PQDx 0198-071-00
WHO PQDx PR
April/2016, version 2.0
PQDx 0005-005-00
WHO PQDx PR
May/2016, version 3.0
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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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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Textes du Codex concernant la résistance aux antimicrobiens d’origine alimentaire
Textos del Codex sobre la resistencia a los antimicrobianos transmitida por los alimentos
Antimicrobial resistance (AMR) is a major global public health concern and a food safety issue. When pathogens become r...esistant to antimicrobial agents they can pose a greater human health risk as a result of potential treatment failure, loss of treatment options and increased likelihood and severity of disease
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The Antimicrobial Resistance Benchmark has evaluated for the second time how the most important players in the antibiotic market are addressing the rise of resistance and the global need for appropriate access to antibiotics. Although we can see progress — it’s hanging by a thread.
We have reac...hed a tipping point where large and prominent drugmakers have retreated from the antibiotics field and smaller innovative biotech companies have gone bankrupt due to the poor financial rewards on offer.
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Antibiotic resistant bacteria are spreading at an alarming rate and some bacterial infections may once again be untreatable. Antibiotic resistance (ABR), conservatively calculated, causes more than 500 000 deaths every year. This number is projected to rise dramatically if radical actions are not ta...ken. Lack of effective antibiotics, diagnostics and vaccines threatens the health of millions and hampers fulfilment of several of the Sustainable Development Goals. Access to effective antibiotics should be part of every adult and child’s right to health.
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Public Report
PQMC 0003-003-00 WHO PQMC PR June/2015, version 2.0
Public Report
PQMC 0001-001-04 WHO PQMC Public Report November/2016, version 8.0
In concordance with the global and WHO activities on ARC, the Ministry of Health and Family Welfare (MoHFW) in Bangladesh has come forward and initiative was taken to conduct program for containment of antimicrobial resistance in Bangladesh. Director, Disease Control and Line Director, Communicable ...Disease Control, DGHS was selected as a national focal point to coordinate the national program. Since AMR is a multi-faceted problem, conduction of activities in well-coordinated manner through One Health approach is very important.
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Maldives has made significant strides in the area of infectious disease prevention and control. This is exemplified by elimination of malaria from Maldives in 2015 and successes in TB control. In addition, Maldives is a front runner in infectious disease prevention through successful water, sanitati...on, hygiene and vaccination campaigns and coverage. However, given the limited evidence that exists with respect to the occurrence of resistant organisms in the nation, it is hard to estimate the exact antimicrobial resistance (AMR) scenario. Also, it becomes difficult to compare the current situation with other countries in the region. Moreover, limited evidence exists on the trends of use of antimicrobial agents (AMA) in Maldives. Although, recent prescription audits have indicated overuse of antibiotics, especially for common conditions such as flu, cough and fever.
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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 Ghanaian Cabinet approved the antimicrobial resistance (AMR)Policy and Implementation plan(hereafter referred to as the national action plan or NAP)in December 2017, whilst the country case study was in progress. This has set in motion the implementation phase for Ghana, which is a long awaited... event since the drafting of the Policy started in 2011. This case study, whilst limited in its ability to interact with all stakeholders, has identified entrypoints within the operational divisions of Ghana Health Services,as potential areas where the AMR policy platform may seek to embed AMR activities. Much work has already been done within Ghana to identify the key entrypoints within the various ministries and government agencieswhere AMR can be incorporated. These stakeholders already form part of the AMR Policy Platform which is the governance structure for AMR and have been participating actively in the development of the AMR Policy and NAP activities formulation.
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The most significant finding of the case study for integrating antimicrobial resistance (AMR)into existing programs and mobilising resources for funding in Nigeria, is that most of the AMR activities within the Nigerian National Action Plan (NAP)canalready be incorporated within exi...sting programs of the Federal Ministry of Health (FMOH), Federal Ministry of Agriculture and Rural Development (FMARD) and their agencies or institutes. Certain programs and initiatives already have an AMR element incorporated or could,with little effort,include some additional AMR actions, however much is already being planned and has started with existing federal funding and existing staffing and other resources including development partner support and is being driven by significant political will from the ministries as well as implementation support from the Nigerian Centers for Disease Control as the focal point.
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Antimicrobials are used in veterinary medicine to treat infectious diseases in animals caused or complicated by microorganisms, mainly bacteria, or to prevent the development or spread of infection in healthy animals.
This situation analysis has gathered information about the current state of AMR, contributing factors and antimicrobial use in Zimbabwe from the human, animal, agricultural and environmental sectors. Data has been gathered from different sectors such as the general public, academia, the Ministry of ...Health and Child Care, the Ministry of Agriculture Mechanization and Irrigation Development and the Ministry of Environment, Water and Climate. It shows that AMR is a real concern in Zimbabwe and a threat to the health outcomes of humans, to the economic productivity of the livestock industry and a risk to the environment.
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Antibiotics have been useful in fighting infectious diseases in our country for decades, but because of the overuse and misuse of these agents, an increasing number of organisms are now resistant to them. The Philippines, like other Southeast Asian countries, has already been encountering the many c...hallenges of antimicrobial resistance (AMR) which include increasing social and economic costs and rising patient mortality. Although considered a global threat, it is already an emerging local health concern which calls for an urgent collaboration among different sectors to provide solutions addressing this growing problem.
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China is one of the major countries for the production and use of antibacterial agents. Antibacterial agents are widely used in healthcare and animal husbandry. It plays a significant role in treating infections and saving patient lives, preventing and treating animal diseases, improving farming ef...ficiency, and guaranteeing public health security. However, antimicrobial resistance has become increasingly prominent due to insufficient research and development capacity of new antimicrobials, sales of antimicrobials without prescriptions in pharmacies, irrational use of antibacterial agents in medical and food animal sectors, non-compliant waste emissions of pharmaceutical enterprises, as well as lack of public awareness toward rational use of antimicrobials. Bacterial resistance ultimately affects human health, but the cause of bacterial resistance and consequences are beyond the health sector. Antimicrobial resistance brings increasing biosecurity threats, worsens environmental pollution, constrains economic development and other adverse effects to human society, thus, there is an urgent need to strengthen multi-sectoral and multi-domain collaborative planning to jointly cope with this issue.
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10 May 2021
This scientific brief replaces the WHO Scientific Brief entitled “’Immunity passports’ in the context of COVID-19”, published 24 April 2020.
This update is focused on what is currently understood about SARS-CoV-2 immunity from natural infection. More information about considera...tions on vaccine certificates or “passports” will be covered in an update of WHO interim guidance, as requested by the COVID-19 emergency committee.
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