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 indicators and questions in this document are designed for use by national AIDS programmes and partners to assess the state of a country’s HIV and AIDS response, and to measure progress towards achieving national HIV targets. Countries are encouraged to integrate these indicators and questions... into their ongoing monitoring efforts and to report comprehensive national data through the Global AIDS Monitoring (GAM) process. In this way they will contribute to improving understanding of the global response to the HIV epidemic, including progress that has been made towards achieving the commitments and global targets set out in the new United Nations Political Declaration on HIV and AIDS: Ending Inequalities and Getting on Track to End AIDS by 2030, adopted in June 2021, and the linked Sustainable Development Goals.
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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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Namibia recorded its first COVID-19 case on 14 March 2020, with cumulative cases reaching 15,773 and 118 deaths by 10 December 2020. Namibia has done relatively well to contain the outbreak.
However, positivity rates have shown a consistent increase above 5 percent in quarter 4 of 2020, necessitati...ng renewed attention to surveillance and outbreak control in 2021.
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6th edition. The HIV epidemic Namibia is gradually being brouhgt under countrol as demonstrated by results in the preliminary report of Namibia Population-Based HIV Impact Assessment (NAMPHIA), a cross-sectional household-based survey that was conducted in 2017. Currently, it is estimated that about... 204,207 Namibians are living with HIV. According to the NAMPHIA preliminary report, HIV prevalence among adults aged 15-64 is 12.6% and the annual HIV incidence is 0.36%. This report, together with HIV programmatic data has show that Namibia is one of the few African countries to meet the 2015 Joint United Nations Program on HIV and epidemic globally by 2030.
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(Published with Decision No. 3003/QðBYT dated 19/8/2009 of the Minister of Health)
Each year WHO and UNICEF jointly review reports submitted by Member States regarding national immunization coverage, finalized survey reports as well as data from the published and grey literature. Based on these data, with due consideration to potential biases and the views of local experts, WHO an...d UNICEF attempt to distinguish between situations where the available empirical data accurately reflect immunization system performance and those where the data
are likely to be compromised and present a misleading view of immunization coverage while jointly estimating the most likely coverage levels for each country.
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El propósito de esta guía es brindar orientaciones clínicas actualizadas en TB/VIH con énfasis en aspectos de diagnóstico, incluidas nuevas técnicas, así como de tratamiento vigente, sin perder de vista un enfoque de salud pública. Al recopilar y consolidar en una sola guía las últimas rec...omendaciones de la Organización Mundial de la Salud en el tema, se busca elaborar un documento de referencia y consulta frecuente, que unifique y estandarice el manejo de la coinfección TB/VIH de manera integral en establecimientos de salud con base en el principio de “dos enfermedades, un solo paciente”. También busca sustentar la actualización de normas y guías nacionales sobre la coinfeccion y complementar el trabajo coordinado que debe existir entre los programas de prevencion y control de TB y VIH a todo nivel en el marco las doce actividades de colaboración TB/VIH recomendadas internacionalmente.
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The purpose of this guide is to provide updated clinical guidance on TB/HIV, with an emphasis on diagnostic aspects—including new techniques—as well as current treatment, while maintaining a public health approach. By compiling and consolidating the latest World Health Organization recommendatio...ns on the subject into a single guide, the aim is to create a reference and consultation document that is frequently used, and that unifies and standardizes the comprehensive management of TB/HIV co-infection in healthcare facilities based on the principle of “two diseases, one patient.” It also seeks to support the updating of national standards and guidelines on co-infection and to complement the coordinated work that must exist between TB and HIV prevention and control programs at all levels, within the framework of the twelve internationally recommended TB/HIV collaborative activities.
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Guidelines on lenacapavir for HIV prevention and testing strategies for long-acting injectable pre-exposure prophylaxis. Web Annex D