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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Overcoming barriers in low- and middle-income countries
For the first time, this year’s report includes information on hepatitis C diagnostics. With a focus on selected countries with diverse HCV epidemics, the report provides updates on the various dimensions of access to HCV diagnostics and pha...rmaceutical products, including product pricing, the regulatory environment and patent status, which together shape the national hepatitis response in different settings. It highlights key areas for action by ministries of health and other government decision-makers, pharmaceutical manufacturers and technical partners.
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2nd edition - Published in 2003, the first WHO/HAI medicine prices manual Medicine Prices – A
New Approach to Measurement Draft for field-testing provides a draft methodology and tools to conduct national medicine prices and availability surveys. This second edition of the survey manual has been... updated to reflect the wealth of practical
experience in conducting medicine prices and availability surveys garnered in the project’s first two phases.
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Journal of the International AIDS Society 2016, 19:20926
There is a growing interest in the potential contribution the private sector can make towards increasing access to antiretroviral therapy (ART) in low‐ and middle‐income settings. This article describes a public–private partnership ...that was developed to expand HIV care capacity in Yangon, Myanmar. The partnership was between private sector general practitioners (GPs) and a community‐based non‐governmental organization (International HIV/AIDS Alliance).
https://doi.org/10.7448/IAS.19.1.20926
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BMC Public Health (2019) 19:1608
https://doi.org/10.1186/s12889-019-7853-3