interim guidance, 14 June 2021
This document is intended for national authorities and decision makers in countries that have introduced large scale public health and social measures. It offers guidance for adjusting public health and social measures, while managing the risk of a resurgence of cases....
Available in English, Arabic, Chinese, French, Russian and Spanish
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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... 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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An Act to provide for the efficient and comprehensive regulation and control of food, drugs, medical devices, cosmetics, herbal drugs and poisons and to repeal the Food
(Control of Quality) Act, 1978, the Pharmaceuticals and Poisons Act, 1978 and to provide for related matters.
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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Contact tracing is a key component of the COVID-19 response, particularly as societies begin to lift non-pharmaceutical interventions. However, it is a time-consuming and resource-intensive effort that depends on a trained and motivated workforce. Emergent digital contact tracing and quarantine (...DCTQ) tools offer the potential to complement and strengthen conventional contact tracing initiatives on an unprecedented scale. Despite their visibility throughout the pandemic
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Submitted to the US Agency for International Development by the Systems for Improved Access to Pharmaceuticals and Services (SIAPS) Program. Arlington, VA: Management Sciences for Health. Submitted to the United Nations Children’s Fund by JSI, Arlington, VA: JSI Research & Training Institute, Inc....
This guide will assist program managers, service providers, and technical experts when conducting a quantification of commodity needs for the 13 reproductive, maternal, newborn, and child health commodities prioritized by the UN Commission on Life-Saving Commodities for Women and Children. This quantification supplement should be used with the main guide—Quantification of Health Commodities: A Guide to Forecasting and Supply Planning for Procurement. * This supplement describes the steps in forecasting consumption of these supplies when consumption and service data are not available; after which, to complete the quantification, the users should refer to the main quantification guide for the supply planning step.
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The report provides a brief introduction to patents and licences and their effect on the market for antiretroviral (ARV) medicines. It gives an overview of the patent landscape with respect to a select number of ARV medicines in developing countries as of April 2014. The focus is primarily on those ...ARVs that are recommended by the World Health Organization (WHO) as well as new ARVs that have either recently obtained regulatory approval or are in phase III clinical trials.
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This Medical Product Alert relates to the recent circulation of two confirmed falsified versions of Quinine
Sulphate circulating in Cameroon and the Democratic Republic of the Congo, containing zero active
pharmaceutical ingredient
This document is a guide defining requirements for quality and safety for malaria rapid diagnostic testing services to safeguard the quality of the results, the safety of the operators and patients and that of the environment for use by national malaria control programmes, regulators, implementers a...nd rapid diagnostic providers.
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Replacement of Annex 2 of WHO Technical Report Series, No. 964... morbidity. These preparations are included in the WHO List of Essential Medicines and should be part of any primary health care package where snakebites occur. Currently, there is an urgent need to ensure availability of safe, effective and affordable antivenoms, particularly to those in developing countries and to improve the regulatory control over the manufacture, import and sale of antivenoms.>
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The framework is to be used as a reference guide, applied according to local priorities and needs, and targeted at academic institutions, educators, accreditation bodies, regulatory agencies and other users. The ultimate aim is to ensure that all health workers are equipped with the requisite compet...encies at pre-service education and in-service training levels to address AMR in policy and practice settings.
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When situations occur in which unwanted events are rightly or wrongly connected with vaccination, they may erode confidence in vaccines and the authorities delivering them. This document presents the scientific evidence behind WHO’s recommendations on building and restoring confidence in vaccines ...and vaccination, both in ongoing work and during crises. The evidence draws on a vast reserve of laboratory research and fieldwork within psychology and communication. It examines how people make decisions about vaccination; why some people are hesitant about vaccination; and the factors that drive a crisis, covering how building trust, listening to and understanding people, building relations, communicating risk and shaping messages to the audiences may mitigate crises. This document provides a knowledge base for stakeholders who develop communication strategies or facilitate workshops on communication and trust-building activities in relation to vaccines and immunization, such as immunization programme units, ministries of health, public relations and health promotion units, vaccine safety communication trainers and immunization advisory bodies.
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Key Features:
• Module Users: Disaster Management Trainers
• Training Targets: State Government and District
officials / Disaster Management Authorities / Disaster
Management Planners and Responders
• Training Duration: 5 working days (one week)
• Trainers Input: Multi-disciplinary
... Training methods: Lecture, Discussion, Film Show,
Field Visits, Group Exercise.
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Globally each year, millions of people suffer illness or lose their lives because the vaccines, medicines and diagnostic tests that they need are either unavailable or unaffordable – and this lack of access to medicine is acute in low- and middle-in-
come countries (LMICs). While the COVID-19 pan...demic laid this inequity bare, it also saw the pharmaceutical industry develop and bring new vaccines and treat- ments to market at unprecedented speed. As the world emerges from the worst
of this crisis, pharmaceutical companies are now at an important juncture, where lessons learned from the pandemic can prove pivotal in finding solutions to bridge long-standing gaps in access to medicine in LMICs.
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The aim of the pandemic preparedness checklist is primarily to provide an outline of the essential minimum elements of preparedness, as well as elements of preparedness that are considered desirable. It is recommended that responsible authorities or institutes in countries that are in the process of... planning should consider the specific aspects of the checklist for which they are responsible. The Checkllist is available in English, Japanese, Russian and Arabic from the website http://www.who.int/influenza/resources/documents/checklist/en/
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Member States have requested WHO policy guidance on how to facilitate the implementation of national AMS activities in an integrated and programmatic approach. This policy guidance responds to that demand from Member States and is anchored in public health guiding principles in the human health sect...or. It aims to provide a set of evidence-based and pragmatic recommendations to drive comprehensive and integrated AMS activities under the purview of a central national coordination unit, National AMR steering or coordinating committees or other equivalent national authorities.
Available in English, French, Spanish, Russian, Arabic, Chinese
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The WHO laboratory biosecurity guidance follows and complements the revision of the Laboratory biosafety manual, fourth edition and provides principles and measures to prevent lapses and incidents throughout the whole value chain of handling high-consequence biological material, technology and infor...mation. The document shares global best practice and covers the biosecurity part of the biological risk management lifecycle, starting from collection, transportation, storage and experiment, and in specific context such as every type of biomedical laboratory, research activities, repository and biobank. It also provides key considerations and best practices for institutional, national and international levels, including regulatory oversight.
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This curricula guide builds on several existing products of WHO and partners, aimed at supporting countries in their effort to address the first objective of the GAP-AMR (to improve awareness and understanding of AMR). It is targeted specifically at health educators and policy planners, and applies ...a systematic modular and submodular collection of learning objectives and outcomes that are organized according to the key occupational groups involved in the use of antimicrobials in human health. It is hoped that educators, faculties of heath personnel training institutions, health regulatory institutions and other users will find it a useful resource in meeting their respective needs for strengthening health workers’ contributions to containing AMR.
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The guidelines reiterate that the general principles of ethics for biomedical research involving human participants shall also be applicable. In addition, the guidelines specify unique provisions for stem cells, because of their inherent property for unlimited proliferation, differentiation to cells... of the germ layers, oncogenic potential, unrecognised toxicities and possible involvement in pre-implantation stages of human development. The guideline therefore focuses on: 1. Monitoring mechanism and regulatory pathway for basic, clinical research and product development based on categories of research and level of manipulation. 2. Procurement of gametes, embryos and somatic cells for derivation and propagation of any stem cell lines, their banking and distribution. 3. Other important areas like international collaboration, exchange of cell/lines and education for stakeholders and advertisement.
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The Pandemic Influenza Preparedness (PIP) Framework is a World Health Assembly resolution adopted unanimously by all Member States in 2011. It brings together Member States, industry, other stakeholders and WHO to implement a global approach to pandemic influenza preparedness and response. The Frame...work includes a benefit-sharing mechanism called the Partnership Contribution (PC). The PC is collected as an annual cash contribution from influenza vaccine, diagnostic, and pharmaceutical manufacturers that use the WHO Global Influenza Surveillance and Response System (GISRS). Funds are allocated for: (a) pandemic preparedness capacity building; (b) response activities during the time of an influenza pandemic; and (c) PIP Secretariat for the management and implementation of the Framework.
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