IFishIENCi Report on regulatory framework and requirements (First Version)

Regulatory oversight of cell therapy in China: Government’s efforts in patient access and therapeutic innovation

Introduction This paper describes a hazard- and risk-based strategy and recommendations on relevant biosafety levels in facility design of a new veterinary faculty building including a veterinary medical teaching hospital. Both animal and human health were considered. Materials and methods Agents listed in the regulatory frameworks on animal and human health were identified as the main potential hazards. Suggestions on biosafety level and facility design were based on the official risk grouping of those agents, the associated risk management procedures, and biosafety experiences from previous faculty buildings. Results and Discussion It was suggested that VHC should not be designed for work with agents requiring facilities at biosafety levels 3 and 4, and that actions in cases of accidental exposure to notifiable infections should follow the regulatory requirements. Facilities requiring biosafety level 2 were identified from risk scenarios and transmission routes. Experiences from the first five years of operation revealed good prevention of spread of infection from patients in isolation facilities and successful elimination of Salmonella and MRSA from the large animal clinic. Conclusion In order to avoid costly construction mistakes, an overall biosafety strategy should be formulated and used as guidance for architects and other relevant stakeholders designing facilities for the animal health sector. Regulatory requirements on infectious diseases must be complied with.

This study examines the impact of API-based financial services and open banking on market competition, customer trust, and data privacy, highlighting key challenges such as compliance complexities, unauthorized access, and data breaches.The research explores cybersecurity threats, regulatory requirements, and technological advancements influencing data security.Mitigation measures, such as regulatory frameworks and technological safeguards, are analysed to improve security while fostering innovation.Findings show that improving API security, authentication protocols, and regulatory compliance is critical for a secure open banking ecosystem.A balance between innovation and security measures will improve consumer trust and facilitate the sustainable growth of digital financial services.

BackgroundIntervening in private drug shops to improve quality of care and enhance regulatory oversight may have health system effects that need to be understood before scaling up any such interventions....

Problem setting. The transformation of the Ukrainian economic system and the financial sector is connected with the new needs of the state, the globalization of the world financial space, and therefore with new challenges and threats. Analysis of recent research and publications. In their works, I. Andrushkiv, L. Nadievets, L. Haryaga, O. Stoyko, and others dealt with issues of increasing the volume of digitalization, digitalization of financial products, and the specifics of the influence of fintech companies on the financial sector. The issue of security of financial institutions was studied by such domestic scientists as: O. Baranovskyi, Z. Varnaliy, S. Yegorycheva and others. Purpose of the research is to analyze the connection of digital financial technologies to the financial security of the state, to study the positive and negative impact of FinTech on the state economic policy and financial security, and to emphasize the need to adapt regulatory approaches to support a safe financial system. Article’s main body. The article is devoted to the issue of the relationship between digital economy technologies used in the financial sector and the financial security of the state. Positive and negative factors of influence of FinTech on banking, budgetary and monetary security, as components of financial security of the state, are determined. The author concludes that the development of financial technologies has the potential to increase financial security by improving the security of transactions, effective compliance with regulatory requirements, expanding access to financial services, and reducing the potential for money laundering and terrorist financing. Digital technologies are a powerful driver of the principles of transparency of financial relations, which is especially noticeable at the level of public finances. A key role in the formation of the financial security of the state is played by the provision of indicators of budget security, therefore the author paid attention to the consideration of the peculiarities of the openness of the budget. RegTech and SupTech, which in turn are technologies for managing regulatory processes and supervisors in the financial industry. Conclusions and prospects for the development. The author concludes that the regulatory framework should be based on risk assessment, contributing to cyber security, data privacy and protection of consumers of financial services, while contributing to the financial security of the state.

The rigorous regulatory landscape for medical devices demands meticulous chemical characterization to ensure safety and compliance. This review examines the critical role of chemical characterization within regulatory frameworks, emphasizing its importance in the approval and market entry of medical devices. Key challenges, including the complexity of sample matrices, trace-level impurity detection, and the necessity of method validation, are thoroughly explored. In addition, the review addresses the dynamic nature of regulatory requirements, analyzing how updates in international standards, such as those from the International Organization for Standardization (ISO), the American National Standards Institute (ANSI), and the Association for the Advancement of Medical Instrumentation (AAMI), or the American Society for Testing and Materials (ASTM), shape the chemical characterization process. The review discusses future directions, including advancements in analytical technologies, the potential for increased automation and standardization, and the growing significance of managing emerging contaminants. By offering a comprehensive analysis of current practices and future trends, this review highlights the essential role of chemical characterization in ensuring the development and regulation of safe and effective medical devices.

In recent decades, there has been a significant evolution in design configurations within the luxury yacht industry, particularly among vessels between 50 and 70 meters in length (LOA), known as superyachts. This study aims to analyse the increase in maximum beam width (BOA) in this category, specifically focusing on units intended for the charter market. A comparative approach was adopted, dividing selected yachts into five main time spans (up to 1997, 1997–2003, 2004–2014, 2012–2018 and after 2018) to focus on the development and effectiveness of the new Rules (Large Commercial Yacht Code). The results show a growing trend in the maximum beam-to-length ratio driven by the need for greater habitability and comfort. It has been significantly affected by market demands for larger interior spaces, particularly in the charter sector, as well as regulatory frameworks such as the International Maritime Labour Convention (MLC) of 2006, which introduced minimum space standards for crew accommodations. These factors played a significant role in shaping the design paradigm of large yachts, as they required a balance between enhanced living spaces and performance requirements. This shift also impacts hydrodynamic resistance, speed, initial and secondary stability, fuel consumption, and manoeuvrability. However, these concerns are addressed by improved hull design, optimised propulsion configurations and modern integrated navigation and control systems. The study provides a useful framework for understanding the impact of increasing beam width on superyachts, illustrating how related factors have influenced design trends over time. It provides a comprehensive overview of the relationship between habitability, performance, and external constraints, highlighting the interplay of market demands and regulatory requirements in driving technical innovations in the maritime sector.

This research examines what happens to financial performance of Jordanian retail businesses after they use FinTech solutions together with innovation and regulatory compliance and investigates operational efficiency and customer satisfaction as intervening variables. The research analysed 291 firms which were chosen from among the full sample of 1,200 retail entities registered with the Jordanian Chamber of Commerce by using PLS-SEM methodology. The research analysed survey results to verify that financial performance of businesses demonstrates considerable growth when using FinTech solutions combined with innovation practices and regulatory requirements. Research confirmed that operational efficiency and customer satisfaction serve as intermediary factors connecting financial performance indicators because they strengthen key performance functions. Financial managers can use this research to obtain specified guidelines for FinTech solution investments that drive innovation within regulatory frameworks. Such FinTech implementations require policymakers to develop regulatory frameworks for their effective implementation. The study creates unique value through its assessment of Jordan's emerging market conditions to explore FinTech solution adoption alongside the resulting performance impact. This research enhances understanding of FinTech adoption in emerging markets through a unified framework that combines multiple constructs while offering actionable recommendations for both businesses and policymakers.

Advanced therapy medicinal products (ATMPs), including cell therapy products, form a new class of medicines in the European Union. Since the ATMPs are at the forefront of scientific innovation in medicine, specific regulatory framework has been developed for these medicines and implemented from 2009. The Committee for Advanced Therapies (CAT) has been established at the European Medicines Agency (EMA) for centralized classification, certification and evaluation procedures, and other ATMP-related tasks. Guidance documents, initiatives, and interaction platforms are available to make the new framework more accessible for small- and medium-sized enterprises, academia, hospitals, and foundations. Good understanding of the centralized and national components of the regulatory system is required to plan product development. It is in the best interests of the cell therapy developers to utilize the resources provided starting with the pre-clinical stage. Whilst there have been no mesenchymal stem cell (MSC)-based medicine authorizations in the EU, three MSC products have received marketing approval in other regions since 2011. The information provided on the regulatory requirements, procedures, and initiatives is aimed at facilitating MSC-based medicinal product development and authorization in the EU.

Following the publication of the regulatory framework for the Fundamental Review of the Trading Book (FRTB) by both the Basel Committee (BCBS) and the EU Regulator, the Financial Institutions have started the mandatory actions to comply with the new regulatory requirements. This article aims to provide an overview of the key challenges that banks have had to face in recent years, with a particular focus on the most significant methodological key points and the main impacts on business from the technicalities of the new regulatory framework, in order to provide guidelines and best practices on Standardized Approach (SA) topics shared between Risk Management and Front Office

Rethinking Duties to Serve in Housing Finance

Succession in small healthcare enterprises, particularly midwife-led birthing clinics in the Philippines, presents unique challenges influenced by family aspirations, regulatory requirements, and mission-driven values. The purpose of this novel type of study is to discover the succession plans of two birthing home owners in the province of La Union using purposive sampling. The study employed a qualitative design guided by the Gioia methodology to capture participants’ lived experiences and surface data-driven concepts. Data were gathered through unstructured interviews. Following Gioia’s three-step analytic process, transcripts were open-coded into first-order concepts, aggregated into second-order themes, and distilled into aggregate dimensions that represent the emergent theory. Analysis produced 17 first-order concepts clustered into 17 second-order themes in the first participant, while the second participant had 23 first-order concepts clustered into 23 second-order themes. These themes converged into 12 aggregate dimensions: Succession Aspirations, Successor Selection Challenges, Preparation for Continuity, Values & Principles for Succession, Fears and Risks in Succession, Transitioning Ownership Role, Foundational Beliefs for Survival, Succession Context, Successor Readiness, Core Qualities for Succession, Sustaining the Legacy and Ownership and Structural Considerations which depict the structural importance of a strong succession plan. The findings reveal that while founders initially aspire for family succession to preserve legacy and socioemotional wealth, the lack of qualified heirs or the departure of family members often necessitates identifying non-family staff as potential successors. Succession success is contingent on a combination of technical competence, regulatory compliance, and values stewardship, including compassion, patient-centered care, and trustworthiness. Founders employ strategies such as staged role transitions, mentoring, comprehensive knowledge transfer, and operational guidance to ensure continuity of operations. Despite fears of business closure, sabotage, and client resistance to new leadership, founders demonstrate resilience by fostering loyalty, emphasizing ethical practices, and creating pseudo-familial relationships with trusted staff. The study proposes a mission-driven succession model, highlighting a shift from family-centered continuity to professionalized, ethically grounded leadership in small healthcare enterprises. Practical implications include guidance for founders on early succession planning, training, and mentoring of successors, as well as recommendations for policymakers to support certification, capacity-building, and regulatory frameworks that facilitate continuity of care. This research contributes to succession literature by integrating socioemotional, institutional, and stewardship perspectives in a context-specific model for healthcare micro-enterprises.

The rapid deployment of Artificial Intelligence (AI) in Anti-Money Laundering (AML) practices within the financial industry presents significant ethical and governance challenges that must be navigated effectively. As financial institutions increasingly adopt AI technologies to enhance their AML efforts, concerns regarding data privacy, algorithmic bias, and transparency emerge. This review explores the ethical implications of AI in AML and offers governance strategies to mitigate risks while ensuring compliance with regulatory frameworks. One of the primary ethical challenges in deploying AI for AML is the potential for algorithmic bias. AI systems trained on historical data may inadvertently perpetuate existing biases, leading to discriminatory practices in transaction monitoring and customer profiling. This raises serious concerns about fairness and equity in the financial sector. Addressing algorithmic bias requires the implementation of rigorous testing and validation processes to ensure AI systems function impartially across diverse populations. Data privacy is another critical issue. The extensive data collection required for effective AML monitoring raises questions about the protection of sensitive customer information. Financial institutions must establish robust data governance frameworks that prioritize privacy and comply with regulations such as the General Data Protection Regulation (GDPR). Ensuring transparency in how data is used and providing clear communication to customers about data practices is essential for building trust. Effective governance frameworks are crucial in navigating these ethical challenges. Financial institutions should adopt a multi-disciplinary approach that includes ethical guidelines, compliance measures, and risk management strategies. Establishing oversight committees can help ensure that AI deployment aligns with ethical standards and regulatory requirements. Furthermore, ongoing training for employees on the ethical use of AI in AML can foster a culture of responsibility and accountability. This review highlights the need for a balanced approach to AI deployment in AML, emphasizing the importance of ethical considerations and governance structures. As the financial industry continues to evolve, addressing these challenges will be essential for maintaining trust, ensuring compliance, and leveraging AI’s potential to enhance AML practices effectively.

Sustainable Supply Chain Management (SSCM) has emerged as a critical paradigm in the modern healthcare landscape, aiming to reconcile the often conflicting objectives of environmental stewardship, social responsibility, and economic viability within medical supply chains. This paper offers a comprehensive theoretical and practical exploration of SSCM within the context of the medical industry. Six keywords - sustainability, supply chain management, healthcare, environmental stewardship, social responsibility, economic viability - encapsulate the essence of this examination. The introduction sets the stage by highlighting the growing importance of sustainability in healthcare operations and the unique challenges faced by the medical sector in achieving sustainable supply chains. It underscores the significance of integrating environmental, social, and economic considerations into the fabric of medical supply chain management practices. The subsequent sections delve into various facets of SSCM in the medical industry. They address key components such as reducing carbon footprint and waste, fostering social responsibility through ethical sourcing practices, and striking a balance between sustainability objectives and cost efficiency. Regulatory frameworks and compliance requirements specific to healthcare supply chains are also explored, emphasizing the need for alignment with evolving sustainability standards. Technological innovations play a pivotal role in driving sustainability in medical supply chains, with advancements in data analytics, blockchain, and IoT enabling enhanced visibility, traceability, and efficiency. Moreover, collaboration and partnerships among stakeholders are deemed essential for fostering sustainable practices across the healthcare ecosystem. Drawing from real-world case studies, the paper illustrates successful implementations of SSCM principles in the medical industry, showcasing best practices and lessons learned. Finally, it prognosticates future trends and challenges, anticipating continued emphasis on sustainability amidst evolving market dynamics and regulatory landscapes. In sum, this theoretical and practical examination underscores the imperative for sustainable supply chain management in the medical industry, offering insights and strategies to navigate the complex interplay of environmental, social, and economic factors in healthcare logistics. Keywords: Sustainability, Supply Chain Management, Healthcare, Environmental Stewardship, Social Responsibility, Economic Viability.

The China State Council released the new generation artificial intelligence (AI) development plan, outlining China's ambitious aspiration to assume global leadership in AI by the year 2030. This initiative underscores the extensive applicability of AI across diverse domains, including manufacturing, law, and medicine. With China establishing itself as a major producer and consumer of medical devices, there has been a notable increase in software registrations. This study aims to study the proliferation of health care-related software development within China. This work presents an overview of the Chinese regulatory framework for medical device software. The analysis covers both software as a medical device and software in a medical device. A comparative approach is employed to examine the regulations governing medical devices with AI and machine learning in China, the United States, and Europe. The study highlights the significant proliferation of health care-related software development within China, which has led to an increased demand for comprehensive regulatory guidance, particularly for international manufacturers. The comparative analysis reveals distinct regulatory frameworks and requirements across the three regions. This paper provides a useful outline of the current state of regulations for medical software in China and identifies the regulatory challenges posed by the rapid advancements in AI and machine learning technologies. Understanding these challenges is crucial for international manufacturers and stakeholders aiming to navigate the complex regulatory landscape.