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Licensed pharmaceutical products (marketing authorization) should be manufactured only by licensed manufacturers (holders of a manufacturing authorization) whose activities are regularly inspected by competent national authorities. This guide to GMP shall be used as a standard to justify GMP status,
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The procurement of essential medicines and other health products is a critical function in support of the effective discharge of WHO’s mandate, and WHO values the importance of the quality of essential medicines and health products that are supplied to countries. The first World Health Assembly in
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Drug Distribution and Control: Preparation and Handling
This Technical Assistance Bulletin is intended to assist pharmacists in the extemporaneous compounding of non-sterile drug products for individual patients. Included in this document is information on facilities and equipment, ingredient
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Revision Bulletin ESPNF
The Global guidance framework for the responsible use of the life sciences: mitigating biorisks and governing dual-use research (the framework) aims to provide values and principles, tools and mechanisms to support Member States and key stakeholders to mitigate and prevent biorisks and govern dual-u
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The WHO BioHub Biosafety & Biosecurity: criteria and operational modalities sets out the requirements to which laboratories wishing to receive biological materials as part of this international exchange system should abide, to ensure safe and secure operations. These provisions are in accordance wit
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The HHFA Comprehensive guide serves as the main reference document for planning and implementing a country HHFA. This guide will promote understanding of:
What the HHFA is and the information it can and cannot provide.
The HHFA modules, questionnaires and CSPro electronic data collection tool.
Th
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i
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The Africa Centres for Disease Control and Prevention (Africa CDC) Biosafety and Biosecurity Initiative was launched by the Africa CDC in April 2019 with the aim of strengthening the African Union (AU) Member States’ biosafety and biosecurity systems and enabling them to comply with national and i
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Trustworthy, evidence-based health guidelines form the basis of national policies affecting both patients and health-care workers. Emphasizing the link between robust evidence and people’s trust in their health systems, Dr Hans Henri P. Kluge, WHO Regional Director for Europe said at the launch ev
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Health facilities in the Region of the Americas frequently suffer the effects of health emergencies and disasters, which jeopardize their ability to provide services to the population. The STAR-H methodology helps staff responsible for health emergency and disaster risk management to identify and as
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En esta nota técnica se explican los 20 aspectos que deben considerarse para evaluar el estado y la seguridad del equipo y los suministros de laboratorio. No se incluyen en este trabajo las instrucciones para los evaluadores de los puntos 93 (Estado y seguridad del equipo médico en las salas de op
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Adolescence is a critical stage in life for physical, cognitive and emotional development, shaping future health and well-being. Comprehensive measurement of adolescent health is essential to prioritize health issues, guide interventions and track progress. However, global, regional and national ado
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The Virtual cGMP Training Marathon for Vaccine Manufacturing: Principles into Practice took place from 12 Sep to 10 Oct 2023 to continue to provide manufacturers & regulators with a comprehensive array of topics to build understanding of current WHO & international GMP standards, technological advan
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Medical devices are used for the prevention, diagnosis and treatment of illness and diseases and for rehabilitation. WHO developed guidance on medical device donation in 2011, which has been now reviewed, with new evidence, new references on considerations for medical device solicitation and provisi
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Providing quality, stigma-free services is essential to equitable health care for all and achieving global HIV goals and broader Sustainable Development Goals related to health. Every person has the right to the highest attainable standard of physical and mental health. Countries have a legal obliga
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Reporting system for the general public - This document aims to provide practical guidelines on how to set up national systems for consumers to report adverse reactions to medicines. The purpose is to help countries set up a well-organized and effective consumer reporting system within their pharmac
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Survey of the Quality of Selected Antimalarial Medicines Circulating in Six Countries of Sub-Saharan Africa
recommended
The survey aimed at evaluating the quality of selected antimalarials in six countries of sub-Saharan Africa (Cameroon, Ethiopia, Ghana, Kenya, Nigeria and the United Republic of Tanzania). These countries have been supported by WHO to strengthen their regulatory controls o
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This manual describes some of the strategic, managerial, financial, technical and scientific aspects to be considered in establishing a national EQA programme for clinical laboratories and other testing services at all health care levels
This checklist covers five areas of competence needed by health care providers to provide quality of care in contraceptive information and services including: respecting users’ privacy and guaranteeing contfidentiality, choice, accessible and acceptable services, involvement of users in improving
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