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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Über SARS-CoV-2-Testsysteme informieren das Bundesinstitut für Arzneimittel und Medizinprodukte (BfArM) und das Paul-Ehrlich-Institut. Die Informationen ergänzen sich, den rechtlichen Rahmen bietet u.a. die Coronavirus-Testverordnung-TestV.
Das BfArM bietet eine Liste von Antigen-Tests zum dir...ekten Erregernachweis des Coronavirus SARS-CoV-2 an. In dieser Liste befinden sich diejenigen Tests, die sich laut Herstellerangaben gemäß den Vorgaben des Medizinproduktegesetzes (MPG) rechtmäßig in Europa bzw. Deutschland in Verkehr befinden und alle vom Paul-Ehrlich-Institut in Abstimmung mit dem Robert Koch-Institut (RKI) festgelegten Mindestkriterien für Antigen-Tests erfüllen.
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Trypanosoma cruzi is the etiological agent of Chagas disease (CD), considered one of the most important parasitic infections in Latin America. Between 25 and 90 million humans are at infection risk via at least one of multiple infection mechanisms. Under natural conditions, the principal transmissio...n modes are transplacental or via one of more than 140 hematophagous triatomine bugs (Reduviidae: Triatominae). Triatomines acquire the parasite from mammal reservoirs due to their obligate blood-feeding (albeit triatomines can also feed on non-reservoir vertebrates such as birds and reptiles). The disease burden for CD in the Latin America and Caribbean region, based on disability-adjusted life-years (DALYs), is at least five times greater than that of malaria, and is approximately one-fifth that of HIV/AIDS. In recent decades, CD has extended to other continents outside natural reservoir or vector distributions due to human migration, with a minimum estimated 10 million individuals infected worldwide.
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BMC Public Health, Volume 18, Article number: 303 (2018)
https://doi.org/10.1186/s12889-018-5208-0
Published: 02 March 2018
Leptospirosis is an infectious disease caused by pathogenic organisms belonging to the genus Leptospira, that are transmitted directly or indirectly from animals to humans. Leptospirosis is a major direct zoonosis. Humanto-human transmission occurs only very rarely.
March 2020
The number of African Union Member States reporting COVID-
19 cases is increasing and there is a likelihood of community transmission. The WHO recently modified the COVID-19 suspect case definition to include severe acute respiratory infection and advises testing of all severe acute res...piratory illness (SARI) cases.1 However, many Member States have not yet started implementing these changes, they are still focussing surveillance efforts on individuals with travel history to an area with local COVID-19 transmission. This means patients with similar symptoms, but no apparent contact, may not
be investigated.
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The Alere Filariasis Test Strip (FTS) is a rapid diagnostic test recommended for mapping, monitoring and transmission assessment surveys (TAS) for the qualitative detection of Wuchereria bancrofti antigen in human blood samples. The FTS has replaced the Binax Now filariasis immunochromatographic tes...t (ICT), which also detects the same antigen in blood samples. The Brugia Rapid point-of-care cassette test (BRT) manufactured by Reszon Diagnostics is recommended for use during TAS to detect IgG4 antibody against Brugia spp. in human blood samples.
Read the Filariasis Test Strip (FTS) Bench Aid. This bench aid provides detailed instruction on the proper use of the new Filariasis Test Strip used for the detection of Wuchereria bancrofti antigen.
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Yaws is targeted for eradication by 2030, using a strategy based on mass drug administration (MDA) with azithromycin. New diagnostics are needed to aid eradication. Serology is currently the mainstay for yaws diagnosis; however, inaccuracies associated with current serological tests makes it difficu...lt to fully assess the need for and impact of eradication campaigns using these tools. Under the recommendation of the WHO Diagnostic Technical Advisory Group (DTAG) for Neglected Tropical Diseases(NTDs), a working group was assembled and tasked with agreeing on priority use cases for developing target product profiles (TPPs) for new diagnostics tools.
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These guidelines have been developed specifically to address ethical issues of conducting research in children.
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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The classification of digital health interventions (DHIs) categorizes the different ways in which digital and mobile technologies are being used to support health system needs. Historically, the diverse communities working in digital health—including government stakeholders, technologists, clinic...ians, implementers, network operators, researchers, donors— have lacked a mutually understandable language with which to assess and articulate functionality. A shared and standardized vocabulary was recognized as necessary to identify gaps and duplication, evaluate effectiveness, and facilitate alignment across different digital health implementations. Targeted primarily at public health audiences, this Classification framework aims to promote an accessible and bridging language for health program planners to articulate functionalities of digital health implementations.
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Journal of Tropical Pediatrics, 2020, 00, 1–5
doi: 10.1093/tropej/fmaa072
Brief Repor
Practical guide for doctors, nurses,laboratory technicians, medical auxiliaries,water and sanitation specialists and logisticians.
The document is a comprehensive guide for managing cholera epidemics, providing detailed protocols for prevention, outbreak investigation, treatment, and control mea...sures. It covers essential aspects like rehydration therapy, water sanitation, hygiene promotion, and setting up treatment centers. Designed for medical and non-medical staff, it aims to support effective epidemic response and reduce cholera-related morbidity and mortality.
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