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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]

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]

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 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

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]

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 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.

Abstract Seeds, as the initial products in agricultural systems, play a pivotal role in ensuring quality, fundamental to national food security and sustainable agricultural development. This study introduces a concept integrating public governance and evolutionary game theory to construct a quadripartite evolutionary game model involving seed companies, certification agencies, farmers, and governmental departments. It considers the strategic choices of these stakeholders under varying economic motivations and market mechanisms, as well as the influence of external regulation and incentives on game strategies. The existence conditions for evolutionarily stable strategy combinations are determined using the Lyapunov first method, and MATLAB is employed for numerical simulation analysis to validate the game analysis under initial conditions. The simulation results reveal two potential equilibrium points corresponding to different strategic choices among stakeholders. The study finds that producing high-quality seeds and the refusal of certification agencies to engage in rent-seeking are crucial for ensuring seed quality. Additionally, the cost–benefit ratio of seed companies, the speculative cost of certification agencies, and the rights-protection cost of farmers are key determinants in the evolution of seed quality assurance strategies. This research also holds practical significance in enhancing seed quality assurance mechanisms and fostering sustainable development in agriculture.

The topic of the research related to capital accounting in commercial enterprises is relevant, as the harmonization of this process in accordance with the requirements of International Financial Reporting Standards (IFRS) becomes an integral component for attracting investment, increasing the transparency of financial reporting, and maintaining competitiveness in the global market. The purpose of the study is to develop and implement the methodology of capital accounting in the accounting activities of commercial enterprises of the Republic of Azerbaijan. Among the methods used, analytical method, statistical method, functional method, method of system analysis, method of deduction, method of synthesis and method of comparison were applied. The research was aimed at in-depth analysis of the essence of capital accounting in Azerbaijani commercial enterprises in the context of modern conditions of market economy. The main attention was paid to the study of the legal and regulatory framework, peculiarities of the authorized capital of limited and joint stock organizations. Within the framework of the research, the key elements of development of financial accounting of capitals complying with IFRS requirements were identified. In addition, specific examples of synthetic accounting of business transactions for capital formation at commercial enterprises are provided, as well as the rules of their reflection in the financial statements are outlined. Special attention is paid to the fundamentals of new accounting rules developed to meet IFRS requirements. As a result of the study, solutions have been proposed to eliminate problems related to capital accounting in accordance with IFRS requirements in the activities of Azerbaijani commercial enterprises. These solutions are oriented to harmonize accounting practices with international standards, improve transparency of financial statements and increase attractiveness for potential investors. The results can be used for Azerbaijani commercial enterprises, contributing to the improvement of financial transparency, attractiveness for investors and harmonization of accounting practices with global standards

ABSTRACTBroad 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.

Seeds, as the initial products in agricultural systems, play a pivotal role in ensuring quality, fundamental to national food security and sustainable agricultural development. This study introduces a concept integrating public governance and evolutionary game theory to construct a quadripartite evolutionary game model involving seed companies, certification agencies, farmers, and governmental departments. It considers the strategic choices of these stakeholders under varying economic motivations and market mechanisms, as well as the influence of external regulation and incentives on game strategies. The existence conditions for evolutionarily stable strategy combinations are determined using the Lyapunov first method, and MATLAB is employed for numerical simulation analysis to validate the game analysis under initial conditions. The simulation results reveal two potential equilibrium points corresponding to different strategic choices among stakeholders. The study finds that producing high-quality seeds and the refusal of certification agencies to engage in rent-seeking are crucial for ensuring seed quality. Additionally, the cost–benefit ratio of seed companies, the speculative cost of certification agencies, and the rights-protection cost of farmers are key determinants in the evolution of seed quality assurance strategies. This research also holds practical significance in enhancing seed quality assurance mechanisms and fostering sustainable development in agriculture. [ABSTRACT FROM AUTHOR]

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbalbased treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An indepth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM. [ABSTRACT FROM AUTHOR]

Geothermal energy exploration, development, and research have been ongoing in Canada for several decades. The country's cold climate and the push to develop renewable energy sources have driven interest in geothermal energy. Despite this drive, regulatory complexities and competition with other relatively inexpensive energy sources with existing infrastructure have hindered development. As such, interest has grown and waned with changes in the energy economy over several decades, leaving many projects at a standstill. As of January 2023, there are currently no operational geothermal power projects in Canada. Many hot spring pool and spa complexes remain active, and Canada is a leading country in the installation of ground source heat pumps (GSHPs; also called geo-exchange systems). However, in the last decade, the interest in deep geothermal systems has renewed, with many new projects starting up across several provinces and territories. Moreover, projects that had shown limited progress for many years—such as Mount Meager in British Columbia—have begun to renew their development efforts. Research is also expanding within prominent research groups and universities. The areas of focus include both building upon previous studies (such as thermal gradients and the heat flow in sedimentary basins) and researching new methods and resources (such as GSHPs, closed-loop systems, integrated geothermal operations, and hybrid systems, including heat storage). The development is supported by federal, provincial, and territorial governments through grants and the development of regulatory frameworks. Although challenges still remain for Canada to develop its geothermal energy resources, several power, thermal, and co-production projects, ongoing research, funding, and regulatory acts are all moving forward to support geothermal development. This paper aims to study Canada's geothermal energy update in 2023 regarding the aspects mentioned above. [ABSTRACT FROM AUTHOR]

Transitioning to renewable energy is an urgent global goal. Wind energy is a promising renewable source with contentious obstacles. Using the Yatir Wind Farm project in Israel as a case study, we explore the potential of framing in identifying and mitigating obstacles in a wind farm project. The cognitive and strategic frames employed by stakeholders were elicited through 18 semi-structured interviews and more than 100 documents. This analysis highlights three conflicting issues: potential or perceived harm to neighboring residents, protecting birds and bats, and adapting to changing regulations throughout the process. Regarding residents' opposition to feared harm from the project, initial cautious curiosity was followed by distrust and deep disappointment due to a lack of transparency and a sense of abandonment facing perceived existential threats to their health and homes. This led residents to conduct legal battles, which resulted in their claims being rejected. It also led to the breakdown of relationships among neighbors opposing and promoting the wind farms. In the case of bird and bat protection, stakeholders initially framed concerns emotionally until the dialogue shifted to scientific discourse, resulting in the successful refinement of mutually agreed upon regulatory guidelines. The structural appeal mechanisms effectively addressed evolving regulations, overcoming the lack of mutual understanding and resulting in the adoption of the majority of the new regulatory requirements. The analysis underscores the importance of understanding stakeholders' frames for effectively working through the complex and transdisciplinary nature of sustainability transitions and achieving successful outcomes. It also reveals the need for formal mechanisms to validate stakeholder needs and integrate them into decision-making processes. Recommendations include early and meaningful public involvement, process improvement for stakeholder engagement, and enhanced transparency in decision-making processes. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

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Dermal injections of hyaluronic acid gel for aesthetic skin rejuvenation are becoming increasingly popular nowadays. Although these products are classified as medical devices, the regulations on their administration by licensed practitioners are still weak, whereas their manufacturers increasingly highlight and advertise the cellular effects that underpin the efficacy of these injections. In this review, we discuss all current knowledge on the mode of action of dermally injected hyaluronic acid and the potential toxicological implications, especially from crosslinked gels, in conjunction with the current global regulations. We also highlight the urgent need for further research to elucidate the therapeutic implications and underscore the imperative need for robust regulatory frameworks to safeguard public health. We conclude that dermal injections of hyaluronic acid have several therapeutic implications that warrant further research and that strict regulations must be applied to their manufacture/quality control and the required qualifications of licensed aesthetic injectors. [ABSTRACT FROM AUTHOR]

Bacteriophage therapy is a promising approach to treating bacterial infections. Research and development of bacteriophage therapy is intensifying due to the increase in antibiotic resistance and the faltering development of new antibiotics. Bacteriophage therapy uses bacteriophages (phages), i.e., prokaryotic viruses, to specifically target and kill pathogenic bacteria. The legal handling of this type of therapy raises several questions. These include whether phage therapeutics belong to a specially regulated class of medicinal products, and which legal framework should be followed with regard to the various technical ways in which phage therapeutics can be manufactured and administered. The article shows to which class of medicinal products phage therapeutics from wild type phages and from genetically modified (designer) phages do or do not belong. Furthermore, the article explains which legal framework is relevant for the manufacture and administration of phage therapeutics, which are manufactured in advance in a uniform, patient-independent manner, and for tailor-made patient-specific phage therapeutics. For the systematically coherent, successful translation of phage therapy, the article considers pharmaceutical law and related legal areas, such as genetic engineering law. Finally, the article shows how the planned legislative revisions of Directive 2001/83/EC and Regulation (EC) No 726/2004 may affect the legal future of phage therapy. [ABSTRACT FROM AUTHOR]

This study is devoted to the analysis of transformations in the use of monetary surrogates within the Ukrainian banking system from 2015 to 2023. Through an extensive examination of financial data, key factors driving the rising prevalence of electronic money and cryptocurrencies have been identified. This phenomenon unfolds against a backdrop of profound technological shifts and economic volatility, compounded by regulatory challenges. The findings underscore a strong interconnection between technological advancements, changes in consumer behavior, and the evolution of the regulatory framework. A notable increase in the volume of electronic money transactions, coupled with the significant expansion of the cryptocurrency market, points to a paradigm shift from traditional banking services towards novel financial instruments. Specifically, electronic money, cryptocurrencies, and digital tokens are emerging as prominent alternatives to conventional currency, offering users avenues for conducting transactions and preserving value amid economic instability. The research also provides an in-depth analysis of the regulatory hurdles confronting financial institutions and government agencies, particularly regarding adherence to anti-money laundering (AML) protocols and know-your-customer (KYC) regulations, alongside the imperative to safeguard consumer rights amid heightened cryptocurrency market volatility. Furthermore, this study addresses the potential long-term ramifications of the proliferation of monetary surrogates on Ukraine’s banking system, including shifts in conventional banking practices, potential risks to financial stability, and implications for monetary policy. Despite notable progress in the integration of new financial technologies, several unresolved challenges persist, particularly concerning the provision of adequate regulatory support for innovation while maintaining the stability of the financial system. In conclusion, this research offers a valuable contribution to the understanding of how technological development and socio-economic changes are reshaping financial systems in emerging economies, with a particular focus on Ukraine. The insights derived from this study may prove instrumental for policymakers and financial institutions as they navigate the evolving conditions and challenges of a rapidly transforming financial landscape.

The European Union and some of its institutions have taken significant steps to address the challenges posed by the development and use of Artificial Intelligence (AI) in various contexts. The ubiquity of AI applications in everyday life, affecting both citizens and professionals, has made AI a common topic of discussion. However, as is evident from the documents analyzed here, concerns have been raised about the possible negative social consequences of AI, in particular discriminatory bias, making it a particularly relevant issue if people-centred, rights-based AI is to be implemented. This article aims to examine the challenges of defining, identifying and mitigating discriminatory bias in AI systems from two perspectives: (1) to conduct an ethical and normative review of European Commission documents from the last 8 years (from GDPR to AI Act regulation); and (2) to expose recommendations for key stakeholders, including designers, end-users and public authorities, to minimize/mitigate this risk. The document review was carried out on 21 EU regulatory and ethical guidelines in the field of AI, from which 152 measures were extracted, differentiated between design, governance and organizational measures. It has also been observed that there is no clear conceptual framework on the issue at the European level, showing a clear problem in providing definitions of algorithmic bias and discrimination, but not in assessing their potential negative impact on individuals. Secondly, these gaps may affect the concreteness and detail of the possible mitigation/minimization measures proposed and, subsequently, their application in different contexts. Finally, the last section of this paper presents a brief discussion and conclusions on possible issues related to the implementation of the measures extracted and certain limitations of the study.

Introduction: A radical shift in energy production is underway worldwide, replacing fossil fuels with renewable sources and causing structural changes in power generation systems. Problem statement: Photovoltaic installations for self-consumption have experienced a steep increase in recent years. They have reached a significant installed capacity to cause a noticeable reduction in consumption from the national grid, which can cause serious management problems. Objectives: In this work, the evolution of the Spanish demand in the last years is analyzed to identify the influence of self-consumption in the overall demand. In addition, a mathematical model is defined to estimate this influence. Methodology: The demand curves of equivalent days in years with high and low installed self-consumption photovoltaic systems have been compared. Then, an estimation of the electricity generated with this source is proposed, with a mathematical model that takes into account data on solar radiation, installed photovoltaic power for self-consumption and other relevant factors. Results: The analysis of the demand has shown a significant reduction of the electricity demand in daylight hours when the number of self-consumption photovoltaic systems increases. Moreover, the proposed model has been able to provide an estimation of the electricity generated with this source. The addition of these estimates to the actual consumption curves of years with a high number of self-consumption installations gives profiles close to those obtained when self-consumption was low. Recommendation: New storage systems need to be implemented and grid management need to be improved to take advantage of the surpluses produced by photovoltaic systems.

India has the credit of running the second largest higher education system in terms of institutions worldwide, despite having only 26.3% Gross Enrollment Ratio (GER), including vocational education. It aspires to achieve a target of 50% GER by 2035. It means it would require a larger number of higher education institutions (HEIs), public and private, in addition to huge fiscal resources. At present about 75% of the HEIs are privately managed with about 66% of student enrolment. Though there is no provision of for-profit higher education institutions in India, many non-profit private HEIs are actually working as for-profit. They are growing fast and are visible too. Therefore, it is high time now to think seriously about the pros and cons, causes and consequences of for-profit and non-profit private HEIs in India. India provides a big market for non-profit and for-profit higher education to domestic and foreign stakeholders.  Already 160 foreign universities are working in collaboration with public or private limited companies in India. This essay provides an analysis of issues related to for-profit and non-profit HEIs, including desirability, size, funding, transparency, accountability, quality, feasibility and sustainability, government policies, regulation, foreign collaborations, private investments, and incentives. The methodology adopted is analytical, comparative, and empirical.

In the following article, a study is carried out on the accounting treatment of tax on income according to the provisions of the National Accounting Standards (NAS) and the International Financial Reporting Standards (IFRS). The research aims to identify the specific aspects of the application of NAS and IFRS for income tax accounting. The following scientific research methods are used in the study: analysis of the normative framework governing the study, synthesis of information, comparison to identify distinctive features.. The results of the research identified the existence of a different approach to income tax accounting according to NAS applied in the Republic of Moldova and IFRS (IAS 12). The result of the study shows that public interest entities that must apply IFRS require a more complex approach to tax on income versus entities that apply the provisions of the national accounting regulatory framework (NAS) of the Republic of Moldova.

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards.In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

This study examines the regulatory and policy framework for social housing in Latvia, focusing on its current state and future directions. Through comprehensive policy analysis and document review, the research traces the historical development of social housing policies, evaluates the existing regulatory landscape, and compares Latvian approaches with EU best practices. The study reveals significant challenges in Latvia’s social housing sector, including limited stock, inadequate funding mechanisms, and policy gaps in addressing the needs of vulnerable populations, particularly the elderly. Despite these challenges, recent initiatives and proposed reforms indicate a growing recognition of the importance of social housing in addressing demographic shifts and economic disparities. The findings highlight the need for a more robust and adaptive policy framework that aligns with EU standards while addressing Latvia’s unique socio-economic context. The study proposes policy recommendations aimed at enhancing the accessibility, affordability, and quality of social housing, with a particular emphasis on age-friendly housing solutions. By identifying key areas for improvement and potential innovative approaches, this research contributes to the ongoing discourse on social housing policy in Latvia and offers insights for policymakers, urban planners, and housing stakeholders.

Abstract Background Nuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by improving access to and availability of radiopharmaceuticals. Main body This paper summarises major considerations for a suitable pharmaceutical regulatory framework to facilitate patient access to radiopharmaceuticals. These include the distinct characteristics of radiopharmaceuticals which require dedicated regulations, considering the impact of the variable complexity of radiopharmaceutical preparation, personnel requirements, manufacturing practices and quality assurance, regulatory authority interfaces, communication and training, as well as marketing authorisation procedures to ensure availability of radiopharmaceuticals. Finally, domestic and regional supply to ensure patient access via alternative regulatory pathways, including in-house production of radiopharmaceuticals, is described, and an outlook on regulatory challenges faced by new developments, such as the use of alpha emitters, is provided. Conclusions All these considerations are an outcome of a dedicated Technical Meeting organised by the IAEA in 2023 and represent the views and opinions of experts in the field, not those of any regulatory authorities.

The number of international visitors in Tanzania has consistently remained around one million since 2012. The current study aimed to investigate the effects of electronic payment in enhancing financial flow on the performance of tour operators' supply chains, guided by the Technology Acceptance Model. A convergent parallel mixed-method design was employed using a sampling frame comprised of 543 tour operators. A sample of 230 respondents was selected using multi-stage sampling. Primary data were collected using a self-administered structured questionnaire and an interview guide. Quantitative data were analysed using descriptive statistics to compute percentages, means of respondents’ answers, and cross-tabulations. Inferential statistics employing Structural Equation Modeling was applied to test hypotheses through IBM SPSS Amos version 20. Qualitative data were thematically analysed using NVivo version 20. The findings revealed that electronic payment positively and significantly influenced tour operators’ supply chain performance. The results of the Structural Equation Modeling using three indicators namely, perceived security, transaction procedures, and regulatory framework, indicate that electronic payment directly influenced tour operators’ supply chain by increasing sales, Return on Assets, and profit. The study recommends that both the government and tour operators invest in modern electronic payment technologies to influence consumers’ purchase decisions, thereby increasing consumers’ spending. Strategic efforts and collaboration between stakeholders, including government bodies, industry regulators, and tour operators, are essential to create a secure, reliable, and trustworthy environment for the success of e - e-payment systems usage.

This article reviews the Romanian legal framework for metropolitan areas (MAs) and functional urban areas (FUAs) over the past decade, examining changes and developments in this area. It provides an overview of the legal provisions concerning MAs and FUAs in Romania, and discusses the various laws, regulations, and policies that govern their formation and operation. The article also analyses the status and the challenges that have emerged in the implementation of the legal framework and highlights the main obstacles faced by Romanian metropolitan areas and functional urban areas. Ultimately, the article seeks to provide insights into the effectiveness of the Romanian legal framework in supporting the development and governance of metropolitan areas and FUAs and identifies areas for further improvement.

ABSTRACTGene technologies, such as transgenesis and new breeding techniques (NBTs), expand the toolbox for plant breeding. Many countries in Africa, however, have long been seen as “slow adopters” of gene technologies for several reasons, one being the lack of, or overly restrictive, biosafety regulatory frameworks. This is sometimes attributed to the influence of the precautionary-oriented EU biosafety policies. This study analyses and compares the biosafety regulatory frameworks and their implementation in Kenya, Nigeria and Uganda, and in the EU member state Sweden. The focus is on (1) the structure of the biosafety regulatory frameworks including the scope of the legislation, (2) the duration and cost of regulatory authorization for field trials with genetically modified (GM) plants, and (3) the regulatory approach to NBT products, i.e. to what extent NBT products are subject to the provisions of the biosafety regulatory framework. The data was collected through studying relevant legal and policy documents as well as interviewing regulatory officers and researchers in the respective countries. We found that the regulatory procedures in the selected countries are relatively straightforward, while the costs and duration may present a challenge. The regulatory approach to NBT products differ between the selected African countries and Sweden, the latter which follows EU regulations. The results are discussed in terms of the impact the regulatory developments in these four jurisdictions may have on international R&D collaborations involving the use of gene technologies and we also weigh the results against the common conception that Europe exerts a heavy influence on African countries in this technology field.

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).

The emergence of autonomous vehicles (AVs) presents a transformative shift in transportation, promising enhanced safety and economic efficiency. However, a fragmented legislative landscape across the United States hampers AV deployment. This fragmentation creates significant challenges for AV manufacturers and stakeholders. This research contributes by employing advanced machine learning (ML) techniques to analyze state data, aiming to identify factors associated with the likelihood of passing AV-friendly legislation, particularly regarding the requirement for human backup drivers. The findings reveal a nuanced interplay of socio-economic, political, demographic, and safety-related factors influencing the nature of AV legislation. Key variables such as democratic electoral college votes per capita, port tons per capita, population density, road fatalities per capita, and transit agency needs significantly impact legislative outcomes. These insights suggest that a combination of political, economic, and safety considerations shape AV legislation, transcending traditional partisan divides. These findings offer a strategic perspective for developing a harmonized regulatory approach, potentially at the federal level, to foster a conducive environment for AV development and deployment. [ABSTRACT FROM AUTHOR]

Combined Heat and Power (CHP) has been identified by the EU as a powerful resource capable of making substantial contributions to energy savings and reducing GHG emissions. Spain's effort to promote CHP has been prolific since the 1980s. In this regard, there have been various Laws, Royal Decrees (RDs) and European Union (EU) Directives addressed to reach the national objectives set for the CHP sector. Despite these attempts, the evolution and growth of installed CHP capacity has been irregular, compared to other technologies. Likewise, the academic treatment of the Spanish CHP evolution has not deserved the same attention as other technologies such as wind, photovoltaic and thermal solar systems. As a result, this article is aimed at providing a comprehensive overview of the regulatory frameworks applied to the Spanish CHP sector and analysing the reasons behind the variable evolution of the installed CHP capacity. The study covers the legislative context from 1980 to 2020, describing the evolution during both the pre-liberalization and liberalization periods, highlighting the modifications in economic policies that affected self-producers and the so-called Special Regime (SR) for CHP, and examining the challenges faced during the cost containment measures that followed. The manuscript finds and explains the connection between the regulatory framework and the evolution of installed CHP capacity in Spain. Likewise, the connection between the industrial situation and the promotion of CHP, as well as the influence of the Spanish Electricity Sector (SES)'s liberalization on the CHP sector are also pointed out. The paper intends to provide valuable insights for CHP experts and policymakers by showcasing the importance of aligning regulatory measures with the objectives of energy efficiency. It also serves as a reference for countries in various stages of promoting CHP, and provides evidence for the importance of stable energy-policy control mechanisms. [ABSTRACT FROM AUTHOR]

Microgrids have emerged as a popular solution for electric energy distribution due to their reliability, sustainability, and growing accessibility. However, their implementation can be challenging, particularly due to regulatory and market issues. Building smaller-scale microgrids, also known as nanogrids, can present additional challenges, such as high investment costs that need to be justified by local demands. To address these challenges, this work proposes an economic feasibility assessment model that is applied to a real nanogrid under construction in the Brazilian electrical system, with electric vehicle charging stations as its main load. The model, which takes into account uncertainties, evaluates the economic viability of constructing a nanogrid using economic indicators estimated by the Monte Carlo simulation method, with the system operation represented by the OpenDSS software. The model also considers aspects of energy transactions within the net-metering paradigm, with energy compensation between the nanogrid and the main distribution network, and investigates how incentives can impact the viability of these microgrids. [ABSTRACT FROM AUTHOR]

Background: Nuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by improving access to and availability of radiopharmaceuticals. Main body: This paper summarises major considerations for a suitable pharmaceutical regulatory framework to facilitate patient access to radiopharmaceuticals. These include the distinct characteristics of radiopharmaceuticals which require dedicated regulations, considering the impact of the variable complexity of radiopharmaceutical preparation, personnel requirements, manufacturing practices and quality assurance, regulatory authority interfaces, communication and training, as well as marketing authorisation procedures to ensure availability of radiopharmaceuticals. Finally, domestic and regional supply to ensure patient access via alternative regulatory pathways, including in-house production of radiopharmaceuticals, is described, and an outlook on regulatory challenges faced by new developments, such as the use of alpha emitters, is provided. Conclusions: All these considerations are an outcome of a dedicated Technical Meeting organised by the IAEA in 2023 and represent the views and opinions of experts in the field, not those of any regulatory authorities. [ABSTRACT FROM AUTHOR]

Climate change has emerged as a global focal point, notably affecting vulnerable countries like Pakistan. The country faces heightened risk, prompting concern among many due to its susceptibility to climate-related hazards. An imperative challenge arising from this phenomenon is the necessary shift towards sustainable energy, particularly concerning energy consumption within the building sector. Buildings significantly contribute to daily energy usage and subsequent GHG emissions. In Pakistan, transitioning to energy-efficient building stock holds pivotal importance in mitigating climate change impacts. This hinges on establishing a robust institutional framework and regulatory structure centered around energy efficiency. While Pakistan possesses policies and national guidelines advocating for energy-efficient buildings, their practical enforcement and application remain inadequate. The inception of the Building Energy Code of Pakistan in 1990, based on ASHRAE 90.1 standards, marked a step forward. However, obstacles rooted in institutional weakness and limited capacity building have impeded its effective adoption and adherence. Although the Energy Provisions of 2011 introduced modifications, their scope remained confined mainly to commercial structures. This paper conducts an extensive assessment of Pakistan's existing institutional and regulatory framework for building energy efficiency and transition. Drawing on literature insights and stakeholder perspectives, an in-depth understanding of prevailing policies and institutions uncovers underlying reasons for noncompliance and limited implementation. Additionally, input was gathered from stakeholders through interviews, aiming to identify barriers obstructing the reinforcement of building energy efficiency measures in Pakistan. Discourse and narrative analysis, informed by literature and stakeholder interviews, revealed the significance of awareness, participation, coordination, capacity building, technical expertise, finance, and resources as key factors contributing to deficient compliance and implementation of existing codes and policy guidelines. This paper also proposes actionable recommendations to expedite the transition towards a sustainable, energy-efficient building stock in Pakistan. [ABSTRACT FROM AUTHOR]

The purpose of this study is to assess the challenges and develop a regulatory framework for the sustainable development of micro and small enterprises (MSE) in the construction industry. A structured questionnaire was used to collect the quantitative data and a semi-structured interview was conducted to get detailed insight into the MSE development. Descriptive analysis was used for the quantitative data analysis and the qualitative data was analysed thematically focusing on the challenges and applicable regulatory instruments. The identified internal challenges are associated with management practice, financial capacity and technical capacity. The external challenges are ineffective policy support and regulation, weak registration practice and demand and price fluctuation. Considering these findings, an improvement regulatory framework with four pillars was developed. The pillars of the improvement regulatory framework are registration and follow-up, access to markets, access to finance, and training and advisory. The identified internal and external challenges are interrelated and situation-dependent; therefore, continual monitoring and controlling of the operating environment would help to ensure the sustainable development of MSE. The nature of the construction industry in developing countries shares common characteristics, hence the findings and the developed improvement framework can be extended to similar contexts. [ABSTRACT FROM AUTHOR]

Islam is a religion which provides guidance for a complete lifestyle. It guides Muslims to adopt good and avoid bad in every aspect of life. In other words, Halal is liked, and Haram is disliked. Islam has outlined rules for Muslims that they should consume products which are prepared through Halal methods. In the modern era, the trends in production and consumption of these products have drastically changed due to technological advancements. On the other hand, Pakistan is a country with a majority Muslim population. Thus, Pakistan is a vast Market for Halal commodities. With Muslim manufacturers, Muslim traders, and Muslim consumers, it is naturally expected that Pakistan should act as the role model for the global halal industry. But unfortunately, Pakistani share in the global halal industry is not significant. Regulatory framework of Halal Industry in Pakistan provides the foundation for the development of the Halal industry where the structural challenges and required reforms are the key issues. This research has highlighted the importance of Halal and the role of those organizations which collectively shape the regulatory framework of Pakistani Halal industry. It also explained the current structure of halal industry in Pakistan. Finally, this research has explored challenges and solutions in the regulatory framework that hinders the growth of Halal industry in Pakistan. [ABSTRACT FROM AUTHOR]

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The increasing drug resistance of bacteria to commonly used antibiotics creates the need to search for and develop alternative forms of treatment. Phage therapy fits this trend perfectly. Phages that selectively infect and kill bacteria are often the only life-saving therapeutic option. Full legalization of this treatment method could help solve the problem of multidrug-resistant infectious diseases on a global scale. The aim of this review is to present the prospects for the development of phage therapy, the ethical and legal aspects of this form of treatment given the current situation of such therapy, and the benefits of using phage products in persons for whom available therapeutic options have been exhausted or do not exist at all. In addition, the challenges faced by this form of therapy in the fight against bacterial infections are also described. More clinical studies are needed to expand knowledge about phages, their dosage, and a standardized delivery system. These activities are necessary to ensure that phage-based therapy does not take the form of an experiment but is a standard medical treatment. Bacterial viruses will probably not become a miracle cure—a panacea for infections—but they have a chance to find an important place in medicine. [ABSTRACT FROM AUTHOR]