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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Available in Chinese, English, French, Russian and Spanish; WHO and UNICEF policy brief, 19 April 2021
Persons with disabilities are disproportionately impacted by COVID-19, both directly because of infection, and indirectly because of restrictions to reduce the spread of the virus. Persons with di...sabilities are a diverse group, and the risks, barriers and impacts faced by them will vary in different contexts according to, among other factors, their age, gender identity, type of disability, ethnicity, sexual orientation, and migration status.
This document presents considerations and actions for the following stakeholders to ensure equity in access to vaccination against COVID‑19 for persons with disabilities
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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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28 May 2021
Contact tracing is a key component of a public health response to infectious disease outbreaks. The purpose of this guidance is to reinforce the place of community engagement and participation in the contact tracing process. The guidance and related products articulate best practice pri...nciples for community engagement and how they can be operationalized as part of any community-centred contact tracing strategy. The material provided can stand on its own or be used to complement other documents that support strategies, implementation plans or training and capacity building modules.
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10 May 2021. Manufactureres:
SK Bioscience Co. Ltd. [COVID-19 Vaccine (ChAdOx1-S [recombinant])]
Serum Institute of India Pvt. Ltd. [COVISHIELD™, ChAdOx1 nCoV-19 Corona Virus Vaccine (Recombinant)]
The ChAdOx1-S/nCoV-19 [recombinant] vaccine is a replication-deficient adenoviral vecto...r vaccine against coronavirus disease 2019 (COVID-19). The vaccine expresses the SARS-CoV-2 spike protein gene, which instructs the host cells to produce the protein of the S-antigen unique to SARS-CoV-2, allowing the body to generate an immune response and to retain that information in memory immune cells. Efficacy shown in clinical trials in participants who received the full series of vaccine (2 doses) irrespective of interval between the doses was 63.1%, based on a median follow-up of 80 days, but tended to be higher when this interval was longer. The data reviewed at this time support the conclusion that the known and potential benefits of ChAdOx1-S/nCoV-19 [recombinant] vaccine outweigh the known and potential risks.
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Available in Arabic, Chinese, English, French, Russian and Spanish. You can download a summary of the main report and background documents!
The report demonstrates that the current system—at both national and international levels— was not adequate to protect people from COVID-19. The time it t...ook from the reporting of a cluster of cases of pneumonia of unknown origin in mid-late December 2019 to a Public Health Emergency of International Concern being declared was too long. February 2020 was also a lost month when many more countries could have taken steps to contain the spread of SARS-CoV-2 and forestall the global health, social, and economic catastrophe that continues its grip. The Panel finds that the system as it stands now is clearly unfit to prevent another novel and highly infectious pathogen, which could emerge at any time, from developing into a pandemic.
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Lymphatic filariasis: managing morbidity and preventing disability: an aide-mémoire for national programme managers, second edition: web annex A: protocol for evaluating minimum package of care of morbidity management and disability prevention for lymphoedema management in designated health facilit...ies.
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Tuberculosis (TB) is, and should be, a curable disease; however, each year significant numbers of patients acquire or develop drug-resistant TB, which has a much lower cure rate. Patients with drug-resistant TB have a high prevalence of symptoms; hence, staff caring for these patients should h...ave some familiarity with palliative care, so that general palliative care principles are available to all patients. The timely identification, and addressing, of adverse events occurring during the treatment course is considered as general palliative care for those receiving curative treatment. This publication summarizes the general palliative care approach, which is recommended for use in settings and services that occasionally treat palliative care patients, but do not provide palliative care as the main focus of their work. The review focuses on 18 high TB priority countries of the WHO European Region.
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13 July 2021
The module provides an overview of factors to consider when monitoring the safety of COVID-19 vaccines administered to pregnant and breastfeeding women. It describes how national routine AEFI surveillance should be adapted to cater for this specific group of population using both pass...ive and active surveillance methods. Specific considerations and limitations of each method are provided as well as tools for implementation.
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Globally, 311,000 women die of cervical cancer every year, 85 percent of them
in resource limited regions of the world. To address this grave threat to women,
the WHO made a call to action in 2018, resulting in accelerated plans to improve
cervical cancer control under the elimination threshold w...ith respect to cervical
cancer incidence. As part of WHO’s approach to cervical cancer control, availability of high quality,
affordable medical devices for HPV screening, and treatment of precancerous
lesions in low resource settings is indispensable.
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The primary audience for this guidance is persons
working directly in vector-borne disease prevention
and control, including programme managers,
researchers and field workers. A brief technical
background is provided for the benefit of persons
without expertise in vector-borne diseases; readers...
working in the field may wish to skip the background
section and begin with the discussion of ethical
issues and values in Chapter 3. The guidance cannot
offer universally applicable answers to the complex
ethical issues raised, nor can it provide a checklist of
issues that are necessarily relevant in all situations.
Rather, its goal is to help readers recognize aspects
of their work that raise significant ethical challenges
and to respond to these challenges in accordance
with internationally accepted values and norms.
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Guide for clinical case management and infection prevention and control during ameasles outbreak. This guide has been developed to reduce the high morbidity and mortality seen in some of the current outbreaks of measles. This short guide outlines practical clinical care interventions and is derived ...from previously published WHO documents.
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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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he WHO South-East Region in 2019 accounted for nearly a million missing TB patients from the estimated incidence. Active case-finding (ACF) or systematic screening for tuberculosis is an important tool to reach out to missing TB patients. When appropriately implemented, the activity is cost effectiv...e, helps to reduce diagnosis and treatment delays, and prevents the spread of the disease. This document presents an analysis of published ACF studies from the Region. It can be used by Member States for effective planning, implementation and monitoring of these activities.
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The assistive technology capacity assessment (ATA-C) is a system-level tool to evaluate a country’s capacity to finance, regulate, procure and provide assistive technology. It can be used for awareness raising, policy and programme design, and ongoing monitoring and evaluation. This manual provide...s guidance and practical information on the ATA-C implementation process. The ATA-C is intended to be implemented by an experienced team, in collaboration with relevant ministries and users’ organizations.
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This is a guidance document for countries and implementing partners on the technical requirements for developing digital information systems for issuing standards-based interoperable digital certificates for COVID-19 vaccination status, and considerations for implementation of such systems, for the ...purposes of continuity of care, and proof of vaccination.
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The portable diagnostic imaging technology covered by this document will serve not only the pressing demands for tuberculosis screening and triage but also other diseases. Therefore, the requirements, accessories, hardware and software packages listed in the following specifications are described in... detail in order to serve also other pathologies and conditions, like trauma and pneumonia.
Through the definition of "minimum technical requirements", this document is recommended to support decision-making regarding the selection, incorporation, allocation and use of portable X-ray systems and is intended for health care providers, managers of imaging departments, procurement and regulatory agencies, policymakers and planning officers in ministries of health, as well as biomedical engineering professionals, medical physicists, the private health sector, medical device industry and intergovernmental and international agencies.
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