These guidelines have been developed to provide guidance to the Ministry of Health in managing applications for registration of human pharmaceutical products in Rwanda. It was compiled by the Technical Working Group (TWG) on Medicines Evaluation and Registration (MER) of the East African Community M...edicine Regulatory Harmonization (EAC MRH) Project. The group relied on their experiences and knowledge on medicines registration requirements of their individual Countries. World Health Organization (WHO) and the International Conference on Harmonization of Technical Requirements of Medicines for Human Use (ICH) and other available literature.
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Introduction, preparations to submit, submission procedure, requirements, main narrative of the protocol, definition of terms. | For Research and ethics clearance in Lesotho
For SARS-CoV-2 testing only
In its resolution 34/16, the Human Rights Council decided to focus its next full-day meeting on “Protecting the rights of the child in humanitarian situations” and invited the Office of the High Commissioner to prepare a report on that issue, in close collaboration with relevant stakeholders. Th...e report is to be presented to the Human Rights Council at its thirty-seventh session to inform the annual day of discussion on children’s rights.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin...g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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This document provides technical guidance for manufacturers seeking World Health Organization (WHO) prequalification of in vitro diagnostic devices (IVDs) for malaria, with a focus on rapid diagnostic tests (RDTs) for symptomatic patients. It summarises the minimum performance requirements, includin...g analytical and clinical performance standards, and emphasises considerations relating to diverse specimen types, testing environments and user populations in low- and middle-income countries. The guidance is aligned with the criteria and prequalification processes of the WHO Global Malaria Programme, while clarifying that demonstration of clinical utility is outside the scope of prequalification.
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Submission by the WHO Collaborating Centre on training and policy on opioid availability and WHO collaborating Centre for community participation in palliative care and long term care To the Indian Nursing Council for consideration to be included in the Undergraduate Nursing education curriculum
Namibia guideline for submission of applications for registration of pharmaceuticals for human use in common technical document format.
Joint Stakeholder Submission
Accessed: 29.09.2019
Technical specifications series for submission to WHO prequalification: diagnostic assessment;TSS-3
Guidance for the preparation and submission of dossiers
Prepared by NGOs: “Legalife-Ukraine”, “Insight”, “Positive Women”, and “Svitanok”
For the submission to the 66th CEDAW Session Geneva, Switzerland
13 February 2017 - 03 March 2017
the Planetary Health Alliance issued a call for planetary health case studies to strengthen and expand the field of planetary health by shining a light on cross-sectoral solutions that optimize human health in the face of anthropogenic environmental change. After receiving submissions and proposals ...from organizations and institutions worldwide, ten diverse case studies were chosen to create a cohesive anthology of examples ranging in thematic area, problem-solving approach, ecosystem characteristics, and geographic region. Our freelance Case Study Writer, Hilary Duff, traveled the world in 2018-2019 conducting interviews with stakeholders and organization leads to build this anthology of planetary health stories. These cases invite students to reflect on the pressing realities of people living in vulnerability, the complex connections between people and planet, and how the anthropogenic acts of one generation can reverberate through the next.
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STAATSKOERANT, 5 MEI 2015 No. 38763
No. 38763 GOVERNMENT GAZETTE, 5 MAY 2015
General Notice
Notice 295 of 2015
Department of basic education
National education policy act, 1996 (Act No 27 of 1996)
Call for written submissions from stakeholder bodies and members of the public on Departmen...t of basic education draft national policy on HIV, STIs and TB
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The National Deployment and Vaccination Plan for COVID-19 vaccines (NDVP): Standard Review Form (SRF) is an excel-based resource used by Regional Review Committees to assess NDVPs submitted to the Partners Platform. The SRF enables countries to prepare their NDVPs for the review process and supports... regions in conducting a consistent and uniform assessment of the submitted NDVPs. This resource should be used in conjunction with the National Deployment and Vaccination Plan for COVID-19 vaccines (NDVP): Submission and Review Process document.
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This document outlines the evaluation process that WHO undertakes to assess novel tools and strategies targeted at VBDs. Its aim is to articulate the linkage between the generation of evidence that demonstrates public health impact of novel interventions, and the development of policy recommendation...s based on the generated data. The document defines standards for the evaluation process, as well as the steps that an applicant needs to undertake, along with some guiding principles that aim to support applicants in the development of submissions with WHO.
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