eastern Mediterranean Region are enrolled in the global AMR
surveillance system, and 17 countries/territories reported data in 2024 (for the year 2023). The total number of isolates reported to the system increased sixfold between 2017 and 2022, but the proportion of blood isolates is relatively very low. Most of the data come from public sector laboratories or hospitals, although the private sector has increased its participation in some countries/territories recently. Three pathogens account for three quarters of all the reported pathogens – Escherichia coli
(26%), Klebsiella pneumoniae (23%), and Staphylococcus aureus (22%).
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The "National Guideline for Cholera Surveillance and Outbreak Response" by the Ethiopian Public Health Institute (EPHI) provides a comprehensive approach to combating cholera outbreaks in Ethiopia. It emphasizes the importance of a multisectoral approach, including case management, WASH measures, an...d the use of cholera vaccines. A key component is the establishment of Cholera Treatment Centers (CTCs) that provide 24/7 care. Additionally, the guideline stresses water quality monitoring and hygiene practices to prevent the spread of cholera and protect public health.
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The Epidemic Preparedness and Response Plan for Cholera in Syria (November 2015) outlines strategies to prevent, detect, and manage cholera outbreaks in the country, where poor water and sanitation conditions, displacement, and damaged healthcare infrastructure increase the risk of disease spread. T...he plan aims to reduce morbidity and mortality through early detection, rapid response, and coordinated interventions. It is divided into four key phases: the Pre-Epidemic Phase, which includes risk assessment, resource mapping, stockpiling medical supplies, training health workers, and raising community awareness; the Alert Phase, which focuses on surveillance, laboratory confirmation, and mobilization of rapid response teams; the Epidemic Phase, which involves case management, infection control, environmental measures such as water chlorination and improved sanitation, and public awareness campaigns; and the Post-Epidemic Phase, which evaluates the response effectiveness and identifies lessons to improve future preparedness. The plan emphasizes multi-sectoral coordination, strengthening health surveillance, and ensuring timely intervention to control and prevent cholera outbreaks in vulnerable communities.
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These guidelines deal specifically with water, sanitation and hygiene, and are designed to be used in schools in low-cost settings in low- and medium-resource countries to:
• assess prevailing situations and plan for required improvements;
• develop and reach essential safety standards as a f...irst goal; and
• support the development and application of national policies.
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Several countries have demonstrated that COVID-19 transmission from one person to another can be slowed or stopped. This document has been prepared based on the evidence currently available about Coronavirus disease 2019 (COVID-19) transmission (human-to-human transmission primarily via respiratory... droplets from, or direct contact with, an infected person), and is designed to ensure that the accommodation sector can protect the health of its staff and clients.
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This booklet presents key messages for action, summarized from a set of
chapters on different environmental health issues.
Advocacy ,Social Mobilization ,Behavior Change Communications
HIV Treatment - Interim Guidance
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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