Legislative and Policy analysis and recommendations for reform
This report presents an analysis of antibacterial agents in preclinical (third annual review) and clinical (fifth annual review) development. The analysis covers traditional (direct-acting small molecules) and non-traditional antibacterial agents in development worldwide. It evaluates to what extent... the present pipeline addresses infections caused by WHO Priority Pathogens, Mycobacterium tuberculosis and Clostridioides difficile. The report also provides an assessment of the traditional agents with respect to whether they meet a set of predefined criteria for innovation, namely absence of known cross-resistance, new target, mode of action and/or class. It also includes an overview of the agents that obtained authorization since 1 July 2017.
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The Zimbabwe National Pharmacovigilance Policy Handbook, 2nd Edition updates the November 2013 version to indicate the Zimbabwe National Pharmacovigilance (PV) Centre’s compliance with the WHO Pharmacovigilance Indicators Handbook 2015.
For the Fiscal Year 2015-2016, the Health Sector continued to implement actions meant to improve the availability, and access to quality healthcare. The following report highlights achievements registered by the health sector for the fiscal 2015-2016 in different health programs, as well as in the a...rea of health system strengthening.
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Made under Section 5 (c) of the Tanzania Food, Drugs and Cosmetics Act, 2003 | Second Edition
Full eHandbook under: http://www.msh.org/resources/health-systems-in-action-an-ehandbook-for-leaders-and-managers
Effective supply management has the potential to make a powerful contribution to the reliable availability of essential medicines, which are a crucial part of the delivery of highqualit...y health care services. Because medicines are costly and poor management so often results in waste, good supply management is also crucial to the cost-effectiveness of providing medicines.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
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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L'objectif de la cartographie est d'obtenir une vision claire et précise des systèmes et politiques d'approvisionnement, de distribution et de financement des produits pharmaceutiques existants au Burkina Faso et de déterminer leur pertinence, leur cohérence et leurs forces et faiblesses en term...es d’efficacité, d’efficience, de durabilité et d’impact à long terme au regard des normes et recommandations nationales, régionales et internationales relatives à la règlementation et aux bonnes pratiques pharmaceutiques et à l'efficacité de l'aide.
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Serie: Documentos Técnico normativos
National Tuberculosis Programme and Senior Paediatricians
This guideline was first developed in 2007 but further updated in 2012 and 2016 to ensure the use of the latest evidence-based international recommendations on childhood TB. The guidelines will fill the gaps in a systematic approach to T...B in children and will help to achieve an internationally recommended standard of care at all levels of the health system in Myanmar.
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