Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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A Meand to enhancing HIV prevention in key populations. This document has been developed out of the increasing need to set up standards and procedures to prevent and respond to violence against key populations.
Zoonotic tuberculosis (TB) is a form of TB in people predominantly caused by the bacterial species, Mycobacterium bovis, which belongs to the M. tuberculosis complex. The implications of zoonotic TB go beyond human health. The organism is host-adapted to cattle, where it is refer...red to as bovine TB, and it also causes TB in other animal species including wildlife. Bovine TB has an important economic impact and threatenslivelihoods.
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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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This paper summarizes the evidence about the health effects of air pollution from particulate matter and their implications for policy-makers, with the aim of stimulating the development of more effective strategies to reduce
air pollution and its health effects in the countries of eastern Europe,... the Caucasus and central Asia.
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Following an overview of maternal and neonatal child health in Nepal and in the districts covered by the project, the briefing outlines the background to the Strengthening Approaches for Maximizing Maternal, Neonatal and Reproductive Health (SAMMAN) project. It then describes the key aspects of the ...two main project approaches: one focused on the community level, and the other on health systems
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Final Report: Women in War
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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he National Department of Health (NDOH) presents this Malaria Elimination Strategic
Plan 2019-2023 for the Republic of South Africa. The strategy comes at an important time
as the Southern African Development Community (SADC) heads of state have recently
renewed the commitment to eliminate malari...a in Botswana, Eswatini, Namibia and South
Africa by 2020 and in the whole SADC region by 2030, with the target of zero local malaria
cases and deaths. South Africa has made steady progress towards this elimination goal
through the implementation of evidence-based malaria policies aligned to the World Health
Organization’s (WHO) Global Technical Strategy.
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