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Access to quality-assured medical products improves health and save lives. However, one third of the world’s population lacks timely access to quality-assured medicines while estimates indicate that at least 10% of medicine in low- and middle-income countries (LMICs) are substandard or falsified (SF), costing approximately US$ 31 billion annually. National regulatory authorities are the key government institutions that promote access to quality-assured medicines and combat SF medical products but despite progress, regulatory capacity in LMICs is still insufficient. Continued and increased investment in regulatory system strengthening (RSS) is needed. We have therefore reviewed existing global normative documents and resources and engaged with our networks of global partners and stakeholders to identify three critical challenges being faced by NRAs in LMICs that are limiting access to medical products and impeding detection of and response to SF medicines. The challenges are; implementing value-added regulatory practices that best utilize available resources, a lack of timely access to new, quality medical products, and limited evidence-based data to support post-marketing regulatory actions. To address these challenges, we have identified seven focused strategies; advancing and leveraging convergence and reliance initiatives, institutionalizing sustainability, utilizing risk-based approaches for resource allocation, strengthening registration efficiency and timeliness, strengthening inspection capacity and effectiveness, developing and implementing risk-based post-marketing quality surveillance systems, and strengthening regulatory management of manufacturing variations. These proposed solutions are underpinned by 13 focused recommendations, which we believe, if financed, technically supported and implemented, will lead to stronger health system and as a consequence, positive health outcomes.
During the past thirty years the Survey of Memphis and others have acquired more than two hundred borehole logs from the Capital Zone of Egypt. Combining these boreholes with maps and satellite images, we show that, during the past five thousand years, the geography of the Nile has been in constant flux with mean rates of migration around 2 m/y and one of its channels becoming extinct, by nature or through human intervention. Re-visiting ancient texts in the light of this changing environment, we show that the literary settings of both fictional and historical texts were real landscapes known to the authors. Hence we infer that ancient descriptions of landscape can be interpreted in a more literal way than before and that the authors were not as prone to writing of a metaphorical realm as was previously thought.
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