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Background: Access to medicine is crucial for the effective functioning of healthcare systems. A robust regulatory framework is necessary to ensure the safety, effectiveness, and availability. However, weak regulatory frameworks persist in many low- and middle-income countries, leasing to the circulation of falsified and substandard medicines as well as anti-competitive restrictions on registering poor-quality medicines, which poses a significant public health threat. This study evaluated the evolution of Zanzibar's medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level. Methods: This study was conducted at the Zanzibar Food and Drug Agency (ZFDA) in Unguja, Zanzibar, using a retrospective cross-sectional review and qualitative approach. It thoroughly reviewed relevant regulatory documents, including Acts, policies, guidelines, and assessment reports. Data were collected using a standardised checklist and analysed to uncover patterns and insights regarding the evolution of Zanzibar's medicine regulatory system. Results: This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities. Conclusion: Zanzibar's medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. Future efforts should address the remaining challenges and foster collaboration with regional and international bodies to ensure the continued evolution and effectiveness of Zanzibar's medicine regulatory framework. [ABSTRACT FROM AUTHOR]

Genetically modified (GM) crops are the most important agricultural commodities that can improve the yield of African smallholder farmers. The intricate circumstances surrounding the introduction of GM agriculture in Africa, however, underscore the importance of comprehending the moral conundrums, regulatory environments, and public sentiment that exist today. This review examines the current situation surrounding the use of GM crops in Africa, focusing on moral conundrums, regulatory frameworks, and public opinion. Only eleven of the fifty-four African countries currently cultivate GM crops due to the wide range of opinions resulting from the disparities in cultural, socioeconomic, and environmental factors. This review proposed that addressing public concerns, harmonizing regulations, and upholding ethical standards will improve the adoption of GM crops in Africa. This study offers ways to enhance the acceptability of GM crops for boosting nutrition and food security globally. [ABSTRACT FROM AUTHOR]

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa's current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. [ABSTRACT FROM AUTHOR]

Supply chain resilience involves creating diverse and redundant sources for raw materials, optimizing logistics, and employing advanced forecasting techniques to anticipate and mitigate potential shortages. Manufacturing resilience focuses on adopting scalable and adaptable production technologies, enhancing quality control measures, and establishing contingency plans for production disruptions. Regulatory resilience entails the capacity to navigate and comply with evolving regulatory landscapes swiftly, fostering collaborations with regulatory agencies to expedite approval processes during emergencies. Innovation and research resilience are crucial for sustaining drug development and responding to emerging health threats. This involves investing in cutting-edge technologies, fostering partnerships for collaborative research, and maintaining a pipeline of new therapies and treatments. Pharmaceutical resilience also requires effective communication and coordination among stakeholders, including pharmaceutical companies, healthcare providers, governments, and international organizations. By enhancing these components, the pharmaceutical sector can better withstand and recover from disruptions, ensuring continuous access to essential medications and safeguarding public health. This abstract emphasizes the multifaceted approach needed to build and sustain resilience within the pharmaceutical industry, ensuring its capacity to meet both current and future challenges effectively. [ABSTRACT FROM AUTHOR]

Phytopathogens can continuously cause serious losses worldwide to crop, fruit, and vegetable yields. The excessive use of conventional fungicides in pathogen management has raised severe environmental and health side effects and induced fungicide-resistant pathogen strains. RNA-based spray-induced gene silencing (SIGS) has emerged as an ecologically sustainable pathogen control approach. Here, we introduce the SIGS mechanism in plant pathogens, summarize the application of SIGS in controlling plant pathogens, and highlight the major considerations of SIGS. In addition, we propose the future perspectives of SIGS in crop protection and disease management. [ABSTRACT FROM AUTHOR]

Copyright of International Journal of Professional Business Review (JPBReview) is the property of Open Access Publications LLC and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

This article examines the critical role of life insurance in India's economic development, focusing on its growth, contributions, and challenges. The life insurance sector in India has experienced significant expansion due to government initiatives like the Pradhan Mantri Jan Dhan Yojana (PMJDY) and Pradhan Mantri Jeevan Jyoti Bima Yojana (PJJBY), which have improved market penetration and accessibility. Key findings include the importance of a robust regulatory framework, the impact of financial inclusion, and the necessity of enhancing public awareness and trust. The study also highlights future research directions, such as exploring technological innovations, evaluating government schemes, and understanding consumer behavior. The article concludes by emphasizing the sector's role in fostering financial stability and economic growth, while addressing ongoing challenges and identifying opportunities for further development. [ABSTRACT FROM AUTHOR]

This opinion paper evaluates the potential of porcine islets as a promising alternative in beta cell replacement therapy for Type 1 Diabetes (T1D), juxtaposed with the current limitations of human donor islets. It analyzes the compatibility of pig islets with human glucose metabolism, their prospects as a limitless and high-quality source of beta cells, and the unique immunogenic challenges they present in xenotransplantation. Additionally, the paper discusses the regulatory and ethical considerations pertinent to the use of porcine islets. By synthesizing current research and expert perspectives, the paper highlights both the opportunities and significant barriers that need addressing to advance pig islets as a viable therapeutic option. The findings advocate for a balanced and forward-looking approach to the integration of pig islets in T1D treatment, underscoring the need for continued research and dialogue in this evolving field. [ABSTRACT FROM AUTHOR]

Repurposing generic drugs as new treatments for life-threatening diseases such as cancer is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. Nonprofit organizations and other non-manufacturers have been ramping up efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these nonmanufacturers find it difficult to obtain regulatory approval in the U.S. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs. This limits the broad clinical adoption of these drugs and patient access. In this paper, we explore the regulatory landscape for repurposing of small molecule generic drugs within the U.S. We describe case studies of repurposed drugs that have been successfully incorporated into clinical treatment guidelines for cancer without regulatory approval. To encourage greater adoption of generic drugs in clinical practice-that is, to encourage the repurposing of these drugs-we examine existing Food and Drug Administration (FDA) pathways for approval of new uses or indications for generic drugs. We show how non-manufacturers, who are generally more active in generic drug repurposing than manufacturers, could utilize existing regulatory authorities and pathways, and we describe the challenges they face. We propose an extension of the existing 505(b)(2) new drug application (NDA) approval pathway, called a "labeling-only" 505(b)(2) NDA, that would enable non-manufacturers to seek approval of new indications for well-established small molecule drugs when multiple generic products are already available. It would not require new chemistry, manufacturing, and controls (CMC) data or introducing new drug products into the marketplace. This pathway would unlock innovation broadly and enable patients to benefit from the enormous potential of low-cost generic drugs. [ABSTRACT FROM AUTHOR]

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients' quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a "medical device lag," where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). [ABSTRACT FROM AUTHOR]

The explosive advancement of contemporary artificial intelligence (AI) technologies, typified by ChatGPT, is steering humans towards an uncontrollable trajectory to artificial general intelligence (AGI). Against the backdrop of a series of transformative breakthroughs, big tech companies such as OpenAI and Google have initiated an "AGI race" on a supranational level. As technological power becomes increasingly absolute, structural challenges may erupt with an unprecedented velocity, potentially resulting in disorderly expansion and even malignant development of AI technologies. To preserve the dignity and safety of human-beings in a brand-new AGI epoch, it is imperative to implement regulatory guidelines to limit the applications of AGI within the confines of human ethics and rules to further counteract the potential downsides. To promote the benevolent evolution of AGI, the principles of Humanism should be underscored and the connotation of Digital Humanism should be further enriched. Correspondingly, the current regulatory paradigm for generative AI may also be overhauled under the tenet of Digital Humanism to adapt to the quantum leaps and subversive shifts produced by AGI in the future. Positioned at the nexus of legal studies, computer science, and moral philosophy, this study therefore charts a course for a synthetic regulation framework of AGI under Digital Humanism. [ABSTRACT FROM AUTHOR]

Copyright of Österreichische Wasser- und Abfallwirtschaft is the property of Springer Nature and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)

Genetically modified (GM) crops are the most important agricultural commodities that can improve the yield of African smallholder farmers. The intricate circumstances surrounding the introduction of GM agriculture in Africa, however, underscore the importance of comprehending the moral conundrums, regulatory environments, and public sentiment that exist today. This review examines the current situation surrounding the use of GM crops in Africa, focusing on moral conundrums, regulatory frameworks, and public opinion. Only eleven of the fifty-four African countries currently cultivate GM crops due to the wide range of opinions resulting from the disparities in cultural, socioeconomic, and environmental factors. This review proposed that addressing public concerns, harmonizing regulations, and upholding ethical standards will improve the adoption of GM crops in Africa. This study offers ways to enhance the acceptability of GM crops for boosting nutrition and food security globally.

The relevance of the article is due to the insignificant contribution of microfinance to the development of the Russian economic system, especially in the context of supporting small and medium-sized businesses. However, the regulator sees it as a promising sector of the financial market and considers its progressive development necessary. The purpose of the work is to study the current state and identify trends in the development of the microfinance market in Russia. The methodological basis of the study includes empirical observation and analysis. During the work, official statistical data and scientific publications on the topic of microfinance have been used. The article provides a review of current legislative documents regulating the microfinance sector, and analyses the state of the market based on statistical data. It is substantiated that some elements of the monetary and financial policies pursued in the Russian Federation can be applied for the successful development of the microfinance sector, contribute to its effective and balanced work, and improve accessibility and sustainability. In the course of the work, key directions for the development of the microfinance market are formed: improving regulation and supervision; promoting financial literacy of the population; application of digital technologies; expansion and diversification of the product portfolio, development of partnerships, social entrepreneurship, which contribute to the sustainable development of this segment of the financial market. Particular attention is paid to a detailed analysis of improving the regulatory framework for microfinance in Russia from the point of view of legislation on bankruptcy of individuals, stimulating innovation and digitalisation, and supporting social entrepreneurship.

Abstract This article examines the critical role of life insurance in India's economic development, focusing on its growth, contributions, and challenges. The life insurance sector in India has experienced significant expansion due to government initiatives like the Pradhan Mantri Jan Dhan Yojana (PMJDY) and Pradhan Mantri Jeevan Jyoti Bima Yojana (PJJBY), which have improved market penetration and accessibility. Key findings include the importance of a robust regulatory framework, the impact of financial inclusion, and the necessity of enhancing public awareness and trust. The study also highlights future research directions, such as exploring technological innovations, evaluating government schemes, and understanding consumer behavior. The article concludes by emphasizing the sector's role in fostering financial stability and economic growth, while addressing ongoing challenges and identifying opportunities for further development.

The article outlines the provisions of the modern regulatory framework that regulates the work of health spa (sanatorium) organizations and the use of natural healing resources for therapeutic purposes. The legislative innovations, the main tasks and problems of the development of the spa and resort industry from a medical point of view are described. The historical background of the development of the spa and resort medical industry in the context of natural resources is presented. It describes the development of health resort business in Russia from the emergence of the first sanatorium to the present day.

Plural policing and public–private partnerships have become increasingly prevalent since the latter half of the twentieth century. Within that period, there has also been a rise in the deployment of security measures and technological advancements in properties, such as intrusion alarm systems. However, this increased use of intrusion alarm systems has placed additional strain on police capacities. Ultimately, this has led to an increasing involvement of additional actors alongside law enforcement agencies—and the establishment of public–private partnerships—in the sphere of alarm use and management. The goal of this paper is to explore the operational processes, assess the existing regulatory framework, and identify challenges and complexities within public–private partnerships concerning intrusion alarm management and policy. In particular, we identified friction points amongst the legal authority, the operational competences, the willingness, and the consensus for executing legal powers by stakeholders in the alarm chain. [ABSTRACT FROM AUTHOR]

Abstract Background Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use, however due to their special properties the availability of approved radiopharmaceuticals is limited. For this reason, they can be produced on a small scale outside the marketing authorization process. Main body The in-house radiopharmaceutical preparations represent an important source of these special medicines for routine nuclear medicine practice. However, a lack of harmonization in Member States’ regulations leads to extreme differences in the use and availability of radiopharmaceuticals across Europe. The aim of this work is to provide an overview of the different national regulatory frameworks in which Directive 2001/83/UE is adopted on the preparation of radiopharmaceuticals outside the marketing authorization track in Europe. Nine different national regulations have been studied to describe how unlicensed radiopharmaceuticals are prepared. Special attention is paid to reflect the minimum standards that these preparations should meet as well as the educational requirements to be a radiopharmacist in charge of them. Conclusion The rapid development of new radiopharmaceuticals used in radiometabolic therapy requires a common regulation that allows balance between the use and preparation of licensed and unlicensed radiopharmaceuticals. The absence of a harmonized regulation for the radiopharmaceutical small-scale preparation and the implementation of Good Manufacture Practices, leads to extreme differences in the use, quality assurance and availability of radiopharmaceuticals in Europe.

The purpose of this article is to investigate the factors that influence the authenticity of heritage hotels in popular tourist destinations. Using the Greek island of Santorini as a case study, the following three (3) factors, which have not been systematically studied so far, are examined and appear to have a significant impact on authenticity in the conversion of a heritage architectural building into a heritage hotel: (a) its structural characteristics, (b) the influence of the star classification system and (c) the extent to which each business promotes authenticity elements and heritage identity. For the purposes of this study, a threefold methodological approach was conducted, which includes archival research in the registry of the Hellenic Chamber of Hotels for all the heritage hotels in Santorini (69 units), research in the accounting data of the island’s heritage hotels certified with the national star ranking system for their services and amenities and research analysis of the information regarding the promotion of the heritage hotels through their official websites. Additionally, a cartographic representation of the locations of these hotels was created and their positioning was compared to the boundaries of traditional or non-traditional settlements. The results validated the basic finding of the literature review, that the authenticity of a heritage hotel is a construction under constant negotiation, influenced by a multitude of factors. The conversion of a historic building into a heritage hotel is a multidimensional process that requires a delicate balance between preserving cultural value and adapting to the needs of modern tourism, as well as a continuous evaluation and review of the policies in place.

Background Ethiopia’s potato seed system is currently hindered by a disjointed regulatory framework, insufficient quality assurance processes, and a lack of collaboration among stakeholders, which collectively impede agricultural productivity and food security. The regulatory environment is characterized by inconsistent seed certification practices and a dependence on informal seed sources, negatively affecting the quality of potato seeds available to farmers. Although potatoes play a crucial role in global food security by providing high yields compared to other staple crops, the sector grapples with significant challenges due to bureaucratic inefficiencies, limited technical expertise, and the widespread presence of counterfeit seeds throughout the value chain. Methods To tackle these challenges, this mini-review outlines potential improvements, stressing the necessity for a unified regulatory framework tailored to the unique issues of vegetatively propagated crops. For this reason, we have used different literature source from web of science, Pubmed, Google Scholar, ResearchGate and other scientific websites. We have documented the most relevant information focusing on potato seed system, regulatory frameworks, quality assurance bottlenecks and pathways for improvement across the seed value chain. Results our paper highlights key recommendations that includes enhancing training for regulatory staff, investing in research for disease-resistant varieties, and bolstering public-private partnerships to encourage innovation and resource sharing. Furthermore, improving traceability in the seed supply chain is essential for maintaining seed quality and integrity. Conclusions This review calls for a comprehensive strategy that fosters stakeholder engagement and promotes sustainable practices to rejuvenate Ethiopia’s potato seed system, thereby supporting the livelihoods of millions of smallholder farmers and strengthening national food security through integrated seed sector development and capacity improvement of the seed regulatory body as well as smallholder farmers.

Background: Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use, however due to their special properties the availability of approved radiopharmaceuticals is limited. For this reason, they can be produced on a small scale outside the marketing authorization process. Main body: The in-house radiopharmaceutical preparations represent an important source of these special medicines for routine nuclear medicine practice. However, a lack of harmonization in Member States' regulations leads to extreme differences in the use and availability of radiopharmaceuticals across Europe. The aim of this work is to provide an overview of the different national regulatory frameworks in which Directive 2001/83/UE is adopted on the preparation of radiopharmaceuticals outside the marketing authorization track in Europe. Nine different national regulations have been studied to describe how unlicensed radiopharmaceuticals are prepared. Special attention is paid to reflect the minimum standards that these preparations should meet as well as the educational requirements to be a radiopharmacist in charge of them. Conclusion: The rapid development of new radiopharmaceuticals used in radiometabolic therapy requires a common regulation that allows balance between the use and preparation of licensed and unlicensed radiopharmaceuticals. The absence of a harmonized regulation for the radiopharmaceutical small-scale preparation and the implementation of Good Manufacture Practices, leads to extreme differences in the use, quality assurance and availability of radiopharmaceuticals in Europe. [ABSTRACT FROM AUTHOR]

For the regulation of its outward foreign investment, China has issued various regulatory documents and policies instruments through different governmental levels and branches, such regulatory regime has governed China’s outward investment activities for more than four decades, and has been significantly complex, fragmented, and decentralized. This article provides a comprehensive and updated analysis on the main aspects and contents of China’s current regulatory regime on outward foreign investment, it finds that many inherent problems remain unresolved. These problems are analysed and unfolded from three main perspective in terms of investment regulation, promotion, and protection. The analysis reveals the potential areas for improvement in China’s regulatory regime thereof, including areas of multilayered regulation, foreign exchange regulation, compliance policies, financial policies, and overseas investment insurance. Considering China’s recent national legislative plan, this article also argues that China’s outward investment may probably continue to be governed by the current regulatory regime over the longer term. [ABSTRACT FROM AUTHOR]

Feed costs present a major burden in animal production for human consumption, representing a key opportunity for cost reduction and profit improvement. Nanotechnology offers potential to increase productivity by creating higher‐quality and safer products. The feed sector has benefited from the use of nanosystems to improve the stability and bioavailability of feed ingredients. The development of nanotechnology products for feed must consider the challenges raised by biological barriers as well as regulatory requirements. While some nanotechnology‐based products are already commercially available for animal production, the exponential growth and application of these products requires further research ensuring their safety and the establishment of comprehensive legislative frameworks and regulatory guidelines. Thus, this article provides an overview of the current state of the art regarding nanotechnology solutions applied in feed, as well as the risks and opportunities aimed to help researchers and livestock producers. [ABSTRACT FROM AUTHOR]

This chapter (Geoanalytical Metrology) is a contribution to the Geostandards and Geoanalytical Research Handbook of Rock and Mineral Analysis – an online textbook that is a fully revised and updated edition of Handbook of Silicate Rock Analysis, which was written by Philip J. Potts and published in 1987 by Blackie and Son (Glasgow). This second edition comprises chapters, written by prominent research scientists, designed to provide comprehensive overviews of the relevant techniques for the elemental characterisation of rocks and minerals. Chapters are designed to allow new practitioners to the field (including research students) to attain a comprehensive understanding of the theory, practice and capabilities of each technique, as well as being of benefit to established research geoanalysts. In addition to the content, chapter titles have been revised where appropriate to reflect progress in this field. Chapter 1, Part 1 (from Section 1 of the handbook dealing with fundamentals of measurement and instrument design) first sets out the overarching conventions that operate in analytical chemistry, including a description of the international organisations and systems that regulate the standards governing the discipline. This is followed by coverage of the statistical basis on which geoanalytical data sets are treated, analysed and interpreted, which summarises most of the relevant tests and terminology employed in this field. The methods by which the calibration of measured signals from instrumental techniques is tackled, followed by method validation, which covers aspects including measurement uncertainty, bias, precision and trueness. Sections detailing metrological traceability and quality management conclude this chapter. [ABSTRACT FROM AUTHOR]

Carbon capture and utilization (CCU) is part of the European Union (EU)'s strategy to become climate‐neutral by 2050. CO2 is needed as a feedstock for the production of climate‐friendly base chemicals and sustainable fuels. Although CO2 capture from industrial point sources is technically feasible and requires less energy than direct air capture, its integration into the circular economy is challenging due to only the temporary recognition of fossil CO2 as a source for the production of climate‐friendly renewable fuels. In this article, CO2 sources such as waste incineration plants, lime production, and steel production are analyzed based on process simulation in terms of their energy demand for CCU and compliance with current EU legislation on renewable fuels over the service life of a CCU plant. [ABSTRACT FROM AUTHOR]

The production of renewable and sustainable fuels must comply with the EU regulatory framework (Renewable Energy Directive (EU) 2023/2413, Commission Delegated Regulations (EU) 2023/1184, and (EU) 2023/1185) for the use of renewable energy in the transport sector. The utilization of steel mill gases (SMGs) and alternative CO2 sources (waste incineration plants (WIPs), lime industry) to produce renewable fuels of non‐biological origin (RFNBOs) and recycled carbon fuels (RCFs) are attractive options as a high share of RFNBOs can be achieved with a significant reduction in greenhouse gas (GHG) emissions compared to fossil fuel use. [ABSTRACT FROM AUTHOR]

Combination products (CPs) combine two or more product types such as drugs, devices, and/or biological products for increased safety and clinical effectiveness. The emergence of innovative CPs poses new challenges for regulatory agencies in assigning jurisdiction for premarket review and oversight. In US, the 1990 Safe Medical Devices Act defines and provides classification criteria for CPs, and the US government has developed a regulatory process through multiple acts, including the 21st Century Cures Act of 2016. Meanwhile, regulators in the European Union (EU) and the Republic of Korea have recently recognized the importance of premarket pathways for CPs. The European Medicines Agency (EMA) has issued guidelines and explanations on compliance issues related to drug–device CPs under MDR. EMA doesn't have the definitions of CPs, but uses the term drug–device combination products (drug-device CPs). CPs are categorized as drugs or medical devices, which follow their relevant regulatory framework. The Ministry of Food and Drug Safety (MFDS) in Korea has legal definitions of CPs under the Notice of the MFDS. CPs are designated as drugs or medical devices according to their primary mode of actions (PMOA) and follow regulatory processes through the framework of drugs or medical devices. This study aims to comprehensively summarize the regulatory oversight of CPs by analyzing the regulatory policies and legal frameworks in the US, the EU, and Korea. The regulatory challenges encountered when developing CPs are also discussed. With specific emphasis on the combination of drugs and devices, this study provides in-depth insights into the regulatory landscape, shedding light on the unique challenges associated with the development of CPs for this particular intersection of drugs and devices. [ABSTRACT FROM AUTHOR]

The Vietnamese government announced the National Digital Transformation Programme by 2025 to invest in Artificial Intelligence (AI) development, to become one of the top players in Southeast Asia by 2030, challenging frontrunners like Indonesia and Singapore. Through educational policies such as establishing AI and data science majors in public universities, the country has started to nurture a domestic talent base. Research labs both within university systems as well as at private industry labs such as VinAI and FPT have recruited Vietnamese nationals as well as international researchers to bolster AI research that puts Vietnam on the global map of AI development. However, the country's pursuit is facing obstacles. Issues involve an AI talent shortage, weak intellectual property laws for solid and safe innovation, and unstable global venture capital funding. We argue that Vietnam could benefit from more policy learning on AI from other jurisdictions such as the European Union and China. Drawing on policy documents from these three jurisdictions, this paper aims to elucidate the core issues shaping the nation's AI development and governance strategies. Our findings shed light on the areas Vietnam should prioritise in order to propel itself into a significant role within the regional and international AI spheres. [ABSTRACT FROM AUTHOR]

As the global financial ecosystem undergoes a paradigm shift toward sustainability, platforms emerge as instrumental intermediaries, connecting diverse stakeholders, facilitating information flow, and catalyzing impactful investments. This paper analyses the evolving landscape of sustainable finance and investigates the role of platforms in fostering its growth. Sustainable finance platform-based enablers were determined using a systematic literature review and bibliometric techniques on a sample of papers retrieved from the SCOPUS database, and included crowdfunding platforms, impact investment platforms, peer-to-peer (P2P) lending platforms, blockchain-based financing platforms, and ESG data platforms. The analysis showed that platform-based solutions act as accelerators of sustainable finance mobilization, by enhancing transparency of the processes, and by improving dissemination and accessibility of the funds needed. Thus, platform-based solutions help a broader set of stakeholders direct the potential of platforms to accelerate the transition toward a more sustainable and inclusive global financial system. [ABSTRACT FROM AUTHOR]

Realizing cultural diversity's impact on regional entrepreneurial activity has become crucial for scholars and policymakers. As a step in this direction, this study integrates insights from creative cognitive psychology and the knowledge spillover theory of entrepreneurship to examine this effect and the boundary conditions explaining it. Based on a six-year multisourced panel dataset for the 50 U.S. states, the analyses support the proposed arguments in that they indicate that cultural diversity is positively associated with entrepreneurial activity, and this relationship is moderated by regional immigration policy and regulatory framework. Specifically, the effect of cultural diversity on entrepreneurship is more substantial when a region's immigration policy climate is more inclusionary than exclusionary. In addition, this relationship is also more robust when a region's regulatory policy is more conscientious than more lax. These findings make novel contributions to our knowledge of how and when contextual conditions regulate (i.e. stimulate or hinder) the effect of cultural diversity on entrepreneurship. The manuscript draws vital implications for policymakers. [ABSTRACT FROM AUTHOR]

The management of drinking water treatment plant (DWTP) sludge is challenging for water treatment facilities. Previous studies reported mainly on handling sludge through landfilling, release into water bodies, discharge into wastewater treatment plants, onsite disposal, and incineration methods for the treatment of sludge. The limitations of these sludge-handling methods are well documented. This article focuses on the hierarchical approach as an alternative and comprehensive method for handling DWTP sludge. The core of hierarchical management streamlines the minimization of the generated DWTP sludge; treatment of DWTP sludge to reduce toxicity; changing of the physicochemical form of DWTP sludge; and finally, the reuse, recycling, and recovery of DWTP sludge. The premise is to achieve zero landfilling of DWTP sludge, establish a circular economy, generate job opportunities, and preserve the environment. Thus, this study also proposes two main technologies, which are gravity-based sludge separators for fractionating the sludge and photocatalytic membrane reactors (PMRs) as a technology for the treating and/or recovery of nutrients and minerals from DWTP sludge. Until the chemical deductive or minus approach becomes a reality in water treatment, the use of PMRs and gravity-based sludge separators will enhance the management of DWTP sludge when incorporated into the hierarchical approach. [ABSTRACT FROM AUTHOR]

The purpose of this article is to investigate the factors that influence the authenticity of heritage hotels in popular tourist destinations. Using the Greek island of Santorini as a case study, the following three (3) factors, which have not been systematically studied so far, are examined and appear to have a significant impact on authenticity in the conversion of a heritage architectural building into a heritage hotel: (a) its structural characteristics, (b) the influence of the star classification system and (c) the extent to which each business promotes authenticity elements and heritage identity. For the purposes of this study, a threefold methodological approach was conducted, which includes archival research in the registry of the Hellenic Chamber of Hotels for all the heritage hotels in Santorini (69 units), research in the accounting data of the island's heritage hotels certified with the national star ranking system for their services and amenities and research analysis of the information regarding the promotion of the heritage hotels through their official websites. Additionally, a cartographic representation of the locations of these hotels was created and their positioning was compared to the boundaries of traditional or non-traditional settlements. The results validated the basic finding of the literature review, that the authenticity of a heritage hotel is a construction under constant negotiation, influenced by a multitude of factors. The conversion of a historic building into a heritage hotel is a multidimensional process that requires a delicate balance between preserving cultural value and adapting to the needs of modern tourism, as well as a continuous evaluation and review of the policies in place. [ABSTRACT FROM AUTHOR]

Abstract\nHIGHLIGHTSIn recent decades, a new health paradigm emerged which increasingly places diet and nutrition at the center of citizens’ healthcare. The resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure product safety and preserve the health of citizens. Dietary supplements (DS) are products which are increasingly occupying a significant market share in Western countries, contributing to meeting the nutritional and physiological needs of a large portion of the global population. Food supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwide. This search aimed of comparing the legislative frameworks currently in force in the European Union (EU) and in the United States (USA), the two main markets in which DS are purchased, to focus on the strengths, similarities and possible shortcomings, against the backdrop of a global market which often transcends the regulatory barriers of individual countries. Both in the EU and the USA, food supplements are governed by specific regulations to ensure their safety and quality. However, the regulatory approaches differ sharply in some cases. It is expected that more and more operators will launch new DS in Western markets. As a result, it is crucial for competent authorities in food safety to deepen and develop additional regulatory tools aimed to control and safeguard the DS market.The resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure food safety and safeguard the health of citizensFood supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwideBoth in the EU and the USA, the two main markets in which DS are purchased, food supplements are governed by specific regulations to ensure their safetyNevertheless, the regulatory approaches differ sharply in some casesAs a result, it is crucial for competent authorities to develop additional regulatory tools aimed to control and safeguard the DS marketThe resulting evolution of the food market has prompted country governments to adapt their regulatory frameworks to ensure food safety and safeguard the health of citizensFood supplements must be safe for use by the final consumer who has access to the global market, but currently they are framed by a different legislation worldwideBoth in the EU and the USA, the two main markets in which DS are purchased, food supplements are governed by specific regulations to ensure their safetyNevertheless, the regulatory approaches differ sharply in some casesAs a result, it is crucial for competent authorities to develop additional regulatory tools aimed to control and safeguard the DS market [ABSTRACT FROM AUTHOR]

Background: This study critically assesses the regulatory challenges faced in Brazil for mechanical ventilators amid the COVID-19 pandemic. It evaluates the effectiveness of expedited regulatory actions, compares strategies with other countries, and proposes future optimization in emergency conditions. Methods: Premarket submissions of mechanical ventilators were surveyed, involving accompanying certification documentation, rejections, approvals, and cancellations. Postmarket occurrences were surveyed until June 2023, evaluating their incidence and presence of certifications. Regulatory pathways in other countries were reviewed for comparison. Results: Brazil's regulatory strategy increased its ventilator supply capacity 17 times in 10 months. However, the absence of essential certifications in 95.52% of the premarket submissions, such as the Certificate of Conformity issued by the Brazilian Conformity Assessment System (CC-SBAC), raised safety and performance concerns. Among temporarily approved ventilators, the main cause of cancellation (76.92%) was the absence of certifications after the temporal approval, notwithstanding the already installed devices maintaining authorization for use in health services. Postmarket alerts lacked CC-SBAC issuance in 75% of the cases when sponsors reported the occurrences. It highlighted the importance of ongoing technical assistance and monitoring, particularly for devices lacking proper certifications. Conclusions: The extraordinary regulatory conditions in Brazil significantly impacted ventilator premarket evaluation. However, lacking essential certifications led to post-approval cancellations. Postmarket occurrences emphasized necessary vigilance, with most alerts involving uncertified devices. Improved premarket evaluation, considering component shortages and real-world usage scenarios, as collaborative efforts from other countries and international bodies, is crucial for ensuring the safety and effectiveness of ventilators in public health emergencies. [ABSTRACT FROM AUTHOR]

A modular strategy is described for the testing and assessment (MoSt) of non-genotoxic carcinogenicity (NGTxC) that is suitable for regulatory applications. It utilizes and builds upon work conducted by the OECD expert group on NGTxC. The approach integrates relevant test methods from the molecular- to cellular- and further to tissue level, many of which have been recently reviewed. Six progressive modules are included in the strategy. Advice is provided for the iterative selection of the next appropriate test method within each step of the strategy. Assessment is completed by a weight of evidence conclusion, which integrates the different streams of modular information. The assessment method gives higher weight to findings that are mechanistically linked with biological relevance to carcinogenesis. With a focus on EU-REACH, and pending upon successful test method validation and acceptance, this will also enable the MoSt for NGTxC to be applied for regulatory purposes across different regulatory jurisdictions. [ABSTRACT FROM AUTHOR]

Patch testing is the only clinically applicable diagnostic method for Type IV allergy. The availability of Type IV patch test (PT) allergens in Europe, however, is currently scarce. This severely compromises adequate diagnostics of contact allergy, leading to serious consequences for the affected patients. Against this background, the European Society of Contact Dermatitis (ESCD) has created a task force (TF) (i) to explore the current availability of PT substances in different member states, (ii) to highlight some of the unique characteristics of Type IV vs. other allergens and (iii) to suggest ways forward to promote and ensure availability of high‐quality patch testing substances for the diagnosis of Type IV allergies throughout Europe. The suggestions of the TF on how to improve the availability of PT allergens are supported by the ESCD, the European Academy of Allergy and Clinical Immunology, and the European Academy of Dermatology and Venereology and intend to provide potential means to resolve the present medical crisis. [ABSTRACT FROM AUTHOR]

This research paper delves into the intricacies surrounding consumer protection in the Indian insurance sector, focusing on the interplay between regulatory frameworks, legal provisions, and industry practices. Through a comprehensive analysis, the paper explores the Consumer Protection Act 2019, the Rights of Consumers under this Act, the Protection of Policyholders' Interest Regulations 2017, the recent judicial verdicts shaping consumer rights, and the overarching Insurance Act 1938. By examining key provisions, regulatory mechanisms, and case law, the paper aims to elucidate the challenges, implications, and potential remedies pertaining to transparency and accountability in insurance consumer protection. Through this exploration, the paper seeks to provide valuable insights for policymakers, regulators, insurers, and consumers alike, contributing to the ongoing discourse on enhancing consumer welfare and market integrity in the Indian insurance landscape. [ABSTRACT FROM AUTHOR]

Net metering (NM) is among the potent regulatory tools used globally for supporting distributed generation and renewable energy sources. This paper examines the trajectory of NM in a developing country such as Pakistan, analyzing the impact of regulatory changes, confidence-building strategies, hindering factors, and technical/financial issues. The three-stage methodology involves three components, namely techno-economic analysis, stakeholder engagement surveys, and impact analysis of financing mechanisms. This study emphasizes the importance of clear regulatory and financial frameworks, grid upgrades, and public–private partnerships for technology distribution in the context of a developing country with weak grid utilities and an import–export energy ratio. It also explores the role of financial incentives, such as tax breaks and subsidies, to encourage investment in NM systems from the perspective of lucrative rates, impact on paybacks, and return on investments, and proposes concrete solutions to enhance financial inclusion for ambitious renewable energy goals. Until April 2023, over 56,000 NM/distributed generation facilities were commissioned, with an installed capacity of 950 MW. By May 2024, the number of NM consumers reached ~100,000, with a 1950 MW capacity, nearly doubling. However, the import and export ratio of IESCO changed most, with 61% exports and 39% imports, directly impacting the revenue stream. A total of 60% of banks have adopted actions linked with green banking criteria, aiming to limit their environmental impact. The change in tariff will result in reduced ROI for NM consumers to 20%, and increase the payback period from less than 4 years to 13 years. Government subsidies, tax breaks, and green financing frameworks are proposed to encourage investment, but have been abruptly halted, and were previously at a 6% interest rate. This research aims to provide insights into effective market evaluation methodologies for NM programs and offer policy recommendations to strengthen legislative and institutional frameworks governing NM. [ABSTRACT FROM AUTHOR]

Despite the prominent role that the Islamic faith plays in shaping the social and regulatory aspects of Arab countries and the constitutional recognition of Islamic law (Sharīʿah) as a main source of legislation in most of these countries, judicial precedents regarding Islamic finance contracts remain scarce in the Arab world. This article sheds light on the judicial treatment of the validity and characterisation of Islamic finance contracts. It examines the economic and regulatory backgrounds of the Islamic finance industry in Egypt, Kuwait, and Oman. This examination provides a necessary prelude to the article's discussion of the Islamic finance contract from jurisprudential and regulatory standpoints. It also provides a foundation for the analysis of noteworthy judicial precedents on the validity and characterisation of the Islamic finance contract. Following such analysis, this article makes recommendations to enhance the regulatory and judicial appreciation for the distinctiveness of Islamic finance. [ABSTRACT FROM AUTHOR]

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The travel and tourism industry in India is one of the country's most vibrant sectors, significantly contributing to economic growth, employment generation, and cultural exchange. Despite its immense potential, the industry faces numerous challenges that hinder its sustainable development. This paper critically examines the challenges of travel and tourism management in India, including infrastructural deficits, environmental concerns, regulatory complexities, seasonality, lack of skilled workforce, and the impact of socio-political factors. It explores how these challenges affect the tourism sector's growth and offers insights into potential solutions and strategic approaches for effective management. The study draws on data from various reports, academic literature, and case studies to provide a holistic understanding of the multifaceted issues plaguing the industry. In conclusion, the paper emphasizes the need for a collaborative effort between government, private sector, and community stakeholders to overcome these challenges and ensure the sustainable development of tourism in India. [ABSTRACT FROM AUTHOR]

Nigeria's economy, marked by its diverse sectors and emerging markets, presents a landscape ripe for financial innovations aimed at fostering economic growth. This study delves into the multifaceted nature of Nigeria's emerging markets and explores the role of financial innovations in propelling economic development. By examining the evolution of financial instruments, regulatory frameworks, and market dynamics, this research elucidates the transformative potential of innovative financial practices in Nigeria. Furthermore, it investigates the impact of technological advancements, such as fintech solutions and digital banking platforms, on expanding financial inclusion and accessibility across various segments of the population. Through empirical analysis and case studies, the study assesses the effectiveness of these innovations in addressing key challenges facing Nigeria's economy, including access to credit, capital formation, and risk management. Moreover, it examines the interplay between financial innovation, government policies, and institutional frameworks in shaping the trajectory of economic growth in Nigeria's emerging markets. The findings underscore the importance of fostering an enabling environment that encourages innovation, entrepreneurship, and sustainable financial practices to drive inclusive economic growth and development. This research contributes to the discourse on financial innovation and economic development in emerging markets, particularly within the context of Nigeria's dynamic economic landscape. [ABSTRACT FROM AUTHOR]