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,... which constitutes one of the elements of the WHO Certification Scheme on the quality of pharmaceutical products moving in international commerce, through the assessment of applications for manufacturing authorizations and as a basis for the inspection of manufacturing facilities. It may also be used as training material for government medicines inspectors, as well as for production, QC and QA personnel in the industry
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Pharmaceutical regulators are at the forefront of ensuring that only safe and effective medicines are authorized and available in the market. This document builds on the recommendations in the above publication and has been prepared to specifically assist national medicines regulatory authorities to... understand the nature and extent of oxytocin quality issues and to provide key technical information and quality requirements for oxytocin products in dossier assessments. Furthermore, this document also presents recommendations on other regulatory actions needed to ensure that only quality-assured oxytocin products are authorized and made available to women.
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National emergency medical teams are the best option for providing immediate and appropriate surge response for emergencies directly affecting populations, while international teams may help relieve overwhelmed health systems. The efficiency and effectiveness of countries and local authorities in mo...bilizing existing resources is only as good as the quality of care they are able to provide. This publication serves as a practical guide for teams and aims to compliment emergency response systems, fostering seamless collaboration with all emergency response actors and networks
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This document aims to describe a minimum set of surveillance activities recommended at the national level to detect and monitor the relative prevalence of SARS-CoV-2 variants and outline a set of activities for the characterization and assessment of risk posed by these variants. A set of indicators ...is also provided to standardize monitoring and public reporting of variant circulation.
The document is primarily intended for national and sub-national public health authorities and partners who support implementation of surveillance for SARS-CoV-2 variants
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A 7.2-magnitude earthquake struck southwestern Haiti at 8:30am local time at a depth of around 10km. The epicentre was recorded around 12km northeast of SaintLouis-du-Sud, about 125km west of the capital Port-au-Prince.
● In the aftermath of the devastating 7.2-magnitude earthquake that hit Hai...ti on 14 August, authorities report more than 2,200 people dead, at least 344 missing, over 12,000 injured and upwards of 130,000 homes damaged or destroyed.
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Countries across the world are facing diverse epidemiological situations with varying response
capacities and access to life saving tools. The World Health Organization (WHO) recommends that national authorities continue to apply a risk-based approach when implementing measures related to COVID-19... and international travel while respecting the dignity, human rights and fundamental freedoms of travellers. This approach should consider the risk posed by travel for the importation and exportation of cases in the context of the evolving epidemiology, including the emergence and circulation of virus variants of concern; the expansion of the COVID-19 vaccination roll-out; and lessons learned while responding to the pandemic, including on the early detection and management of cases and the application of public health and social measures.
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Rumors emerge when people feel left out of the discussion, when their questions cannot be answered by authorities or their doubts are dismissed by official sources. But also, rumors present an opportunity – to understand the questions, concerns and anxieties communities may have about this pandemi...c.
During the COVID-19 pandemic, Internews has followed its rumour-tracking methodology, including social media listening, to identify those rumors that are posing additional risks to the communities, ensuring content is collected from diverse demographic groups.
Internews produces and distributes rumor bulletins through its Rooted in Trust and its H2H (humanitarian-to-humanitarian network) projects. Rooted in Trust has collected close to 6,000 rumors from seven countries in 12 languages, and collects data across seven major social media platforms and a wide range of feedback collection channels. H2H is a collaboration to support responders at every level by analyzing information gaps and addressing them with evidence-based content in relevant languages, formats, and channels.
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This document aims to describe a minimum set of surveillance activities recommended at the national level to detect and monitor the relative prevalence of SARS-CoV-2 variants and outline a set of activities for the characterization and assessment of risk posed by these variants. A set of indicators ...is also provided to standardize monitoring and public reporting of variant circulation.
The document is primarily intended for national and sub-national public health authorities and partners who support implementation of surveillance for SARS-CoV-2 variants
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This chronology of facts has challenged public health systems worldwide and regulatory bodies are no exception. Regulatory authorities with mechanisms in place to authorize the use of investigational products had to development guidelines and procedures, create task forces and alliances to maximize ...the efficiency of assessment, review and authorizations of medical products. Vaccines are undoubtedly the most complex medical products to develop, from concept to a stage where sufficient evidence of quality, safety and efficacy are collected to provide an assurance that their use will provide more benefits than risks when used in the context of a public health emergency.
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The war in Ukraine will have direct and indirect health consequences on conflict affected people, including internally displaced people and refugees. Governments in countries receiving refugees are providing them with access to healthcare. This document aims to provide information to guide individua...l health assessment carried out by frontline health providers at border areas, reception centres, transit centres and individual clinics as well as national public health agencies/authorities in countries receiving refugees and third country nationals.
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In the light of the transmissibility of coronaviruses, and the global experience with MERS-CoV (ongoing) and SARS in 2003 which were also caused by coronaviruses, South African authorities have compiled this guideline document to support surveillance, case finding, diagnosis, management and public h...ealth responses to cases under investigation.
*Please note*
The interim guidelines are based on what is currently known about the Coronavirus Disease 2019 (COVID-19). The National Department of Health (NDOH) and National Institute for Communicable Diseases will update these interim guidelines as needed and as additional information becomes available.
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This document provides interim guidance to countries on testing considerations and strategies for suspect cases of severe acute hepatitis of unknown aetiology in children. It is primarily intended for clinical, programmatic, laboratory and diagnostic stakeholders across Member States and national pu...blic health authorities involved in the identification and investigation of cases of severe acute hepatitis in children.
This document is part of a package of guidance for this event, which includes suggested minimum reporting variables and a clinical Case Report Form support Member States with case investigation and reporting.
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ummer is here and there are a lot of great opportunities for people to gather and enjoy themselves. Public health authorities are working together with event organisers and civil society organisations to reach out to people attending events, including at-risk groups, about monkeypox in Europe. This ...toolkit, jointly created by the World Health Organization (WHO) Regional Office for Europe and the European Centre for Disease Prevention and Control (ECDC), provides them with customisable tools on monkeypox for mass gatherings, both for consideration and use.
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MEDBOX Issue Brief no. 24 (Sept.2022)
On 20 September 2022, Uganda health authorities declared an outbreak of Ebola disease, caused by Sudan virus,
following laboratory confirmation of a patient from a village in Madudu sub-county, Mubende district, central
Uganda.
Therefore the MEDBOX Team cre...ated this issue brief to give a quick overview of the most important documents and training material.
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After more than 3 years with no cases of cholera reported in Haiti, on 2 October
2022, the national authorities reported two confirmed cases of Vibrio cholerae O1
in the greater Port-au-Prince area.
On this platform you can find the latest situation updates.
The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities,
or concerning the delimitation of its fr...ontiers or boundaries. Dotted and dashed lines on maps represent approximate border lines for which there may not yet be full agreement.
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The boundaries and names shown and the designations used on this map do not imply the expression of any opinion whatsoever on the part of the World Health Organization concerning the legal status of any country, territory, city or area or of its authorities, or concerning the delimitation of its fro...ntiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not yet be full agreement.
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The boundaries and names shown and the designations used on this map do not imply the expression
of any opinion whatsoever on the part of the World Health Organization concerning the legal status
of any country, territory, city or area or of its authorities, or concerning the delimitation of its f...rontiers or boundaries. Dotted lines on maps represent approximate border lines for which there may not
yet be full agreement.The boundaries and names shown and the designations used on this map do not imply the expression
of any opinion whatsoever on the part of the World Health Organization concerning the legal status
of any country, territory, city or area or of its authorities, or concerning the delimitation of its frontiers
or boundaries. Dotted lines on maps represent approximate border lines for which there may not
yet be full agreement.
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Medical care for people caught up in armed conflict and other insecure environments saves lives and alleviates suffering. It is one of the most immediate and high priority needs of an affected population and is often the first type of response activated and/or requested by authorities and affected c...ommunities. Medical teams working in armed conflict and other insecure environments
frequently face serious threats to their security and safety, challenges to patient access, and at times limited acceptance by affected communities in which they work and parties to the conflict. Such difficulties are likely to increase (6) and
thereby creating a critical need to establish contact and trust with all sides in conflicts and in other insecure environments to ensure operational continuity. This trust can best be achieved when all sides perceive the medical teams to be neutral, impartial, and independent, and specifically not aiding (or being perceived to aid) any one party to achieve a military, political or economic
advantage. For medical teams that are deploying increasingly closer to the frontlines, the implications of and consequences for both staff and patients of teams not being fully prepared, and/or not fully comprehending the context in which they work, can be severe. Medical response can easily be hindered or compromised by intentional or unintentional acts and the behaviour and
conduct of the teams themselves
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The boundaries and names shown and the designations used on this map do not imply
the expression of any opinion whatsoever on the part of the World Health Organization
concerning the legal status of any country, territory, city or area or of its authorites, or
concerning the delimitation of its f...rontiers or boundaries. Dotted lines on maps
represent approximate border lines for which there may not yet be full agreement.
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