Regulatory Departments Research Articles

Navigating the Regulatory Maze: The Vital Role of Regulatory Affairs in Pharmaceutical Safety and Quality

The real struggle of pharmaceutical industries for survival lies in performing processes by following the guidelines of various regulatory authorities around the globe to provide assured quality of the process under regulations [1]. A profession under-regulated industry, such as that controlling pharmaceuticals, medical devices, energy, and banking, is called Regulatory Affairs (RA) [2]. They may involve minor or major multinational corporations, including innovative biotechnology companies, which have a specific meaning and a separate specialized depart-ment of RA professionals. This department helps to guide the company on the regional and global laws and regulations set forth by different regulatory authorities and helps safeguard the products’ life cycle. The purpose of regulatory departments or pro-fessionals is to develop and promote heavily controlled therapeutic or pharmaceutical goods and build a platform for marketing approval. In addition to this, RA in the pharmaceutical industry is comparatively a new field to safeguard public well-being by monitoring the safety and efficacy of the products [3]. Furthermore, in the late 1950s, multiple tragedies resulted in an increase in legislation for pharmaceutical goods’ quality, safety, and efficacy. As a part of this, strict norms were made for Marketing Authorization (MA) and Good Manufacturing Practice (GMP) [4]. These tragedies included (i) sulphanilamide elixir; (ii) vac-cine tragedy; and (iii) thalidomide tragedy [4]. The present article covers the regulatory affairs’ responsibilities and importance in the context of pharmaceutical industries.

Research on the Game Strategy of Mutual Safety Risk Prevention and Control of Industrial Park Enterprises under Blockchain Technology

Systematic management of corporate safety risks in industrial parks has become a hot topic. And risk prevention and control mutual aid is a brand-new model in the risk and emergency management of the park. In the context of blockchain, how to incentivize enterprises to actively invest in safety risk prevention and control mutual aid has become a series of key issues facing government regulators. This paper innovatively combines Prospect Theory, Mental Accounting, and Evolutionary Game Theory to create a hypothetical model of limited rationality for the behavior of key stakeholders (core enterprises, supporting enterprises, and government regulatory departments) in mutual aid for safety risk prevention and control. Under the static prize punishment mechanism and dynamic punishment mechanism, the evolutionary stabilization strategy of stakeholders was analyzed, and numerical simulation analysis was performed through examples. The results show: (1) Mutual aid for risk prevention and control among park enterprises is influenced by various factors, including external and subjective elements, and evolves through complex evolutionary paths (e.g., reference points, value perception). (2) Government departments are increasingly implementing dynamic reward and punishment measures to address the shortcomings of static mechanisms. Government departments should dynamically adjust reward and punishment strategies, determine clearly the highest standards for rewards and punishments, and the combination of various incentives and penalties can significantly improve the effectiveness of investment decisions in mutual aid for safety risk prevention and control. (3) Continuously optimizing the design of reward and punishment mechanisms, integrating blockchain technology with management strategies to motivate enterprise participation, and leveraging participant feedback are strategies and recommendations that provide new insights for promoting active enterprise investment in mutual aid for safety risk prevention and control. The marginal contribution of this paper is to reveal the evolutionary pattern of mutual safety risk prevention and control behaviors of enterprises in chemical parks in the context of blockchain.

Study on the motivation of enterprise greenwashing behavior based on the perspective of environmental commitment implementation

With the rapid economic growth, the issue of ecological environmental protection has been widely concerned by the public, and has triggered diversified discussions. As the main participants in social and economic activities, enterprises play a pivotal role in this issue, not only bearing social responsibility, but also playing a decisive role in environmental protection practices. In the context of consciously undertaking social responsibilities and responding to institutional requirements, enterprises often express their firm position and commitment to environmental protection and compliance with laws and regulations through information disclosure. In practice, some enterprises run counter to their environmental protection commitments, choosing to "low investment, high return" as the goal of greenwashing behavior. Taking Hegang as the research object, this paper summarizes the process of implementing environmental commitment as the result of the joint action of two factors: implementation ability and implementation motivation. Then, the paper analyzes the major environmental pollution cases of Hesteel, analyzes the motivation of Hesteel's greenwashing behavior from the perspective of the implementation ability and implementation motivation of environmental commitment, and finally puts forward corresponding suggestions for the shortcomings of the enterprise itself and external regulatory departments in preventing greenwashing behavior, in order to optimize the governance mechanism and improve regulatory efficiency.

Analysis and Governance Strategies of Online Gambling Crimes under New Live Streaming: Taking Lottery Games as an Example

With the development of multimedia technology and the increasing popularity of online live streaming, new forms of online gambling crimes using online live streaming platforms for game live streaming have also emerged, and new operating modes and criminal methods have been used. This gambling method involves certain game anchors using their online popularity, as well as the trust of some fans and their viewers in their anchors during live broadcasts, to attract viewers to participate in gambling through various means and gimmicks. This new type of network under game live streaming involves various factors such as law, technology, and regulation. Live streaming platforms, hosts, and users who watch live broadcasts must strictly abide by laws and regulations. Government regulatory departments also need to strengthen their supervision of whether gambling is involved in the field of online live streaming, protect the legitimate rights and interests of the public, and maintain a healthy and orderly online environment.

Analysis of Labor Relations in Private Enterprises A Three-party Game Based on Overtime Work

At present, China has successively introduced multiple laws and regulations to prevent employees from being forced to work overtime. However, this situation is still serious in private enterprises, which has led to gradually tense labor relations. Starting from the issue of overtime, this article constructs a game model between government regulatory departments, enterprises, and employees, explores the impact of government regulation on the labor management relationship of private enterprises, and uses evolutionary games to analyze the stability of the strategies of the three parties. The result shows that there is a stable equilibrium solution in the tripartite game: private enterprises arrange employees to work overtime normally, employees take the initiative to work overtime, and the government's project management department strictly supervises them. Among them, strict supervision by labor supervision agencies plays an important role in balancing labor management relations, therefore, certain incentive measures should be given to labor supervision agencies to ensure their strict supervision; Private enterprises should strictly abide by market order, proactively reduce the burden on employees, and avoid forcing employees to work overtime excessively; Employees should maintain a good work attitude and promote the development of common interests with private enterprises.

The Enlightenment that Archegos Defaults Event to Our Country Finance Supervises

At the end of March 2021, the default of Archegos, an American hedge fund, led to a total loss of more than 10 billion dollars for a number of investment banks, which exposed the absence of supervision in the United States financial regulators. Based on the publicly disclosed information in the market, this paper analyzes the main process and key links of the incident in detail, summarizes and summarizes the defects and problems in the supervision of family office as a financial subject and derivatives trading in the United States, and puts forward opinions and suggestions on the supervision of family office and derivatives for financial institutions and regulatory departments in China.

Pt Nanoparticles Embedded Polypyrrole‐Carbon Black/SrSnO3 Photocatalyst with Stable and Superior Photodegradation Performance

AbstractCurrently, the primary focus for scientific authorities and regulatory departments revolves around water pollution. In this regard, photocatalysis has emerged as a highly effective, affordable, and goal‐oriented approach. Thus, recognizing the urgency of this issue, we focused our efforts towards developing a novel ternary photocatalytic structure based on mesoporous SrSnO3, combined with polypyrrole‐doped carbon black (PPC) and platinum nanoparticles (Pt NPs). Pt NPs, PPC and SrSnO3‐based nanocomposite photocatalyst was developed through a very simple chemical method followed by ultrasonication and photoreduction techniques. XRD analysis confirmed orthorhombic phase of SrSnO3, while the formation of the ternary nanocomposite among Pt NPs, PPC and SrSnO3 has been confirmed by X‐ray photoelectron spectroscopy (XPS) and Fourier Transform Infrared (FTIR) spectroscopy. Transmission electron microscopy (TEM) revealed the presence of Pt NPs (5–15 nm), beads/dense cocoon like structures of PPC along with rod, spherical and needle shape nanostructures of SrSnO3 in newly created ternary photocatalyst. Diffuse reflectance spectroscopy (DRS) showed lowering of band gap energy in case of Pt@PPC/SrSnO3. Newly developed Pt@PPC/SrSnO3 nanocomposite worked efficiently when employed on colorless insecticide imidacloprid (IMD) and on colored methylene blue (MB) dye under UV‐light. Pt@PPC/SrSnO3 photocatalyst exhibited excellent performance with 96.03 % removal of pollutant IMD in only 20 min, almost 296 % more efficient than bare SrSnO3. Furthermore, the Pt@PPC/SrSnO3 ternary photocatalyst showed rapid removal of MB with almost total elimination of dye molecule in just 16 min.

SHORTAGE OF ESSENTIAL MEDICINES DURING THE COVID-19 PANDEMIC: CROSS SECTIONAL STUDY FROM COMMUNITY PHARMACIES

Background: The drug shortage is a very serious issue regarding the quality of Health System of any country. The problem is increased in the pandemic causing serious issues to the health system. Objectives: The objective of current study was to evaluate the factors responsible for the drug shortages in Pakistan and way forward to avoid these problems in the future. Methodology: A cross-sectional observational study was carried out in different cities of Pakistan. An online form was designed after thorough literature review. The study population included Staff pharmacists, Pharmacy managers and pharmacists self-owning pharmacies. Data was then collected, analyzed using SPSS-26. Results: The majority of pharmacists agreed that Global restrictions on trade activities added to drug shortage during COVID-19. The knowledge was relatively higher in pharmacists of Punjab as compared to pharmacists of other provinces. Majority of pharmacist (52%) from Punjab province of Pakistan strongly believed that Provincial drug regulatory department should play its role effectively during the emergency crisis to prevent drug shortages during the pandemic. Conclusion: In order to prevent the problem of drug shortages, efforts should be made to control the factors responsible for the drug shortages and local production should be enhanced along with proper control by regulatory authorities.

The impact and management of internet-based public opinion dissemination during emergencies: A case study of Baidu News during the first wave of coronavirus disease 2019 (COVID-19).

The coronavirus disease 2019 (COVID-19) public health emergency has had a huge impact worldwide. We analyzed news headlines and keywords from the initial period of COVID-19, and explored the dissemination timeline of news related to the epidemic, and the impact of Internet-based media on the public using lifecycle theory and agenda-setting theory. We aimed to explore the impact of Baidu news headlines on public attention during the first wave of COVID-19, as well as the management mechanism of regulatory departments for social public opinion. We searched Baidu News using the keywords "Novel Coronavirus" and "COVID-19" from 8 January to 21 February 2020, a total of 45 days, and used Python V3.6 to extract news samples during the first wave of the epidemic. We used text analysis software to structurally process captured news topics and content summaries, applied VOSviewer V6.19 and Ucinet V6.0 to examine key aspects of the data. We analyzed the impact of Baidu News headlines on social opinion during the first wave of COVID-19 in the budding, spread, and outbreak stage of the information lifecycle. From clustering visualization and social network analysis perspectives, we explored the characteristics of Baidu News during the initial stage of the COVID-19. The results indicated that agenda-setting coverage through online media helped to mitigate the negative impact of COVID-19. The findings revealed that news reporting generated a high level of public attention toward a specific emergency event. The public requires accurate and objective information on the progress of COVID-19 through Baidu News headlines to inform their planning for the epidemic. Meanwhile, government can enhance the management mechanism of news dissemination, correct false and inaccurate news, and guide public opinion in a positive direction. In addition, timely official announcements on the progress of the COVID-19 outbreak and responses to matters of public concern can help calm tensions and maintain social stability.

Study on the Whole Process Supervision Technology of Digital Intelligent Enabling for Building Safety and Quality Appraisal Institutions

In order to fully implement the "Notice of The General Office of the State Council on Printing and Printing the Special Rectification Work Plan for the Safety of Self-built Houses", in view of the endless collapse of houses such as self-built houses, the traditional supervision methods of housing safety appraisal agencies are dishonest and the agency appraisal reports are distorted. Based on the principle of "the whole process of Internet + digital intelligence", this paper develops a set of digital and intelligent regulatory software system suitable for regulatory departments. It mainly introduces the basic application functions of this system, and takes the whole-area appraisal project of Taizhou City as an example to show that this regulatory system manages in all aspects such as human, machine, material, law and environment. The system has the advantages of thoughtful use steps, simple steps, scientific and accurate. At the end of this paper, the benefits and promotion value of the whole process of intelligent enabling supervision system are summarized and analyzed.

Is the “Lehman Crisis” Reappearing

On March 7, 2023, Silicon Valley Bank (SVB) announced that it is honored to have been named the best bank in the United States by Forbes magazine for five consecutive years. Dramatically, three days later, it collapsed within 48 hours due to insolvency, causing a huge uproar and becoming the largest bank failure in the United States since the 2008 financial crisis. This case firstly introduces SVB and its unique business model, outlines its process of suffering from severe runs and ultimately leading to bankruptcy after monetary policy changes, and states its series of subsequent impacts on the global economy after bankruptcy. Next, analyze the reasons for the bankruptcy of SVB from two aspects: the deficiencies in its own risk control and the lack of supervision from internal and external regulatory departments. Finally, by reviewing the entire process of the bankruptcy of SVB, we can obtain the enlightenment for China's banking industry and financial regulatory agencies from this incident.

Leveraging blockchain to anchor information for supervision in PPP projects: a conceptual framework

PurposeThe information used for supervision by regulatory departments in public-private partnership (PPP) projects is primarily transmitted and processed by the PPP implementation department, which negatively impacts the information quality, leading to information asymmetry and undermining the overall effectiveness of supervision. This study aims to explore how to use blockchain to anchor the information used for supervision in PPP projects to the original information, to strengthen the oversight.Design/methodology/approachThis paper adopts the principles of design science research (DSR) to design a conceptual framework that systematically organizes information along the information dissemination chain, ensuring the reliable anchoring of original information. Two-stage interviews involving experts from academia and industry are conducted, serving as formative and summative evaluations to guide the design.FindingsThe framework establishes a weak-centralized information organizing mode, including the design of governance community and on-chain and off-chain governance mechanisms. Feedback from experts is collected via interviews and the designed framework is thought to improve information used for supervision. Constructive suggestions are also collected and analyzed for further development.Originality/valueThis paper provides a novel example exploring the inspirations blockchain can bring to project governance, like exercising caution regarding the disorderly expansion of public sector authority in addressing information disadvantages and how to leverage blockchain to achieve this. Technical details conveyed by the framework deepen understanding of how blockchain benefits and the challenges faced in successful implementation for practitioners and policymakers. The targeted evaluation serves as rigorous validation, guiding experts to provide reliable feedback and richer insights by offering them a more cognitively convenient scenario.

Information transmission effect of forward-looking text: evidence from mergers and acquisitions report of Chinese listed firms

ABSTRACT This paper examines the transmission effect of forward-looking text information in M&A announcement reports. We find that there is a significant positive relationship between forward-looking text information in M&A announcement reports and short-term cumulative abnormal returns (CAR). After a series of robustness tests, the conclusion remains unchanged. Further study finds that the positive relationship is more significant in firms with low-quality internal control and high levels of accrued earnings management. Overall, the result enriches the research literature on the economic consequences of text information disclosure. At the same time, it also provides an empirical basis for regulatory departments to improve the text information disclosure system of mergers and acquisitions.

Analysis of U.S. and Hong Kong Cryptocurrency Regulation Approach

Cryptocurrencies have been defined and regulated differently in all corners of society. Much research has been made on countries' institutional measures to consummate regulations toward cryptocurrencies further. This paper explores the definition and nature of cryptocurrencies through a literature review method. The nature of cryptocurrencies has directly led to their benefits and misuse. This paper also explores the regulatory measures made by the U.S. and the flaws revealed in the Coinbase Case and Ripple Case. The ambiguous definition between regulatory departments and overlapping law enforcement power has made investors not knowing what course to take. New measures are taken in Hong Kong through a compulsory licensing system and laying major responsibility on platform service providers. This paper examines the new efforts and proposes some potential flaws under the new regulatory system. The Hong Kong regulatory approach is believed to provide insight and reference for other markets that would like to include cryptocurrencies into regulation.

Case Analysis and Future Expectations of Chinese Enterprises Suffering Heavy Losses in the International Futures Market: Take the Bank of China and Tsingshan LME as Examples

Affected by various factors such as COVID-19 epidemic and war, the world economic situation changes more frequently, which leads to increased instability in the international and domestic financial derivatives market. For the substantial changes in the international and domestic financial derivatives market, how to deal with sudden changes and analyze the failure cases in the change of financial derivatives is of far-reaching significance to the rapidly developing domestic financial derivatives market. By taking the Bank of China “crude oil treasure’ margin call liquidation case and Tsingshan LME Nickel Futures Squeeze Case as the core of the study, this paper uses case analysis method to deeply study the possible problems and failures in the futures market under the condition of financial derivatives market instability and puts forward suggestions on how to deal with these problems. This paper analyzes the attributes and characteristics of China’s ‘crude oil treasure’ products and nickel futures products, restores the event process, describes the impact of the event on investors, trading institutions and banks, and puts forward suggestions for improvement. The suggestions in this paper are as follows: First, the company and the regulatory department should strengthen risk supervision and management; Second, companies and investors should improve their professional capabilities.

Building Information Modeling and Artificial Intelligence Based Smart Construction Management: Materials and Electrical

With the development of society and technological progress, the requirements of government regulatory departments for engineering construction efficiency, quality, and safety are constantly increasing. The traditional extensive construction process can no longer meet the requirements of modern construction industry development. Based on the shortcomings of traditional construction processes, the concept of intelligent construction has been introduced. The construction of new smart and digital twin (DT) cities is entering an explosive period. The application of building rapid modeling technology based on artificial intelligence (AI) and building information modeling (BIM) integration in smart cities has gradually begun new explorations and attempts, and its application value is becoming increasingly prominent. A brand-new auto-machine learning (auto-ML) integrated algorithm technology platform for 3D building modeling is being developed and improved over time by combining AI and BIM technology in a deep way. This allows for fast and accurate modeling as well as high-value scenarios in the smart city industry, including architecture, municipal engineering, roads, and bridges.

Risk Management Analysis of Medical Device Registration Self-inspection

Through the analysis of laws and policies related to registration self-inspection, visiting and researching enterprises, holding symposiums, and issuing nationwide questionnaires, the risks in the registration self-inspection process were summarized, analyzed, and evaluated. From the aspects of regulatory departments and manufacturing enterprises, we suggest to improve China's medical device registration regulations system and reduce the risks of all parties in the registration self-inspection work.

Multicomponent Analysis of Liuwei Dihuang Pills by a Single Marker Quantification Method and Chemometric Discrimination of Fingerprints.

An effective and comprehensive quality evaluation method for Liuwei Dihuang pills (LDP) was established by the simultaneous determination of 8 active components in LDP by the quantitative analysis of multicomponents by single marker (QAMS) method and high-performance liquid chromatography (HPLC) fingerprint combined with chemometrics. These 8 active components were determined by QAMS and the external standard method (ESM), and the quantitative results of the two methods were compared to validate the accuracy and feasibility of the QAMS method. 8 active components showed good linear relationships within their ranges, whose average recoveries were 99.7∼102.3%. No significant difference was found (P > 0.05) in the quantitative results determined by QAMS and ESM. Furthermore, the fingerprint of LDP was also established, with 11 common peaks identified, and the similarity of the fingerprints of 21 batches of LDP was greater than 0.95. The 21 batches of LDP were basically divided into 3 groups by hierarchical cluster analysis (HCA) and principal component analysis (PCA), and 3 differential markers were screened out by orthogonal partial least squares discriminant analysis (OPLS-DA). The established QAMS method is accurate, economical, fast, and convenient and can simultaneously determine the content of 8 active components in LDP. HPLC fingerprint combined with chemometric analysis more comprehensively evaluated the quality consistency of different batches of LDP and analyzed the markers that cause quality differences between batches. It can provide a scientific basis and reference of quality consistency evaluation for the manufacturers and drug regulatory departments of the preparation.

Game Analysis on Supervision of live goods problem with Tiktok Platform Participation including the absence of Lemon market

With the internet and technology development, the utilization rate of short video platforms has gradually increased, and online shopping has become very common. On September 20, 2016, Tiktok short video platform was launched. A TikTok mall is a delivery tool provided by Tiktok e-commerce for merchants. The platform reduces the threshold for merchants to meet the requirements and implements a comprehensive opening policy to obtain more user traffic. Inevitably, lowering the threshold brings the disadvantage of merchants selling fake and inferior products, leading to the lemon for the market and significantly impacting the platform atmosphere and user traffic. Based on the idea of mixed strategy and a journal about the online game theory of product quality, this paper adds more variables, taking into account the negative impact of Tiktok's actual scheme policy and lemon market. Constructing a game theory model including merchants and Tiktok regulatory department, analyze its nash equilibrium and derivative of each variable. Finally, find out that the lemon market exists on the Tiktok platform. Second, the higher cost of high-quality firms leads to strengthening supervision to prevent the low-quality firms from being driven out of the market. Third, the lower profit of low-quality goods, the merchants prefer to sell high-quality goods. The strategies selected by the regulatory authorities on the Tiktok platform and the strategies of the merchants are influenced by the production costs of different quality, the regulatory costs, and the rewards obtained from the efforts made by the regulatory authorities in sampling inspection. These factors will also influence their profits. This paper will prove the conclusion with accurate data.

Principles for Health Information Collection, Sharing, and Use: A Policy Statement From the American Heart Association.

The evolution of the electronic health record, combined with advances in data curation and analytic technologies, increasingly enables data sharing and harmonization. Advances in the analysis of health-related and health-proxy information have already accelerated research discoveries and improved patient care. This American Heart Association policy statement discusses how broad data sharing can be an enabling driver of progress by providing data to develop, test, and benchmark innovative methods, scalable insights, and potential new paradigms for data storage and workflow. Along with these advances come concerns about the sensitive nature of some health data, equity considerations about the involvement of historically excluded communities, and the complex intersection of laws attempting to govern behavior. Data-sharing principles are therefore necessary across a wide swath of entities, including parties who collect health information, funders, researchers, patients, legislatures, commercial companies, and regulatory departments and agencies. This policy statement outlines some of the key equity and legal background relevant to health data sharing and responsible management. It then articulates principles that will guide the American Heart Association's engagement in public policy related to data collection, sharing, and use to continue to inform its work across the research enterprise, as well as specific examples of how these principles might be applied in the policy landscape. The goal of these principles is to improve policy to support the use or reuse of health information in ways that are respectful of patients and research participants, equitable in impact in terms of both risks and potential benefits, and beneficial across broad and demographically diverse communities in the United States.