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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.
The fight against fake drugs by NAFDAC in Nigeria
The fight against fake drugs by NAFDAC in Nigeria Olike Chinwendu
KIT (Royal Tropical Institute) Development Policy & Practice Vrije Universiteit Amsterdam
(2008)
CC
Review over the work and challenges of the Nigerian National Agency for Food and Drug Administration and Control (NAFDAC) in combatting counterfeiting of medicines in Nigeria.
Fact Book on WHO Level I and Level II monitoring indicators - To monitor the progress of efforts to improve the global medicines situation, WHO has developed a system of indicators that measure important aspects of a country’s pharmaceutical situa
...
tion. Level 1 indicators measure the existence and performance of key national pharmaceutical structures and processes. Level II indicators measure key outcomes of these structures and processes in the areas of access, product quality and rational use. These indicators can be used to assess progress over time; to compare situations between countries; and to reassess and prioritize efforts based on the results.
This Fact Book gives the results of the assessment of Level I indicators conducted in 2003 and of Level II indicator surveys conducted between 2002 and 2004
more
Replacement of Annex 2 of WHO Technical Report Series, No. 964
...
Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
more
more
The Ministry of Health has developed the first version of the Service Standards and Service Delivery Standards for the health sector in Uganda. The main objective is to provide a common understanding of what is expected by the public, service users and service providers in ensuring provision of cons
...
istently high quality service delivery. These standards also provide a roadmap for improving the quality, safety and reliability of healthcare in Uganda.
The application of these standards is expected to improve transparency and accountability in service delivery; fairness and equity in service provision; building a culture of quality management; regulation, management and control of public and private providers; and management of expectations of service recipients. more
The application of these standards is expected to improve transparency and accountability in service delivery; fairness and equity in service provision; building a culture of quality management; regulation, management and control of public and private providers; and management of expectations of service recipients. more
This compendium collates current tools and resources on quality improvement developed by the WHO Service Delivery and Safety Department and provides examples of how the tools and resources have been applied in country settings. The target audience f
...
or this document are ministries of health, facility quality improvement teams, researchers and development agencies. WHO technical programmes, regional and country offices can also use the document in their technical cooperation work with the identified audience. Those working to improve the quality of health service delivery can also make good use of this resource
more
Q 12: In children and adolescents with anxiety disorders, what is the effectiveness and safety, considering system issues in low- and middle-income countries, of using pharmacological interventions in non-specialist settings?
he refugee flow to Ethiopia continued during 2018, with 36,1351 persons seeking safety and protection within the country’s borders. At the start of 2019, the nation hosted 905,8312 thousand refugees who were forced to flee their homes as a result
...
of insecurity, political instability, military conscription, conflict, famine and other problems in their countries of origin. Ethiopia is one of the largest refugee asylum countries world-wide, and the second largest in Africa, reflecting the ongoing fragility and conflict in the region. Ethiopia provides protection to refugees from some 26 countries. Among the principal factors leading to this situation are predominantly the conflict in South Sudan, the prevailing political environment in Eritrea, together with conflict and draught in Somalia.
more
Revised working paper following AVAREF meeting February 2019.
WHO has published a roadmap aiming to coordinate partners’ actions and contributions to the licensing and roll-out of Merck’s Ebola vaccine (VSV-ZEBOV) in African countries. The vaccine was developed during the West Africa Ebola epi
...
demic of 2014-2016, during which more than 11 000 people lost their lives to the disease. The vaccine was tested in European and African countries at the time and is currently used under an “expanded access” protocol in the Democratic Republic of Congo.
WHO will expedite prequalification and licensing of the vaccine for use in countries at risk of Ebola outbreaks and will coordinate work between those countries’ regulatory authorities and the European Medicines Agency and the US Food and Drug Administration.
more
In recognition of the growing problem of antimicrobial resistance (AMR), its increasing threat to human, animal and plant health, and the need for a One Health approach to address this issue, the 39th Session of the Codex Alimentarius Commission (CAC) agreed it was important for the food
...
safety community to play its part and re-established the ad hoc Codex Intergovernmental Task Force on Antimicrobial Resistance (TFAMR) ). The objectives of the Task Force were
to revise the current Codex Code of Practice to Minimise and Contain Antimicrobial Resistance and to develop new guidance on surveillance programmes relevant to foodborne AMR.
more
Antimicrobial resistance has become one of the most eminent threats to global health and a rising concern for healthcare specialists. All around the world, many common infections are becoming resistant to the antimicrobial medicines used to treat th
...
em, resulting in high morbidity and mortality with serious social and economic implications. Additionally, there are few new antibiotics being developed but they are expensive and are not new classes. Antimicrobials are critical in the management of infectious diseases. They are also essential tools for protecting animal health and welfare, and contribute in production of safe food. Inappropriate use of antimicrobials can lead to resistance which is known as the antimicrobial resistance (AMR) resulting in high morbidity and mortality with serious social and economic implications.
more
The issue of Antimicrobial resistance has become one of the most substantial health issues, prompting the World Health Assembly (WHA) to urge Member States to finalise tailor made national action plans by May 2017, aligning them with objectives of the Global Action Plan (GAP). These cover awareness,
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surveillance and research, hygiene infection prevention & control, optimal use of antimicrobial medicines and economic case for sustainable investment. Indonesia, by virtue of its geographical terrain and complex interactions with diverse stakeholders, indicates a higher burden of AMR. Most of the country’s data currently relies on local studies conducted by labs and universities. To get a more accurate estimate of the situation, one has to rely on results from the Regional Resistance Surveillance Programme. By undertaking such measure, Indonesia would acquire data to detect AMR trends at a national level.
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Antimicrobial agents play an indispensable role in animal health and welfare management. At the same time, the need for prudent use is obvious to ensure good food safety outcomes and to manage the potential risk of antimicrobial resistance. The emer
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gence of multi-resistant bacteria is posing challenges to health professionals and communities around the world for both human and animal health. These bacteria are not destroyed by the common antimicrobial agents and so pose a risk to people, particularly children, the elderly and those with poorly functioning immune systems, as well as to animals.
Throughout the years, the dairy sector has been very much aware of the need for responsible use and has, in many countries, implemented adequate measures throughout the dairy supply chain.
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As the number of transboundary pest and animal and foodborne disease outbreaks rises, so does the number of people who are chronically hungry due to these and other factors. The correlation can be explained by the link between our health and that of the planet. We rely on land and sea for the produc
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tion of safe and quality foods for our daily nourishment. Pests and disease epidemics negatively impact the quality, quantity and safety of our food sources, and cripple economic growth and efficiencies in production. Furthermore, the epidemic and endemic levels of the pathogens and disease vectors can be difficult to control. This is why FAO stresses and promotes the special efforts required for cost-effective preventive measures rather than the more expensive control, disinfestation, treatment and disposal measures. When preventive measures are late or difficult, preparedness and contingency plans must be in place to enable rapid response. Early warning systems, based on close monitoring, surveillance, and timely reporting are fundamental to warn and empower communities to safeguard their livelihoods and assets by enhancing disease and pest prevention measures and for government services to take immediate measures to protect communities and national economies.
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The era of effective antibiotics is coming to a close. In just a few generations, many “miracle medicines”have been beaten into ineffectiveness by the bacteria they were intended to eradicate. Bacteria quickly adapt to t
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he presence of antibacterial agents in order to survive. The misuse of antibiotics,which is an international problem, only exacerbates the steady evolution of resistance. In August 2010, the journal Lancet Infectious Diseases posed the question "Is this the end of antibiotics?" documentingthe rapid spread of multidrug-resistant bacteriaand predicting that 10 years remain in the useful life of many agents.
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23 April 2020EMA/202483/2020 Rev
Chloroquine and hydroxychloroquine are known to potentially cause heart rhythm problems, and these could be exacerbated if treatment is combined with other medicines, such as the antibiotic azithromycin, that have s
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imilar effects on the heart.
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Accessed: 02.05.2020
These interim IPC recommendations for health settings have been developed through the contributions of many individuals and institutions, such as the Centers for Disease Control-Kenya; ITECH; US Agency for International Development (USAID)
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Medicines, Technologies, and Pharmaceutical Services (MTaPS) Program; and WHO that are committed to ensuring that the transmission of COVID-19 to HCWs and the public within the health care setting is limited. The Ministry of Health (MOH) through the Directorate of Health Standards Quality Assurance and Regulations wishes to thank all the contributing authors led by the sub-committee on case management and IPC for the COVID-19 response for their expertise and time given to writing these guidelines.
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This guidance document has been produced by WHO to assist blood services in the development of national plans to respond to any emerging infectious threats to the sufficiency or safety of the blood supply, whether from an existing infectious agent t
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hat is changing in incidence and spread, or from a newly identified infectious agent. It is intended that this document be followed to guide the national blood service through the process of planning how to respond in a timely, controlled and appropriate way to any specific infectious threat that may subsequently emerge. It is acknowledged that it is not only the blood supply that may be affected by such emerging infectious threats; in those countries undertaking transplantation, the supply of cell, tissues and organs may also be threatened. Increasingly, blood services are taking overall national responsibility for transplantation in their capacity as the organization responsible for the collection, processing, storage and supply of cells, tissues and organs. This approach is both sensible and appropriate, as the overall donor selection and screening processes are the same or very similar. This guidance document can therefore also be used to assist those bodies responsible for the provision of cells, tissues and organs to prepare for an emerging infectious threat.
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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
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safety and efficacy of the most promising vaccine candidates among the region’s populations.
While current COVID-19 clinical trial activity on the continent is limited, Africa has substantial experience and capabilities to conduct clinical trials for preventative vaccines across a range of diseases, and many organizations on the continent are working tirelessly to help prepare additional trials on potential COVID-19 vaccines. As the number of candidate vaccines in the development pipeline continues to increase, it will be important for organizations responsible for managing clinical trials in the region to partner with vaccine developers to identify potential and appropriate trial locations, provide support to remove any critical obstacles impeding commencement and progress of trials, and to provide oversight ensuring that trials are conducted safely and ethically.
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7 June 2021
The Africa Regulatory Taskforce is a joint effort established by the Africa Centres for Disease Control and Prevention (Africa CDC), the African Union Development Agency (AUDA-NEPAD) coordinated African Medicines Regulatory Harmonizatio
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n (AMRH) Initiative, and the World Health Organisation’s (WHO) African Vaccine Regulatory Forum (AVAREF) to enable and provide support for an effective regulatory framework for COVID-19 Vaccines in Africa.
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