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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.
Of the 50 antibiotics in the pipeline, 32 target WHO priority pathogens but the majority have only limited benefits when compared to existing antibiotics. Two of these are active against the multi-drug resistant Gram-negative bacteria, which are spr
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Improvements in water sanitation and hygiene (WASH) and wastewater management in all sectors are critical elements of preventing infections and reducing the spread of antimicrobial resistance (AMR) as identified in the Global Action Plan to combat AMR. Yet, at present, WASH and wastewater management
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In preparing this paper, the Pharmacovigilance Group of the Pan American Health Organization’s Pan American Network for Drug Regulatory Harmonization (PANDRH) adopted the perspective of PAHO/WHO, which considers Pharmacovigilance, an essential com
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Drugs and medical supplies are dispensed at the cutting edge level of the interface between the public health system and the people. Availability or lack of it brings either credit or discredit to the public health system. The primary reason for holding stocks of medicines and medical supplies in a
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Long-term polio vaccine security – the timely, sustained, and uninterrupted supply of suitable types of affordable, quality-assured polio vaccines – is essential in the global effort to achieve and maintain a polio free world. However, fragmented approaches and short-term planning pose considera
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Every day, fake medicines and medical products are sold at street corners, in open air markets or on unregulated websites in several countries in the African Region. These poor quality, unsafe medicines and pharmaceutical products promote drug resis
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Cardiovascular disease (CVD) is the leading cause of global deaths, with the majority occurring in low- and middle-income countries (LMIC). The primary and secondary prevention of CVD is suboptimal throughout the world, but the evidence-practice gaps are much more pronounced in LMIC. Barriers at the
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Ahead of World Malaria Day, the WHO Global Malaria Programme published a new operational strategy outlining its priorities and key activities up to 2030 to help change the trajectory of malaria trends, with a view to achieving the global malaria targets. The strategy outlines 4 strategic objectives
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Guidelines for the production of extemporaenous formulations and hospital based sterile preparations
In order to streamline and effectively control compounding of medicinal products in hospitals and pharmacies, these Guidelines for Production of Extemporaneous and Hospital Based Sterile Preparations has been crafted. The purpose of these guidelines therefore is to assist pharmacists in
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This document summarizes the results of the WHO-commissioned full value proposition for new tuberculosis (TB) vaccines. The assessment was commissioned to provide early evidence for national and global decision-makers involved in TB vaccine development and implementation, who include stakeholders in
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The pamphlet "Methamphetamine" provides information about methamphetamine, an illegal stimulant with high abuse potential, though it has limited medical uses for conditions like ADHD and narcolepsy. It explains short-term effects such as appetite suppression, increased heart rate and blood pressure,
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To support its R&D activities on Chagas disease, DNDi launched the Chagas Clinical Research Platform (CCRP). The platform brings together partners, experts, and stakeholders to provide support for evaluation and development of new treatments for Chagas disease. The patient-centred platform aims to f
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The extensive use of antimicrobials in human and veterinary medicine in recent years has accelerated the emergence and spread of resistant microorganisms. This situation has been worsened by the lack of investment in developing new effective antibiotics. The severity of the consequences is clear to
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