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 report reviews and analyses the Affordable Medicines Programme, which was introduced in Ukraine in April 2017 to provide patients with improved access to 23 outpatient medicines for the treatment of chronic noncommunicable diseases. The evaluation combines both quantitative and qualitative anal...ysis. The findings confirm that the Programme has contributed to a significant increase in access to needed outpatient medicines in Ukraine. Further, while implementation was successful overall, uptake across regions was uneven. The report concludes by listing a number of policy options to support the sustainability and expansion of the Affordable Medicines Programme.
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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.
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The Social and Behaviour Change Communication (SBCC) Strategy for the Prevention of the Re-establishment of Malaria Transmission in Timor-Leste forms part of the National Strategic Plan (NSP) for 2021–2025. The strategy aims to support Timor-Leste's efforts to sustain malaria elimination by promot...ing responsive and preventive behaviours through targeted communication and community engagement. Created in collaboration with the Ministry of Health, the WHO, the Global Fund and other stakeholders, the SBCC strategy implements recommendations from the 2020 external review of the National Malaria Programme. Building on previous BCC initiatives (2015–2020), it emphasises surveillance, diagnosis, treatment and vector control, particularly focusing on vulnerable populations. The SBCC strategy provides partners and implementers with a dynamic guide to designing context-specific communication interventions that support malaria elimination and prevent the re-establishment of transmission.
Accessed on 18/06/2025.
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Report of a virtual meeting 21–23 June 2022
Pillar 3 of the Global technical strategy for malaria 2016–2030 calls for the transformation of malaria surveillance into a core intervention in all malaria-endemic countries, as well as in countries which have eliminated malaria but remain susceptible to re-establishment of transmission. This ref...erence manual covers subjects that are relevant to both settings.
The target readership of this manual includes staff working in ministries of health, national malaria programmes and health information systems; partners involved in malaria surveillance; and WHO technical officers who advise countries on malaria surveillance.
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Implementation reference guide. This Malaria Surveillance Assessment Toolkit implementation reference guide is a comprehensive reference document, as well as a step by-step guide. It aligns and adapts available tools into a single set of standardized tools, which can be used to conduct malaria surve...illance assessments across all transmission settings. Use of these standardized tools allows comparison of results between countries and within the same country over time, enabling countries to track their progress towards surveillance system strengthening.
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This policy brief presents a summary of current evidence on vulnerability to TB and proposes interventions for equitable, person-centred, and human rights-based TB prevention and care. It aligns with WHO policies and guidance on TB prevention and screening, management of TB and comorbidities, access... to health care, universal health coverage, determinants of TB, TB-associated impairment and disability, social protection, as well as ethics, equity and human rights.
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The Rwanda Malaria Strategic Plan 2020–2024 outlines Rwanda’s national strategy to reduce malaria morbidity and mortality by at least 50% compared to 2019 levels. The vision is a malaria-free Rwanda contributing to socioeconomic development.
The plan includes strengthening prevention through lo...ng-lasting insecticide-treated nets, indoor residual spraying, and larval source management; ensuring universal access to testing and treatment; improving surveillance and data use; and enhancing program management, coordination, and financing. It also emphasizes community engagement and behavior change to ensure at least 85% of the at-risk population adopts protective practices.
The strategy builds on past lessons, involves multi-sectoral collaboration, and aligns with global malaria goals. It highlights equity, quality services, and evidence-based interventions as guiding principles, aiming to mobilize national and international resources for sustained impact.
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National tuberculosis (TB) prevalence surveys provide a nationally representative measurement of the burden of TB disease in the population, at a given point in time. Repeat surveys allow assessment of trends and tracking of progress towards national and global targets for reductions in TB disease b...urden. Survey data also provide important insights that can help national TB programmes to identify ways to improve TB diagnosis and treatment.
National TB prevalence surveys are relevant in countries that do not yet have national disease notification and vital registration systems that are of sufficiently high quality and coverage to allow reliable tracking of TB disease burden.
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The World Health Organization recently redefined leprosy elimination as a phased process, with the first milestone being the
interruption of transmission, achieved when no new child cases (defined as younger than 15 years) are reported for five consecutive years.
In Pakistan, the well-functioning ...leprosy programme, with effective case management, context-specific active case-finding strategies and
a robust data management system, has contributed to a decrease in new cases. Between 2001 and 2023, new adult cases dropped by 75%
(from 878 cases to 220 cases annually) and child cases by 83% (from 93 to 16). To support the country’s goal of no new child cases by 2030
and ultimately eliminate the disease, the nongovernmental organizations Marie Adelaide Leprosy Centre and Aid to Leprosy Patients, with
support from the German Leprosy and Tuberculosis Relief Association, have developed a zero leprosy roadmap. As part of this roadmap,
the leprosy elimination strategy emphasizes improving active case-finding and providing post-exposure prophylaxis for contacts of leprosy
cases, who are at the highest risk
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The report summarizes the estimates of the burden of disease attributable to unsafe drinking water, sanitation, and hygiene for the year 2019 for four health outcomes - diarrhoea, acute respiratory infections, soil-transmitted helminthiases, and undernutrition - which are included in the reporting o...f the Sustainable Development Goal indicator 3.9.2. The report includes estimates at global, regional and country level for 183 WHO Member States.
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World Health Organization. (2022). Toolkit for developing a multisectoral action plan for noncommunicable diseases: module 4: developing an implementation plan.
This guideline aims to improve the quality of essential, routine postnatal care for women and newborns with the ultimate goal of improving maternal and newborn health and well-being. It recognizes a “positive postnatal experience” as a significant end point for all women giving birth and their n...ewborns, laying the platform for improved short- and long-term health and well-being. A positive postnatal experience is defined as one in which women, newborns, partners, parents, caregivers and families receive information, reassurance and support in a consistent manner from motivated health workers; where a resourced and flexible health system recognizes the needs of women and babies, and respects their cultural context.
This is a consolidated guideline of new and existing recommendations on routine postnatal care for women and newborns receiving facility- or community-based postnatal care in any resource setting.
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This guideline aims to improve the quality of essential, routine postnatal care for women and newborns with the ultimate goal of improving maternal and newborn health and well-being. It recognizes a “positive postnatal experience” as a significant end point for all women giving birth and their n...ewborns, laying the platform for improved short- and long-term health and well-being. A positive postnatal experience is defined as one in which women, newborns, partners, parents, caregivers and families receive information, reassurance and support in a consistent manner from motivated health workers; where a resourced and flexible health system recognizes the needs of women and babies, and respects their cultural context.
This is a consolidated guideline of new and existing recommendations on routine postnatal care for women and newborns receiving facility- or community-based postnatal care in any resource setting.
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The Leprosy Programme and Transmission Assessment (LPTA) is an activity that is carried out by internal teams towards the end of Phase 1 (see Leprosy Elimination Framework in the Annex) when a subnational jurisdiction (typically second-tier) reaches the milestone for interruption of transmission, i....e., zero autochthonous child cases for a consecutive period of five years. It also needs to be done at the end of Phase 2, when the second milestone of elimination of leprosy disease has been reached. An LPTA will be carried out to document that all relevant programme criteria have been met and examine trends of epidemiological indicators in such jurisdiction to confirm that the milestone has been achieved. The LPTA includes assessment of health facilities that provide leprosy services. LPTA comprises of review of epidemiological data, health facility assessment and data validation and verification of the programme criteria through observation during a field visit. The evidence collected in this way in subnational health administrative units is compiled in a Leprosy Elimination Dossier to be submitted to WHO when the country reaches the milestone for elimination of disease in the country as whole. Countries that have not detected any new leprosy cases in the past three years or more can use the LPTA at national level prior to or as part of the verification process. Countries likely to be among the first to apply for verification may have had no new cases detected for more than 10 years.
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