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
more
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%).
more
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.
more
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.
more
Overuse and misuse of antibiotics in animals and humans is contributing to the rising threat of antibiotic resistance. Some types of bacteria that cause serious infections in humans have already developed resistance to most or all of the available treatments, and there are very... few promising options in the research pipeline
more
Ebola interventions: The intervention to combat Ebola aims to stop human-to-human transmission. The package is composed of five elements necessary to control the spread of the disease: care to patients, contact monitoring, safe burials, laboratory support and social mobilisation.
The document al...so describes key information on Ebola virus disease, patient care, contact tracing and monitoring, safe and dignified burial, laboratory diagnosis.
more
The effective vaccine management (EVM) workshop, jointly organized by WHO and UNICEF, was attended by participants from 13 countries, who reviewed the various EVM benchmarks, identified the gaps in policies, guidelines, SOPs and job aids, and developed respective country action plans to fill these g...aps. This meeting report outlines the proceedings and outcomes of the workshop conducted in Bangkok, Thailand, in December 2024
more
Sudan virus disease is a severe, often fatal illness affecting humans and other primates that is due to Orthoebolavirus sudanense (Sudan virus), a viral species belonging to the same genus of the virus causing Ebola virus disease. This webinar will provide an overview of the current outbreak of Suda...n virus disease: what we know, the current outbreak in Uganda, and prevention and control measures.
more
Significant progress has been made in the eradication of three priority diseases in the African Region, as a result of extensive collaboration between the Regional Office, WHO country offices and countries. For example, in August 2020, the region was certified free of wild poliovirus. In the area of... neglected tropical diseases, Guinea worm disease is on the verge of eradication, and 12 member states are within reach of being certified as having eradicated yaws by the end of this year.
more
Prepared by the Independent Panel for Pandemic Preparedness and Response for the WHO Executive Board, January 2021
“The world was not as prepared as it should have been, and it must do better,” concludes a WHO panel reviewing the pandemic response "
HIV Treatment - Interim Guidance
Weekly Epidemiological Record (WER), 17 September 2021, Vol. 96, No. 37 (pp. 445-460)
Compilation of country case studies and best practices. World Health Report (2010) Background Paper, 25
The "Regional Action Plan 2017–2030: Towards a Malaria-Free South-East Asia Region" by the World Health Organization (WHO) outlines a strategic framework to eliminate malaria in the 11 countries of the WHO South-East Asia Region by 2030. It focuses on reducing transmission, particularly of Plasmod...ium falciparum and P. vivax, addressing multidrug resistance, improving surveillance, and ensuring universal access to diagnosis, treatment, and prevention. The plan sets clear objectives and milestones and emphasizes strong governance, cross-border collaboration, community involvement, and sustainable financing to achieve and maintain a malaria-free status across the region.
more
New data from the WHO reveal that an estimated 2.2 billion cases of malaria and 12.7 million deaths have been averted since 2000, but the disease remains a serious global health threat, particularly in the WHO African Region. According to WHO’s latest World malaria report, there were an estimated ...263 million cases and 597 000 malaria deaths worldwide in 2023. This represents about 11 million more cases in 2023 compared to 2022, and nearly the same number of deaths. Approximately 95% of the deaths occurred in the WHO African Region, where many at risk still lack access to the services they need to prevent, detect and treat the disease.
more
The Plan of Action for Malaria Elimination 2021-2025 has been developed in consultation with countries and regional partners as a framework of reference to guide the efforts of countries and the contributions of donors and partners towards elimination of the disease in the Americas. The Plan subscri...bes to the goals and pillars of the WHO Global Technical Strategy against Malaria 2016-2030 (GTS), while presenting key elements to address the specific challenges of the Region. The document seeks to guide national plans and promote an inter-programmatic- intersectoral approach, and joint efforts between countries and partners. The Plan is also the reference framework for PAHO technical cooperation in malaria in the period 2021-2025. The goals to be achieved require changes in action against malaria that must occur at the operations level and for which regulatory and policy adjustments are required from the national levels. Thus, the Plan promotes a systematic action of detection, diagnosis and response, which must be massively implemented and monitored programmatically. A main element of change is action aimed at recognizing the need to address key malaria foci in each country with specific, information-based operational solutions. The Plan of Action seeks to promote these changes in malaria programs in the countries and through the interactions among all actors. The model proposed in this plan is based on a cross-functional dialogue and interconnections across the lines of action (SL). Strategic lines 1, 2 and 3, which correspond to the three pillars of the WHO/GTS, complement each other, and are not designed to function independently. The idea of the consolidated supportive elements - strengthened health systems, strategic planning, financing, partnerships, advocacy, and operational research (SL 4) is to provide the platform, operational structures and alliances for the more specific malaria interventions presented in strategic lines 1, 2 and 3.
more
The guidelines are primarily intended for health-care professionals working in first- or second-level health-care facilities, including emergency, inpatient and outpatient services. They are also directed at policy-makers, health-care planners and programme managers, academic institutions, non-gover...nmental and civil society organizations to inform capacity-building, teaching and research agendas.
Web annex A provides the quantitative evidence reports, Web annex B summarizes the qualitative and economic evidence and Web annex C presents the Evidence-to-Decision frameworks.
more
The guidelines are primarily intended for health-care professionals working in first- or second-level health-care facilities, including emergency, inpatient and outpatient services. They are also directed at policy-makers, health-care planners and programme managers, academic institutions, non-gover...nmental and civil society organizations to inform capacity-building, teaching and research agendas.
Web annex A provides the quantitative evidence reports, Web annex B summarizes the qualitative and economic evidence and Web annex C presents the Evidence-to-Decision frameworks.
more