DRUGS REGULATORY UNIT | NOVEMBER 2009 | SECOND EDITION
Emergence of antimicrobial resistance is a result of the use, overuse and misuse of antibiotics both in humans and animals. In Ethiopia, there are indications on the misuse of antibiotics by health care providers’, unskilled practitioners, and drug consumers. These coupled with rapid spread of res...istant bacteria and inadequate surveillance contributed to the problem. Bacterial infections are the major causes of death in Ethiopia. Studies on antibacterial resistance and on bacterial infections have shown that emerging antibacterial resistance threatens the management of bacterial infections; however, the prevention and containment has received far too little attention.
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Good Manufacturing Practice (GMP) describes a set of principles and procedures that, when followed, ensure that medicines and related substances are of high quality, safety and efficacy. SAHPRA is a
participating authority of the Pharmaceutical Inspection Cooperation Scheme (jointly known as PIC/S).... PIC/S aims to develop international standards between countries and pharmaceutical inspection
authorities, to provide harmonised and constructive co-operation in the field of GMP. PIC/S affiliation is subject to initial and periodic assessment of the participating authority to ensure that it has equivalent legislation, regulatory and enforcement procedures and inspection capacity.
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This policy brief aims to provide a review of the current progress on implementing the Malawi national action plan on AMR, identifies critical gaps, and highlights findings to accelerate further progress in the human health sector. The target audience includes all those concerned with implementing a...ctions to combat antimicrobial resistance in Malawi.
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Document No. : FDA/SMC/SMD/GL-RAR/2013/01
Document No. : FDA/SMC/SMD/GL-SMP/2015/05 |
These guidelines are for information, guidance and strict compliance by Marketing Authorization Holders and Local Representatives of regulated products to help in the continuous safety monitoring of products granted marketing authorization in Ghana.
Translation of the 1st ed., 2003
These guidelines were written for anyone trying to meet and solve the challenges of operating a warehouse today. They are an important reference tool for managers and staff, whether they are constructing a new warehouse, implementing a new warehouse syste...m, or redesigning their current system.
Guidelines for Warehousing Health Commodities is for use by supply chain managers, logistics advisors, and warehouse managers who want to improve and increase efficiency in their current health commodity warehouse.
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Document No. : FDA/SMC/CTD/GL-CCT/2013/01
Communication to Healthcare Professionals Mar-2020
This guideline is intended to assist healthcare professionals in the participation of very important process of continuous surveillance of safety and efficacy of the health products which are used in their clinical practice. Continuous evaluation o...f medicines’ benefit and harm help to achieve the ultimate goal of safe and effective treatments available to patients.
The guideline is intended to assist healthcare professionals in the reporting of suspected adverse drug reactions (ADRs) associated with the use of all registered health products, including medicines, old medicines, medical devices and in-vitro diagnostics (IVDs).
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