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Publication Years
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1510
191
15
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Category
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Toolboxes
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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
Project Paper to provide an additional grant for: Human Development Systems Strengthening Project (HDSSP)(P145965, H9360)
IN THE AMOUNT OF SDR 21.8 MILLION (US$30 MILLION EQUIVALENT) WITH AN ADDITIONAL GRANT FROM THE GLOBAL FINANCING FACILITY (GFF) IN THE AMOUNT OF US$ 10 MILLION TO THE DEMOCRATIC REPUBLIC OF CONGO FOR A HUMAN DEVELOPMENT SYSTEMS STRENGTHENING PROJECT
Int Health. 2012 December 1; 4(4): 253–259. doi:10.1016/j.inhe.2012.07.001
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
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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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Rwanda: FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES
MINISTERIAL ORDER Nº 002/17/10/TC OF 27/10/2017 DETERMINING THE FEES FOR REGISTRATION OF PHARMACEUTICAL PRODUCTS, MEDICAL DEVICES AND OTHER RELATED SERVICES | Official Gazette nº 46 of 13/11/2017
The purpose of these guidelines is to help health workers to participate in the process of continuous surveillance of safety and efficacy of the pharmaceutical products which are used in clinical practice, thus help to achieve the ultimate goal to make safer and more effective treatment available to
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patients. This guideline addresses specifically the issues on what to report, why to report, when to report, where to report and how to report.
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This document describes the key areas that national governments should consider for the introduction and scale-up of point-of-care (POC) diagnostics within national programmes, as new innovative POC technologies are being introduced into the market. The next steps taken to include these new innovati
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ons within the broader context of national diagnostic networks of conventional laboratories could influence the achievement of the 2030 Fast Track targets for ending the AIDS epidemic.
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa. more
POC diagnostics, when strategically introduced and integrated into national diagnostic networks, may help catalyse changes that improve the way diagnostics and clinical services are delivered. This document distils this understanding based on programmatic and market experiences of introducing POC diagnostics through catalytic investments in POC HIV technologies across numerous countries in sub-Saharan Africa. more
A new formulation of a drug to prevent excessive bleeding following childbirth could save thousands of women’s lives in low- and lower-middle-income countries, according to a study led by the World Health Organization (WHO) in collaboration with MSD for Mothers and Ferring Pharmaceuticals.
Curren
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tly WHO recommends oxytocin as the first-choice drug for preventing excessive bleeding after childbirth. Oxytocin, however, must be stored and transported at 2–8 degrees Celsius, which is hard to do, in many countries, depriving many women of access to this lifesaving drug. When they can obtain it, the drug may be less effective because of heat exposure.
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A survey of prevention, testing and treatment policies and practices
This document provides a generic model that can be used for risk assessment of exposure to insecticide products applied as indoor residual sprays. It aims to harmonize the risk assessment of such insecticides for public health use in order to generate comparable data for their registering and labell
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ing by national regulatory authorities. The assessment considers both adults and children (all age groups) as well as people in the following specific categories:
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides. more
- those preparing the spray;
- those applying the spray;
- residents living in the treated houses;
- residents who participate in preparing and applying insecticides. more
Recent systematic reviews and meta-analysis of the impact of chemical-based mollusciciding (King et al., 2015, Sokolow et al., 2016) have concluded that regular mollusciciding is likely to contribute significantly towards elimination of schistosomiasis in high-risk areas. The WHO roadmap’s new foc
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us on “transmission control, wherever possible” (WHO, 2012a) reinforces the need to promote intermediate-host snail control to prevent schistosomiasis transmission.
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]). more
This operational manual is intended to facilitate the reintroduction of practices and protocols for use of molluscicides in the field in schistosomiasis control programmes. It is complemented by guidelines on the laboratory and field testing of the efficacy of molluscicides for schistosomiasis control (WHO, 2017 [in preparation]). more