Regulatory Framework Research Articles

The Role of the State Civil Apparatus (ASN) in Preventing and Suppressing the Practice of Money Politics

This study aimed to analyze the constrained role of the State Civil Apparatus (ASN) in suppressing the practice of money politics which contributes to high-cost elections during general elections. ASN’s political activities are heavily restricted, limiting its ability to actively and directly engage in the electoral process. However, statutory provisions also mandate that ASN serve as both the implementer of public policy—an inherently political product—and as a unifying force for the nation. In its role as a unifier, ASN must actively contribute to ensuring that elections are conducted fairly and appropriately for the future of the nation. The object of this study was to examine the limited authority and role of ASN in suppressing the practice of money politics. The study employed a qualitative descriptive analysis to explore the issue from the ASN’s perspective, focusing on the potential contributions of its authority and role in enhancing the quality of elections. The findings indicated that ASN can leverage its authority and role both individually and institutionally to suppress money politics practices. Individually, ASN members can contribute through socialization, advocacy, political education, information dissemination, and anti-money politics campaigns. Institutionally, contributions can be made by strengthening regulatory and policy frameworks, enhancing the integrity and capabilities of ASN personnel, conducting studies, analyses, and discussions to improve electoral process quality, and enforcing strict sanctions against perpetrators of money politics.

General context and relevant public datasets available for improving pathways in Paediatric Cancer applying Artificial Intelligence. A review

Due to the promise of transforming healthcare and medicine that Artificial Intelligence (AI) has posed, the number of applications has increased exponentially. These applications range from screening and disease diagnosis to prognosis, treatment planning, and follow-up. In complex topics such as childhood cancer, these techniques are being expanded with the ambition of improving the quality of care by allowing healthcare professionals to make more informed decisions. However, the adequate application of such techniques heavily depends on the data, which creates a set of challenges including collection, bias, and scarcity among others. Furthermore, ethical, legal, and regulatory frameworks increase even more the difficulties to develop AI-powered solutions. In this paper, we present an exhaustive literature review to identify and analyse public datasets targeting two common childhood cancer types, such as neuroblastoma and nephroblastoma. Moreover, the complex context for the development of AI- based software solutions is outlined. It includes the description of the most relevant techniques to address problems associated with data sharing and training. Finally, a set of code snippets is provided to perform exploratory analysis for the available data.

Public attention and “Environmental Disclosure Greenwashing”: pressure from oversight or incentive from legitimacy

PurposeThis study aims to investigate whether public attention influences corporate decisions on environmental disclosure, thereby revealing how society perceives and understands environmental issues and how corporations respond to these expectations.Design/methodology/approachWe selected publicly listed Chinese firms as our sample. An “Environmental Disclosure Greenwashing” (EDG) Index was developed through textual analysis of their annual reports using natural language processing. Financial data were obtained from the CSMAR database, and multivariate regression was used for analysis.FindingsThe impact of public attention on EDG primarily manifests as an oversight pressure effect rather than a legitimacy incentive effect. As public attention intensifies, firms tend to adopt more substantial environmental actions instead of merely symbolic environmental disclosures. Formal regulatory frameworks might inadvertently trigger corporate EDG, but public attention can correct the adverse effects possibly introduced by formal regulations. Notably, in firms facing lower institutional pressure, the influence of public attention is more pronounced.Practical implicationsThe evidence suggests that public attention reduces corporate EDG. These findings have significant implications for the regulation of environmental disclosures among firms in emerging economies.Originality/valueThe study integrates research in environmental disclosure with the concept of “greenwashing”, unveiling the limitations of the “disclosure as governance” viewpoint. It elucidates the impact of an informal external oversight mechanism (i.e. public attention) on complex corporate environmental disclosure decisions.

Transitioning to Sustainable Economic Resilience through Renewable Energy and Green Hydrogen: The case of Iraq

The study investigates the potential of transitioning Iraq, a nation significantly dependent on fossil fuels, toward a green hydrogen-based energy system as a pathway to achieving sustainable economic resilience. As of 2022, Iraqi energy supply is over 90% reliant on hydrocarbons, which also account for 95% of the country foreign exchange earnings. The global energy landscape is rapidly shifting towards cleaner alternatives, and the volatility of oil prices has made it imperative for the country to diversify its energy sources. Green hydrogen, produced through water electrolysis powered by renewable energy sources such as solar and wind, offers a promising alternative given country vast renewable energy potential. The analysis indicates that, with strategic investments in green hydrogen infrastructure, the country could reduce its hydrocarbon dependency by 30% by the year 2030. This transition could not only address pressing environmental challenges but also contribute to the economic stability of the country. However, the shift to green hydrogen is not without significant challenges, including water scarcity, technological limitations, and the necessity for a robust regulatory framework. The findings underscore the importance of international partnerships and supportive policies in facilitating this energy transition. Adopting renewable energy and green hydrogen technologies, the country has the potential to become a leader in sustainable energy within the region. This shift would not only drive economic growth and energy security but also contribute to global efforts towards environmental sustainability, positioning country favorably in a future low-carbon economy.

Mexican calea (Calea zacatechichi Schltdl.) interferes with cholinergic and dopaminergic pathways and causes neuroglial toxicity

Ethnopharmacological relevanceThe use of “Mexican calea” (Calea zacatechichi Schltdl.) in ritualistic ceremonies, due to its dream-inducing effects, was until recently limited to indigenous communities in Mexico. However, the plant has recently gained popularity in Western societies being commonly used in recreational settings. Despite the traditional and recreational uses, mechanisms underlying its reported oneirogenic effects remain unknown, with no data available on its neurotoxic profile. Aim of the studyThe scarcity of toxicological data and the unknown role of major neurotransmitter systems in the dream-inducing properties of the plant prompted us to investigate which neurotransmitters might be affected upon its consumption, as well as the potential cytotoxic effects on neurons and microglial cells. Furthermore, we aimed to explore a relationship between the recorded effects and specific constituents. Materials and methodsEffects on cholinergic and monoaminergic pathways were investigated using enzymatic assays, with the latter also being conducted in neuronal SH-SY5Y cells along with the impact on glutamate-induced excitotoxicity. Investigation of the neurotoxic profile was approached in neuronal SH-SY5Y and microglial BV-2 cells, evaluating effects on metabolic performance and membrane integrity using MTT and LDH leakage assays, respectively. Potential interference with oxidative stress was monitored by assessing free radical’s levels, as well as 5-lipoxygenase mediated lipid peroxidation. Phenolic constituents were identified through HPLC-DAD-ESI(Ion Trap)MSn analysis. ResultsBased on the significant inhibition upon acetylcholinesterase (p < 0.05) and tyrosinase (IC50 = 60.87 ± 7.3 μg/mL; p < 0.05), the aqueous extract obtained from the aerial parts of C. zacatechichi interferes with the cholinergic and dopaminergic systems, but has no impact against monoamine oxidase A. Additionally, a notable cytotoxic effect was observed in SH-SY5Y and BV-2 cells at concentrations as low as 125 and 500 μg/mL (p < 0.05), respectively, LDH leakage suggesting apoptosis may occur at these concentrations, with necroptosis observed at higher ones. Despite the neurocytotoxic profile, these effects appear to be independent of radical stress, as the C. zacatechichi extract scavenged nitric oxide and superoxide radicals at concentrations as low as 62.5 μg/mL, significantly inhibiting also 5-lipoxygenase (IC50 = 72.60 ± 7.3 μg/mL; p < 0.05). Qualitative and quantitative analysis using HPLC-DAD-ESI(Ion Trap)MSn enabled the identification of 28 constituents, with 24 of them being previously unreported in this species. These include a series of dicaffeoylquinic, caffeoylpentoside, and feruloylquinic acids, along with 8 flavonols not previously known to occur in the species, mainly 3-O-monoglycosylated derivatives of quercetin, kaempferol, and isorhamnetin. ConclusionsOur findings regarding the neuroglial toxicity elicited by C. zacatechichi emphasize the necessity for a thorough elucidation of the plant's toxicity profile. Additionally, evidence is provided that the aerial parts of the plant inhibit both acetylcholinesterase and tyrosinase, potentially linking its psychopharmacological effects to the cholinergic and dopaminergic systems, with an apparent contribution from specific phenolic constituents previously unknown to occur in the species. Collectively, our results lay the groundwork for a regulatory framework on the consumption of C. zacatechichi in recreational settings and contribute to elucidating previous contradictory findings regarding the mechanisms underlying the dream-inducing effects of the plant.

Assessment of water quality and emerging pollutants in two fish species from the mallorquin swamp in the Colombian Caribbean

The Mallorquín Swamp, an important ecosystem in Atlántico, Colombian Caribbean, underwent environmental monitoring at eight points during rainy, transition, and dry seasons. This was to assess water quality, seasonal variation, and the bioaccumulation of metals, emerging pollutants, and organic compounds in the fish Ariopsis canteri and Mugil incilis. Water parameters were analyzed using descriptive statistics and multifactorial ANOVA with the Tukey HSD test for seasonal differences. Normality and variance of the fish results were verified, and differences between groups were evaluated using ANOVA or Kruskal-Walli's method when data transformation failed. Spearman correlation was used to relate the results. Water sampling revealed variations in temperature, dissolved oxygen, salinity, and nutrient levels. Significant differences in alkalinity and hardness were observed across seasons and sample points. The most probable number (MPN) levels of Total coliform and E. coli peaked near areas with domestic wastewater inputs, reaching 5.4x106 and 4.0x106 MPN, respectively, indicating potential microbiological contamination of water. Fish samples revealed high concentrations of persistent substances such as methylmercury, polycyclic aromatic hydrocarbons (PAHs), and emerging pollutants. Heavy metal analysis showed elevated iron levels (5.28 ± 0.657 mg/L), while emerging pollutants, including ibuprofen (218 μg/L) and naproxen (343.89 μg/L), exhibited high concentrations near human settlements. Ariopsis canteri showed higher bioconcentration tendencies for methylmercury (238.5 ± 100 μg/kg), and acenaphthene (7782 ± 4123.8 μg/kg), possibly influenced by its feeding habits and habitat preferences. In contrast, Mugil incilis exhibited higher bioaccumulation trends of PAH (2376.23 ± 599.63 μg/kg acenaphthene) and emerging pollutants like galaxolide (139.49 ± 34.98 μg/kg), possibly due to its mobility and exposure to various contaminants in their environment. These findings emphasize the need to monitor and manage aquatic ecosystems' health to mitigate anthropogenic influences on water quality and biodiversity. This research serves as a reference for global conservation efforts, emphasizing the need for comprehensive monitoring and regulatory frameworks to protect aquatic environments and ensure their sustainability for future generations.

The Pivotal Role of Libraries in Sustainable AI Development

Artificial Intelligence (AI) has gained exceptional public and media coverage since the launch of the ChatGPT platform, a generative conversational intelligence, in November 2022. Nevertheless, AI is already an integral part of our digital daily lives, as we navigate through social networks, use our GPS, or consult recommendations on e-commerce websites. Due to its pervasive influence across all sectors of our societies, AI is gradually becoming a pivotal subject in terms of regulation, societal direction, and legislation. As early as 2021, UNESCO published a report presenting avenues for ethical considerations in AI. In June 2023, the European Union also established a regulatory framework outlining requirements and obligations for AI usage. As a digital manifestation and given the "new ways in which its use influences human thinking, interaction and decision-making and affects education, human, social and natural sciences, culture, and communication and information" (UNESCO. General Conference, 41st, 2021), public libraries have a role to play in enabling residents within their communities to grasp this technology. Their role is all the more significant as AI generates concerns and distrust (Gillath et al., 2021) among populations when "libraries also continue to enjoy a high level of trust and appreciation in most of their communities" (Arlitsch \&amp; Newell, 2017). Understanding AI thus constitutes a new cornerstone for accessing the necessary information to advance sustainable development, as outlined in the Lyon Declaration (2014). Moreover, comprehension of AI aligns with the ethical concerns articulated by UNESCO in terms of explainability and transparency and aligns with several Sustainable Development Goals (SDGs) of the 2030 Agenda. These goals include quality education (4), industry, innovation and infrastructure (9), reduced inequalities (10), sustainable cities and communities (11), as well as responsible consumption and production (12). The role of public libraries in advancing the goals of the 2030 Agenda is beyond dispute (IFLA, 2016), and various digital literacies are already integral to their actions. As AI is predominantly developed by global economic giants and permeates all of our practices, "Shouldn’t [libraries] be the bastions of information literacy and information privacy in an AI world?" (Cox et al., 2018). Thus, to what extent can public libraries take on this subject to promote and offer relevant literacy? For this study, we will conduct a cross-analysis among three European countries—Spain, France, and Italy—to provide insights into the diverse ways in which AI influences professional practices. Through a literature review and semi-structured interviews, the objective is to delineate the challenges of Artificial Intelligence within the framework of the Agenda 2030 program. Subsequently, we will delve into the specificity of AI Literacy in comparison to Information Literacy, a practice already adopted by libraries. Finally, we will analyze the current and prospective role of AI in libraries to propose avenues for implementing concrete actions.

Ethical Ramifications of the Dark Side of Business Practices in the International Business Area

ABSTRACTThe dark side of international business practices has attracted significant research attention recently. However, researchers are struggling to delve into the ethical ramifications of these practices because of a limited understanding of ethical and digital transformation issues in international business, which may be caused, inter alia, by sociocultural and market disparities, lack of regulatory frameworks, information asymmetries, data ubiquity, and power imbalance among key stakeholders. This paper addresses this important gap through four key themes—ethical considerations, data processing issues, legal considerations, and managerial contingencies. We discuss how to step forward in research on ethics in international business, assessing potential risks associated with privacy concerns, big data, cybersecurity, content analysis, stakeholder relationships, and discriminatory outcomes. Finally, we propose a research agenda and recommendations to address the ethical challenges and dilemmas international businesses face due to disruptive technologies (e.g., artificial intelligence) and cross‐market challenges (e.g., legal jurisdictions).

APPLICATION OF JOINT TENANCY ON REAL PROPERTY AND ITS IMPACT UNDER THE LAW OF SUCCESSION IN MALAYSIA

Joint ownership refers to property owned by two or more persons. Two significant forms of joint ownership in real estate exist joint tenancy and tenancy-in-common. Under common law, joint tenancy is applied as a mechanism for administering an estate, which takes effect after the joint owner's or joint tenant's death. The National Land Code (Act 828) recognises only tenancy-in-common tenancy rather than joint tenancy. Hence, this study proposes a regulatory framework and a suitable mechanism for the land conveyance process in the application of joint tenancy. This study is based on qualitative research and analysis of primary and secondary materials. For a comparative analysis, the study explores the law and practice of joint tenancy in Singapore and Australia for the dual legal and Torren systems. It is predicted that the joint tenancy application would give the proprietor more options in planning the management of his property and rightly give the surviving joint tenant full enjoyment of the property.

Reputation, commitment, and financial market regulation

This paper explores the interplay between reputation mechanisms, pre-commitment strategies, and financial market regulation. Through a theoretical model, we analyze how repeated interactions between market participants, combined with regulatory oversight, can lead to improved compliance and market efficiency. The study demonstrates that reputation mechanisms serve as powerful self-regulatory tools, as negative reputational feedback exerts a stronger influence on market behavior than positive feedback, particularly when the cost of non-compliance is high. Additionally, we investigate the role of pre-commitment in promoting market cooperation and separating equilibria, where high-quality suppliers distinguish themselves from lower-quality competitors. However, in the absence of stringent regulatory enforcement, pre-commitments may be exploited by low-quality suppliers, leading to market inefficiencies. Our findings suggest that a reputation-based, tiered regulatory framework can optimize resource allocation and enhance the effectiveness of financial market regulation. The paper concludes with policy recommendations for integrating these mechanisms into current regulatory practices and outlines areas for future research.

Toxic-Free Environment: Forever Chemicals Removal from Water and Wastewater

Per- and polyfluoroalkyl substances (PFAS), commonly known as "forever chemicals," are persistent synthetic compounds that have been widely utilized since the mid-20th century across various industries. Due to their environmental persistence and potential health risks, PFAS has become a significant concern, particularly in relation to water and wastewater contamination. This paper investigates the complex challenges associated with PFAS, focusing on existing regulatory frameworks, treatment strategies, and innovative clean technologies that aim to reduce or eliminate these harmful substances. The study emphasizes the importance of advanced treatment methods such as electrochemical degradation, nanofiltration, adsorption, and biodegradation, each offering varying degrees of success. Despite advancements in treatment technologies, prevention remains the most effective strategy to minimize PFAS pollution. The paper calls for collaborative efforts from regulatory bodies, industries, and communities to implement more sustainable practices, ensuring a toxic-free environment and aligning with circular economy principles. Continuous research and international cooperation are crucial for developing effective long-term solutions to address PFAS contamination and safeguard both public health and the environment.

Financial reporting quality and disclosure on stock price of listed deposit money banks in Nigeria

Due to the lack of a regulatory framework, financial scandals, fraud and poor disclosure in financial reports, investors and other stakeholders lose confidence in the firm's performance, which could lead to lower share prices. Investors and financial analysts who have noticed the impact of accounting quality and disclosures on stock prices have necessitated this study. This study looked at the impact of financial reporting quality and disclosure on the stock price of listed deposit money banks in Nigeria. The study made use of secondary data gathered from the annual report of listed DMB in Nigeria. The data generated were analysed using descriptive statistics, correlation analysis and Panel ordinary least square regression to understand the degree of relationship among the variables. A correlation matrix was carried out to test for multi-collinearity within the selected variables. Findings revealed that the combined effect of financial reporting quality and disclosure has a positive and significant impact on the stock price of listed deposit money banks in Nigeria. The study thereby recommends that for financial institutions to achieve sustainable performance levels, they should ensure that they meet stakeholders’ demands, which mainly rest on accounting information comprehensiveness and quality. Furthermore, the quality of accounting should be improved by ensuring companies adhere to accounting standards and financial regulations regarding disclosures.

India's Potential as a Leader in Cancer Care Progress in the Future: A Synthetic Interdisciplinary Perspective.

This paper comprehensively analyzes India's potential to become a leader in cancer care in the Global South, particularly in precision population cancer medicine (PPCM). Through an interdisciplinary lens, it examines the current landscape of cancer care in India, highlighting its strengths, weaknesses, opportunities, and threats in this domain. This review explores the concept of knowledge translation and its importance in bridging the gap between knowledge generation and implementation in medical sciences and applies this to the Indian healthcare scenario. The review then delves into India's technological prowess, exemplified by its digital health initiatives such as the CoWIN (winning over COVID-19) app and the Ayushman Bharat Digital Mission, which provide a strong foundation for leveraging advanced technologies in healthcare. The authors discuss India's pharmaceutical industry, often referred to as the "pharmacy of the world," emphasizing its crucial role in global drug manufacturing and distribution. It also examines the country's emerging genomic research landscape, including initiatives such as GenomeIndia and the Indian Cancer Genome Atlas Foundation, which are pivotal for advancing personalized medicine. A significant portion of the review is dedicated to analyzing India's clinical trial ecosystem. It traces the evolution of regulatory frameworks governing clinical research in the country and highlights recent reforms that have made India an increasingly attractive destination for global studies, the potential adoption of innovative trial designs and artificial intelligence (AI)-driven analyses. Crucially, the authors confront the formidable obstacles inherent in India's complex healthcare landscape, illuminating the unique challenges that must be overcome. The review acknowledges India's underrepresentation in global clinical trials despite its large population and significant cancer burden. The issue of financial toxicity in cancer care is discussed, underscoring the need for affordable treatment options. The study also points out the nascent state of India's genomic databases, which account for only a small percentage of global genetic data. Despite these challenges, the authors posit that by effectively leveraging its information technology (IT) infrastructure, robust pharmaceutical sector, and large, diverse population, India has the potential to develop unique, country-specific solutions for cancer care. The study suggests that by fostering genomic research, strategically reforming its clinical trial ecosystem, and harnessing its digital capabilities, India could transform its cancer care landscape and emerge as a model for other developing nations in the Global South. In essence, this paper provides a roadmap for India's journey towards becoming a leader in PPCM, offering valuable insights for policymakers, healthcare professionals, and researchers in the field of oncology and precision medicine. Indeed, by using PPCM as a "pilot project," India can learn to use its new strategies to improve non-cancer care disease prevention, early detection, and improved and more cost-effective management. This approach could revolutionize cancer care in India and serve as a model for other developing nations in the Global South. By leveraging the strategies and technologies developed for PPCM, India could significantly enhance its healthcare system, highlighting the importance and urgency of improving cancer care in the region.

Integrating policy incentives and risk management for effective green finance in emerging markets

Integrating policy incentives and risk management is pivotal for driving the growth of green finance in emerging markets. The transition to sustainable finance necessitates an alignment between government policies and financial institutions to mitigate the risks associated with green investments. This abstract explores how policy incentives, such as tax breaks, subsidies, and regulatory frameworks, can encourage financial institutions to channel investments into green projects while addressing market-specific challenges like underdeveloped financial infrastructure and regulatory gaps. In emerging markets, the perceived risks of green investments, such as uncertain returns and regulatory volatility, often deter private sector engagement. However, integrating robust risk management strategies—including diversification, public-private partnerships, and risk-sharing mechanisms—can significantly reduce these risks, thereby enhancing the attractiveness of green finance. Additionally, government-backed incentives can lower capital costs for green projects, enabling financial institutions to provide more favorable lending terms. Regulatory frameworks that standardize green finance criteria and reporting are also critical for fostering transparency and accountability, which in turn build investor confidence. The interplay between policy incentives and risk management is further highlighted through case studies from emerging markets that demonstrate successful implementation of green finance initiatives. These examples illustrate how policy-driven support mechanisms and comprehensive risk management frameworks can unlock significant investment potential in green infrastructure, renewable energy, and sustainable agriculture. By fostering a supportive policy environment and addressing risk factors through innovative financial instruments, emerging markets can enhance green finance flows, promote sustainable development, and contribute to global climate goals. This integrated approach is essential for bridging the financing gap in green projects, ensuring that environmental sustainability is aligned with economic growth and risk mitigation.

A legal and regulatory compliance framework for maritime operations in Nigerian oil companies

The maritime sector plays a critical role in Nigeria's oil industry, serving as the primary conduit for offshore oil exploration, production, and transportation. As the country remains heavily reliant on its oil revenues, ensuring that maritime operations comply with legal and regulatory standards is crucial for operational safety, environmental sustainability, and economic stability. This review outlines a comprehensive legal and regulatory compliance framework for maritime operations in Nigerian oil companies, focusing on the roles of key regulatory bodies such as the Department of Petroleum Resources (DPR), the Nigerian Maritime Administration and Safety Agency (NIMASA), and the National Environmental Standards and Regulations Enforcement Agency (NESREA). It explores major laws such as the Coastal and Inland Shipping (Cabotage) Act, Petroleum Industry Act (PIA), and Environmental Impact Assessment (EIA) Act, highlighting their implications for offshore drilling, oil transportation, and environmental protection. Additionally, the review discusses the compliance challenges Nigerian oil companies face, including environmental risks, maritime security threats, jurisdictional conflicts, and the technical demands of adhering to safety standards. To address these challenges, the study emphasizes the need for regular audits, technology integration, capacity building, and collaborative engagements between oil companies and regulatory authorities. Through case studies on oil spill response and the enforcement of cabotage laws, the review underscores the importance of robust regulatory enforcement to ensure safety, mitigate environmental damage, and enhance operational efficiency. This framework is essential for the future growth of Nigeria’s oil sector, balancing economic gains with legal compliance and sustainability in maritime operations.

Green chemistry in manufacturing: Innovations in reducing environmental impact

Green chemistry has emerged as a transformative approach in reducing the environmental impact of the manufacturing industry. This review paper provides a comprehensive examination of how green chemistry principles are applied in various manufacturing sectors to minimize hazardous waste and energy consumption. The paper begins by outlining the core principles of green chemistry, highlighting their relevance to sustainable industrial practices. Key innovations in chemical engineering are discussed, focusing on waste reduction, energy-efficient processes, and the use of renewable raw materials. Through detailed case studies in the pharmaceutical, textile, and automotive industries, the paper demonstrates how the adoption of green chemistry has significantly reduced the environmental footprint of these sectors. The review also explores the challenges industries face in implementing green chemistry and the future direction of this field, emphasizing the role of policy and regulatory frameworks in driving further innovation. The findings suggest that while progress has been made, there are substantial opportunities for growth, especially in expanding the use of green chemistry across diverse industries. This paper concludes with recommendations for continued research and broader adoption of green chemistry to promote sustainable manufacturing.

Regulatory requirements for biosimilars as per CDSCO in India in comparison with Yemen

This study examines the regulatory requirements for biosimilars in India and Yemen, highlighting similarities and differences between the Central Drugs Standard Control Organization (CDSCO) and the Ministry of Public Health and Population (MOPHP). The regulatory landscape for biosimilars is evolving globally, with varying requirements across countries. This comparative analysis examines the regulatory requirements for biosimilars in India, governed by the Central Drugs Standard Control Organization (CDSCO), and Yemen. A comprehensive review of guidelines, regulations, and approval processes reveals both similarities and differences between the two countries. While both CDSCO and Yemen require a comparability exercise to demonstrate bio similarity, differences exist in the regulatory framework, clinical trial requirements, and approval processes. CDSCO has a separate regulatory framework and abbreviated pathway for biosimilars, whereas Yemen adopts the MOPHP guidelines and has a registration process. This analysis highlights the need for manufacturers to understand the nuances of each market's regulatory requirements to ensure successful approval and commercialization of biosimilars. The findings of this study can inform regulatory agencies, industry stakeholders, and researchers working in the field of biosimilars.

Advancing food safety standards through technology integration and policy development

Food safety is a critical global concern, directly impacting public health, economic stability, and international trade. With the complexity of modern food supply chains and the rising incidence of foodborne illnesses, traditional food safety measures are often insufficient to address the growing risks. This review explores how integrating advanced technologies and developing robust policies can significantly enhance food safety standards. Technological innovations, including the Internet of Things (IoT), blockchain, artificial intelligence (AI), and automation, offer promising solutions for real-time monitoring, traceability, and predictive analytics in food production and distribution. IoT and sensors enable constant monitoring of environmental conditions like temperature and humidity, while blockchain ensures transparency and traceability across supply chains. AI and machine learning are transforming food safety by predicting contamination risks and optimizing inspection processes, while robotics and automation reduce human error in food processing plants. Alongside technological advancements, policy development plays a crucial role in reinforcing food safety standards. Global harmonization of food safety regulations, stronger enforcement mechanisms, and public-private partnerships are essential for ensuring widespread compliance. Incorporating technology into regulatory frameworks is key to addressing new challenges and maintaining food safety across borders. Governments must also prioritize consumer education and awareness through policies that leverage technology platforms to promote food safety knowledge. Case studies demonstrate the successful application of these technologies in sectors like dairy and meat processing, showcasing the potential for broader industry adoption. However, challenges such as high implementation costs, regulatory lag, and data security concerns remain. This review argues that a synergistic approach combining technological integration with forward-thinking policy development is essential for advancing global food safety standards and safeguarding public health in the future.

Setting new benchmarks for combating financial crimes and ensuring the safety and security of America's digital financial landscape

The increasing digitalization of financial services in the United States has introduced significant challenges in combating financial crimes, including fraud, money laundering, and cybercrimes. As digital transactions become more pervasive, so too do the opportunities for illicit activities that exploit the vulnerabilities of these systems. This research seeks to establish new benchmarks for combating financial crimes and ensuring the security of America's digital financial landscape. By leveraging advanced technologies such as Artificial Intelligence (AI), Machine Learning (ML), and blockchain, this study explores innovative approaches to enhancing fraud detection, improving transparency, and reducing the risk of money laundering. A mixed-methods approach was employed, combining qualitative analysis of existing regulatory frameworks with quantitative case studies to assess the effectiveness of these technologies in real-world applications. The results indicate that AI and ML significantly enhance financial institutions' ability to detect fraudulent activities in real-time, reducing false positives and allowing for more efficient resource allocation. Furthermore, blockchain technology improved financial transactions' traceability, enhancing financial systems' transparency and accountability. The study concludes with recommendations for policy and practice, emphasizing the need for adaptive regulatory frameworks, increased investment in advanced technologies, and more vital collaboration between the public and private sectors. These findings suggest that a proactive approach, integrating technological innovation with strategic policy measures, is crucial for safeguarding America's financial infrastructure against emerging threats in the digital era.

Long-term Evaluation of Machine Learning Based Methods for Air Emission Monitoring.

Machine learning (ML) techniques have been researched and used in various environmental monitoring applications. Few studies have reported the long-term evaluation of such applications. Discussions regarding the risks and regulatory frameworks of ML applications in environmental monitoring have been rare. We monitored the performance of six predictive models developed using ML and statistical methods for 28 months. The six models used to predict NOx emissions were developed using six different algorithms. The model developed with a moderate complexity algorithm, adaptive boosting, had the best performance in long-term monitoring, with a root mean square error (RMSE) of 0.48 kg/hr in the 28-month monitoring period, and passed two of the three relative accuracy test audits. High complexity models based on gradient boosting and neural network algorithms had the best training performance, with a minimum RMSE of 0.23 kg/hr and 0.26 kg/hr, but also had the worst RMSE scores, of 0.51 kg/hr and 0.57 kg/hr, during the monitoring period. In addition, all six models failed all three relative accuracy test audits. The following problems were observed: (1) Complex ML models tended to have overfitting problems, thus indicating the importance of the trade-off between model accuracy and complexity. (2) Model input sensor drift or out of high-frequency ranges from the training data resulted in inaccurate predictions or an accuracy lower than the minimum allowed by regulators. (3) Existing regulatory frameworks must be modernized to keep pace with current machine learning practices. Some statistical tests are unsuitable for applications developed by using ML methods.