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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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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This template dossier complements and should be used after fulfilling the criteria and preconditions specified in the Process of validation of elimination of kala-azar as a public health problem in South-East Asia. The national kala-azar programme should be in the consolidation phase of elimination;... that is, the annual incidence of kala-azar in the implementation unit is maintained below 1 case (new plus relapse) per 10 000 population for a minimum of 3 consecutive years.
The template is designed to help national kala-azar elimination programmes prepare a dossier documenting the essential evidence supporting the request to the World Health Organization (WHO) to validate the status of kala-azar elimination as a public health problem in their country. The information presented in this document will help independent assessors understand the national programme’s specific context, achievements and relevant epidemiological data.
The dossier should be organized according to the following sections:
- Description of the country context and health system capabilities
- Historical data and delineation of endemic areas
- Surveillance and elimination activities
- Epidemiological data
- Vector control strategy and activities
- Post-validation surveillance plan
Once the dossier is prepared, it should be examined and duly endorsed by the National Task Force on kala-azar elimination and/or neglected tropical diseases, or a similar body, before submission to WHO.
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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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