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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Q 1: Are antidepressants (Tricyclic Antidepressants (TCA) and Selective Serotonin Reuptake Inhibitors (SSRI)) better (more
effective than/as safe as) than treatment as usual (placebo) in adults with depressive episode/disorder?
This publication describes an arduous campaign to tackle the use of antimicrobials - specifically antibiotics - in the Danish swine-producing sector thanks to the collaboration between the regulatory sector within the Ministry of Environment and Food, private veterinary practitioners and swine produ...cers. The document is a retrospective tribute to all those who had the foresight to make significant changes to ensure consumer protection - improving hygiene at primary sites, developing options for intervention, identifying sites for intervention, setting targets, restructuring the relationship between the veterinary services and farmers, and implementing changes in behaviour for greatest impact
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These WHO interim recommendations for use of the COVID-19 vaccine BIBP produced by Sinopharm were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
Th...is document has been updated: version 15 March 2022.
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Tuberculosis (TB) is the deadliest infectious disease in most low- and middle-income countries, claiming more than 4,000 lives each day. The unprecedented COVID-19 pandemic has seriously impacted people with pre-existing health conditions. People with TB are usually more vulnerable to other infectio...ns, including the novel coronavirus, due to pre-existing lung damage. They are also at higher risk of developing complications from COVID-19.
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In many countries neonatal tetanus is responsible for half of all neonatal deaths due to vaccine-preventable diseases and for almost 14% of al¡ infant deaths. It is estimated that in the 1970s more than 10,000 newborns died annually from neonatal tetanus in the Americas. Neonatal tetanus is prevent...ed by immunization and/or assuring clean delivery and post-delivery practices.
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Introduction, preparations to submit, submission procedure, requirements, main narrative of the protocol, definition of terms. | For Research and ethics clearance in Lesotho
To improve survival and quality of life among the 2.5 million children living with HIV, a comprehensive package of prevention, care and treatment is required. This package should include management of infections such as pneumonia, diarrhoea, malaria and ear infections, as well as common opportunisti...c infections and HIV-related co-morbidities. WHO is developing a series of guidelines on each of these conditions, following the GRADE approach. The document on the management of pneumonia and diarrhoea in HIV-infected infants and children is the first of this series. The recommendations are similar to those for non infected children, but they cover specific aspects related to HIV infection.
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Guidance for General Medical and Specialised Mental Health Care Settings
Infectious Diseases of Poverty (2020) 9:74
To detect acute schistosomiasis, low-intensity infections, or to verify the success of treatment with
praziquantel, highly sensitive test methods are required. The aim of this study was therefore to demonstrate the
performance of Schistosoma mansoni spec...ific DNA detection in serum and urine using real-time polymerase chain
reaction (PCR) in an endemic area before and after treatment.
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Rabies is fatal, vaccine-preventable disease responsible for an estimated 59,000 human deaths each year. Most cases are transmitted by dogs, and most deaths occur in underserved populations in Africa and Asia. Approximately 40% of deaths occur in children.