Government Regulatory Agencies Research Articles

Decarbonizing Maritime Transport through Green Fuel-Powered Vessel Retrofitting: A Game-Theoretic Approach

Addressing the urgent global challenge of man-made greenhouse gas emissions and climate change necessitates collaborative action between shipping lines and government regulatory agencies. Aligning with the International Maritime Organization’s emissions reduction strategy, this paper presents a novel bi-level programming model that unifies these stakeholders. On the upper level of the proposed bi-level model, a number of shipping lines optimize retrofitting plans for their vessels to maximize economic benefits. On the lower level, the regulatory agency responds to the carbon reduction efforts by setting retrofitting subsidies and emission penalty rates. This framework represents a multi-leader–single-follower game involving shipping lines and the regulatory agency, and its equilibrium is determined through an equilibrium problem with equilibrium constraints (EPEC). The EPEC comprises multiple single-leader–follower problems, each of which can be formulated as a mathematical program with equilibrium constraints (MPEC). The diagonalization algorithm (DM) is employed for its solution. Simulation studies performed based on a ten-year planning period show that the proposed approach can effectively promote vessel retrofitting and the use of green fuels, which leads to an annual emission reduction of over 50%.

GENERIC DRUG REGISTRATION AND COUNTRY-SPECIFIC REQUIREMENTS IN SAUDI ARABIA, QATAR, BAHRAIN, AND OMAN

Objective: This research aims to examine the regulatory framework and prerequisites for generic drug registration in the Middle East and North Africa (MENA) region, with a specific focus on the countries that make up the Gulf Cooperation Council (GCC). This will enable a deeper understanding of the procedures, records, schedules, and discrepancies related to registration. Methods: The study makes use of an extensive examination of the rules, regulations, and practices about the registration of generic drugs in the MENA. Official government sites, regulatory agencies, and respectable trade journals for the pharmaceutical sector were used as sources of information. The main procedures for registering generic drugs were explained and inspected, encompassing the submission of documents, dossier preparation, bioavailability/bioequivalence tests, and application filing. Results: There are substantial growth prospects for generics. Research highlights the sequential registration process for generic drugs, submitting documents electronically using the Common Technical Document (eCTD) method. For registration to be successful, specific records and data such as bioavailability/bioequivalence research data must be provided. Conclusion: The effective registration of generic medications in the MENA region, especially in the GCC nations, depends on understanding and abiding by nation-specific regulatory standards. The research offers a tactical guide that outlines the essential procedures, paperwork needs, and regional variances in the generic medicine registration process. The goal is to offer affordable healthcare solutions by navigating the regulatory landscape meticulously and streamlining the approval and market entry process for generic pharmaceuticals in the MENA region.

The Challenges and Opportunities of Environmental Law Enforcement: A Systematic Review

Introduction: The formation of environmental law in many countries worldwide will unavoidably be promoted and coordinated by the non-governmental environmental groups currently in the world. In addition, it will benefit some developing countries where environmental protection is not a priority, environmental laws are not well-established, and oversight is not rigorous enough. Objective of research: This paper aims to explore the challenges and opportunities of environmental law enforcement in many countries in the world. Methods: A systematic review was used in this study. Based on the Preferred Reporting Items for Systematic Reviews and Meta-Analyses, this study followed the steps of a systematic review of the literature (PRISMA). The final sample of 35 publications was analyzed, considering the year of publication, methods utilized, geographical location, the topic of challenges, and opportunities in enforcing environmental law. Responding to environmental crime is largely the responsibility of government enforcement and regulatory authorities, whether at the national, subnational, or municipal levels. Results and Discussion: The primary reaction agencies in most areas of the world are police, customs and border protection, and environmental regulatory agencies. To assist developing nations in improving environmental legal instruments and supervision; to achieve the ultimate goal of regional and even global environmental law coordination; to train relevant persons, relevant agencies, and other topics in the necessary environmental skills and knowledge; and to transfer and teach environmental knowledge and law within a specified time frame. Conclusion: Although some countries have a thorough legislative structure for environmental protection, local government independence and law enforcement must be improved. The ability of environmental law to serve a purpose is critical in determining whether the measures should be fully implemented.

Decision Analysis of Cold Chain Supply Chain Based on a Stochastic Evolution Model

Accelerating the development of cold chain logistics for agricultural products is not only an objective requirement for the development of agricultural product circulation but also a necessary demand to promote rural revitalization and upgrade agricultural consumption. Addressing the evolutionary problems of cold chain transportation in uncertain environments, this study considers the actual stochastic disturbances in the cold chain supply chain system, introducing Gaussian white noise to reflect the random perturbations experienced during the evolution of the cold chain. A three-party stochastic evolutionary game model is established involving farmers, logistics enterprises, and government regulatory authorities. Based on this model, numerical simulation analysis is conducted to explore the effects of different factors such as the intensity of random disturbances and the loss transfer coefficient on the fluctuation of strategic choices of the entities and the convergence speed to a stable state during evolution. Finally, combining the results of numerical simulation, relevant policies and recommendations are proposed to provide insights and guidance for the development of cold chain logistics in agricultural products.

A systematic review of the impacts of oil spillage on residents of oil-producing communities in Nigeria.

Oil spillage is common in oil-producing communities of Nigeria, and it impacts negatively on the residents of these communities. This study analysed available research data on oil spillage incidents in these communities to determine their main causes and impacts on the residents. This study highlights the immediate and long-term consequences of oil spills on residents of oil-host communities in Nigeria. A systematic review of published studies was carried out, and 22 studies were identified from the literature search. The main causes of oil spills were identified as sabotage (87%), leakage from corroded pipelines (62%), and equipment failure (45%). Others were mystery spills and operational failures. Unemployment, abject poverty, marginalization, and inaction of government regulatory agencies are enabling factors for sabotage and vandalism of oil pipelines. It was found that exposure to oil spills impacts directly and indirectly on residents of oil-host communities, with accompanying health, socioeconomic, and environmental implications. Oil spills in these communities impact on all facets of their life, thereby infringing on their rights to existence and survival. The major interventions were targeted at improving health services, education, infrastructure, skill acquisition, and employment. These in turn reduced the occurrence of violence, insurgency, and human trafficking in the oil-producing communities. It is recommended that government regulatory agencies should be revamped and repositioned to effectively perform their duties. Interventions should be targeted at addressing the causes of agitation by indigenes by involving them in the decision-making process. Also, appropriate remediation strategies should be adopted to clean up the oil spills.

A stochastic and time-delay evolutionary game of food safety regulation under central government punishment mechanism

Food safety is a pressing issue affecting public health, and strengthening food safety regulation has become a widespread consensus. This study addresses the three-party game involving food production enterprises, third-party testing agencies, and government regulatory authorities. Considering the influence of random disturbances and time delays on the strategy-choosing and behavioral evolution of game players, a three-party stochastic evolutionary game model for food safety regulation with time delays is established. The stability of the model is analyzed by using Lyapunov's method, and the strategy evolution of the game players is investigated while combining numerical simulations. The study shows that the net benefit of the players' expected strategies is key in determining whether the overall game system can reach the optimal equilibrium. The level of penalties imposed by the central government on local government regulators is key to food safety. The main factors influencing the strategy-choosing of game players are the level of penalties imposed by the local government regulators on third-party testing agencies, together with the supervision costs of the local government regulators. Random disturbances have a certain impact on strategy-choosing of the game players, with a greater impact on testing agencies, followed by food production enterprises, and a weaker impact on government regulatory authorities. The time delay factors exhibit a certain delay effect on the evolutionary path of strategy-choosing among the game players, which aligns with the actual situation. The findings of the study have implications for food safety regulation.

Evolutionary Game and Simulation Analysis of Food Safety Regulation under Time Delay Effect

This study develops a tripartite evolutionary game dynamic model with a time delay effect to analyze the interactions among food enterprise, government regulatory, and food inspection agencies in managing food safety risks. This model enables government regulatory agencies to more accurately assess and predict food safety risks, thereby implementing more effective preventative measures, ensuring the maximization of policy effectiveness and reducing food safety incidents. The results emphasize the significance of recent company performance by showing that regulatory and inspection entities’ strategic decisions are significantly impacted by delay effects from food companies. This study also shows that negative self-feedback intensity drives food enterprises to develop safer products and encourages tighter government oversight. Recommendations include improving consumer reporting channels, changing government incentives and penalties, allocating resources efficiently, and advancing information technology to decrease the effects of time delays and improve food safety management. Governments can improve food safety regulation by using strategic insights from numerical simulations.

Evolution of stakeholder behavior strategies in the water quantity eco-compensation mechanism of water use coordination inside and outside the river

Eco-compensation is an important means to implement the rights and responsibilities of ecological protection and alleviate the water conflicts inside and outside the river. Previous studies focused on water conflicts among users, overlooking the government's regulatory role in the eco-compensation mechanism and the coordinating function of water transfer compensation fees among users. This study constructed a tripartite evolutionary game model involving government regulatory agencies (GRA), in-channel ecological environment water demanders (EEWD), and off-channel socio-economic water users (SEWU). The evolutionary stability strategies (ESS) of the GRA, EEWD, and SEWU and the evolutionary trend of the tripartite system were analyzed using the finite rationality evolutionary game model, and the sensitivity analysis of the influencing factors was conducted using the eigenvalues of the Jacobi matrix and numerical simulation. Taking the Bai River Basin in Nanyang, China, as the case study, the results showed that the GRA's rewards and penalties were controlled within a reasonable range can promote the enthusiasm of the participating subjects in the water quantity compensation mechanism; water quantity compensation standard for the SEWU was an important indicator for the smooth implementation of the compensation mechanism, the loss coefficient and the overall ecological benefit allocation coefficient of the EEWD will influence the formulation of water quantity compensation standards. This suggested that the GRA should enhance the management of the eco-compensation-related policies and laws and regulations, limit the SEWU's eco-compensation standard, and improve the net benefit of EEWD, to achieve the optimal eco-compensation strategy of ''supervision, protection, compensation''. The research results provide a reference value for the formulation of the water quantity eco-compensation mechanism for water use coordination inside and outside the river.

A Political and ethical landscape of brain organoid research

Human cerebral organoids (hCOs), produced in labs through directed cell culture of embryonic or induced pluripotent stem cells, closely replicate the 3-dimensional architecture of the human brain on a micro scale. This technology has been used to model neurological disease and shows promise to complement or supplant animal subjects in preclinical therapeutic investigation. However, attention must be paid by researchers and institutions to the various ethical concerns associated with hCO development. Human-animal chimeras produced through the grafting of hCOs have shown integration of neurological function, calling into question the moral status of both the animal chimeras and the organoid itself. Sensationalist reporting on such acts may also prompt public backlash, potentially jeopardizing hCO research and the promised benefits thereof. Moreover, concerns arise over privacy and consent for past and prospective donors of stem cells used to produce organoids. Genetic information may be considered privileged to the public domain and disrupted trust can reduce the supply of willing donors. Though hCOs are believed thus far to lack the capacity for consciousness and cognitive function, consideration must be given to their potential status as moral agents with further development or enhancement. Boundaries concerning organoids adhered to by researchers have been largely voluntary and informal to this point. By edict or by the power of the purse, governmental regulatory agencies ought to formalize necessary guidelines to ensure compliance with ethical principles and the adequate representation of all affected stakeholders in future decisions.

Strengthening the Downstream Supply Chain Management for Vaccines in the Philippines: Food and Drug Administration Perspective

The case study examines the framework established by the Food and Drug Administration Philippines to facilitate the Vaccine Supply Chain in the Philippines. During the pandemic, the said regulatory body must ensure its efficiency and safety. AnyLogistix, a system software employed in Post Market Surveillance for vaccines in Norway, was discovered during the research process. This software has facilitated the efficient assessment and monitoring of vaccines in Norway. Consequently, this case study explores the potential benefits of implementing anyLogistix in the Philippines to enhance drug and vaccine cold chain management. The Grounded Theory was used to assess the readiness and acceptance of local companies and organizations responsible for managing cold chain facilities and vaccines in the Philippines, to pave the way for future advancements in the field. Ultimately, the acceptability of the comparative study validates the approval of stakeholders, cold chain facilities, and government regulatory agencies in using anyLogistix as an automated system to efficiently monitor the post-market surveillance in the downstream stages of the supply chain for vaccines spearheaded by the Food and Drug Administration-Philippines. This study conducted a survey among 14 expert panelists both male and female in which 8 out of 14 panelists expressed dissatisfaction with the current system of how the government responds to pandemic outbreaks, 10 out of 14 panelists were not familiar with anyLogistix, and 11 out of 14 panelists shows interest in using this Norwegian software to improve the efficiency in responding to vaccine supply management issues, therefore, anyLogistix could be a good development that the Food and Drug Administration could utilize. Keywords: Strategic continuity, Business plan, Sustainability, Adaptability, Private Emission Testing Centers, Motor Vehicle Inspection System, Regulatory pressure, Leadership change, Policy shifts, Mixed methods research.

Good Governance and Tourism in South Asian Emerging Economies: The Mediating Role of Foreign Direct Investment

This study examined the role of good governance in promoting tourism in emerging South Asian countries and also tested the mediating role of foreign direct investments (FDI). The study used panel data collected from seven South Asian countries from 1996 to 2018. Panel data regression models were estimated to test the research hypotheses. The results showed that the country’s good governance has a positive and significant influence on tourism receipts and arrivals. Moreover, the mediation analysis results supported that foreign direct investments mediated the relationship between good governance indicators like government effectiveness, political stability, voice and accountability, and control over corruption and tourism. Based on the results, the study proposed the governance-led FDI and FDI-led tourism hypotheses, the study’s main contribution. The study has implications for the government regulatory agencies relating to governance, tourism departments, foreign prospect investors, and policymakers.

The Impact of Ownership Concentration on Corporate Financialization: The Mediating Effect of Financing Constraints

This article selects small and medium-sized listed companies (with stock codes starting with 002) as the research subjects, constructing a panel dataset spanning from 2017 to 2021, resulting in a total of 4324 observations. Through an extensive review and analysis of existing literature and relevant theories, it comprehensively explores the effects of equity concentration on corporate financialization and whether these effects differ in state-owned enterprises. Additionally, it investigates the moderating effects of financing constraints as a variable. After empirical analysis and robustness tests, the following conclusions are drawn: Equity concentration has a significantly negative impact on corporate financialization. Moreover, equity concentration exacerbates financing constraints, which, in turn, suppress corporate financialization. Furthermore, compared to state-owned enterprises, equity concentration has a more pronounced inhibitory effect on corporate financialization in non-state-owned enterprises. In the context of this study, state-owned enterprises in China are those in which ownership or control belongs to the state. The research on the impact of corporate financialization in this article can provide a theoretical basis for government and financial regulatory agencies to formulate financial policies in practical terms.

Update on the advances and challenges in bioequivalence testing methods for complex topical generic products.

Most of the government regulatory agencies, including the United States Food and Drug Administration and the European Medicine Agency, demand that the generic complex topical products prove pharmaceutical and bioequivalence. The evaluation of bioequivalence for complex topical dermatological formulations is a challenging task that requires careful consideration of several factors. Although comparative clinical studies are still considered the gold standard approach for establishing bioequivalence in most formulations, these studies can be costly and insensitive to detect formulation differences. Therefore, significant efforts have been made to develop and validate alternative approaches that demonstrate bioequivalence and expedite the availability of high-quality generic topical dermatological products. This article reviews the current methods for determining the bioequivalence of topical formulations in humans, with particular emphasis on recent advances in these methodologies. Most of the alternative methods are sensitive and reproducible, with the capability to ease the financial burden of comparative clinical studies within a short delivery time. The limitations associated with each technique are reviewed in detail.

Patient engagement in designing, conducting, and disseminating clinical pain research: IMMPACT recommended considerations.

In the traditional clinical research model, patients are typically involved only as participants. However, there has been a shift in recent years highlighting the value and contributions that patients bring as members of the research team, across the clinical research lifecycle. It is becoming increasingly evident that to develop research that is both meaningful to people who have the targeted condition and is feasible, there are important benefits of involving patients in the planning, conduct, and dissemination of research from its earliest stages. In fact, research funders and regulatory agencies are now explicitly encouraging, and sometimes requiring, that patients are engaged as partners in research. Although this approach has become commonplace in some fields of clinical research, it remains the exception in clinical pain research. As such, the Initiative on Methods, Measurement, and Pain Assessment in Clinical Trials convened a meeting with patient partners and international representatives from academia, patient advocacy groups, government regulatory agencies, research funding organizations, academic journals, and the biopharmaceutical industry to develop consensus recommendations for advancing patient engagement in all stages of clinical pain research in an effective and purposeful manner. This article summarizes the results of this meeting and offers considerations for meaningful and authentic engagement of patient partners in clinical pain research, including recommendations for representation, timing, continuous engagement, measurement, reporting, and research dissemination.

Evaluation of the Histomorphology of Small Intestine of Wistar Rats Exposed to Eliozu Dumpsite Leachate

This study is aimed to evaluate the histomorphology of small intestine of Wistar rats exposed to Eliozu dumpsite leachate. The toxic effect of Eliozu dumpsite leachate has been studied, where the researcher has identified that the leachate has toxicological effects on some organ tissues like the blood, reproductive tracts and hormones, oxidative stress parameters and the cerebral cortex. Twenty-five female Wistar rats weighing between 120-140 g were obtained from the animal house unit of Faculty of Basic Medical Sciences, University of Port Harcourt, Nigeria. The rats were randomly assigned into five groups of five (5) rats in each group. Group 1 served as a control and orally received 1 ml of bottled water; group 2 orally received 1 ml of water from a borehole close to the dumpsite. Groups 3, 4 and 5 received 1 ml of 10%, 50%, and 100% leachate concentrations orally for 30 days. In the present study, an alteration in the histoarchitecture of the small intestine of the Eliozu dumpsite leachate treated animals was observed; the small intestine of the control group has shown normal intestinal histoarchitecture. The mucosa forms a series of finger-like villi, each showing lamina propria, blood capillaries etc. the simple columnar mucosal epithelium contains absorptive goblets cells, crypts of Liberkuhn in the mucosa and Brunner’s glands. It is concluded that exposure to the Eliozu dumpsite leachate and the consumption of the nearby borehole water with significant heavy metals and microorganism have caused the histopathological alterations in gastrointestinal tracts (small intestines) of animals and it is recommend that Government and environmental regulatory agencies find an ecofriendly method to treat Eliozu dumpsite leachate.

The Research of Financial Fraud and Regulatory Countermeasures to the Listed Companies Based on Game Theory

Accounting Fraud, as immoral behavior which violates the law, may cause severe damage to economic and market trust. The listed companies may acquire short term benefits through accounting fraud; therefore, the government regulatory authority should set up severer policy to prevent and avoid this behavior from happening. This review article aims to analyze the existing problem of accounting fraud, games between listed companies and regulatory authorities based on game theory, and the mechanism that caused accounting fraud to happen. The articles have found that the behavior of accounting fraud may confuse the investors by its invalid financial report, which often results in wrong investment decisions. If the accounting fraud has been revealed and known by the public, the listed companys share price will plummet, overall market confidence will suffer, and the entire economic system and financial stability will also be affected. By damaging the financial stability and decreasing the overall investments, accounting fraud handicaps economic growth by its possible consequence of decreasing the economic activity, capital expenditures, and the employment opportunities. However, the game theory research on the games between listed companies and regulatory authorities may offer supervisory measures to reduce and prevent the occurrence of financial fraud.

An evolutionary game for the behavior of third-party evaluators in pension public–private partnership incorporating public participation

This study analyzes the impact of public participation on the choice of third-party evaluators' behavior strategies during the service quality supervision process of China's pension public–private partnership project. An evolutionary game model between third-party evaluators and government regulators is developed, wherein the evolution rule of the two sides and public participation’s influence on their behavior under the two different conditions are analyzed, and a numerical simulation is carried out using MATLAB 2016a. It is found that third-party evaluators may choose the false evaluation strategy without public participation because of the inducement of rent-seeking or insufficient government punishment when the regulatory revenue of the government regulatory agencies is less than the regulatory cost. In contrast, in the case of public participation, the true evaluation strategy is chosen with an improvement in the level of public participation or an increase in reputation incentive. This suggests the construction and improvement of a third-party evaluation system, which shows that the construction of the service quality supervision system in China’s pension PPP project has a large operating space.

Impact of earnings management on dividend policy: does board independence matter?

PurposeThis paper empirically examines whether sophisticated governance mechanism affects the relationship between earnings management and dividend policy of non-financial firms.Design/methodology/approachThe sample of the study includes non-financial firms listed on the stock exchanges of twenty developed and developing economies from the period 2005–2017. The Generalized Method of Moments (GMM) was applied to estimate the econometric models.FindingsThe results confirm the positive association between earning management and the dividend payout ratio of the sample firms. These findings are in line with the signaling theory, which suggests that firms engage in earnings manipulation to signal to the market that they can maintain a smooth dividend distribution. Moreover, findings suggest that board independence, being a mechanism of corporate governance, significantly negatively moderated the relationship between earnings management and the dividend payout ratio of non-financial firms.Practical implicationsThe findings provide valuable suggestions to government bodies, regulatory authorities and corporate managers to focus on the effectiveness of governance mechanisms to improve the reliability of financial reports.Originality/valueThese findings imply that the effect of earning management on the dividend payout ratio is less pronounced in firms with more independent directors on the company board.

The fossil fuel industry's suppression of public knowledge surrounding the toxic effects of benzene

Abstract Individuals working in industries that produce or use benzene, a chemical compound known to produce chronic health effects including leukemia and death, are occupationally exposed to the highest levels of benzene. It is much less known how corporations, and in particular Shell Oil Company, suppressed public health information and formed relationships to promote false data to influence legislation and standards regarding benzene. We conducted archival research in the UCSF Chemical Industry Documents Library by reviewing the Benzene collection which contains 4,025 Shell Oil Company internal documents (1920s-1990s). We conducted standard snowball keyword search methods and thematically coded for major events, individuals, and relationships regarding the suppression of benzene. In 1949, Shell executives privately admitted that there was no safe level of exposure to benzene. During the 1950s, Shell unsuccessfully attempted to find cheaper alternatives to replace benzene used in petroleum. As scientific evidence emerged regarding the health harms of benzene in the 1960s and 1970s, government regulatory agencies increasingly proposed regulations to minimize benzene exposure. In response, Shell executives funded research to downplay benzene exposure to workers. Shell also used these studies to suppress and misdirect emerging evidence. Meanwhile Shell developed internal employee handbooks and monitoring programs to minimize any threats of company liability instead of dropping the usage of benzene. Internal Shell documents reveal the company suppressed public knowledge surrounding the toxic Effects of benzene since the 1940s. Governments should ban the use of benzene to protect the health and safety of workers.

Evolutionary Game Analysis of Copyright Protection for NFT Digital Works Considering Collusive Behavior

The non-fungible tokens trading of digital content works, as an emerging business model, has rapidly developed while also posing challenges to current copyright protection. The NFT infringement incidents in recent years have exposed many issues, such as lack of government regulation, imperfect copyright protection mechanisms, and illegal profits from service platforms. Considering the collusive behavior during the NFT minting process, this study uses evolutionary game theory to model a game composed of three populations: digital content creators; NFT service platforms; and government regulatory agencies. We derived and analyzed the replication dynamics of the game to determine the evolutionary stability strategy. In addition, combined with numerical simulations, we also analyzed the impact of individual factors on the stability of system evolution. This study identifies that the incentives and fines set by the government must be above a certain threshold in order for game results to develop toward an ideal equilibrium state, and the government can try to improve the efficiency of obtaining and updating market information and set dynamic punishment and reward mechanisms based on this. This study also found that excessive rewards are not conducive to the government fulfilling its own regulatory responsibilities. In this regard, the government can use information technology to reduce the cost of regulation, thereby partially offsetting the costs brought about by incentive mechanisms. In addition, the government can also enhance the governance participation of platforms and creators to improve the robustness of digital copyright protection by strengthening media construction and cultivating public copyright awareness. This study helps to understand the complex relationship between NFT service platforms, digital content creators, and government regulatory authorities and proves the practical meaning of countermeasures and suggestions for improving government digital copyright regulations.