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The growing challenges for people in low and middle-income countries to access new medicines.
Analysis 58
European Scientific Journal, November edition vol. 8, No.26 ISSN: 1857 – 7881 (Print) e - ISSN 1857- 7431
Accessed: 29.09.2019
PQDx 0027-012-00 WHO
PQDx Public Report
May/2017, version 4.0
PQDx 0033-013-00 WHO
PQ Public Report
July/2016, version 5.0
PQDx 0006-005-00 WHO
PQDx PR
February/2016, version 2.0
PQDx 0053-006-00 WHO
PQ Public Report
June/2016, version 2.0
PQDx 0018-010-00 WHO
PQDx PR
July/2016, version 3.0
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
...
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
...
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
...
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
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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
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HIV/AIDS Programme
Public Report
PQMC 0003-003-00 WHO PQMC PR June/2015, version 2.0
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
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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
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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
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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
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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
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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
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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
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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
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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
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COVID-19 has turned the world upside down. Everything has been impacted. How we live and interact with each other, how we work and communicate, how we move around and travel. Every aspect of our lives has been affected.
COVID-19 disproportionately affects the poor and vulnerable. Community health workers are poised to play a pivotal role in fighting the pandemic, especially in countries with less resilient health systems. Drawing from practitioner expertise across four WHO regions, this article outlines the targete
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This guide contains recommendations for health and safety practices and approaches to COVID-19 prevention, based on materials developed by many organisations.
The speed of developing diagnostics for SARS-CoV-2, the causative agent of coronavirus disease 2019 (COVID-19), has been quite remarkable. Diagnostics have focused on nucleic acid amplification testing (NAAT) to identify infected individuals in acute-phase disease for timely implementation of mitiga
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The outbreak of COVID-19 comes with unpredictable primary and secondary impacts on vulnerable and food-insecure populations across the world. Mortality and morbidity appear to be most acute for elderly people, and those with underlying health conditions. At the same time, the widely anti
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Version 4
The purpose of these standard operating procedures (SOPs) is to offer policy guidance and to provide performance standards on how to respond to any type of poliovirus outbreak or event in a timely and effective manner, and specifically, to stop an outbrea
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2020 is a critical year for our Joint Programme as we collectively define the path to getting back on track to ending the AIDS epidemic by 2030. Our revised timelines for adoption of the next strategy are highly ambitious. We need the full support of all the tremendously dedicated people in UNAIDS-w
...
Global procurement for COVID-19 vaccines
As part of our commitment to the fight against NCDs, Nigeria was signatory to the political declaration at the UN General Assembly High Level Meeting on NCDs in September 2011. Thus, the purpose of this document is to develop and ensure the implementation of policies and p
...
The pandemic presents tough choices for governments, local communities, health and school systems, as well as families and businesses: How to re-open safely? How to safeguard people’s lives and protect their livelihoods? Where to allocate scarce resources? How to protect those unable to protect th
...
The document "Priority medical devices list for the COVID-19 response and associated technical specifications" complements this guideline.
This document provides interim guidance on the quality, performance characteristics and related standards of personal protective equipment (PPE) to be used i
...
The publication provides an overview and analysis of international instruments that set standards related to the use of antimicrobials across the human, animal and plant sectors, and their release into the environment. The purpose of the document is to identify existing instruments and standards in
...
This article is part four in a series of explainers on vaccine development and distribution
Available in different languages
This article is part two in a series of explainers on vaccine development and distribution. Part one focused on how vaccines work to protect our bodies from disease-carrying germs. This article focuses on the ingredients in a vaccine and the three clinical trial phases. Part three outlines the nex
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August 2020, The Africa Joint Continental Strategy for COVID-19 is underpinned by the need to limit transmission, prevent deaths and reduce associated harms. Participation by African nations in clinical trials is an essential step to ensure that sufficient data is generated on the safety and efficac
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9 September 2020
In a snapshot, fair allocation of vaccines will occur in the following way:
An initial proportional allocation of doses to countries until all countries reach enough quantities to cover 20% of their population
This document is also available in Arabic | Chinese | French | R
...
Working Document Nov. 2020
The COVAX Supply and Logistics workstream lead by UNICEF, Gavi and WHO have released a working copy of the COVID-19 Vaccination, Country Readiness & Delivery: Supply and Logistics Guidance. Countries might find this Guide useful when developing and strengthening their sup
...
Summary of the Ethopian country office of WHO on COVID-19 activities.
Join the campaign to call on countries and companies to ensure that by the time World Health Day arrives on 7 April, COVID-19 vaccines are being administered in every country, as a symbol of hope for overcoming both the pandemic and the inequalities that lie at the root of so many global health chal
...
Manufacturers:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) ir
...
1 March 2021
This article is part of a series of explainers on vaccine development and distribution. Learn more about vaccines – from how they work and how they’re made to ensuring safety and equitable access – in WHO’s Vaccines Explained series.
The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in
...
10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto
...
This article is part of a series of explainers on vaccine development and distribution. Learn more about vaccines – from how they work and how they’re made to ensuring safety and equitable access – in WHO’s Vaccines Explained series.
Vaccines are supported by decades of medical research.
...
Background paper 7
The Independent Panel for Pandemic Preparedness and Response
May 2021
Background paper 13
The Independent Panel for Pandemic Preparedness and Response
May 2021
Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to
...
12 February 2021
Training on handling, storing and transporting Pfizer BioNTech COVID-19 Vaccine COMIRNATY® (Tozinameran)
recommended
4 August 2021. Currently, Pfizer BioNTech COVID-19 Vaccine COMIRNATY® (Tozinameran) is the only COVID-19 vaccine that should be stored and transported at -60ºC to -86ºC ultra-low temperature (ULT) conditions. Prior to use the vaccine can be transferred to -20ºC freezer or +2-8ºC refrigerator at
...
The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirements, accessories, hardware and software packages listed in the following specifications are described in
...
This training module is designed to equip HWs with knowledge and communication skills to build their confidence and support them in their ability to promote acceptance of COVID-19 vaccination among other HWs.
обновленная версия от 04/10/2021
Информация о введении вакцин
High prices, hard-to-access human insulin, few insulin producers, and weak health systems are just some of the barriers that people with diabetes face a century after insulin was discovered, WHO notes in a new report
This guidance should be followed if an unlicensed medicine is prepared in
a registered pharmacy. The preparation of an unlicensed medicine (for
example unlicensed methadone, or menthol in aqueous cream) in a pharmacy is called ‘extemporaneous preparation’.
The guidance should be read alon
...
WHO/UNICEF/UNFPA joint statement
Three Years After Enactment of the Drug Quality and Security Act
European Journal of Biomedical and Pharmaceutical Sciences, vol.3 (2016) 1, 192-206
This review shows that if all sub areas of pharmaceutical waste management can efficiently work back to back environmental pollution and dangers to human health can reduce significantly.
Global UNIDO Project: Strengthening the local production of essential medicines in least developed and developing countries
9 Febr. 2022
The COVID Covovax™ (SIIPL) and Nuvaxovid™ (Novavax) vaccine explainer includes key vaccine specific information on the vaccine specific requirements.
PHARMA’S RESPONSE TO THE COVID-19 VACCINES CRISIS. Update Feb., 14, 2022. In September 2021, Amnesty International published A Double Dose of Inequality, which assessed the extent to which the pharmaceutical industry was restricting access to Covid-19 vaccines. This report updates that assessment
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22 Sept. 2021
The rapid development of effective Covid-19 vaccines in 2020 gave hope to the world in the darkest days of the deadly pandemic. However, the vaccine roll-out has been massively skewed towards wealthy nations. While rich states have hoarded vaccines, companies have also played a decisi
...
The Kenyan Health Sector has been playing a critical role in
providing health care services in response to the population
needs in line with the Kenya Health Policy, 2014-2030’s goal
of attaining the highest possible health standards in a manner
responsive to the population needs.
In 2018, the Intergovernmental Panel on Climate Change announced that to restrict global temperature rise to 1·5°C, greenhouse gas emissions must decrease 45% by 2030 compared with 2010, and reach net zero by 2050.1
Antibiotics 2022, 11(3), 329; https://doi.org/10.3390/antibiotics11030329.
The authors found that the most-represented antibiotics on the Rwandan market were amoxicillin, co-trimoxazole and cloxacillin. No counterfeit antibiotics were found in this study. However, substandard batches with moderate
...
Joule 5, 2687–2714 October 20, 2021 Cell Press
Environmental pollution, protection, quality and sustainability
This report’s central premise is that diagnostics and therapeutics, and associated test to treat strategies, are fundamental components of the pandemic response, both for COVID-19 and for future health threats. Two years into the COVID-19 pandemic, this report reflects on the main challenges and k
...
The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards
the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized
...
This document outlines the working structure and guiding principles for collaboration of COVAX, the Vaccines pillar of the Access to COVID-19 Tools Accelerator (ACT-A). The working structure of COVAX continues to adapt to emerging needs and the changing trajectory of the pandemic. Some components of
...
In one of his final essays, statesman and former United Nations secretary general Kofi Annan said, ‘Snakebite is the most important tropical disease you’ve never heard of’. Mr. Annan firmly believed that victims of snakebite envenoming should be recognised and afforded greater efforts at impro
...
The report aims to capture lessons from the COVID-19 pandemic and to highlight the opportunity for more ambitious global action: expanding sustainable access to vaccines for all towards the Immunization Agenda 2030 and pandemic prevention, preparedness and response efforts. The report is organized i
...
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
...
CEPI is seeking to raise $3.5 billion to implement CEPI’s next 5-year plan. To mitigate the immediate threat of COVID-19 variants, it is activating key elements of this plan now—and seeking to mobilise a portion of this $3.5 billion in 2021. We have already launched R&D programmes to initiate de
...
As a global community of +750 representatives of the world’s civil society, the C20 official Engagement Group of the G20 is submitting a list of policy priorities for the upcoming G20 Finance Ministers & Central Bank Governors meeting on July 18th and the G20 Extraordinary Sherpa Meeting on July 2
...
Previous advocacy efforts have achieved tangible goals in terms garnering political commitments
to increase financing for TB—as seen at the 2018 UN High-Level Meeting on TB. The challenge
now is to ensure that these commitments are actually met within a global biomedical research
ecosystem that
...
In line with the Climate and Environment Charter for Humanitarian Organisations which IFRC, ICRC and various Red Cross Red Crescent National Societies have endorsed, this short Guide aims to help practitioners integrate environmental and climate change considerations into their work. It has been dev
...
Zimbabwe has, over the years, grappled with the repercussions of the climate crisis, which have led to erratic rainfall patterns characterized by either severe floods or prolonged periods of drought. The nation has experienced a concerning trend of numerous regions reporting rainfall levels below th
...
