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 document contains preliminary report on all aspects of WHO’s response in the Ebola outbreak. WHO Member States will discuss the report at the sixty-eighth World Health Assembly.
A formulary of dermatological preparations and background information on therapeutic choices, production and dispensing. 2nd edition
First Revised Edition
March 2000
Responses to epidemics, emergencies and disasters raise many ethical issues for the people involved, including public health specialists and policy makers. This training manual provides material on ethical issues in research, surveillance and patient care in these difficult contexts.
Procedures Manual - Medicines registration in Madagascar - 2016 version
Healthcare Waste Management Toolkit for Global Fund Practitioners and Policy Makers: Part A
The purpose of the WHO Manual for the Public Health Management of Chemical Incidents is to provide a comprehensive overview of the principles and roles of public health in the management of chemical incidents and emergencies. While this information is provided for each phase of the emergency cycle, ...including prevention, planning and preparedness, detection and alert, response and recovery, it is recognized that the management of chemical incidents and emergencies requires a multi-disciplinary and multi-sectoral approach and that the health sector may play an influencing, complementary or a leadership role at various stages of the management process. The target audience includes public health and environmental professionals, as well as any other person involved in the management of chemical incidents.
WHO and all those involved in the development of the publication hope that the publication will have wide application, especially in developing countries and countries with economies in transition, and that in the future the health sector will be better prepared to acknowledge and fulfill its roles and responsibilities in the management of chemical incidents and emergencies, thereby contributing to the prevention and mitigation of their health consequences.
The publication is also available in French: http://apps.who.int/iris/bitstream/handle/10665/246117/9789242598148-fre.pdf?sequence=1 and in Spanish: http://apps.who.int/iris/bitstream/handle/10665/246118/9789243598147-spa.pdf?sequence=1
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Africa’s health sector is facing an unprecedented financing crisis, driven by a sharp decline of 70% in Official Development Assistance (ODA) from 2021 to 2025 and deep-rooted structural vulnerabilities. This collapse is placing immense pressure on Africa’s already fragile health systems as ODA ...is seen as the backbone of critical health programs: pandemic preparedness, maternal and child health services, disease control programs are all at
risk, threatening Sustainable Development Goal 3 and Universal Health Coverage. Compounding this is Africa’s spiraling debt, with countries expected to service USD 81 billion by 2025—surpassing anticipated external financing inflows—further eroding fiscal space for health investments. Level of domestic resources is low. TThe Abuja Declaration of 2001, a pivotal commitment made by African Union (AU) member states, aimed to reverse this trend by pledging to allocate at least 15% of national budgets to the health sector. However, more than two decades later, only three countries—Rwanda, Botswana, and Cabo Verde—have
consistently met or exceeded this target (WHO, 2023). In contrast, over 30 AU member states remain well below the 10% benchmark, with some allocating as little as 5–7% of their national budgets to health.
In addition, only 16 (29%) of African countries currently have updated versions of National Health Development Plan (NHDP) supported by a National Health Financing Plan (NHFP). These two documents play a critical role in driving internal resource mobilisation. At the same time, public health emergencies are surging, rising 41%—from 152 in 2022 to
213 in 2024—exposing severe under-resourcing of health infrastructure and workforce. Recurring outbreaks (Mpox, Ebola, cholera, measles, Marburg…) alongside effects of climate change and humanitarian crises in Eastern DRC, the Sahel, and Sudan, are overwhelming systems stretched by chronic underfunding. The situation is worsened by Africa’s heavy dependency with over 90% of vaccines, medicines, and diagnostics being externally sourced—leaving countries vulnerable to global supply chain shocks. Health worker shortages persist, with only 2.3 professionals
per 1,000 people (below the WHO’s recommended 4.45), and fewer than 30% of systems are digitized, undermining disease surveillance and early warning. Without decisive action, Africa CDC projects the continent could reverse two decades of health progress, face 2 to 4 million additional preventable deaths annually, and a heightened risk of a pandemic emerging from within. Furthermore, 39 million more
Africans could be pushed into poverty by 2030 due to intertwined health and economic shocks. This is not just a sectoral crisis—it is an existential threat to Africa’s political, social, and economic resilience, and global stability. In response, African leaders, under Africa CDC’s stewardship, are advancing a comprehensive three-pillar strategy centered on domestic resource mobilization, innovative financing, and blended finance.
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ຢາຕ້ານເຊື້ອຈຸລະຊີບ (Antimicrobial medicines) ມີຄວາມສໍາຄັນຫຼາຍຕໍ່ວຽກງານການແພດ, ສາທາລະນະສຸກ, ສຸຂະພາບສັດ ແລະ ການຜະລິດອາຫານ. ເນ...່ອງຈາກວ່າ ຢາດັ່ງກ່າວນີ້ ແມ່ນໃຊ້ເພື່ອປ້ອງກັນ ແລະ ປິ່ນປົວພະຍາດຊືມເຊື້ອ ທີ່ມີ ຈໍາພວກເຊື້ອຈຸລິນຊີ (Bacteria) ເປັນຫນື່ງໃນສາເຫດທີ່ເຮັດໃຫ້ຄົນ ແລະ ສັດເສຍຊີວິດ ໃຫ້ຫຼຸດລົງໄດ້ ແລະ ມີບົດບາດຫຼາຍໃນວົງ ການແພດແຜນປະຈຸບັນ ເປັນຕົ້ນແມ່ນ ການຜ່າຕັດ ຊຶ່ງມີຄວາມສ່ຽງຕໍ່ການຕິດເຊື້ອໄດ້ງ່າຍຈຶ່ງຈໍາເປັນຕ້ອງໄດ້ເພິ່ງພາຢາຕ້ານເຊື້ອຈຸລະ ຊີບ ທີ່ມີປະສິດທິພາບເພື່ອປ້ອງກັນ ແລະ ປິ່ນປົວການຕິດເຊື້ອທີ່ອາດເກີດຂຶ້ນ. ນອກຈາກນີ້ແລ້ວ ມັນຍັງມີຄວາມຈໍາເປັນສໍາລັບ ປ້ອງກັນ ແລະ ປິ່ນປົວ ໃນວຽກງານສັດຕະວະແພດ ແລະ ການກະສິກໍາ ເປັນຕົ້ນ: ການລ້ຽງສັດ, ການປະມົງ, ການປູກຝັງ ແລະ ມີຄວາມສໍາຄັນຕໍ່ ສຸຂະພາບສັດ ພືດ ຕ່ອງໂສ້ການຜະລິດອາຫານ ແລະ ເສດຖະກິດຂອງຊາດອີກດ້ວຍ.
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MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
SITUATION ANALYSIS AND RECOMMENDATIONS
First edition, November 1997 | Revised July 2002
PQDx 0181-031-00
WHO PQ Public Report
March/2017, version 3.0
Global UNIDO Project: Strengthening the local production of essential generic drugs in the least developed and developing countries
The publication provides an overview and analysis of international instruments that set standards related to the use of antimicrobials across the human, animal and plant sectors, and their release into the environment. The purpose of the document is to identify existing instruments and standards in ...order to guide both their implementation and to inform discussions and direction for future international instruments related to antimicrobial use.
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