Regulatory Agencies Research Articles

A Review on Genotoxic Impurities in Pharmaceutical Dosage Forms and Strategies for Identification

Abstract: Genotoxic pollutants can be broadly defined as pollutants that, regardless of the mechanism, cause significant changes in genetic material. People all over the world suffer from various health problems due to genotoxic pollutants. Recent recommendations from drug regulatory agencies in Europe and the United States (USA) require the monitoring of genotoxic and potentially genotoxic contamination in drug formulations at the ppm level. Therefore, this review evaluates several regulatory agency guidelines for monitoring genotoxic contamination, impurity levels, and toxicity in pharmaceutical products. The review also discusses analytical considerations for measuring genotoxic pollutants at trace levels and concludes with several examples of measuring several important classes of genotoxic pollutants. We will also explain our results. The article provides detailed information on genotoxicity studies of waste solutions, metal wastes, and isolated pollutants.

Psychological Trauma Level Among Post Eartquake Children in Kajai West Pasaman West Sumatera

Indonesia is a country situated in the middle of two seas encircling continents. Indonesia is situated in the area of the world's most active earthquakes, as shown by its location on tectonic plates encircled by active volcanoes. Because of this, Indonesia is susceptible to a variety of natural calamities, including tsunami and eathquakes. An earthquake is a sudden, mild to strong shaking of the ground brought on by a shift in the earth's plates. Victims of earthquakes may have psychological and physical effects. For victims, it causes severe anguish and sadness. Examining the degree of trauma experienced by children following the earthquake in Kajai, West Pasaman, West Sumatra, Indonesia, is the goal of this study. In West Kajai Pasaman, West Sumatra, 303 post-earthquake children were the sample for this quantitative study, which used a descriptive research approach. According to the study's findings, mild trauma was experienced by 30.4% of post-earthquake children, moderate trauma by 62.7%, and severe trauma by 6.9% of the population. It is anticipated that this study would draw attention to the number of traumatized youngsters in Kajai village. The regulatory agencies will find these insights useful in reducing

The repercussions of enacting the IMO 2020 regulation for mitigating ship emissions in Malaysian waters

ABSTRACT The IMO 2020 regulations, introduced by the International Maritime Organization (IMO), came into effect on January 1, 2020, with the primary goal of reducing sulphur oxide emissions from ships by capping the allowable sulphur content in marine fuels at 0.50%. This measure aims to minimize the harmful environmental and health impacts of sulphur emissions, which contribute to air pollution and acid rain. However, the implementation of these regulations has posed considerable challenges for Malaysia’s maritime sector, particularly due to increased operational costs and difficulties in complying with the stringent requirements. This study critically analyses the challenges associated with the enforcement of IMO 2020 regulations in Malaysia, focusing on regulatory compliance. By conducting a comprehensive review of existing literature and integrating insights from key stakeholders and regulatory authorities, this research evaluates the current state of implementation. The findings reveal that the enforcement of IMO 2020 in Malaysia has been suboptimal, largely due to gaps in regulatory execution and industry preparedness. For Malaysia to fully align with international standards and contribute to the preservation of a sustainable maritime ecosystem, concerted efforts are essential to enhance enforcement mechanisms and ensure compliance with global emission reduction targets.

Reporting MRONJ as an adverse drug reaction: an oral surgery survey.

Introduction Medication-related osteonecrosis of the jaw (MRONJ) is a significant adverse drug reaction associated with anti-angiogenic and anti-resorptive medications. The aim of this survey was to highlight the importance of reporting adverse drug reactions, including MRONJ.Methodology An electronic survey was disseminated to dentists working in the oral surgery department Birmingham Community Healthcare Trust in November 2021. The survey consisted of 14 open and closed questions relating to the identification and reporting of MRONJ as an adverse drug reaction.Results Although 97% of participants had seen a patient with MRONJ, only 19% had reported an adverse drug reaction to any medication. Interestingly, 27% of respondents felt that MRONJ should be classified as a 'post-operative complication' rather than an 'adverse drug reaction'. In total, 22% of participants were unaware of how to report an adverse drug reaction.Conclusion This survey acts as an important reminder to encourage both patients and dental professionals to report adverse drug reactions, including suspected MRONJ, to the Medicines and Healthcare products Regulatory Agency. Reporting aids accurate national data collection, highlights risk and supports ongoing research in this area.

Identification and characterization of alkaline hydrolytic degradation products of ivacaftor by UPLC-PDA and UPLC-ESI-QTOF-MS techniques.

The study of inherent stability characteristics of drugs has been advocated to be important by various regulatory agencies like the ICH, USFDA, and others. The current work was envisaged to investigate the forced degradation profile of the drug ivacaftor under ICH-prescribed stress conditions, identification of its potential degradants, and postulation of the degradation routes for their generation. The stress degradation studies were performed on the drug as per the ICH guideline Q1A(R2). A UPLC-photodiode array-based chromatographic method was developed to satisfactorily resolve the drug from its degradation products, validated in accordance with various ICH prescribed parameters, and assessed for its BAGI practicality index. The degradation products were identified and characterized by UPLC-ESI-QTOF-MS studies. The drug was found to significantly degrade under conditions of alkaline hydrolytic stress and it was found to be stable under all other stressor environments including acid/neutral hydrolytic, photolytic, thermal, and oxidative stress. Four alkaline hydrolytic degradation products (I-IV) were revealed by UPLC-QTOF-MS studies which were well-resolved from the drug over a C18 UPLC column by the developed UPLC-PDA method. The detection wavelength was selected as 310 nm. Characterization of the four degradation products (I-IV) was carried out by their mass spectral data and their respective degradation routes were elucidated. A UPLC-PDA method was developed and validated for ivacaftor and its practicality BAGI index was computed. Four alkaline hydrolytic degradation products of ivacaftor were revealed through UPLC-ESI-QTOF-MS studies and corresponding degradation routes were elucidated.

An Empirical Analysis of Motivating Factors Behind Purchase of Gold Investment

This study is based on a sample of 613 respondents chosen using judgement cum convenience sampling to understand the gold-buying behaviour of individual investors. The paper attempts to explore the various attributes that investors consider important while investing in gold. Six underlying factors of importance are extracted, namely, family and cultural influence, diversification properties, safe haven properties, financial security, wealth preservation and liquidity. The influence of family and culture is evident from the results, with buying at weddings and festivals being a major reason to purchase gold, followed by investment purposes. Furthermore, the attitude of investors towards the imposition of taxes and tariffs on gold by the government is found to be negative, which could adversely affect investment in gold. Taking the findings into consideration, regulatory authorities could devise strategies to formulate a comprehensive gold policy to help gold contribute more to the exchequer instead of adversely affecting the current account.

Exploring financial graph literacy: determinants and influence on financial behavior

Purpose Graphs are widely used in the banking and finance domain to support consumers’ decision-making process, but subjects differ in their ability to understand them. This study aims to detect the determinants of the ability to read and process financial information conveyed in the graphical format, i.e. financial graph literacy (FGL) and the relationship between FGL and subjects’ actual financial behavior (FB). Design/methodology/approach Data are collected by administering a structured questionnaire to the Italian adult population (n = 502). The survey includes different sections aimed at collecting information about sociodemographic and socioeconomic variables, financial literacy and FB. The econometric analyses are developed using OLS and Poisson regressions. Findings The results show that gender, geographical area, education, marital status and income are crucial determinants of FGL. Moreover, the analysis reveals that an increase in the FGL indicator is associated with a higher propensity for individuals to purchase banking or financial products or actively manage financial resources; results are robust, even controlling for financial knowledge. Originality/value Although previous research investigates the impact of graphs in financial decision-making, no studies measure the ability of consumers to read and interpret financial information conveyed in the graphical format. This study is the first to investigate the determinants of FGL and link it to actual FB. Implications for policymakers, regulatory and supervisory authorities and financial intermediaries are discussed.

The characteristics, challenges, and opportunities of China’s food safety inspection supervision in the distribution sector

Concerns about public food safety are comparatively common in the Chinese food distribution industry. A dearth of expertise and scarce resources lead to frequent instances of incapacity and inadequate oversight, which negatively affect stakeholders in the circulation industry. The main challenges to food supervision are the need for more alignment between the technical specifications, comprehensiveness, and continuity of the existing food safety supervision legislation and the real circumstances facing the regulatory agencies. Despite the circulation field’s critical position in food safety regulation, its complex and variable characteristics make it challenging to implement and manage. There exist notable concerns over inadequate food safety standards and supervisory frameworks, vagueness in enforcing rules, and insufficient workforce and technical know-how in food safety supervision. The opportunities for regulating the food business with the government’s focus and attention considerably outweigh the obstacles that lie ahead. The growth of the food business needs to be viewed in the larger framework of the country’s economic development. Professional involvement and collaboration with technical departments can help regulatory bodies tackle non-compliant actions in the market circulation process in a timely way, resulting in a more evidence-based and responsive regulatory approach. Establishing a healthy equilibrium and elucidating the relationship between oversight and the food business will be crucial in the future.

Compliance with anti-money laundering laws and their impact on banking operations in Pakistan: banking expert’s opinion

Purpose Despite sound anti-money laundering (AML) regulations and membership in the financial action task force, money laundering remains a severe concern faced by Pakistan because of its weak AML regime. This led to an investigation of the perceptions of banking expert’s regarding the AML law’s costs and complexity, mapping of compliance cost and measures taken by Pakistani banks in compliance with AML laws. Design/methodology/approach A socio-legal study approach was adopted based on library-based, and interviews using social media platforms to treasure the experts’ opinions regarding the impact of AML laws on baking operations in Pakistan. A semistructured interview-based questionnaire was handed out to Pakistani banking officers. Findings The findings revealed that, for banks to meet the AML obligation, they must overcome challenges including cost and complexity. Nevertheless, these costs are less expensive than the penalties assessed for noncompliance. Practical implications Following AML regulations can help the banking industry grow, which, in turn, attracts more foreign investment by boosting consumer confidence. However, it is difficult and expensive to comply with these requirements. The current research hopes that the financial regulatory authorities of Pakistan will adopt more effective measures for efficient compliance with AML laws. Originality/value The impact of compliance with AML laws on banking operations in Pakistan was examined in this study for the first time using banking officers’ opinions from various banks best of author’s knowledge.

CONCESSÃO DO SERVIÇO DE GÁS CANALIZADO: ASPECTOS JURÍDICOS, REGULATÓRIOS E ECONÔMICOS

The concession of natural gas services in Brazil is regulated by the Federal Constitution, the Concessions Law (Law No. 8,987/1995) and the Gas Law (Law No. 14,134/2021), which regulates the transportation and commercialization of natural gas. With the approval of the New Gas Law (Law No. 14,134/2021), the sector underwent significant changes, aiming to promote competition and attract new private investments. The legislation seeks to guarantee the economic-financial balance of contracts, free access to infrastructure and reasonable tariffs. The gas distribution service is the responsibility of the States, and supervision is carried out by regulatory agencies. Recent jurisprudence from the Superior Court of Justice (STJ) has reaffirmed the need for efficiency and continuity in service, in addition to ensuring respect for consumer rights and balance between concessionaires and the granting authority. The evolution of the gas regulatory framework is an important step towards the country’s sustainable and energy development.

Corporate Boards and Firm Value: Evidence from Nigeria

Aim: The basis for the formation of the corporate board is to, among others, give strategic direction to the firm, monitor the activities of the salaried agents and reduce the likelihood of disincentive to investment. The aim of this study is to examine the efficacy of corporate boards in relation to the value of firms listed in Nigeria. Study Design and Methodology: It is a cross-sectional research design that empirically examined the influence of board mechanisms and Tobin’s Q of firms listed on the Nigerian Stock Exchange. The study used annual data of a panel sample of 85 firms from 2004 through 2023, It applied a Generalized Least Squares (GLS) econometric technique. Place and Duration of Study: This study examined the role of the boards of firms listed on the Nigerian Stock Exchange between 2004 and 2023. Results: The findings argued in favour of smaller boards, increased board independence and higher market capitalisation since they showed significant improvements in value of the firms in the sample. The findings imply that smaller boards that are highly independent tend to have better corporate governance and thus, superior firm value. Conclusion: In conclusion, the results advocate that the regulatory agencies and boards of the studied firms enact policies that will encourage minimum board sizes that are sufficiently independent.

The Impact of Investor Sentiment on Corporate Financial Decision-making: Taking New Media Platforms as an Example

In accordance with the theory of asymmetry, this article studies the impact of investor sentiment on the proportion of corporate accounts receivable. During the research process, 2617 listed companies in the Shanghai and Shenzhen A-share markets from 2011 to 2022 were selected as samples. The article constructs a multiple regression model, selects investor sentiment as the core explanatory variable, accounts receivable ratio as the dependent variable, and adds revenue growth rate, largest shareholder shareholding ratio, price to book ratio, and cash flow ratio as control variables. Descriptive statistics, analysis of Correlation, test of collinearity, analysis of regression, test of heterogeneity, and analysis of robustness are used to explore the financial indicators and financial decisions of enterprises; Research has indicated that a negative correlation exists between investor sentiment and the proportion of corporate accounts receivable. Meanwhile, there are also certain differences between state-owned enterprises and non-state-owned enterprises. Based on this, this article proposes relevant improvement suggestions for enterprises, investors, and regulatory authorities, which will help facilitate the healthy and stable development of the capital market.

Analyzing risk contagion and volatility spillover across multi-market capital flow using EVT theory and C-vine Copula

There exists a potential interdependence among the United States markets, alongside an exceptional dependence on the East Asian stock markets. This transmission of risks is similarly evident in funds that are traded within markets. The current study seeks to uncover the pathways of risk contagion among various financial markets. This study examines how risks of funds spread across borders among China, the United States, and East Asia using Extreme Value Theory (EVT) and C vine copula quantile regression. It uses models such as AR (1), EGARCH (1, 1), Peak over Threshold (POT), and Copula methods to predict volatility events and correlation patterns during times of high volatility versus regular periods. Notably, the United States exhibits a risk transmission effect on the East Asian market compared to China. Furthermore, the findings indicate that, in times of high volatility, the risk spillover effect is comparatively weak, which is contrary to the situation of the US market. The study suggests that China's financial impact could progressively rise due to initiatives aimed at sector integration and enhancing financial independence. These findings have enlightening consequences for macro-prudential regulatory agencies, emphasizing the necessity of effective regulation to address cross-border risk spillovers. International investors can benefit from these results by incorporating risk-hedging strategies, accurately evaluating derivatives, and making wise investment decisions.

A Survey of Artificial Intelligence Applications in Nuclear Power Plants

Nuclear power plants (NPPs) rely on critical, complex systems that require continuous monitoring to ensure safe operation under both normal and abnormal conditions. Despite the potential of artificial intelligence (AI) to enhance predictive capabilities in these systems, limited research has been conducted on the application of AI algorithms within NPPs. This presents a knowledge gap in the integration of AI for improving safety, reliability, and decision making in NPP. In this study, we explore the use of AI methods, including machine learning and real-time data analytics, applied to NPP components to address the nonlinearity and dynamic behavior inherent in reactor operations. Through the implementation of AI and Internet of Things (IoT) devices, we propose a system that enables early warning and real-time data transmission to regulatory authorities and decision-makers, ensuring better coordination during incidents. Lessons from past nuclear accidents, such as Chernobyl, emphasize the importance of timely information dissemination to mitigate risks. However, this integration also presents challenges, including cybersecurity risks and the need for updated regulations to address AI use in safety-critical environments. The results of this study highlight the urgent need for further research on the application of AI in NPPs, with a particular focus on addressing these challenges to ensure safe implementation.

The effect of environmental information disclosure on environmental rating divergence

This study examine the relationship between environmental information disclosure and environmental rating divergence by empirically analyzing China's A-share listed companies from 2011 to 2020. The findings reveal a positive correlation between environmental information disclosure and rating divergence. When regulatory authorities tighten the norms for environmental information disclosure, the impact of corporate environmental disclosure on rating divergence is significantly reduced. Heterogeneity analyses indicate that the variations in environmental information disclosure are less pronounced among large-scale firms and state-owned enterprises. Additionally, audits conducted by the Big Four and the professional board contribute to mitigating the divergence in environmental information disclosure.

Leveraging real-world data to conduct externally controlled trial for rare diseases with count-type endpoints: utilizing multiple entries – a simulation study

ABSTRACT Conducting randomized controlled trials for medications targeting rare diseases presents significant challenges, due to the scarcity of participants and ethical considerations. Under such circumstances, leveraging real-world data (RWD) to generate supporting evidence may be accepted by the regulatory agency. Constructing an external control arm (ECA) from RWD for a single-arm trial has been conducted occasionally. A complication in this design is that patients from RWD may be eligible at multiple time points. Most studies approach this by selecting one time point as the index date for ECA patients. Here, we propose a novel design for externally controlled trials that permits the inclusion of ECA patients at various entry points. Accompanying this design, we make recommendations for statistical methods to account for measured confounders, limited sample size, within-subject correlation, and potential overdispersion inherent in count data. Furthermore, we present an idea for the blinding process for this type of study. We have conducted a series of simulations to assess the performance of the design and statistical methods in terms of bias, type I error, and efficiency, as compared to the approach of selecting only one entry per ECA patient. The study and parameter setup were based on a hypothetical case inspired by a rare disease study. The results indicate that allowing multiple entries for ECA patients can lead to enhanced performance in many aspects. It provides a controlled type I error, robustness against certain model misspecifications, and a moderate power improvement compared with selecting a single entry per ECA patient.

Human Rights System Guidelines on the Benefit from Scientific Progress in Access to Medicines

Abstract Health innovation and research has become an economic and profitable activity. Market practices have exposed inequalities, scarcities and inequities in access to treatments and have significantly reduced the decision-making power of governments in the field of public health. Documentary research on the human right (HR) to health (Art. 12) and its interrelationship with the right to benefit from scientific progress (Art. 15, b) of the International Covenant on Economic, Social and Cultural Rights (CESCR) on access to medicines in three bodies of the UN system - the ICESCR Monitoring Committee (CESCR), the Human Rights Council (HRC) and World Health Organisation - over the last 10 years. The documents address three main topics. Market: marketing restrictions, price controls and using flexibility in pharmaceutical patents to reduce costs and produce generics. Innovation: patent protection without barriers to access to medicines for people in need. Health system interventions: giving priority to economic efficiency and sustainability by institutionalising health technology assessment, selecting essential medicines, developing clinical guidelines and integrating and linking regulatory agencies. These normative guidelines minimise the ethical, political and legal dimensions of the human right to enjoy scientific progress in access to medicines as a priority value that should guide public and private action, and emphasise technocratic and financial measures that seek to reconcile the liberal and social logic of the ICESCR. Key messages • In order to maximise the guarantee of human rights in access to medicines, economic and financial considerations should play only a residual role in human rights. • To give countries greater decision-making power at the global health, the scope of the right to benefit from scientific progress and its applications in health care needs to be expanded.

Traceability for strengthening supply chain systems and enhancing real-time visibility: Focus of NAFDAC on advancing vaccine traceability in Nigeria

This study explores the successful implementation of activities aimed at scaling traceability for COVID-19 and routine immunization (RI) vaccines to the local government area and selected healthcare facilities in Nigeria, funded by the Bill and Melinda Gates Foundation. The study was executed by the National Agency for Food and Drug Administration and Control (NAFDAC) and sought to enhance supply chain systems by deploying advanced traceability mechanisms and ensuring real-time stock visibility. The article discusses the accomplishments, challenges, and regulatory framework of NAFDAC, emphasizing GS1 technology-driven traceability, and presents the results of the field scanning activities conducted in July 2023. The approach involved a phased public sector pilot, showcasing the feasibility and challenges of tracking vaccine movement through the supply chain. The result shows the detection of 43 unique products across 1022 facilities from a total of 110,113 scans, offering valuable insights into vaccine distributions. The strategic goals of the project aligned with developing safety surveillance systems in low- and middle-income countries (LMICs) to facilitate patient access to global health products. Similarly, significant improvement in traceability through automated data capture (barcode scanning) and expanded coverage for COVID-19 and selected RI vaccines in Nigeria was found. Against this background, the information derived from this report will build confidence in patients regarding vaccine authenticity, establish a transparent and robust supply chain, and foster pharmacovigilance capability through integration with the track-and-trace systems. Thus, the study provides invaluable insights and opportunities for global health practitioners, policymakers, and researchers to incorporate track-and-trace into regulatory systems by other national regulatory authorities.

Assessing the adequacy and sustainability of the Northern Territory health workforce with respect to burden of disease and injury, 2009-2021: an analysis of administrative data.

To assess the adequacy of the Northern Territory health workforce with respect to population size and burden of disease, overall and by selected health specialties; to assess its sustainability by investigating changes in workforce numbers. Analysis of Australian Health Practitioner Regulation Agency (AHPRA) health workforce data (2013-2021) and burden of disease data (disability-adjusted life-years, DALYs) drawn from national and NT burden of disease studies (and projected for 2019-2021). NT and Australian health workforces, 2009-2021. Adequacy of the NT health workforce, assessed as the ratio of the mean annual numbers of NT health workers per 1000 population or health workers per 1000 DALYs (2009-2013 and 2014-2018) to those of the Australian workforce (2013 and 2018); sustainability of the NT health workforce, defined as the number of health workers per 1000 population or per 1000 DALYs increasing between 2013 and 2021. The number of health workers per 1000 population was slightly higher in the NT than for Australia in both time periods (2009-2013 v 2013: 23.30 v 21.79 per 1000 population, 6.9% larger; 2014-2018 v 2018: 25.79 v 23.47 per 1000 population, 9.9% larger); however, it was smaller with respect to burden of disease (2009-2013 v 2013: 82.6 v 107.4 health workers per 1000 DALYs, 23.1% fewer; 2014-2018 v 2018: 91.5 v 117.1 per 1000 DALYs, 21.8% fewer). In particular, 464 more nurses and midwives (11.4% more than the mean for 2013-2021), 196 more physiotherapists (115%), 189 more psychologists (102%), 152 more pharmacists (79%), and 144 more dentists (106%) are needed in the NT to match the corresponding numbers of health workers by disease burden for Australia as a whole. The number of Aboriginal health practitioners per 100 000 DALYs fell during the study period. Health worker population density alone does not reliably assess health workforce needs; burden of disease information is important for workforce planning that meets population health needs. The NT health workforce needs to be increased by about 28% to reflect the population burden of disease and injury. Shortages in the NT health workforce must be eliminated to close health gaps between Indigenous and non-Indigenous Australians.

One HPV Vaccination Message Does Not Fit All: Differences Between Young Adults Deciding to Be Vaccinated and Parents Deciding for Their Children

ABSTRACT Despite decades of research on HPV vaccination, the U.S. has still not achieved optimal vaccination rates. This study investigated two different message strategies (agency assignment and deviance regulation marking) for encouraging HPV vaccination in two different populations: parents considering vaccinating their children and young adults (18–26) considering vaccinating themselves. Using a 2 × 3 × 3 online experiment, this study examined the differences between the two message target groups and the effects of the different message strategies on psychological precursors to HPV vaccination and vaccination intention. The findings indicate that using both agency and deviance regulation marking message strategies provided a significant increase in HPV vaccination intentions. However, there were many differences in terms of the variables influencing HPV vaccination decision making in young adults (18–26) and parents making decisions for their children. Specifically, using human agency and a deviance message increased HPV vaccine confidence in young adults, but did not in parents. Implications of these findings for designing different messages directed to these target groups along with future directions are discussed.