Search

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]

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.)

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]

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]

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]

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]

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 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.

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 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.

Agriculture has a strategic role in providing food for the population. This causes significant government intervention in this sector, and therefore the development of high-quality approaches to this process remains relevant. This study aimed to provide recommendations for this process in Ukraine, particularly in the context of economic digitalisation. To achieve this, graphical analysis, modelling, abstraction, and the method of logical reasoning were used. The role of digital technologies in achieving more effective results in the context of improving the efficiency of agricultural development was described in detail in the paper. In addition, a conclusion was made about the necessity of cooperation between the state and enterprises in this area. This is primarily associated with the challenges that may arise in companies implementing such practices. Understanding the presence of these challenges, the likelihood of further implementation of such type of technologies in enterprises decreases. Several approaches were proposed in the paper to reduce the negative impact on agricultural companies. Given the consequences of the full-scale Russian invasion of Ukraine, particular attention was paid to non-financial approaches, as well as to the problems existing within the current legislative framework. Furthermore, separate conclusions were drawn based on statistical data regarding the development of science and education in Ukraine overall. The study’s practical value lies in that the findings will enhance the efficiency of the state sector’s functioning in Ukraine in agricultural regulation

Corruption is a global problem undermining social, economic, and political stability in many countries of the world. Kazakhstan, as a rapidly developing country, realises the harmful role of corruption in society and is taking significant steps to combat this problem. The purpose of the study was to investigate the procedures used to look into and prosecute cases of corruption. To achieve the objectives of the article the following methods were used: analysis of legislation, dogmatic method, methods of interpretation and comparison, statistical data method. Legislative documents, reports and other sources related to corruption and its counteraction in Kazakhstan were considered; study of the work of anti-corruption institutions: analytical work was carried out to study the role and activities of anti- corruption institutions in Kazakhstan and identified the key social determinants of corruption in the country. The article highlighted the main legislative acts adopted by Kazakhstan to combat corruption, and their impact on the public and legal space. It can be concluded that the adopted legislative acts and the activities of anti-corruption institutions have a positive impact on the fight against corruption and increased transparency in the country. It was concluded that in order to update the legislation and introduce new norms, the legislator should conduct a thorough study of the social determinants of corruption. Thus, the practical significance of this study is that its theoretical conclusions can be used by government agencies to improve the fight against corruption in Kazakhstan

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]

Copyright of Bulletin of the 'Carol I' National Defence University / Buletinul Universitatii Nationale de Aparare 'Carol I' is the property of Carol I National Defence University 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.)

Copyright of Cyber Security & Data Governance is the property of Editorial Office of Information Technology & Network Security 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.)

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]

This paper explores the impact of cryptocurrencies on international trade, focusing on the regulatory challenges in China, the European Union, and Serbia. Cryptocurrencies offer promising opportunities for cost efficiency and transparency, yet their adoption in global trade encounters legal complexities, particularly in anti-money laundering efforts. This study aims to underscore the importance of a shared regulatory framework to strengthen trust and facilitate seamless cross-border transactions between China and Central and Eastern European Countries (CEEC) for win-win cooperation. Through a comparative analysis of the regulatory landscapes, this study offers insights into aligning legal frameworks to navigate the intricacies of cryptocurrency adoption in global commerce. It argues that a unified approach to cryptocurrency regulation can significantly streamline trade, promote transparency, and strengthen economic relationships. By proposing harmonized regulatory measures, this research emphasizes the potential of cryptocurrencies to reshape international trade dynamics, while also stressing the importance of comprehensive legal structures to address the challenges posed by the digital financial landscape. [ABSTRACT FROM AUTHOR]

The investigatory framework of cybercrime is as essential as the legal and institutional framework governing cybercrime. This article argues that an effective investigation process is fundamental to the effective prosecution of cybercrime offences. Cybercrime investigation involves digital forensics, intelligence gathering, lawful interception, and use of communication data and internet networks. At its core, cybercrime investigation necessitates a comprehensive cybercrime investigation framework backed by a legal framework that ensures effective evidence collection, preservation, and analysis. This article evaluates the cybercrime investigation structure in Nigeria and highlights the gaps in Nigeria's regulatory framework. It identifies the challenges that hinder Nigeria's successful investigation and prosecution of cybercrime offences. The study adopts a comparative methodology by juxtaposing cybercrime investigation in Nigeria with the law and practice in the United Kingdom (UK). The UK has a robust cybercrime investigation framework, strengthened by its Cyber Security Strategy 2022. The findings show that, unlike the UK's Regulation of Investigatory Powers Act, 2000 and the Investigatory Powers Act, 2016, the Nigerian Cybercrimes (Amendment) Act, 2024, the Administration of Criminal Justice Act, 2015 and other laws, are silent on essential investigatory initiatives, steps and specialised powers. The study proposes a practical cybercrime investigation framework to implement Nigeria's effective prosecution of cybercrime offences. [ABSTRACT FROM AUTHOR]

Mexico has the in-house technical and regulatory capacity to undertake human genome editing (HGE) governance. However, its regulatory framework must be reformed to be more targeted and govern the application of any emerging HGE technologies, leaving no room for unethical or unsafe practices for reproductive purposes. [ABSTRACT FROM AUTHOR]

The management and reconstruction of critical-sized segmental bone defects remain a major clinical challenge for orthopaedic clinicians and surgeons. In particular, regenerative medicine approaches that involve incorporating stem cells within tissue engineering scaffolds have great promise for fracture management. This narrative review focuses on the primary components of bone tissue engineering—stem cells, scaffolds, the microenvironment, and vascularisation—addressing current advances and translational and regulatory challenges in the current landscape of stem cell therapy for critical-sized bone defects. To comprehensively explore this research area and offer insights for future treatment options in orthopaedic surgery, we have examined the latest developments and advancements in bone tissue engineering, focusing on those of clinical relevance in recent years. Finally, we present a forward-looking perspective on using stem cells in bone tissue engineering for critical-sized segmental bone defects. [ABSTRACT FROM AUTHOR]

This article explores some of the shortcomings of the Private Security Industry Regulatory Authority (PSIRA) in regulating and effecting control over the Private Security Industry (PSI) in South Africa. In South Africa, all Private Security companies must comply with PSIRA by registering as security providers, however this study revealed a non-compliance. This shortcoming is demonstrated by flyby- night security companies that provide security services at shopping centres and shopping malls particularly in the parking areas who fail to comply with PSIRA in terms of registration. The main aim of this research was to analyse whether the PSCs comply with the regulatory framework as per the Private Security Industry Regulation Act 56 of 2001 in South Africa in Gauteng Province. A qualitative research design was applied to determine whether PSIRA enforces compliance as per regulatory framework and to establish whether the current private security service providers are registered with PSIRA. The population of the study involved security managers and owners of the private security companies in South Africa. The findings revealed that there is non- compliance to PSIRA by Security providers. It is recommended that the regulator be capacitated with resources to improve its compliance. [ABSTRACT FROM AUTHOR]

This article introduces a novel approach to enhancing mobile network operator (MNO) performance ranking in Nigeria through the development and implementation of a Quality of Service Key Performance Indicator (QoSKPI) Index. As mobile technologies evolve and reliance on mobile services increases, the need for robust and comprehensible network performance metrics becomes critical. This study addresses gaps in current methodologies, which often assess Quality of Service (QoS) parameters independently, by aggregating multiple QoS Key Performance Indicators (KPIs) into a single comprehensive metric. By applying the Analytical Hierarchy Process (AHP), the research develops a QoSKPI Index that combines various network performance indicators into a unified ranking system. This index is validated against consumer complaints and empirical data to ensure its relevance and accuracy in reflecting the actual network performance experienced by users. Significant findings illustrate the utility of the QoSKPI Index in benchmarking MNOs' QoS performance, providing a clear empirical basis for ranking that can influence user choice and regulatory strategies aimed at enhancing network quality across Nigeria. [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.

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 non-manufacturers 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.

This study explores the policy process in the Namibian Electricity Supply Industry in relation to the development of the Modified Single Buyer market model. The research employs the Advocacy Coalition Framework as a theoretical framework wherein actors within a policy subsystem are conceptualized as forming advocacy coalitions based on shared beliefs and engaging in coordinated efforts over time to influence policy direction. The analysis has uncovered the existence of two prominent coalitions: the progressive coalition is advocating for market liberalisation, while the conservative coalition is seeking to preserve the status quo and resist the adoption of the new electricity market model. The study concludes that powerful actors in the Electricity Supply Industry, although equipped with enormous economic resources and strong political ties, could not prevent the regulator from implementing comprehensive changes in the electricity sector. However, the conservative coalition has managed to negotiate for a phased implementation of the policy to ensure minimal disruption in the industry and to guarantee the security of the electricity supply in the long run. The phased implementation also allows sufficient time for this coalition to realign their business strategies within the new regulation policy and maintain their status as relevant and critical actors.

Touristic islands around the world are facing crucial energy challenges, including fossil fuel dependency, high electricity costs, high environmental impact and vulnerability to EU climate change targets and policies. On May 18, 2017, fourteen EU countries signed a “Political declaration on clean energy for EU islands” with the aim of accelerating the clean energy transition on more than 2,700 islands in Europe, supporting islands in reducing their energy import dependency, maximizing distributed energy generation near consumption and adopting innovative energy solutions. However, most of the population on EU islands is concentrated in the Mediterranean Sea, in Spain, Italy and Greece. More specifically, six islands account for the majority of the island's population (approximately 10.78 million): Sicily, Sardinia, the Balearic Islands, the Canary Islands, Crete and Corsica.Realising the importance of the role of local and regional authorities in the islanded Energy Transition, the EU has triggered and supported the creation of the Covenant of Mayors (CoM) for Climate & Energy and the initiative for Clean Energy of EU Islands. These instruments have promoted energy transition awareness among the municipalities and the importance of the bottom-up approach (from local to national). This paper proposes, based on a review of state-of-the-art energy models and methodologies, to identify the main gaps in specific energy indicators capable of easily modelling, assessing and monitoring progress towards the energy transition for policy makers. Furthermore, it presents the main barriers and constraints identified in island areas of Italy, Spain and Greece.