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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Las recomendaciones contenidas en este módulo son un componente de las directrices unificadas de la OMS sobre la tuberculosis (TB) y están destinadas principalmente para el uso de los programas nacionales de control de la tuberculosis, los organismos de salud pública y otros interesados clave que... participan en la planificación, ejecución y seguimiento de las actividades de gestión programática de la TB farmacorresistente. El objetivo esta actualización es proporcionar información basada en la evidencia sobre determinadas áreas críticas que ayude a fundamentar el uso de nuevos esquemas totalmente orales y la posible ampliación de la ficha técnica de los nuevos medicamentos contra la TB. Los interesados directos podrán distinguir entre las recomendaciones anteriores que siguen siendo válidas, las que se han actualizado y las que se han elaborado recientemente sobre la base de estudios adicionales, teniendo en cuenta la gama de beneficios conocidos y posibles daños, los ejercicios de modelización y otros datos para fundamentar el proceso de toma de decisiones.
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These WHO interim recommendations for use of the Sinovac-CoronaVac were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been updat...ed: version 15 March 2022.
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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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This summary assesses the current state of evidence on each approach in tabular form, providing: the definition and objectives; evidence of effectiveness; operational considerations (e.g., training, staffing, and logistics); cost considerations and evidence on cost-effectiveness; operational success...es and challenges; and areas for future research and learning. This document is not intended to endorse any particular approach. Rather, it aims to objectively present the state of the existing evidence on each approach, so as to inform decision-making among practitioners looking to further test, refine and implement such approaches.
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orientations provisoires, 25 juin 2021. Des tests de diagnostic rapides et précis sont un outil essentiel pour prévenir et contrôler la propagation du COVID-19. Ce document décrit les recommandations relatives aux stratégies nationales de dépistage et à l'utilisation de la PCR et des tests an...tigéniques rapides dans différents scénarios de transmission de l'épidémie de COVID-19, y compris la manière dont les tests pourraient être rationalisés dans les milieux à faibles ressources. Tous les tests doivent être suivis d'une réponse de santé publique forte, comprenant l'isolement des personnes dont le test est positif et la fourniture de soins, la recherche des contacts et la mise en quarantaine des contacts.
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Este documento de referência foi preparado pelo Grupo de Trabalho sobre Vacinas contra COVID-19 do Grupo Consultivo Estratégico de Especialistas em Imunização (SAGE) para orientar as discussões do SAGE em sua reunião extraordinária de 8 de fevereiro de 2021, que resultou na publicação do do...cumento da OMS de 10 de fevereiro de 2021 Recomendações provisórias para o uso da vacina AZD1222 [ChAdOx1-S (recombinante)] contra COVID-19 desenvolvida pela Universidade de Oxford e pela AstraZeneca. Os dois documentos estão disponíveis na página sobre COVID-19 do SAGE: https://www.who.int/groups/strategic-advisory-group-of-experts-on-immunization/covid-19-materials. Têm sido usados vetores de adenovírus deficientes na replicação contendo um transgene específico do patógeno como novas vacinas devido à sua capacidade de induzir respostas humorais e celulares fortes.
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Cet article fait partie d’une série d’explications à propos de la mise au point et de la distribution des vaccins.
Available in English, French, Spanish, Arabic, Chinese and Russian
These WHO interim recommendations for use of the BBV152 COVAXIN vaccine were developed on the basis of advice issued by the Strategic Advisory Group of Experts on Immunization (SAGE) and the evidence summary included in the background document and annexes referenced below.
This document has been ...updated: version 15 March 2022.
The vaccine is formulated from an inactivated SARS-CoV-2 antigen and is presented in single dose vials and multidose vials of 5, 10 and 20 doses.
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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... selection, training, documentation and record keeping, stability and beyond-use dating, packaging and labeling, and limited batch compounding. This document is not intended for manufacturers or licensed repackagers.
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In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in ...discharging their legal and professional obligations to patients in the area of extemporaneous dispensing. This guidance will help to assure the safe and appropriate preparation and supply of extemporaneously prepared medicinal products to patients, where
the supply of such products is necessary.
Extemporaneous and hospital based sterile preparations are critical for patients whose clinical needs cannot be met by registered medicinal products. The guidelines outline the principles and application of the concepts of Good Manufacturing Practice (GMP) requirements for premises, equipment, personnel, storage, quality management system, quality control, compounding processes as well as documentation.
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This guideline aims to improve the quality of donations and the management thereof and serve as the basis for policies of the State and other organizations in the giving and receiving of donations of medicines, medical devices and IVDs.
Over the last three or four decades, there has been an enorm...ous increase in scientific knowledge about the mode of action, effects and side effects of medicines, medical devices and IVDs. It is important for all
stakeholders to understand that these products have both benefits and risks, that they have to be used carefully and appropriately and that some can do more harm than good.
There are many different scenarios for the donation of medicines, medical devices and IVDs. Donations may take place in acute emergencies or as part of development aid in non-emergency situations. They may involve donations (i.e. direct or through private voluntary organizations), aid by governments or persons authorized to sell medicines, medical devices and/or IVDs.
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Three Years After Enactment of the Drug Quality and Security Act
ournal of Public Health in Africa 2021; volume 12:2009