The report focuses on antibacterial resistance (ABR) in common bacterial pathogens. There is a major gap in knowledge about the magnitude of this problem. Antimicrobial resistance (AMR) threatens the effective revention and treatment of an ever-increasing range of infections caused by bacteria, para...sites, viruses and fungi. This WHO report, produced in collaboration with Member States and other partners, provides for the first time, as accurate a picture as is presently possible of the magnitude of AMR and the current state of surveillance globally. It examines the information on AMR, in particular antibacterial resistance (ABR), at country level worldwide.
more
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.
more
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.
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.
more
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
more
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.
more
Serie: Documentos Técnico normativos