Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
The WHO South-East Asia (SEA) Region bears a high burden of tuberculosis (TB) and MDR-TB. In 2015, the Region accounted for nearly 200 000 or 35% of the global estimated new RR/MDR-TB cases eligible for treatment. Extensively drug-resistant TB (XDRTB) has also been reported from s...ix countries of the SEA Region. MDR-TB could potentially replace drug-susceptible TB, and constitutes a threat to global public health security. The South- East Asia Regional Response Framework for DR-TB 2017–2021 complements the Ending TB in the South-East Asia Region: Regional Strategic Plan 2016–2020” and outlines key strategies for reducing morbidity, mortality and transmission of DR-TB.
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Venturini et al. BMC Infectious Diseases 2014, 14(Suppl 1):S5 http://www.biomedcentral.com/1471-2334/14/S1/S5
Antimalarial drug resistance has emerged as a threat to global malaria control efforts, particularly in the Greater Mekong subregion. Drawing on data collected through more than 1000 therapeutic efficacy studies as well as molecular marker studies of Plasmodium falciparum drug resistance, the Report... on antimalarial drug efficacy, resistance and response: 10 years of surveillance (2010–2019) presents a decade’s worth of data on drug efficacy and surveillance, as well as recommendations to monitor and protect the efficacy of malaria treatment in the decades to come.
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The World Health Organization (WHO) convened a meeting of the Technical Advisory Group on Buruli ulcer at its headquarters in Geneva, Switzerland on 25 to 27 March 2019
Buruli ulcer caused by Mycobacterium ulcerans is a neglected tropical disease characterized by extensive ulceration involving predominantly the upper and lower limbs of patients. The disease is common in rural tropical communities in West and Central Africa, where access to proper health care is lim...ited. Pathogenesis of the characteristic painless ulcers is linked to the elaboration by M. ulcerans of a lipid toxin called mycolactone that has potent cytopathic, immunosuppressive, and analgesic effects on a host of cells in cutaneous tissues. Mycolactone is known to profoundly inhibit secretion of a plethora of proteins that are essential for wound healing. Even though a combination antibacterial therapy of streptomycin and rifampicin for 8 weeks is effective for treatment, it relies on good and appropriate wound management to prevent secondary bacterial infections and improve healing. Evidence-based interventions for wound care in Buruli ulcer disease are often lacking and have relied on expert advice and recommendations. Surgical interventions are limited to debridement of necrotic tissue and grafting of extensive ulcers, usually after antibiotic therapy. Patients’ rehabilitation is an important component of care to reduce disabilities associated with the disease and proper integration into the community after treatment.
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The Practical manual on laboratory strengthening, 2022 update provides practical guidance on implementation of WHO recommendations and best practices for TB laboratory strengthening. It is an updated version of the GLI Practical Guide to Laboratory Strengthening published in 2017 and provides the la...test practical guidance on use of newly recommended diagnostics as well as guidance in key technical areas, including quality assurance and quality management systems, specimen collection and registration, procurement and supply-chain management, diagnostic connectivity, biosafety, data management, human resources, strategic planning, and model algorithms. The key changes are:
inclusion of recent or updated WHO recommendations for tests to diagnose TB and detect drug resistance;
alignment with the latest WHO critical concentrations for phenotypic drug-susceptibility testing (DST) and the new definitions of pre-XDR-TB and XDR-TB;
updated information on building quality-assured TB testing and management capacity using the Stepwise Laboratory Quality Improvement Process Towards Accreditation (SLIPTA) approach (Score-TB package1);
updated information on assessing, analysing and optimising TB diagnostic networks; and
updated information on the use of next-generation sequencing (NGS) to detect mutations associated with drug resistance for surveillance purposes.
The document also provides references to resources and tools relevant for work on laboratory strengthening.
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i...nternational requirements for biosafety and biosecurity including the International Health Regulations (IHR) (2005), the Biological Weapons Convention (BWC), and United Nations Security Council Resolution (UNSCR) 1540 and the multi-country Global Health Security Agenda (GHSA). The World Health Organization (WHO) Joint External Evaluation (JEE) and the Global Health Security Index report confirmed the known capacity gaps in biosafety and biosecurity among Africa Union Member (AU).
The regional consultations by Africa CDC conducted between 2019-2021 highlighted the deficiency or limited availability of standardized and regionally recognized training programs in the continent, limiting biosafety and biosecurity capacity building efforts in the region. In response, Africa CDC working with AU Member States developed a home grown, implementable and accessible professional training and certification program that is both recognized and endorsed by AU Member States. The Regional Training and Certification Program for Biosafety and Biosecurity Professionals, for African Biosafety and Biosecurity Professionals (RTCP-BBP) has four (4) areas of specialization, namely
Selection, Installation, Maintenance and Certification of Biological Safety Cabinets
Biorisk Management
Design and Maintenance of Facilities Handling High Risk Pathogens (Biocontainment Engineering)
Biological Waste management
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N Engl J Med 2022; 386:911-922, DOI: 10.1056/NEJMoa2104535
Four months of antituberculosis treatment was noninferior to 6 months of treatment in children with drug-susceptible, nonsevere, smear-negative tuberculosis (SHINE Study)
Blueprint for EECA countries, first edition
The international community sits at the tipping pointof a post-‐antibiotic era, where common bacterial infections are no longer treatable with the antibiotic armamentarium that exists. In South Africa, t...he identification of the first case of pan-‐resistant Klebsiella pneumoniae(Brink et al, J Clin Microbiol. 2013;51(1):369-‐72) marks a watershed moment and highlights ourtip of the antibiotic resistance ‘iceberg’ in this country. Multi-‐drug resistant (MDR)-‐bacterial infections, predominantly in Gram-‐negative bacteria such as Klebsiella pneumoniae, Escherichia coli, Pseudomonas aeruginosaand Acinetobacter baumanniiare now commonplace in South African hospitals. Whilst a number of expensive new antibiotics for Gram-‐positive bacterial infections have been manufactured recently (some of which are licenced for usein South Africa), no new antibiotics active against Gram-‐negative infections are expected in the next 10-‐15years. Hence what we have now, needs conserving
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This strategic framework marries formerly separate mandates for HIV and TB management in to one, comprehensive collaboration. It provides a structure for how to: strengthen the health care system to respond effectively to both epidemics, reduce the burden of HIV/AIDS in TB patients, and establish a ...monitoring and evaluation system for the collaborative activities. Activities include: improving TB infection control in health care and other settings, enhancing TB/HIV diagnostic capacity, and harmonize data collection tools and local, national and international TB/HIV indicators.
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