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 Guidelines for variation to registered pharmaceutical products.
Rwanda’s fourth health sector strategic plan (HSSP4) is meant to provide the health sector with a Strategic Plan that will highlight its commitments and priorities for the coming 6 years. It will be fully integrated in the overall economic development plan of the Government. HSSP4 will fulfill the
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country’s commitment expressed in the national constitution, National Strategy for Transformation (NST) and the aspirations of the Health Sector Policy 2015. The strategies herein adhere to the Universal Health Coverage (UHC) principles towards realisation of the Sustainable Development Goals (SDGs). HSSP4 therefore lays a foundation for Vision 2050 (“The Rwanda We Want”), which will transform Rwanda into a high-income country by 2050. HSSP4 anticipates the epidemiological transition of the country, the increase in population and life expectancy and the expected increase of the health needs of the elderly, notably in Non Communicable Diseases (NCDs). HSSP4 also anticipates a decrease in external financial inflows, hence it is imperative to build secure / resilient health systems.
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India contributes to 16% of the global maternal deaths and around 27% of global newborn deaths. Reducing the burden of maternal and newborn mortality and morbidity in urban poor settings today requires an expansion of effective Maternal and Newborn Health (MNH) care services and lowering the barrier
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s to the use of such services, especially availability and accessibility.
For designing sensitive, responsive and relevant urban health policy and action, it is important for planners and programme managers to understand the context with regard to current systems and mechanisms, potential organisations and best practices.
In order to adres this need, Save the Children’s Saving Newborn Lives programme commissioned a study that reviewed the literature and looked at available secondary data on MNH in urban poor settings.
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Nepal is on target to meet the Millennium Development Goals for maternal and child health despite high levels of poverty, poor infrastructure, difficult terrain and recent conflict. Each year, nearly 35000 Nepali children die before their fifth birthday, with almost two-thirds of these deaths occurr
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ing in the first month of life, the neonatal period. As part of a multi-country analysis, we examined changes for newborn survival between 2000 and 2010 in terms of mortality, coverage and health system indicators as well as national and donor funding.
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The State of the World's Midwifery
A policy brief highlighting key factors associated with adolescent pregnancy. Adolescent pregnancy undermines girls’ human rights and reduces opportunities to realize their full potential.
ECDC Technical Report
In line with ECDC’s recommendations provided in the ’Risk Assessment of HTLV-1/2 transmission by tissue/cell transplantation’ dated 14 March 2012, this Directive replaces the term ‘incidence’ with ‘prevalence’ in the description of endemic areas of HTLV-1/2 i
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nfection. According to the new requirements ‘HTLV-1 antibody testing must be performed for donors living in, or originating from high-prevalence areas or with sexual partners originating from those areas or where the donor’s parents originate from those areas’ and this applies to both donors of non-reproductive tissues and cells and reproductive cells.
ECDC contracted experts from the Institut Pasteur in Paris to systematically review the published evidence on the distribution of HTLV-1 infection prevalence throughout the world and to identify high-prevalence countries and areas.
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This report is primarily intended for the community of policymakers and researchers concerned about the rising risks of domestic, regional, and global infectious disease epidemics, and the collective failure to take the coordinated actions required to reduce such risks. These risks include the expec
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ted health, economic, and societal costs that are borne by countries, regions, and even all nations in the case of pandemics (which are worldwide epidemics). These risks also include the consequences of increasing antimicrobial resistance (AMR) and its spread within regions and globally. A necessary first step is to monitor whether a broad range of stakeholders are acting to prevent outbreaks from becoming epidemics, whether their capacities to respond to epidemics are robust, and whether preparedness to respond to pandemics and limit the resulting economic and health damage is improving. Analyzing the adequacy of these efforts is vitally important for the decisions of policymakers to invest in the public health and disaster-risk management capacities. Early and effective control of disease outbreaks prevents substantial health and economic costs whether or not the disease can spread globally and become a pandemic.
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The purpose of this Emergency Response Framework (ERF) is to clarify WHO’s roles and responsibilities in this regard and to provide a common approach for its work in emergencies. Ultimately, the ERF requires WHO to act with urgency and predictability to best serve and be accountable to populations
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affected by emergencies.
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The WHO Framework Convention on Tobacco Control (WHO FCTC) is an evidence-based treaty that reaffirms the right of all people to the highest standard of health and was developed in response to the globalization of the tobacco epidemic. Member States of the WHO South-East Asia Region have made
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attempts to implement the demand and supply reduction strategies for tobacco control as recommended by the treaty. While recognizing the need to accelerate implementation of the WHO FCTC in the Region, this document has been developed to support the Member States in implementing the treaty using a ‘PRACTICAL’ Approach which pertains to identified demand and supply reduction strategies under the treaty.
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The Asia Pacific Observatory on Health Systems and Policies is a collaborative partnership which supports and promotes evidence-based health policy making in the Asia Pacific Region. Based in WHO’s Regional Office for South-East Asia, it brings together governments, international agencies, foundat
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ions, civil society and the research community with the aim of linking systematic and scientific analysis of health systems in the Asia Pacific Region with the decision-makers who shape policy and practice.
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Review of International, Regional and National Policies and Legal Frameworks that Promote Migrants and Mobile Populations' Access to Health and Malaria Services in the Greater Mekong Subregion (Cambodia, Lao People's Democratic Republic, Myanmar, Thailand and Viet Nam)
Migrants and mobile popul
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ations face many obstacles in accessing equitable essential health care services due to factors such as living and working conditions, education level, gender, irregular migration status, language and cultural barriers, anti-migrant sentiments, and lack of migrant-inclusive health policies among others. Despite significant progress having been made in the context of malaria control in the Greater Mekong Subregion (GMS), human movements can impact malaria transmission patterns and potentially introduce drug-resistant parasites. This legal framework review therefore serves as a guidance document on approaches to address malaria and malaria elimination for migrant and mobile populations (MMPs) in five countries of the GMS.
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Based on WHO South-East Asia Regional Strategy on Autism Spectrum Disorder
The collaborative framework for implementation of the “WHO South-East Asia Regional Strategy on Autism Spectrum Disorders” articulates to Member States: the nature of autism spectrum disorder and the issues faced by
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PwASD and their caregivers; the foundation on which the Regional Strategy and the collaborative framework is based; desired outcomes against each objective of the ASD Regional Strategy; recommended actions to fulfill each objective; requisite parameters that should govern the recommended actions; and suggested guidelines for monitoring, evaluating and reporting a Member State’s progress towards fulfilling the objectives. It encourages Member States to share best practices and information for promoting cooperation and partnerships for development of effective and sustainable programmes.
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This publication outlines public health aspects of alcohol use and harm in WHO South East Asia Region Countries. It summarizes Global Regional and country specific data and also discusses aspects of alcohol control that are important in the context of the Region. The possible future trend of alcohol
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use in the Region is also analysed and current and future barriers to effective alcohol control in countries of the Region are discussed.
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Oral diseases are among the most common chronic diseases worldwide and constitute a major public health problem due to the huge health and economic burden on individuals, families, societies, and health care systems. The recent emphasis on the role of determinants of health, common risk factors and
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their recognition in the context of the growing burden of noncommunicable diseases (NCDs) provides good opportunities for integrating oral health into NCD prevention and control efforts. This Strategy for oral health in South-East Asia, 2013-2020, presents guidance to Member States in developing national policy and action plans to improve oral health within existing socioeconomic, cultural, political and health system contexts. It expresses the consensus on major strategies in the area of oral health promotion as well as oral disease prevention and control for the South-East Asia Region aiming at reducing the health and socioeconomic burden resulting from oral diseases, reducing oral health inequities, and improving the quality of life of the population.
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This report aims to raise awareness about the role that the reform of public health laws can play in advancing the right to health and in creating the conditions for people to live healthy lives. By encouraging a better understanding of how public health law can be used to improve the health of the
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population, the report aims to encourage and assist governments to reform their public health laws in order to advance the right to health.
The report highlights important issues that may arise during the process of public health law reform. It provides guidance about issues and requirements to be addressed during the process of developing public health laws. It also includes case studies and examples of legislation from a variety of countries to illustrate effective law reform practices and some features of effective public health legislation.
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The skin of a patient is the first and most visible structure of the body that any health-care worker encounters during the course of an examination. To the patient, it is also highly visible, and any disease that affects it is noticeable and will have an impact on personal and social well-being. Th
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e skin is therefore an important entry point for both diagnosis and management. Many diseases of humans are associated with changes to the skin, ranging from symptoms such as itching to changes in colour, feel and appearance.
This training guide explains how to identify the signs and symptoms of neglected tropical diseases of the skin through their visible characteristics. It also contains information on how to diagnose and manage common skin problems that front-line health workers may encounter.
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