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Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods: The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19. [ABSTRACT FROM AUTHOR]

Background: The Every Newborn Action Plan (ENAP) and Ending Preventable Maternal Mortality targets cannot be achieved without high quality, equitable coverage of interventions at and around the time of birth. This paper provides an overview of the methodology and findings of a nine paper series of in-depth analyses which focus on the specific challenges to scaling up high-impact interventions and improving quality of care for mothers and newborns around the time of birth, including babies born small and sick.Methods: The bottleneck analysis tool was applied in 12 countries in Africa and Asia as part of the ENAP process. Country workshops engaged technical experts to complete a tool designed to synthesise "bottlenecks" hindering the scale up of maternal-newborn intervention packages across seven health system building blocks. We used quantitative and qualitative methods and literature review to analyse the data and present priority actions relevant to different health system building blocks for skilled birth attendance, emergency obstetric care, antenatal corticosteroids (ACS), basic newborn care, kangaroo mother care (KMC), treatment of neonatal infections and inpatient care of small and sick newborns.Results: The 12 countries included in our analysis account for the majority of global maternal (48%) and newborn (58%) deaths and stillbirths (57%). Our findings confirm previously published results that the interventions with the most perceived bottlenecks are facility-based where rapid emergency care is needed, notably inpatient care of small and sick newborns, ACS, treatment of neonatal infections and KMC. Health systems building blocks with the highest rated bottlenecks varied for different interventions. Attention needs to be paid to the context specific bottlenecks for each intervention to scale up quality care. Crosscutting findings on health information gaps inform two final papers on a roadmap for improvement of coverage data for newborns and indicate the need for leadership for effective audit systems.Conclusions: Achieving the Sustainable Development Goal targets for ending preventable mortality and provision of universal health coverage will require large-scale approaches to improving quality of care. These analyses inform the development of systematic, targeted approaches to strengthening of health systems, with a focus on overcoming specific bottlenecks for the highest impact interventions. [ABSTRACT FROM AUTHOR]

Summary: This is the first 1-year longitudinal study which assesses vitamin D deficiency in young UK-dwelling South Asian women. The findings are that vitamin D deficiency is extremely common in this group of women and that it persists all year around, representing a significant public health concern. Introduction: There is a lack of longitudinal data assessing seasonal variation in vitamin D status in young South Asian women living in northern latitudes. Studies of postmenopausal South Asian women suggest a lack of seasonal change in 25-hydroxy vitamin D [25(OH)D], although it is unclear whether this is prevalent among premenopausal South Asians. We aimed to evaluate, longitudinally, seasonal changes in 25(OH)D and prevalence of vitamin D deficiency in young UK-dwelling South Asian women as compared with Caucasians. We also aimed to establish the relative contributions of dietary vitamin D and sun exposure in explaining serum 25(OH)D. Methods: This is a 1-year prospective cohort study assessing South Asian ( n = 35) and Caucasian ( n = 105) premenopausal women living in Surrey, UK (51° N), aged 20-55 years. The main outcome measured was serum 25(OH)D concentration. Secondary outcomes were serum parathyroid hormone, self-reported dietary vitamin D intake and UVB exposure by personal dosimetry. Results: Serum 25(OH)D <25 nmol/L was highly prevalent in South Asians in the winter (81 %) and autumn (79.2 %). Deficient status (below 50 nmol/L) was common in Caucasian women. Multi-level modelling suggested that, in comparison to sun exposure (1.59, 95 %CI = 0.83-2.35), dietary intake of vitamin D had no impact on 25(OH)D levels (−0.08, 95 %CI = −1.39 to 1.23). Conclusions: Year-round vitamin D deficiency was extremely common in South Asian women. These findings pose great health threats regarding the adverse effects of vitamin D deficiency in pregnancy and warrant urgent vitamin D public health policy and action. [ABSTRACT FROM AUTHOR]

Background: Portion size estimation is fundamental to the accuracy of dietary recall, as well as interventions in obesity. Data on portion size estimation aids (PSEA) for Asian foods are limited. PSEA for Asian foods were developed and their accuracy and precision were tested for inclusion in a food atlas. Methods: Sixteen food items were selected to represent all food groups. Small and life size photographs were developed, and line diagrams were drawn. These, together with household utensils, were tested among a random sample of 80 schoolchildren (aged 10-16 years). A total of 3180 estimations were made: 876 for small photographs ( n = 11 foods), 558 for life size photographs ( n = 7 foods), 1271 for line diagrams ( n = 16 foods) and 475 for household utensils ( n = 6 foods). Results: Line diagrams had a high percentage (63.9%) of correct estimations and a low percentage of over estimations (18.0%) and under estimations (18.1%), whereas household utensils performed poorly with 0.6% correct estimations. Greater accuracy and precision were obtained for amorphous foods with small photographs and for non-amorphous foods with line diagrams. The combination of small photographs (for vegetables) and line diagrams (for other foods) achieved a high correlation ( r = 0.959, P ≤ 0.001), percentage correct estimations (68.3%) and low under estimations (19.9%) and over estimations (11.8%). Food texture, but not age or sex, was associated with correct estimations in all of the PSEA, except household utensils. Conclusions: Accuracy and precision of a combination PSEA is convincing, enabling inclusion into an Asian food atlas for dietary assessment and intervention. [ABSTRACT FROM AUTHOR]

In resource-poor countries, substantial sums of money from governments and international donors are used to purchase equipment for health facilities. WHO estimates that 50–80% of such equipment remains non-functional. This article is based on experience from various projects in developing countries in Asia and Africa. The key issues in the purchase, distribution, installation, management and maintenance of equipment for emergency obstetric care (EmOC) services are identified and discussed. Some positive examples are described to show how common equipment management problems are solved. [Copyright &y& Elsevier]