Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP... shall be used as a standard to justify GMP status, which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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The occurrence of a high percentage of couterfeit medicines on the global medicines market is often attributed to a lack of effective regulation and a weak enforcement capacity. This review, while f...ocusing on counterfeit medicines and medical devices in developing countries, will present information on their impact and how these issues can be addressed by regulation and control of the supply chain using technology appropriate to the developing world.
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Antimicrobial resistance (AMR) is a threat to global health and development and it contributes to millions of deaths worldwide each year. Inappropriate use and overuse of antibiotics are driving an increase in AMR and have a detrimental impact on the effectiveness of these critical ...ibute-to-highlight medbox">medicines. Through the Global Action Plan on AMR, WHO is working to improve the surveillance of antimicrobial resistance and reduce inappropriate antibiotic consumption.
There is a recognized need for high-quality resources to improve antibiotic prescribing globally. To address this need, a pragmatic approach was taken by WHO to develop actionable guidance for empiric antibiotic use.
The WHO AWaRe (Access, Watch, Reserve) antibiotic book provides concise, evidence-based guidance on the choice of antibiotic, dose, route of administration, and duration of treatment for more than 30 of the most common clinical infections in children and adults in both primary health care and hospital settings. The information included in the book supports the recommendations for antibiotics listed on the WHO Model Lists of Essential Medicines and Essential Medicines Children and the WHO AWaRe classification of antibiotics.
The WHO AWaRe antibiotic book is accompanied by summary infographics for each infection for both adults and children that provide a quick-reference guide for health care workers at the point of care.
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Accessed on 31.03.2023
COUNTDOWN Nigeria has applied a Participatory Action Research (PAR) approach to improve equity of Mass Administration of Medicines (MAM) and inform Neglected Tropical Dise...ase (NTD) policy through an enhanced community engagement strategy. A situational analysis conducted in 2016 identified community engagement as a
bottleneck to achieving equitable coverage of MAM within different and emerging contexts (border, migrant, rural and urban) of Nigeria, related to programmatic, social, political and environmental changes over time See: (Dean et al., 2019), (Oluwole et al., 2019) and (Adekeye et al., 2019)
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Global HIV control funding falls short of need. To maximize health outcomes, it is critical that national governments sustain reasonable commitments, and that international donor assistance be distributed according to country needs and funding gaps.... We develop a country classification framework in terms of actual versus expected national domestic funding, considering resource needs and donor financing. With UNAIDS and World Bank data, we examine domestic and donor HIV program funding in relation to need in 84 low- and middle-income countries. We estimate expected domestic contributions per person living with HIV (PLWH) as a function of per capita income, relative size of the health sector, and per capita foreign debt service.
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The aim of the framework is to provide guidance to Member States and partners on region-specific priority actions towards the goals, targets and milestones of the GTS. The central pillar of the framework is the adoption of programme phasing and tran...sitioning, aimed at facilitating a tailored approach to malaria control/elimination. This is in response to the increasing heterogeneity of malaria epidemiology among and within countries of the region.
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This global status report on prevention and control of NCDs (2014), is framed around the nine voluntary global targets. The report provides data on the current situation, identifying bottlenecks as well as opportunities and priority ...ribute-to-highlight medbox">actions for attaining the targets. The 2010 baseline estimates on NCD mortality and risk factors are provided so that countries can report on progress, starting in 2015. In addition, the report also provides the latest available estimates on NCD mortality (2012) and risk factors, 2010-2012.All ministries of health need to set national NCD targets and lead the development and implementation of policies and interventions to attain them. There is no single pathway to attain NCD targets that fits all countries, as they are at different points in their progress in the prevention and control of NCDs and at different levels of socioeconomic development. However all countries can benefit from the comprehensive response to attaining the voluntary global targets presented in this report.
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This user guide is designed to provide national malaria control programmes with general information on glucose-6-phosphate dehydrogenase (G6PD) deficiency. Individuals with this condition may be at risk of adverse effects from ...-to-highlight medbox">medicines commonly used to cure Plasmodium vivax malaria, as well as from other medicines and substances.
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The manufacturing process is one of the key steps where quality control is required to ensure quality of medicinal products, including herbal medicines. Good manufacturing practices (GMP) is one of ...the most important tools for this measure.
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The Pharmacovigilance team in WHO aims to assure the safety of medicines and vaccines by ensuring reliable and timely exchange of information on safety issues, promoting pharmacovigilance activities... throughout the Organization and encouraging participation in the WHO Programme for International Drug Monitoring. This text was developed in consultation with the WHO Collaborating Centre for International Drug Monitoring and the national pharmacovigilance centres participating in the WHO Programme for International Drug Monitoring.
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After years of relative calm, Zimbabwe has been grappling with a cholera outbreak since 12 February 2023. This resurgence is not an isolated incident, as 10 more countries (Malawi, Mozambique, Somalia, Kenya, Ethiopia, Zambia, South Sudan, Burundi, Tanzania and South Africa) in Eastern and Southern ...Africa are facing similar challenges with cholera an acute watery diarrhea.
To date, a total of 13,176 suspected cases and 1,543 confirmed cases have been reported.This stark reality underscores the need for continued coordinated action to control the spread of this preventable disease.
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Specific measures are being taken within the National Tuberculosis Control Programme (NTP) to address the MDR TB problem through appropriate management of patients and strategies to prevent the propagation and dissemination of MDR TB.
The term ..."Programmatic Management of Drug Resistant TB" (PMDT) refers to programme based MDR TB diagnosis, management and treatment. This guideline promotes full integration of basic TB control and PMDT activities under the NTP, so that patients with TB are evaluated for drug resistance and are placed on the appropriate treatment regimen and properly managed from the outset of treatment, or as early as possible. The guidelines also integrate the identification and treatment of more severe forms of drug resistance, such as extensively drug resistant TB (XDR TB).
At the end, the guideline introduces new standards for registering, monitoring and reporting outcomes of multidrug resistant TB cases.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop...ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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This guideline covers making people aware of how to correctly use antimicrobial medicines (including antibiotics) and the dangers associated with their overuse and misuse. It also includesmeasures to prevent and ...edbox">control infection that can stop people needing antimicrobials or spreadinginfection to others. It aims to change people's behaviour to reduce antimicrobial resistance and thespread of resistant microbes.
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Healthy communities rely on well-functioning ecosystems. They provide clean air, fresh water, medicines and food security. They also limit disease and stabilize the climate. But biodiversity loss is happening at unprecedented rates, impacting human ...health worldwide, according to a new state of knowledge review of the Convention on Biological Diversity (CBD) and WHO.
The report synthesizes the available information on the most important inter-linkages between biodiversity, ecosystem stability, and epidemic infectious diseases such as the Ebola virus; and the connection between biodiversity, nutritional diversity and health. It also covers the potential benefits of closer partnerships between conservation and health, from improved surveillance of infectious diseases in wildlife and human populations, to promoting access to green spaces to promote physical activity and mental health. It also highlights the many areas in which further research is needed.
The Joint report hopes to provide a useful reference for the Sustainable Development Goals and post-2015 development agenda, which represents an unique opportunity to promote integrated approaches to biodiversity and health by highlighting that biodiversity contributes to human well-being, and highlighting that biodiversity needs protection for development to be sustainable.
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This was a Phase 3, multi-center, randomized, open-label, parallel-group, active control study where 273 male and female patients with first stage Trypanosoma brucei gambiense HAT were treated at si...x sites: one trypanosomiasis reference center in Angola, one hospital in South Sudan, and four hospitals in the Democratic Republic of the Congo between August 2005 and September 2009 to support the registration of pafuramidine for treatment of first stage HAT in collaboration with the United States Food and Drug Administration. Patients were treated with either 100 mg of pafuramidine orally twice a day for 10 days or 4 mg/kg pentamidine intramuscularly once daily for 7 days to assess the efficacy and safety of pafuramidine versus pentamidine. Pregnant and lactating women as well as adolescents were included.
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Health care waste management (HCWM) and infection prevention and control (IPC) represent serious concerns for HIV programs. Improperly handled infectious health care waste poses risks to health workers, their clients, the community, and the environm...ent. Improper injection practices can lead to new HIV and other infections for health workers and clients. Beginning in 2015, AIDSFree continued the work started by the Government of Nigeria and USAID in 2004 to strengthen activities in IPC and HCWM. This report describes AIDSFree's results over 15 months of implementation of HCWM and IPC activities in seven Nigerian states prioritized by the U.S. President's Emergency Plan for AIDS Relief (PEPFAR)
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Asthma can be a serious disease, but if you understand
the disease and take the right medication to control it, you
should have no problems or symptoms due to your asthma,
even when you are pregnant. To be free from asthma
attacks, you should al...so check your lung function and use
an action plan if any symptoms occur.
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A survey was conducted in countries in all six WHO regions and focused on the building blocks that are considered prerequisites to combat antimicrobial resistance: a comprehensive national plan, laboratory capacity to undertake surveillance for resistant microorganisms, access to safe, effective ant...imicrobial medicines, control of the misuse of these medicines, awareness and understanding among the general public and effective infection prevention and control programmes.
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• provide scientific information on the safety, efficacy, and quality control/ quality assurance of widely used medicinal plants, in order to facilitate their appropriate use in Member States;
• provide models to assist Member States in develop...ing their own mono- graphs or formularies for these or other herbal medicines; and
• facilitate information exchange among Member States.
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