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When the regulatory requirements are converged or harmonized, the country-specific variance of countries is often reduced or omitted, and this facilitates the possibility of preparing a core dossier that caters to multiple countries. When such options of a core dossier are acceptable to multiple countries, the resource required to prepare the dossier and the time taken to prepare it is also reduced, thus eliminating resource constraints in supporting dossier planning and preparation and indirectly facilitating earlier submission in countries. In this paper, the authors have illustrated a process applied to standardize the dossier requirements amongst selected countries in Asia, producing an output of a core dossier that applies to four submission types amongst these countries. The core dossier adopts the International Council for Harmonization—Common Technical Dossier format as a reference. Main focus is the standardization of format and requirements within the Module 3 or Chemistry Manufacturing Controls sections of the dossier, which from the authors' organizational experience usually notes a higher variances and country-specific elements. Development of the dossier standardization process is due to an internal hurdle within the authors' organization, where global resource constraints and prioritizations of dossier preparation and compliance review process needed to be improved to facilitate earlier or near-simultaneously submissions in the majority of the Asia countries. The paper demonstrates an assessment of the dossier components and standardization to assemble a fit-for-purpose core dossier termed 'Asia Core Dossier' (ACD). ACD has been successfully implemented within the authors' organization to reduce country-specific requirements and facilitate earlier (fit for strategy) submissions in the selected Asia countries. The paper also discusses the tangible benefits of the authors' experiences from utilizing the ACD. Regulatory professionals in different organizations could reference the ACD as a template for preparing a simplified and efficient dossier and as a relevant component of Good Submission Practice (GSubP). [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has shed light on long-standing constitutional violations within the US correctional system, particularly affecting vulnerable populations such as senior inmates. By analyzing the impact of COVID-19 in prisons, the challenges faced in implementing preventive strategies, and the specific vulnerabilities of elderly prisoners, this paper identifies potential constitutional infringements experienced by senior inmates during the pandemic and the physical, mental, and social effects of the pandemic on this population. Specifically, this paper aims to bridge the fields of constitutional law, prison reform, elder law, and the COVID-19 pandemic by examining the impact of the pandemic on the rights of senior inmates under the US Constitution's Eighth Amendment protection against cruel and unusual punishment. The objective is to examine whether potential violations have occurred and propose actions to prevent violations in the future while ensuring accountability and redress if such violations occur. To address such violations, the paper emphasizes the need for increased sanitation measures and decarceration as preventive measures in future public health crises. [ABSTRACT FROM AUTHOR]

Research studies generate data in various forms. Data can be quantitative or qualitative. Research involving human subjects requires protection of data to ensure privacy. Various regulations and local policies need to be followed to ensure data security. Data management plans are critical for effective data stewardship and include details plan on data collection, management, storage, and formatting. This paper will review data collection tools, data security strategies, file management, data storage, government regulations, prepping data for analysis, reference management, and file management. [ABSTRACT FROM AUTHOR]

The intensification of efforts by state and nonstate actors to address issues affecting global health has produced a patchwork of transnational regulatory governance. Within this field, nongovernmental organizations (NGOs) are expected to perform authoritative roles in holding business actors to account and enhance the democratic legitimacy of institutions via their participation in governance processes. While there exists a large body of conceptual and empirical research on global business regulation and private authority, we surprisingly know little about the governance functions of NGOs engaged in influencing the practices of corporations that produce health-harming commodities. This knowledge gap is especially pronounced in the issue area of noncommunicable diseases. This article begins to address this gap by mapping the networks of NGOs that engage in regulatory activities (rule-setting, monitoring, and enforcement) related to the (ultra)processed food and alcohol industries. We identify the networks of NGOs involved in global policy making across health, regulatory standards, and multistakeholder initiatives using nonstate actor submissions to consultations held by World Health Organization, UN Codex Alimentarius Commission (Codex), and the UN Global Compact. This paper examines NGO governance functions and their patterns of engagement and participation across institutional spheres. Overall, the article makes a twofold contribution to existing debates. First, we identify the governance functions through which NGOs attempt to hold corporations to account, contrasting their "watchdog" function with other governance functions. Second, we examine the representation of NGOs, highlighting asymmetries in participation of NGOs in the Global North and South. [ABSTRACT FROM AUTHOR]

Despite acknowledging the risks of the COVID-19 pandemic for the prison population, Brazil's Supreme Court declined to issue structural injunctions during the health crisis ordering lower courts to consider these risks when making incarceration-related decisions. These injunctions could have been crucial to mitigate mass incarceration and protect the prison population during the pandemic. Through an examination of the Supreme Court's rulings in structural cases and in a sample of over 4,000 habeas corpus decisions, this paper argues that granting these injunctions would have overwhelmed the court with an unmanageable influx of individual claims. Consequently, the Supreme Court acted strategically in anticipation of its limited institutional capacity to enforce compliance with structural injunctions among lower courts. This case study illustrates how practical considerations can hinder structural decisions in criminal law and highlights the limits of structural litigation and constitutional jurisdiction to address mass incarceration. [ABSTRACT FROM AUTHOR]

Recognizing law as a determinant of scarcity in health care is vital. This paper underscores the need for a comprehensive approach to manage scarcity beyond intellectual property, using targeted regulations to promote affordability and counter market distortions. I argue that relying on law solely to ensure democratic deliberations for resource allocation overlooks market failures and economic inequalities that contribute to scarcity. I examine different "legal determinants of scarcity" that can be used, on the basis of the right to health, to improve or positively influence the availability and affordability of health technologies through complementary policies such as direct price control, competitive procurement, competition laws, and public-private partnerships. I conclude by asserting that health care affordability must be a central positive human rights obligation in economic and health policies and that states must strive to diversify their approaches to eliminate persistent economic barriers. [ABSTRACT FROM AUTHOR]

Real-world data (RWD) and real-world evidence (RWE) have garnered great interest for supporting drug research and development (R&D) by medical researchers and regulators in recent years. The application and development of RWD/E in drug regulatory decision-making have been vigorously promoted in China. This study seeks to provide a broad overview of how RWE has been contributing to drug regulatory decisions in China. In this paper, we review the development of RWD and RWE, summarize key elements that promote application of RWE, introduce relevant methods and guidelines, elaborate on the opportunities and challenges of RWE in regulatory decision-making in China, and put forward suggestions to promote the application of RWE in China's regulatory decision-making and to further facilitate innovative drug evaluation and regulation. [ABSTRACT FROM AUTHOR]

Green innovation is an important driving force for sustainable development. However China often imposes a wide variety of government regulations on green innovation One important reason behind these government regulations is the confinement of the cultural market. However, does this confinement actually affect the green innovation in China? By employing a 278 Chinese cities' dataset, we examine the effect of cultural reform pilot project on green innovation. Through the spatial difference-in-difference approach with the time trend, our results show that cultural reform pilot project (CRPP) is a significant determinist affecting the green innovation in China. Specifically, implementing CRPP promote green innovation in pilot cities which resulting from labour productivity exaltation, marketization rate increasing. The CRPP also have a spatial ripple effect which resulting from economic density promotion. Furthermore, the green innovation promotion is greater in cities which participating into World Technopolis Association, being included in the National Historical and Cultural Cities List and having high political hierarchy. Our conclusions still robustness after adopting a series of tests and alternative analyses. This paper not only provide evidence for the further implementation of cultural reform pilot project nationwide, but also provide policy implications on sustainable development in the post Covid-19 era. • Based on the theory of economic geography and the perspective of deregulation. • Examine both the direct and indirect effects of CRPP on green innovation via SDID approach. • Implement CRPP promotes green innovation both in pilot cities and neighbouring cities. • CRPP exalt ate labour productivity, increase marketization rate and promote economic density. • Effect of CRPP on green innovation exhibits heterogeneity on cities. [ABSTRACT FROM AUTHOR]

Xi Jinping's ascent to power as Chairman of the Chinese Communist Party (CCP) was accompanied by changes in national governance strategies in the People's Republic of China (PRC) that have progressively incorporated the use of big data. Shortly after, in May 2015, the Chinese State Council released a set of policy reforms under the abbreviation fang guan fu ... (decentralise, manage, and service). These reforms promoted big data led (1) market regulation, (2) supervision and management systems, and (3) service provision processes. By applying a case study analytical approach, this paper explores how advancements in big data contributed to these reforms aimed at centralising information in China. Combining the joint knowledge of surveillance and China studies scholarship, this paper offers evidence of big data surveillance streamlining China's fragmented intergovernmental policy system. We build on David Murakami Wood's 2017 outline of a political theory of surveillance and argue that decentralisation of data collection points and centralisation of both bureaucratic and public access to information are key components of the Party-state's regulatory governance strategy incorporating the use of big data and comprehensive surveillance. Our findings have implications for future analyses of the relationship between political organisations and surveillance within other nation-state contexts, particularly in situations where Chinese technologies and systems are being adopted and adapted. [ABSTRACT FROM AUTHOR]

Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods: The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19. [ABSTRACT FROM AUTHOR]

This article expands upon a session, titled "Implications of Pediatric Initiatives on CNS Drug Development for All Ages--2020 and Beyond," that was presented as part of a two-day meeting on pediatric drug development at the International Society for Central Nervous System (CNS) Clinical Trials and Methodology (ISCTM) Autumn Conference in Boston, Massachusetts, in October 2020. Speakers from various areas of pediatric drug development addressed a variety of implications of including children in drug development programs. The speakers wrote summaries of their talks, which are included here. The session's lead chair was Dr. Gahan Pandina, who wrote introductory and closing comments. Dr. Joseph Horrigan addressed the current landscape of pediatric development programs. Dr. Gahan Pandina addressed how the approach to research in pediatric populations affects the drug development process and vice versa. Dr. Alison Bateman-House discussed the ethical implications of research in the pediatric population. Dr. Luca Pani discussed some of the global regulatory issues and challenges concerning research in pediatric patients. Dr. Judith Kando served as a discussant and posed new questions about means of facilitating pediatric research. Finally, Dr. Gahan Pandina provided closing comments and tied together the presented issues. This paper should serve as an expert-informed reference to those interested and involved in CNS drug development programs that are aimed at children and/or required, through regulations, to include children as part of the approval process. [ABSTRACT FROM AUTHOR]

Laws facilitating the involuntary civil commitment (ICC) of people with substance use disorders vary considerably internationally and across the United States. Puerto Rico, a colonial territory of the United States since 1898, currently harbors the most punitive ICC legislation in the country. It is the only place in the United States where self-sufficient adults who pose no grave danger to themselves or others can be involuntarily committed to restrictive residential facilities for over a year at a time without ever being assessed by a health care professional. The involuntary commitment of otherwise-able citizens--many of whom have never been diagnosed with a substance use disorder--continues to be ignored nationally and internationally. In this paper, we specify how Puerto Rican ICC law and procedures systematically violate rights and liberties that are supposed to be guaranteed by Puerto Rico's Mental Health Act, the US Federal Supreme Court, and the Universal Declaration of Human Rights. To ensure that Puerto Rico's ICC procedures conform to prevailing local, national, and international standards, we propose a series of legislative reforms. Finally, we highlight the importance of addressing the preponderance of poorly constructed ICC laws both within the United States and internationally. [ABSTRACT FROM AUTHOR]

Political Risk Analysis (PRA) levels are theoretically postulated to increase in a hybrid regime. This paper argues that there is a change to this hypothesis. A single case research design was employed, using Zimbabwe from 1990 to 2018. During the period, Zimbabwe showed five diverse forms of hybridity which are liberal, competitive illiberal, competitive, illiberal, and military hybrid regimes. A conceptual framework is developed to assess political risk in a hybrid regime using hybrid regime indicators and some political risk factors of most concern to developing countries. 28 key informants from six categories of respondents were interviewed. Illegitimacy, corruption, the staleness of leadership, adverse government regulation, election violence, and severed home-host state relations were confirmed to increase the perception of political risk in a hybrid regime. Investors were observed to have developed a tolerance for some "unacceptable" factors that increased political risk. Military tutelage, weak institutions, flawed elections, military generals in power, undemocratic means to retain power, minimum horizontal accountability and weak rule of law were found to not automatically increase political risk as before. The paper concludes that there is no single form of hybridity and as such different forms of hybrid regimes accrue different levels of political risk, some lower levels while others substantially higher levels. Therefore, in a hybrid regime, a differentiated PRA monitoring, assessing and mitigation strategy will be most effective for management to implement. Future studies can apply the analytical framework of assessing PRA in a hybrid to another hybrid regime to expand the theoretical propositions made by this paper. [ABSTRACT FROM AUTHOR]

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• Modeling total dissolved gas with consideration of fish safety assessment. • Simultaneous operation of cascades could aggravate cumulative effects. • Optimization of the release structures decreases the generated saturation. • Discontinuous discharge reduces the maximum duration. • Ecological regulation of the cascades extends safe zones to fish in a large extent. The supersaturated total dissolved gas (TDG) downstream from a dam can result in an increased incidence of gas bubble disease in affected fish. With the development of cascade hydropower, the cumulative effect of cascades on TDG supersaturation is becoming increasingly prominent. This paper presents operational regulations for cascades based on the effect of TDG supersaturation on fish. Optimal regulation of the release structures and discontinuous discharge methods were proposed, and the TDG distribution for cascades in the downstream region of the Jinsha River was simulated. The results indicated that the adoption of bottom orifices rather than spillway tunnels significantly decreased the TDG oversaturation level. Moreover, a discontinuous discharge pattern instead of a continuous pattern minimized the maximum duration of the high TDG level. Based on a comparison of the simulated results of different operational scenarios for the cascades, a regulation scheme was proposed that can reduce the TDG supersaturation risk degree for fish. This paper provides a reference for eco-environmentally friendly operations of cascades to minimize the potential risks of supersaturated TDG to fish. [ABSTRACT FROM AUTHOR]

Access to medicines and the right to health continues to be widely discussed in academic literature. United Nations human rights bodies have done much work to elaborate on the normative content of the right to health and the obligations of states to uphold this right, although translating this into tangible benefits to the public at national level remains a challenge. This paper explores the case of Peru to evaluate prominent decisions of the Constitutional Court that have been instructive in clarifying the state's obligations in relation to health. I argue that the court's rights-based approach offers lessons that other states can draw on to meet their obligations to ensure the right to health by securing access to essential medicines. [ABSTRACT FROM AUTHOR]

• Examines the evolution of internal control disclosures in Chinese listed firms, identifying issues such as delays and inconsistencies, impacting transparency and governance. • Proposes a unified conceptual framework and standardized reporting protocols to improve disclosure quality and corporate governance. • Highlights the importance of regulatory reforms, technological advancements, and enforcement of compliance for enhancing internal control reporting. • Stresses the critical role of stakeholders, including management and auditors, in implementing effective reporting strategies. • Advocates for future research using quantitative methods and case studies to strengthen the conceptual framework and improve disclosure practices. In the realm of corporate finance, the transparency of internal control evaluations significantly impacts investor trust, market efficiency, and governance. This study examines the evolution of internal control report disclosures among Chinese listed firms, tracing their shift from voluntary to mandatory within two decades, aiming for international alignment. Utilizing descriptive analytics, data trend analysis, and visualization, we identify critical flaws in current disclosure practices, including reporting delays, incompleteness, inconsistencies, and non-standardized evaluation criteria. These shortcomings undermine the reports' quality and reliability, emphasizing the need for a unified conceptual framework and standardized reporting protocols to improve disclosure quality. Our findings highlight the essential role of enhanced internal control disclosures in advancing corporate governance and market integrity. The paper suggests that addressing these issues could significantly benefit the investment landscape. It calls for further research, possibly through quantitative analysis and case studies, to develop more effective disclosure strategies. [ABSTRACT FROM AUTHOR]

In order to analyze the strategic choices of core enterprises subsidizing small and medium-sized enterprises (SMEs) to achieve pollution co-governance under government regulation, this paper constructs an evolutionary game model between core enterprises and SMEs and reveals the impact of SMEs pollution problems on various subjects under the rigid constraints of environmental protection. The strategy evolution process under the reward and punishment mechanism is analyzed, and the effect of the parameters such as the intensity of production restriction and the incentive on the evolution result is estimated based on the system dynamics model. Simulation results show that core companies are more sensitive to incentives in their strategic choices, and SMEs are more sensitive to punishment. Production restrictions have different effects on core companies and SMEs. Lower production restrictions cannot affect the strategic choices of core companies, but increase the burden on SMEs. Only if both the environmental incentives and production restriction strategies were executed well, the involvement of core enterprises in the pollution treatment would work efficiently. [ABSTRACT FROM AUTHOR]

The paper examined the impact of monetary and fiscal policy instrument on rice productivity and employed vector autoregressive model using Augmented Dickey Fuller unit root text, followed by Johansen Co-integration test among the series using annual data for the period 1981-2016. The results also show that all the monetary and fiscal policy instrument fitted co-integrate with rice production. Therefore, long run relationship exists among the variables and rice productivity. In the long-run, interest rate, exchange rate, money supply and public expenditure significantly affected rice productivity with adjusted R² value of 60%. The result also shows that there is deceleration in exchange rate, interest rate and rice output. The speed of adjustment where monetary and fiscal policies variables will equate rice productivity in the short run is- 0.365830. The study concludes that there exist no short-run effects of policies instruments on rice productivity but on the long run. From this finding, the study recommended regulations of interest rate to a single digit, exchange rate should be friendly. Government should increase spending to agriculture and by extension policy focus on rice production to boost rice productivity). The study also recommended government regulation of policies instruments and to desist from frequent policies change. [ABSTRACT FROM AUTHOR]

The COVID-19 pandemic has shone a bright light on industrial slaughterhouses in the United States and their impacts on the vulnerable beings--both human and animal--they exploit. But the severity of these impacts is the result of a long history of failed regulatory oversight. This paper highlights the inadequacies of the current regulatory system in the United States and how they have contributed to dangerous conditions for slaughterhouse workers, environmental degradation, and severe animal suffering. Further, it argues that a rights-centered One Health approach would provide the necessary conceptual foundation for a new regulatory framework that can meaningfully address the interconnected rights, health, and well-being of humans, animals, and the environment. As a first step in establishing this new framework, the United States should create a federal Slaughterhouse Oversight Commission to strengthen the rights, health, and well-being of humans and animals. [ABSTRACT FROM AUTHOR]

Based on the regulatory situation for cannabis (Cannabis spp., Cannabaceae) in the United States, the premise of this proposed federal framework is to create a regulatory model specific to a plant-based end product that can be used for both social and therapeutic purposes. Cannabis products currently are being regulated at the state level, with the exception of US Food and Drug Administration (FDA)-approved drug products such as Epidiolex® (GW Pharmaceuticals; Cambridge, UK). The proposed framework, by design, defers to the existing state-regulated infrastructures by leaving state autonomy intact to the greatest degree possible, with minimal federal entanglement. Importantly, the framework also sets forth that the federal interface would be conducted via the US Department of Agriculture (USDA) and the cannabis plant would not be a federally scheduled substance. The full paper explains why this proposed dynamic is integral to the long-term success of the regulated cannabis market, and addresses why commonly cited frameworks, such as the alcohol and tobacco models, are not appropriate for a modern cannabis market. The scope of the proposed framework does not include the production, manufacture, or regulation of no- or low-THC hemp* or any crop cultivated under the provisions of the Agriculture Improvement Act of 2018 (the 2018 Farm Bill).[1] The cannabis plant has a long history of human use for different purposes and is one of hundreds of botanicals with therapeutic properties supported by clinical data and traditional use. The proposed framework is a 21st-century pathway to market for plant-based products that respects the efforts of the states and balances an appropriate federal intersection with long-term market interests. This article is taken from a longer paper by the authors and has been revised for HerbalGram. The full paper, as referenced in this article, can be accessed at https://tinyurl.com/cannabisframework. [ABSTRACT FROM AUTHOR]

This paper investigates the epidemiology and public health response of novel coronavirus infection (COVID-19) in the Nordic region. The data on cases and deaths due to COVID-19 were drawn from the European Centre for Disease Prevention and Control. The data on age- and sex-wise cases, deaths and intensive care unit (ICU) admissions, and public health interventions in the Nordic region through November 10, 2020, were obtained from respective countries' health ministries. Sweden accounted for 60.59% of cases (162 240 of 267 768 cases) and 81% of deaths (6057 of 7477 cases) in the Nordic region. The incidence rate for the Nordic region was 989.59 per 100 000, varying from 327.30 per 100 000 in Finland to 1616.51 per 100 000 in Sweden, and the mortality rate for the region was 27.63 per 100 000, ranging from 5.3 per 100 000 in Norway to 60.35 per 100 000 in Sweden. The case–fatality ratio of the Nordic region was 2.79%. Females were more susceptible to COVID-19 infection than males (52.30% vs 47.66%), while males had a greater proportion of deaths (54.7%) and ICU need (71.99%) than females. It is imperative to continue with social distancing, mandatory masks, testing, prohibition of mass gatherings, isolation of confirmed cases, and preventing the importation of cases from other countries to avoid the further resurgence of cases. [ABSTRACT FROM AUTHOR]

Highlights • Variegated perspectives are required for conceptualizing governmentality. • Applying governmentality to Asian contexts extends Foucault's western analyses. • Governmentality framework delivers insightful analysis to Gross National Happiness. • Biopower embodying non-western spiritualities emerges in the Bhutan context. • Gross National Happiness is a governance model inclusive of neoliberal tendencies. Abstract This paper employs a "variegated governmentality" framework to analyse Bhutan's well-known Gross National Happiness (GNH) agenda. GNH is both a philosophy and form of governance that the Royal Government uses to guide national policymaking. While previous research frames GNH in terms of Foucault's early discussion of governmentality, it does so by establishing monolithic characterizations of governance rationalities and positioning them against one another. By contrast, we suggest that GNH can be more productively understood in terms of Foucault's more recently translated work as embodying multiple governance rationalities situated alongside each other and locally understood as complementary. From this perspective, recent promotion of neoliberalism within the country can be understood not as an intrusion of "western rationality" upon a distinct GNH but rather as a component of the complex bricolage that GNH has become. We suggest that this produces an indigenous form of biopower, which we term 'Buddhist Biopower', appealing to a combination of Bhutanese tradition and religious belief to legitimize the state's claim to govern in the interest of the population. A policy review of Bhutan's GNH Index and Eleventh Five Year Plan is conducted to illustrate this analysis. In this way, the paper brings together research concerning multiple governmentalities and variegated neoliberalization to illuminate the complex ways that biopower can be exercised in the contemporary world. [ABSTRACT FROM AUTHOR]

Background: The quality of data from clinical trials has received a great deal of attention in recent years. Of central importance is the need to protect the well-being of study participants and maintain the integrity of final analysis results. However, traditional approaches to assess data quality have come under increased scrutiny as providing little benefit for the substantial cost. Numerous regulatory guidance documents and industry position papers have described risk-based approaches to identify quality and safety issues. In particular, the position paper of TransCelerate BioPharma recommends defining risk thresholds to assess safety and quality risks based on past clinical experience. This exercise can be extremely time-consuming, and the resulting thresholds may only be relevant to a particular therapeutic area, patient or clinical site population. In addition, predefined thresholds cannot account for safety or quality issues where the underlying rate of observing a particular problem may change over the course of a clinical trial, and often do not consider varying patient exposure. Methods: In this manuscript, we appropriate rules commonly utilized for funnel plots to define a traffic-light system for risk indicators based on statistical criteria that consider the duration of patient follow-up. Further, we describe how these methods can be adapted to assess changing risk over time. Finally, we illustrate numerous graphical approaches to summarize and communicate risk, and discuss hybrid clinical-statistical approaches to allow for the assessment of risk at sites with low patient enrollment. Results: We illustrate the aforementioned methodologies for a clinical trial in patients with schizophrenia. Conclusions: Funnel plots are a flexible graphical technique that can form the basis for a riskbased strategy to assess data integrity, while considering site sample size, patient exposure, and changing risk across time. [ABSTRACT FROM AUTHOR]

Background: Current clinical trial labels are designed primarily to meet regulatory requirements. These labels have low patient and site utility, few are opened, and they have limited space and small fonts. As our world transitions from paper to electronic, an opportunity exists to provide patients with information about their investigational clinical trial product in a way that is more easily accessible, meets Health Authority requirements, and provides valuable additional information for the patient and caregiver. Methods: A TransCelerate initiative was launched to understand the current regulatory and technology landscape for the potential use an electronic label (eLabel) for investigational medicinal products (IMPs). Concepts and an example proof of concept were developed intended to show the "art of the possible" for a foundational eLabel and a "universal printed label." In addition, possible patient-centric enhancements were captured in the eLabel proof of concept. These concepts were shared with Health Authorities as well as patient and site advisory groups to gather feedback and subsequently enhance the concepts. Results: Feedback indicated that the concept of an eLabel provides value and concepts should continue to be pursued. While the Health Authorities engaged with did not express issues with the use of an eLabel per se, the reduction in the content on the paper label is not possible in some geographic locations due to existing regulations. Conclusions: There is nothing that prevents transmitting the label electronically in conjunction with current conventional labeling. While there are still some regulatory barriers that need to be addressed for reducing what is on the paper label, advancement toward a more patient-centric approach benefits stakeholders and will enable a fully connected patient-centric experience. The industry must start now to build the foundation. [ABSTRACT FROM AUTHOR]

This paper illustrates the substantial role of non-criminal justice bodies in punishing persons for fraud related behaviours in England and Wales. It illustrates the substantial role of government regulators, delegated regulators, self-regulators, fraudster databases and the use of contempt of court in civil courts in dealing with fraudsters. Using data from the Ministry of Justice, the number of persons sanctioned for fraud offences are juxtaposed against data drawn from the regulatory bodies within the broader ‘fraud justice network’. The paper shows that over one million individuals are sanctioned for fraud offences each year and the great majority do not trouble the criminal justice system. [ABSTRACT FROM AUTHOR]

Introduction: Biosimilars are a cost-effective alternative to original biologic medicines that allow patients access to biologic therapies for various chronic diseases. Our paper aims to provide an overview of biosimilars in Malaysia with emphasis on the comparison of Malaysian guidelines with guidelines from well-established regulatory agencies, a review of biosimilars' market approval and their reported adverse effects (AEs) as well as clinical trials conducted in Malaysia. Methods: We searched the official websites of the National Pharmaceutical Regulatory Agency (NPRA) Malaysia and three other well-established agencies, online databases of Medline® and EMBASE for guidelines on legislation and regulations of biosimilars. Meanwhile, we extracted the reports of AEs involving biosimilars in Malaysia from the NPRA database and for global AEs from the World Health Organisation VigyLize database. The ClinicalTrials.gov Website by the U.S. National Library of Medicines was the source for data on clinical trials. Results: Malaysia followed the principles of the European Medicines Agency biosimilar regulations and issued their guideline in 2008. Since then, NPRA has approved 24 biosimilar products and recorded 499 AE reports, of which 43 (8.6%) were serious. NPRA has also approved ten Phase III clinical trials in Malaysia with four trials still ongoing. Conclusion: Malaysia follows a stringent regulatory pathway for the approval of biosimilars enacted by well-established regulatory agencies to maintain the quality, efficacy and safety of biosimilars. Introducing biosimilars to the Malaysian market would improve patients' accessibility to biologic therapies. [ABSTRACT FROM AUTHOR]

• Non-participation in collective activities was a dominant strategy in the Lake Naivasha basin. • Choice of decision to participate was significantly influenced by expected benefits, human capital and labour endowments. • Informal sanctions, norms of trust and attitudes/perceptions significantly and positively correlated with participation. The fact that agriculture is associated with negative external effects on ecosystems is of great concern. Most of these agri-environmental externalities are public goods in nature and therefore solving them through conventional market and regulation tools is challenging. Collective action has been identified as an option in dealing with externalities emanating from activities touching on agriculture and the environment especially in circumstances where markets and government regulation are not effective. In this paper, we assess the potential for collective action in addressing agri-environmental externalities. The study achieves this objective using cross-sectional household survey data collected from 307 households in the Lake Naivasha basin, Kenya. Results indicate that non-participation in collective action initiatives is a dominant strategy in the Lake Naivasha basin. The study also identifies factors that influence the probability of participating and therefore could be catalysts to encourage participation. Such factors include expected private incentives, labour endowments and agricultural commercialization. Positive perceptions and attitudes, the presence of social sanctions and norms of trust were also found to significantly influence participation. To deal with agri-environmental challenges through collective action, policy needs to focus on facilitating selective incentives, awareness creation and embracing local participation in resource management. [ABSTRACT FROM AUTHOR]

Background: The COVID-19 pandemic has profoundly impacted the country's health systems and diminished its capability to provide safe and effective healthcare. This article attempts to review patient safety issues during COVID-19 pandemic in India, and derive lessons from national and international experiences to inform policy actions for building a 'resilient health system'. Methods: Systematic review of existing published articles, government and media reports was undertaken. Online databases were searched using key terms related to patient safety during COVID-19 and health systems resilience. Seventy-three papers were included dependent on their relevance to research objectives. Findings: Patient safety was impacted during COVID-19, owing to sub-optimal infection prevention and control measures coupled with reduced access to essential health services. This was largely due to inadequate infrastructure, human and material resources resulting from chronic underinvestment in public health systems, paucity of reliable data for evidence-based actions and limited leadership and regulatory capacity. Conclusions: India's health systems were found ill prepared to tackle large-scale pandemic, which has major implications for patient safety. The shortcomings observed in the COVID-19 response must be rectified and comprehensive health sector reforms should be initiated for building agile and resilient health systems that can withstand future pandemics. [ABSTRACT FROM AUTHOR]

With scientific and molecular advancements related to disease pathogenesis, advances in gene and stem cell therapies, and the promise of lucrative markets for biopharmaceutical companies, there has been a rapid expansion in the number of potential new muscular dystrophy (MD) treatments. The first champion for a newly diagnosed MD patient and their caregivers is typically an MD-specific patient advocacy group (PAG). Muscular dystrophy PAGs have been among the most active in the rare disease drug development space. Notable achievements in the last decade include promulgating the first U.S. clinical research guidance, setting up registries and natural history studies, and investing in companies—some of which have brought potentially disease-modifying products to the market. This paper will discuss five key strategies that have been successfully employed by MD PAGs to advance treatments: (1) creating a national registry, (2) understanding the barriers to identifying patients with certain subtypes of muscular dystrophy to participate in clinical trials, (3) partnering with the biopharmaceutical industry, (4) collaborating with the regulators, and (5) incorporating market access and use insights early in clinical development. While clearly helpful within the MD community, these tactics could also be employed by PAGs representing other types of rare diseases. [ABSTRACT FROM AUTHOR]

Pharmaceutical residues can harm the environment. Therefore any Marketing Authorisation Application (MAA) for a medicinal product for human use shall be accompanied by an "indication of any potential risks presented by the medicinal product for the environment" according to Article 8(3)(g) of the Directive 2001/83/EC. Since 2006 a guideline document from the European Medicines Agency (EMA, formerly EMEA) is available for this task, which is now called the "Environmental Risk Assessment" (ERA). Recently the EMA released a draft revision of an updated ERA guideline. The present paper provides a summary of the intended innovation. A number of options have been discontinued, but some of them cannot be easily recognised, even though they are potentially affecting the MAA and its costs in a relevant way. A new specifically tailored experimental testing course for antibiotics and a secondary poisoning assessment is introduced. The selection of required study types is altered and the environmental fate evaluation is adapted to the scientific progress. In the recent situation it is suggested that marketing authorisation applicants may reconsider the conduct of water/sediment studies for substances not requiring these according to the guideline revision. The new tailored testing approach for antibiotics avoids any vertebrate use, because it demands no fish study, therefore it may be applied henceforth. If the new prescriptions are not yet in force at the point in time of the MAA submission, appropriate waivers should be stated in the ERA. No further HPLC-study types and acute earthworm toxicity tests should be performed, since the guideline update draft does not accept them. In preclinical toxicity and pharmacokinetic studies, additional data gathering on metabolites should be considered in order to avoid unnecessary leaflet warnings. The cost for ERA may change significantly, with a tendency to increase for generic pharmaceutical MAA, but with a possible reduction for substances of low environmental concern. Earlier consideration of ERA in the drug development process is recommended. [ABSTRACT FROM AUTHOR]

This paper uses Foucault's concepts "discipline" and "biopower" to expose the complexity of power relations in Augustan Rome and its historiography. Focusing on Augustus' Res Gestae and Tacitus' Annales, I argue that the absolute sovereignty of the emperor did not preclude the advancement of techniques to classify, hierarchize and normalize individuals, nor did Imperial sovereignty work against the development of a discourse about the enhancement and protection of the population. By demonstrating the conceptual and historical relevancy of Foucault's modern power triad of "sovereignty-discipline-government" to first century CE Rome, the paper suggests that biopolitical societies have a far more extensive history than the one said to have started around the turn of the eighteenth century. [ABSTRACT FROM AUTHOR]

Introduction: The aim of this study was to explore patients' knowledge and perspectives in Istanbul, Turkey about the pharmaceutical regulatory review and reimbursement processes with respect to patients' access to new medicines. Methods: For the purpose of this study a tailored made paper-based questionnaire, Patient Perspective Questionnaire (PPQ), was developed and subsequently piloted in the target population. A total of 350 patients were recruited consecutively into the study from hospital outpatient clinics, general practice, community pharmacies, patient organisations in 28 different districts of Istanbul receiving treatment for chronic conditions. In addition, 22 patients were randomly selected from the cohort for face-to-face interviews in order to obtain further insights about the relevance of the PPQ, and to help with formalising a set of recommendations for the involvement of patients in both processes. Data processing and analyses were carried out using SPSS version 23 statistical software. Results: Overall 210 (60% response rate) completed the PPQ (51% males) with the mean age of 56, median of 54 and range of 18–75. Most patients in this study (84%) seemed to know that medicines had to be approved by the government. However, 81% of patients were not aware of the regulatory review process with 73% being unaware of approval timelines. Furthermore, 78 (37%) patients described the Turkish approval process to be of a lower standard compared to that of the US and EU. However, 147 (70%) of patients believed that there are novel alternative medicines for their disease available in other developed countries. Similarly, 126 (60%) patients thought that new medicines only become available in Turkey after their availability in the other developed countries. In contrast, patients in this cohort were more aware of the reimbursement system in Turkey where the majority expressed their satisfaction and 34% described access to new medicines to be adequate. In addition, the majority of patients (75%) recognised that the government is the main payer, even though insufficient information is provided about new medicines. Patients stated that they do not have any role in the decision-making process for the approval or reimbursement of new medicines and therefore most of them indicated that they wish to be more involved in reimbursement (60%) as well as in the approval process (58%). Discussion: Faster access to medicines, improved health and pharmaceutical care as well as lower prices were considered by the study patients as the improvement priorities. Further, they were able to offer academic collaboration and active patient involvement in both processes as possible solutions. [ABSTRACT FROM AUTHOR]

• We look at the evolution of the Indian Board Network following regulatory changes. • We find that the innermost core fractures into two after the change. • We find that the degree distribution becomes more egalitarian following the change. • At the same time, the relative degree and coreness of the firms remains constant. • We also see that the determinants of degree and coreness do not change over time. Board interlock networks are known to exhibit concentration of influence by a small group of elites. In this paper, we study a policy intervention aiming to curb this influence. We analyze the evolution of Indian board interlocking network from 2008 to 2016, a period that covers pre- and post-enactment of government regulation (Companies Act, 2013) limiting the number of directorships held by a single director. We utilize this enactment as an exogenous shock to analyze its effects on architecture of the network. To quantify the changes in cohesiveness, we extract the core-periphery structure in terms of the k -cores of the network and study its evolution over the years. Impacts of the regulation are strikingly demonstrated by fracture of the innermost core of the pre-regulation period into two new cores in the post-regulation period. At the macroscopic level, we find substantial changes in the degree distribution as the network became more egalitarian in terms of connectivity from an erstwhile highly unequal degree distribution. While the actual degree and coreness of companies had undergone substantial changes, we find that relative ranks in terms of degree or coreness of individual companies were very persistent. Empirically, we find that the same social and economic factors that determine the degree/coreness of a company before and after the regulation. We conclude that the regulation reduced concentration of elite control through changes in the core-periphery organization and degree distribution, while mobility of the companies across the network was low and stable throughout the entire period. [ABSTRACT FROM AUTHOR]

When does a single positive adequate and well-controlled study of a new drug meet the statutory requirement to demonstrate substantial evidence of effectiveness? The answer to this question, particularly with respect to new molecular entities, has been of considerable debate since 1962 when the requirement that new drugs prove their benefit to patients became law. A 1997 revision to the statute provided one pathway to a single-study approval (a single adequate and well-controlled study plus confirmatory evidence), while a 1998 guidance issued by FDA provided additional pathways, one of which is the one that is most frequently cited by FDA (a single statistically very persuasive study). This paper explains these 2 distinct pathways and provides illustrative examples of how FDA uses each of these 2 pathways. Regulators, industry, patients, and investors should each find this exegesis of these 2 independent, yet equally viable and valuable, pathways to an FDA approval both illuminating and invaluable. [ABSTRACT FROM AUTHOR]

Canada has been discussing whether to implement an orphan drug policy for more than 25 years. Recently, the federal government announced funding for orphan drugs starting in 2022, and the Canadian Senate has recommended that the country develop an orphan drug policy. This paper uses a list of orphan drugs approved by the United States Food and Drug Administration between 2008 and 2017, inclusive. It then compares Canada, which has no orphan drug policy, and Australia, which has had such a policy since 1997. There was no difference between the countries in the proportion of orphan drugs approved, the time drugs spent in the regulatory review process, and any delay in marketing the drugs in the respective countries compared to the United States. Both Canada and Australia approved virtually all of the drugs that offered a moderate to significant therapeutic improvement. If Canada hopes to provide faster access to orphan drugs, especially those that are therapeutically innovative, it will need to develop a policy that is significantly different from that in Australia. [ABSTRACT FROM AUTHOR]

This paper considers the robust output regulation problem for a class of nonlinear systems that are not detectable by the regulated output. Different from the previous results on the subject, it is supposed that the regulated system is in the normal form not defined on the conventional regulated output. We propose a novel internal model structure that, together with a high-gain stabilizing action, solves the problem robustly with respect to possible uncertainties affecting the system. [ABSTRACT FROM AUTHOR]

While the sharing economy brings significant social benefits in China, it comes with regulatory challenges that are novel and unpredictable. How should regulators handle these challenges? This paper offers fresh insights into the regulatory approach to the ride-hailing industry, the most comprehensively regulated sharing industry in China. A historical review identifies three regulatory approaches deployed to date: self-regulation, market-based regulation and government regulation. Self-regulation relies on the platforms with incentive to provide better service for greater profit, and to deal with sharing-specific challenges. Market-based regulation invites rivals to keep a watchful eye on other players, in order to enhance their market position by outperforming the competition. Both approaches are capable of delivering quick, and often innovative, responses to new challenges. Government regulation, on the other hand, came late and plays a neutral role. The rules there are mostly of the "old wine in a new bottle" kind; in other words, applying existing (old) rules to the new sharing economy. Those rules could contribute to a level playing field for traditional and sharing-market players if managed properly. This article argues that government regulations are inadequate for solving sharing-specific challenges such as the legal status of the participants, the challenges of uncertain externalities, and new forms of competition. Instead, regulators should in the future give more affirmative value to self-regulation and market-based regulation. These complementary approaches are capable of yielding innovative and sharing-specific regulatory responses, from which the government regulators can glean and evaluate before codifying them. [ABSTRACT FROM AUTHOR]

This paper proposes a blood-glucose regulation approach employing a fractional-order proportional-integral-derivative (FOPID) controller, whose parameters are tuned using a numerical optimization methodology. The proposed technique is tested on 100 virtual patients using the Dalla Man model, an in silico type-1 diabetic patient model from the literature. The results are favorably compared with the ones obtained with a standard PID control. In a series of simulated tests, the FOPID approach leads to better results in terms of regulating the blood glucose levels between the specified limits, at the expense of requiring a higher, yet reasonable amount of insulin injected to the patient. Simulations were run for one day, and two different diets were considered. The quality of the regulation was measured in terms of the integral of blood glucose beyond the specified limits of 70 and 180 mg/dl. The values obtained with the PID controller were 17.5 ± 18.9 and 13.1 ± 16.8 min g/dl, while the FOPID controller leads to values of 7.3 ± 9.3 and 7.0 ± 8.0 min g/dl, respectively. On the other hand, the FOPID increased the request amount of insulin, from 1.9 ± 1.6 and 1.7 ± 1.5 nmol/kg to 3.0 ± 2.2 and 2.7 ± 2.0 nmol/kg (still within the expected daily range of 3–6 nmol/kg of insulin). [ABSTRACT FROM AUTHOR]

Public universities and their research faculty have become important participants in governmental regulatory policy making. The public often chaffs from such regulatory controls and demands that the scientific foundations of such policies be open to public examination. In the absence of quantitative information on the volume and nature of such requests, an analysis was conducted, documenting that on average Category I & II public research universities receive one records request every day. These requests, however, only rarely request records associated with academic research. The mean probability of a public university research academic receiving a record request is 0.00062, or one request every 1,600 years. However, when the request lands on a faculty member's desk, it can impose significant work that takes time away from academic pursuits and raises complaints of harassment. Nevertheless, such requests can disclose important information not otherwise available to the public or the greater research community. Faculty who have been asked to divulge their work have claimed a "scholar's privilege" which would exempt them from any form of public inspection of their work. Examination of state protections and jurisprudence on academic freedom demonstrate the complete absence of a scholar's privilege or any traditional antecedents to one. Further, examination of state protections shows a checkerboard of highly variable protections across the nation, none which expressly create a scholar's privilege. Because there is a tenable argument that the academy has lost much of the public's confidence and because there have been some high-profile cases where the academy has been unable to self-regulate to a point where not even peer review succeeds in exposing blatantly fraudulent "research," this paper also reviews the state protections and proposes a model state protection schema that provides relief to affected academics while ensuring transparency to the public when needed. [ABSTRACT FROM AUTHOR]

This paper considers environment management in a new context. In the e-waste recycling industry, most e-waste is irresponsibly recycled and disposed of by informal enterprises, causing serious secondary pollution. Cooperation between emerging online recyclers and offline formal disposing enterprises can help reduce secondary pollution and improve the efficiency of resource reuse to achieve co-benefits, but they operate at a cost disadvantage compared with informal enterprises, which results in a weak motivation for cooperation. Reasonable government regulations are critical to the cooperation between these two types of enterprises. Existing research lacks attention to this. We develop evolutionary game models under a market mechanism and under government regulation to study the influence of multiple factors, including the impact of the prospective loss on the strategies evolution of the game players. We also analyze the effect of government regulation when the market mechanism fails. The results show that: (1) there is a threshold for the ratio of cooperation costs to the excess benefits obtained from cooperation (i.e., between 0.31 and 0.35). When the ratio is greater than the threshold value, the market mechanism fails, and the enterprises' behavior evolves towards non-cooperation. (2) Compared with earnings, enterprises are more sensitive to the prospective loss. Therefore, the government should provide subsidies that help reduce the cost for enterprises to cooperate, and penalize enterprises failing to cooperate. (3) There is a threshold effect in government subsidies and penalties (thresholds between 0.25 and 0.3 and 0.3–0.4, respectively). Only when exceeding the threshold, can they be effective. However, excessive subsidies and penalties also have limitations, and moderate subsidies and penalties can effectively promote the cooperation between the two types of enterprises. Our findings clarify the conditions under which the government can promote online and offline cooperation on e-waste recycling. These insights can also offer a reference for other countries and industries facing similar challenges. • We build evolutionary game models for the promotion mechanism of online and offline E-waste recycling cooperation. • We analyze the influence of factors on the behavioral evolution of the E-waste recycling enterprises. • We explore the regulatory strategies of government when the market mechanism fails. [ABSTRACT FROM AUTHOR]

In this article, the author discusses a bill that proposes a nationwide tax on plastic bags in the U.S. She explores the importance of plastic bag regulation, its impact on marine life, the impacts of paper relative on plastic bags, and the issues of recycling. It suggests how to improve the Plastic Bag Reduction Bill and decrease the plastic bag pollution through the implementation of tax on plastic bags.

The Quality Management System (QMS) initiative of TransCelerate BioPharma Inc has identified potential benefits that could be captured from the development of a flexible, proactive clinical QMS conceptual framework for clinical research. Such a framework would aid organizations in seamlessly managing the complex clinical trial environment and, ultimately, in expediting delivery of needed treatments to patients. This article chronicles the evolution of a TransCelerate concept paper describing a proposed clinical QMS framework and reviews feedback from varied global clinical trial stakeholders during socialization of the concept paper. Many stakeholders recognized the potential for the concept paper to inform development of a harmonized International Council for Harmonisation (ICH) guideline, providing needed clarity from regulators on their expectations for QMS in the clinical realm. Accordingly, the article also describes TransCelerate’s efforts to work with regulators to facilitate harmonization on this important topic and reviews ongoing work to develop additional tools and resources that may support organizations in evaluating whether and how they might translate the conceptual framework principles into practice. [ABSTRACT FROM AUTHOR]