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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This report has been developed, based on data provided by the TB & ORD surveillance system from across Rwanda. It provides a comprehensive picture of the occurrence and management of TB & ORD and Leprosy in Rwanda. It is structured based on the 2013-2018 Rwanda TB national strategic plan (2013-2018 ...TB NSP) and on the 2014-2018 Rwanda Leprosy national strategic plan (2014-2018 Leprosy NSP).
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2nd edition.
T The Compendium has been developed as a clear and concise instrument to facilitate the understanding and planning of delivery of high-quality care for everybody affected by TB. It incorporates all recent policy guidance from WHO; follows the care pathway of persons with signs or sympt...oms of TB in seeking diagnosis, treatment and care; and includes key algorithms and cross-cutting elements that are essential to a patient-centered approach in the cascade of TB care.
The Compendium is structured into 33 WHO standards and consolidates all current WHO TB policy recommendations into a single resource, with electronic links to the individual, comprehensive WHO policy guidelines
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AIDS Research and Therapy 2015, 12:12 (24 April 2015)
Guidance for the preparation and submission of dossiers
The five hepatitis viruses have different epidemiological profiles, and their impact, duration, and transmission route also vary. The most common transmission routes contributing to the spread of hepatitis are exposure to infected blood via blood transfusion or unsafe injection practices, consumptio...n of contaminated food and drinking water, and transmission from mother to child during pregnancy and delivery. Also, unsafe injection practices, including the use of unsterile needles and syringes, serve as a major pathway for the spread of hepatitis B and C, and reducing transmission of both diseases requires addressing these practices.
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Direct acting antivirals (DAAs) have revolutionized treatment for hepatitis C. Combi-
nations of DAAs can cure infection with HCV in 12 weeks, are highly effective and
have limited side-effects. Affordability of DAAs has improved significantly, but access remains lim-
i...ted. Initially, due to their high prices, affordability of DAAs was limited in high-, middle- and low-
income countries alike. Now there is a divide between those countries where, because of intellectual
property barriers, prices have remained (very) high and other countries where generics are, or can be,
available at much lower prices. The result is a dual market
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