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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Early-warning indicators to prevent stock-outs and overstocking of antiretroviral, antituberculosis and antimalaria medicines.
The provision of safe and efficacious blood and blood components for transfusion or manufacturing use involves a number of processes, from the selection of blood donors and the collection, processing and testing of blood donations to the testing of patient samples, the issue of compatible blood and ...its administration to the patient. There is a risk of error in each process in this “transfusion chain” and a failure at any of these stages can have serious implications for the recipients of blood and blood products. Thus, while blood transfusion can be life-saving, there are associated risks, particularly the transmission of bloodborne infections.
Screening for transfusion-transmissible infections (TTIs) to exclude blood donations at risk of transmitting infection from donors to recipients is a critical part of the process of ensuring that transfusion is as safe as possible. Effective screening for evidence of the presence of the most common and dangerous TTIs can reduce the risk of transmission to very low levels.
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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.
The project will support preventive actions, traditional medicine and the coordination and
implementation capacities of the national framework for HIV/AIDS control.
The recommendations cover the level of blood pressure to start medication, what type of medicine or combination of medicines to use, the target blood pressure level, and how often to have follow-up checks on blood pressure. In addition, the guideline provides the basis for how physicians and other h...ealth workers can contribute to improving hypertension detection and management.
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As we approach World Asthma Day on the May 2, 2023, we reflect on the theme “ Asthma Care for All”. Prevalence of Asthma is increasing amongst children, adolescents and adults. Under-diagnosis, underutilization of inhaled corticosteroids, inaccessibility of treatment, and unaffordability of medi...cines are amongst the challenges that low-middle income countries are faced with. This commentary seeks to highlight the challenges, the resources available and to suggest recommendations that can be implemented to improve asthma care for all and reduce burden of asthma in Africa.
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his first edition describes the standard operating procedures for health products for NTDs amenable to preventive chemotherapy and the medicines donated to treat them. These include albendazole for lymphatic filariasis and soil-transmitted helminthiases; azithromycin for trachoma and yaws; diethylca...rbamazine citrate for lymphatic filariasis; ivermectin for onchocerciasis and lymphatic filariasis; mebendazole for soil-transmitted helminthiases; praziquantel for schistosomiasis; and triclabendazole for foodborne trematodiases. Standard operating procedures for diseases amenable to case management will be covered in subsequent editions, including the application process for requesting medicines (Chapter 1). In the meantime, the procedures described in the rest of the document apply for both case management and preventive chemotherapy NTD health products.
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The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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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 situation. 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
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Issue Brief 31: Antimicrobial resistance (AMR) can occur when viruses, bacteria, parasites and fungi change over time. There is no longer a response to medicines, and the infection treatment gets really difficult which increases the risk of a disesase spread, which can lead to severe health problems.... AMR is an increasing threat to global public health worldwide that requires cross-sectional and cross-disciplinary action. It is present in every country and is spurred by several human-made factors, including over- and/or inadequate use of antibiotics, poor hygiene and infection prevention control, and excessive usage of antibiotics outside the health care sector e.g. in life stock production.
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This guideline is intended to provide requirements to applicants wishing to submit
applications for registration of medicines in Botswana.
The Multi-professional Patient Safety Curriculum Guide (2011) was developed to assist in the teaching of patient safety in universities and schools in the fields of dentistry, medicine, midwifery, nursing and pharmacy. It also supports the on-going training of all health care professionals.
The C...urriculum Guide is comprised of two parts. Part A is a teachers’ guide designed to introduce patient safety concepts to educators. It relates to building capacity for patient safety education, programme planning and design of the courses. Part B provides all-inclusive, ready-to-teach, topic-based patient safety courses that can be used as a whole, or on a per topic basis. There are 11 patient safety topics, each designed to feature a variety of ideas and methods for patient safety learning. Universities are encouraged to start with Part A which provides comprehensive advice on how to introduce and build patient safety courses.
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Antimicrobial resistance (AMR) is described as a situation when bacteria, viruses, fungi and parasites
change over time and no longer respond to medicines, making infections harder or impossible to treat,
and increasing the risk of disease spread, severe illness and death.1 AMR in recent years has... become
a global priority in public health due to its widespread consequences and increasing occurrence from
time to time. AMR has a formidable impact where the existing antibiotics and other antimicrobial
medicines become ineffective, and infections become increasingly difficult or impossible to treat.
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One of the many gender inequities in the health and care workforce that COVID-19 has exposed is around the fit and design of Personal Protective Equipment (PPE). The rapid onset and scale of COVID-19 led to shortages of PPE in most countries, causing preventable infection and mortality among healthc...are workers and others on the front lines. Even though most health workers are women, manufacturing specifications for medical PPE are usually drawn up based on the male body and there have been many reports of PPE not designed for women's bodies. WGH undertook a global research project to document the challenges women health workers have faced.
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How to address the global crisis in antibiotic research and development.
The report includes a comprehensive summary and critical evaluation of recent initiatives to overcome the barriers to achieve sustainable access to antibiotics. As antibiotic resistance will continue to develop as long as we ...depend on these medicines to treat bacterial infections, a continuous supply of new effective antibiotics is needed. The report identifies five key challenges that must be solved in order to achieve sustainable access for all, and charts out options for governmental action in response to each of them.
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Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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One health Response to AMR Containment.
In a significant move for the public health sector, Kerala has become the first state in India to launch an action plan to combat the growing cases of antimicrobial immunity, arising primarily from irrational use of medicines and excessive antibiotics used in... livestock and poultry.
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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 medicines commonly used to cure Plasmodium vivax malaria, as well as from... other medicines and substances.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential 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.>
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