These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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These guidelines present evidence-based recommendations and best practice statements on use of medically important antimicrobials in food-producing animals, based on the WHO list of critically important antimicrobials for human medicine (WHO CIA List). These guidelines aim primarily to help preserve... the effectiveness of medically important antimicrobials, particularly those antimicrobials judged to be critically important to human medicine and also help preserve the effectiveness of antimicrobials for veterinary medicine, in direct support of the WHO global action plan on antimicrobial resistance
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Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spreading rapidly and require urgent solutions.
Gr...am-negative bacteria, such as Klebsiella pneumoniae and Escherichia coli, can cause severe and often deadly infections that pose a particular threat for people with weak or not yet fully developed immune systems, including newborns, ageing populations, people undergoing surgery and cancer treatment.
The report highlights a worrying gap in activity against the highly resistant NDM-1 (New Delhi metallo-beta-lactamase 1), with only three antibiotics in the pipeline. NDM-1 makes bacteria resistant to a broad range of antibiotics, including those from the carbapenem family, which today are the last line of defence against antibiotic-resistant bacterial infections.
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A role for nuclear techniques
Antimicrobials play a critical role in the treatment of human and animal (aquatic and terrestrial) diseases, which has led to their widespread application and use. Antimicrobial resistance (AMR) is the ability of microorganisms to stop an antibiotic, such as an antimic...robial, antiviral or antimalarial, from working against them. Globally, about 700 000 deaths per year arise from resistant infections as a result of the fact that antimicrobial drugs have become less effective at killing resistant pathogens. Antimicrobial chemicals that are present in environmental compartments can trigger the development of AMR. These chemicals can also cause antibiotic-resistant bacteria (ARB) to further spread antibiotic resistance genes (ARG) because they may have an evolutionary advantage over non-resistant bacteria.
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In aquaculture, antibiotics have been used mainly for therapeutic purposes and as prophylactic agents. The contribution to antimicrobial resistance of antibiotics used in aquaculture is reviewed here, using a risk analysis framework. Some recommendations on responsible conduct in this context are pr...oposed, aimed at diminishing the threat of build up of antimicrobial resistance.
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This publication describes an arduous campaign to tackle the use of antimicrobials - specifically antibiotics - in the Danish swine-producing sector thanks to the collaboration between the regulatory sector within the Ministry of Environment and Food, private veterinary practitioners and swine produ...cers. The document is a retrospective tribute to all those who had the foresight to make significant changes to ensure consumer protection - improving hygiene at primary sites, developing options for intervention, identifying sites for intervention, setting targets, restructuring the relationship between the veterinary services and farmers, and implementing changes in behaviour for greatest impact
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These guidelines form part of efforts to institutionalise the prevention and containment of antimicrobial resistance (AMR) in health care facilities in South Africa, as outlined in the Antimicrobial Resistance Strategic Framework and Implementation Plan. The focus of these guidelines is on two inte...rrelated aspects of prevention of healthcare associated infections (HAIs) and their spread; and the application of antimicrobial stewardship (AMS) practices at hospital level.
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AMR is one of the Key priority of the global health security agenda action package, as well as it is one of the commitments of Ministry of Public Health Afghanistan to combat AMR. In Afghanistan because of war and some other political issues the borders of the country are not well secured and well c...ontrolled therefore control of smuggling of medicine is a big challenge in front of the rational use of medicine. Lack of knowledge (professionals and public), poor economic state, conflict of war, presence of remote areas and etc…. are the other main challenges for this to won the battle of combating AMR.
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Antimicrobials are precious agents for combating infectious diseases and had saved millions of lives throughout the world. However, the current trend of increasing antimicrobial resistance (AMR) has become a global health problem with increased morbidity and mortality in infectious diseases. Sri La...nka is not an exemption and face many health related issues with multidrug resistant (MDR) organisms. Currently there is a global effort in combating antimicrobial resistance. WHO extends its fullest support and plays a major role in motivating the countries to combat antimicrobial resistance with national action plans in place. Sri Lanka has initiated combating AMR with multisectoral collaboration, under one health concept. The development of the National Strategic Plan (NSP) 2017-2022 provides the roadmap to combat AMR.
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Stewardship is defined as “the careful and responsible management of something entrusted to one’s care”. It was originally applied in the health-care setting as a tool for optimizing antimicrobial use, termed “antimicrobial stewardship” (AMS). Stewardship has since be...en applied in the context of governance of the health sector as a whole, taking responsibility for the health and well-being of the population and guiding health systems at the national and global level.
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The systematic surveillance of antibiotic use and antibiotic re-sistance prevalence in humans and animals is imperative for managingbacterial infectious disease (JPIAMR, 2019;WHO, 2015). Many low-income countries currently face substantial challenges in building national surveillance systems due to ...a lack of infrastructure and resources,resulting in a shortage of systematic data (FAO/OIE/WHO, 2018)
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The infectious disease burden in India is among the highest in the world. A large amount of antibiot-ics are consumed in fighting infections, some of them saving lives, but every use adding to antibiotic resistance in bacteria. Antibiotic use is increasing steadily (table 1), particularly ... certain antibiotic classes (beta-lactam antibacterials), most notably in the more prosperous states. Resistance follows in lock-step.
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Overuse of antimicrobial agents occurs globally in both community and hospital settings. Misuse of antibiotics can lead to a variety of adverse outcomes, including the development of antimicrobial resistanceand increased cost of hospitalization. This issuehas been particularly problematic in de...veloping countries, where antibiotic-management programs rarely exist and where antibiotics can be purchased without aprescription. In Thailand, the rate of antibiotic resistance among gram-positive and gram-negative or-ganisms has increased significantly over the past decade. These findings provide compelling evidence ofthe need for more-rational use of antimicrobial agents in Thailand.
Clinical Infectious Diseases2006; 42:768–752006 by the Infectious Diseases Society of America.
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WHO would like to express its gratitude and appreciation to all Member States that provided information to the WHO survey on policies and activities at the national level in the area of antimicrobial resistance. The contribution of staff in WHO Regional and Country Offices has been invaluable: in ga...ther-ing original data and information from Member States, in supporting the process of aggregation of these data; and in reviewing the regional analysis of the findings that reflect the country situation at the point when the survey was conducted. The support and commitment of the members of the WHO Task Force on Antimicrobial Resistance, comprising WHO staff from Headquarters and Regional Offices has, is also acknowledged.
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