Specific Regulatory Framework Research Articles

Multimodal Hong Kong: A review of policies regarding soundscape and smellscape of Chinese temples

Many people in Hong Kong regularly visit Chinese temples, and see this not necessarily as a religious activity, but as a traditional practice. Temples represent the local intangible cultural heritage. The dense urbanity and mixed population characterise Hong Kong and make it valuable to study its sounds and smells. Most temples existed earlier than modern urban areas, which grew around them. The temple soundscape consists of drums, bells, coin donations, ventilation fans, as well as chanting, especially during festivals. The smellscape consists of ritual burning of incense and paper, fruit offerings, and building materials e.g., wood and cement. The burning causes particle pollution, health concerns, and residential nuisance, that may conflict with the wish for sustaining a valuable heritage. Smells and air quality have recently become debated, raising the question of the need for a specific regulatory framework. There is currently a lack of official provision that directly protects the sounds and smells of these temples in Hong Kong. This paper reviews the current state of Hong Kong policies in regard to soundscape and smellscape, with comparison to China and France, because of the latter's progressive agenda in preserving sensory heritage in the countryside.

SUSTAINABLE AND RESPONSIBLE LEISURE: RECREATIONAL MARITIME FISHING IN SPAIN

Recreational sea fishing is an important activity, both from a socio-economic and environmental point of view, as it is a source of wealth but also a threat to natural resources. For this reason, each autonomous community has developed a specific regulatory framework for its regulation, focusing on sustainability and the protection of marine resources. These regulations include restrictions on the volume of catches, the species permitted, and the prohibition of the commercialization of catches. The aim of this article is to provide an extensive comparison of some of them, showing their similarities and also their regulatory differences, as well as possible gaps and inconsistencies.

CREDIT DERIVATIVES: TRADING PROTECTION

The article describes the main forms of credit derivatives, the evolution of their development and conditions of use. Particular attention is paid to the conditions of protection against credit risk. The authors demonstrate the possibility and expediency of using credit derivatives in the financial practice of Ukrainian companies in the context of transformation of the current legislation. It is established that credit notes, as a form of credit derivatives, are a more reliable financial instrument. From an economic point of view, they are considered to be securities with a certain set of risks and benefits for investors, which should be taken into account when developing a financial strategy for all capital market participants. The subject of the study is the intricacies of using credit derivatives in financial management, with a special emphasis on their role and conditions in modern Ukrainian financial practice. The research methodology includes a critical review of the existing literature combined with an analysis of the current use of credit derivatives in Ukraine. This approach offers a dual perspective that not only summarises the global context but also takes into account the nuances of local implementation. The purpose of this study is to investigate the effectiveness of credit derivatives as financial instruments for risk hedging and profitability optimisation. By examining different types of these instruments, the study aims to draw practical conclusions and provide recommendations for integrating these instruments into financial management practices in Ukraine. The research concludes that credit derivatives offer significant advantages as reliable financial instruments that contribute to risk management and economic development. The paper highlights their potential to positively impact financial market development, especially under conditions that facilitate risk hedging. The findings of the publication support the creation of a specific legislative and regulatory framework that would facilitate the wider introduction and efficient use of credit derivatives in Ukraine. This includes emphasising the need for specific amendments to existing tax codes and financial regulations to create a favourable environment for these instruments.

Evidence for initiating food safety policy: An assessment of the quality and safety of donated food at an Australian food bank

Food banks play a vital role in addressing the needs of people experiencing food insecurity. Food banks rely on the food industry, particularly supermarkets, for food donations, and on voluntary labor to scrutinize and sort donations for quality and safety. Currently, national food safety laws and policies in Australia regulate food businesses, but do not specifically apply to donations. There are reports of expired, spoiled, and rotten food donations and clients express dissatisfaction with the quality and safety of food provided. This study describes a novel approach to visually identify and assess the safety and quality of food donations at an Australian food bank. Data from an audit of donations to a metropolitan food bank were analyzed. Food safety assessment criterion were developed based on food safety standards and applied to 1217 items (84,996 kg) of donated food. Each product was visually inspected and assessed as ‘safe’, ‘unsuitable’, ‘potentially unsafe’, or ‘unsafe for human consumption’ upon receival. Of the 84,996 kg of donated food, 96 % was categorized as satisfactory and 4 % (3761 kg) was categorized as either unsafe (2024 kg), potentially unsafe (1313 kg) or unsuitable (424 kg) for consumption. Supermarket donations comprised 90 % (by weight) of the unsafe and unsuitable food. The overall proportion of visually unsafe and unsuitable foods was low, but consumption of any unsafe, hazardous and/or damaged products poses a risk to the consumer. Given the vulnerability of clients receiving this food, the public health risk is high. The management of potential risk is problematic too as multiple decisions to determine appropriateness for distribution, places demands on food banks and hampers efficiency. The findings underscore the clear need for a specific food safety regulatory framework for donated food in Australia.

Towards a macroprudential regulatory framework for mutual funds?

AbstractThis paper highlights the procyclical and unstable behaviour of mutual funds, characterized by a varying sensitivity on common asset pricing factors. It proposes a novel factor model that allows for regime changes associated with macroeconomic and financial state variables. Estimated on a panel covering 825 US equity mutual funds over a period of 30 years, it appears that the yield curve, the dividend yield, short term interest rates and the industrial production coincide with regimes switches in the Fama–French factors. Furthermore, the estimated regimes coincide with financial crises and economic downturns, thus confirming the procyclical behaviour of mutual funds' returns. These findings, coupled with the emerging systemic role of mutual funds, promote the consideration for a specific macroprudential regulatory framework targeted at the mutual fund industry.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration.

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Regulatory Aspects for Approval of Advanced Therapy Medicinal Products in the EU.

In the European Union (EU), advanced therapy medicinal products (ATMPs) undergo evaluation by the European Medicines Agency's (EMA) Committee for Advanced Therapies (CAT) to obtain marketing authorization under the centralized procedure. Because of the diversity and complexity of ATMPs, a tailored approach to the regulatory process is required that needs to ensure the safety and efficacy of each product. Since ATMPs often target serious diseases with unmet medical need, the industry and authorities are interested in providing treatment to patients in a timely manner through optimized and expedited regulatory pathways. EU legislators and regulators have implemented various instruments to support the development and authorization of innovative medicines by offering scientific guidance at early stages, incentives for small developers and products for rare diseases, accelerated evaluation of marketing authorization applications, different types of marketing authorizations, and tailored programs for medicinal products with the orphan drug designation (ODD) and the Priority Medicines (PRIME) scheme. Since the regulatory framework for ATMPs was established, 20 products have been licenced, 15 with orphan drug designation, and 7 supported by PRIME. This chapter discusses the specific regulatory framework for ATMPs in the EU and highlights previous successes and remaining challenges.

On the seismic design and behavior of Automated Rack Supported Warehouses

Automated Rack Supported Warehouses, consisting of huge steel buildings offering optimized storage solutions, have been facing a huge diffusion in the last decade, mainly due to the necessity of having bigger and more efficient places to stock and handle goods through automated systems. However, there is not a specific regulatory framework for them, and they are currently being designed to adopt the approach used for traditional steel racks. Even if traditional steel racks and ARSWs have several common aspects, there are relevant differences that do not allow to adopt the same design approach, especially for seismic actions. To highlight the factors and parameters currently influencing the seismic design and the behavior of these constructions, and the consequent need for a different design approach, the present paper presents a critical analysis of the seismic design approach currently adopted by technicians and designers. Then, a set of 5 structures designed by 5 of the major European companies specialized in this field is used to perform both the critical analysis of the different design approaches adopted and the assessment of the seismic performance. The seismic assessment results highlight the typical criticalities and the necessity of a novel proper design approach.

Perceptions about controlled human infection model (CHIM) studies among members of ethics committees of Indian medical institutions: A qualitative exploration

Introduction: Controlled Human Infection Model (CHIM) studies provide a unique platform for studying the pathophysiology of infectious diseases and accelerated testing of vaccines and drugs in controlled settings. However, ethical issues shroud them as the disease-causing pathogen is intentionally inoculated into healthy consenting volunteers, and effective treatment may or may not be available. We explored the perceptions of the members of institutional ethics committees (IECs) in India about CHIM studies. Methods: This qualitative exploratory study, conducted across seven sites in India, included 11 focused group discussions (FGD) and 31 in-depth interviews (IDI). A flexible approach was used with the aid of a topic guide. The data were thematically analyzed using grounded theory and an inductive approach. Emerging themes and sub-themes were analyzed, and major emergent themes were elucidated. Results: Seventy-two IEC members participated in the study including 21 basic medical scientists, 29 clinicians, 9 lay people, 6 legal experts and 7 social scientists. Three major themes emerged from this analysis-apprehensions about conduct of CHIM studies in India, a perceived need for CHIM studies in India and risk mitigation measures needed to protect research participants and minimize the associated risks. Conclusion: Development of a specific regulatory and ethical framework, training of research staff and ethics committee members, and ensuring specialized research infrastructure along with adequate community sensitization were considered essential before initiation of CHIM studies in India.

Naturally traditional or traditionally natural – exploring the concepts natural and traditional in marketing research

The purpose of this research is to understand how current marketing research conceptualises natural and traditional products – products that strongly attract consumer attention and capture large and growing market shares yet remain vague and weakly defined by a regulatory framework. The analysis is conducted on systematically selected research articles published in relevant journals over the past two decades. The results show that the natural products are mostly defined by the way they are produced and the ingredients they do not contain, while no consensus was reached for the traditional products. Furthermore, not only is the concept of traditional defined by an unusually large number of themes, but the themes also vary considerably depending on stakeholder group from which they originate, indicating an inevitable communication problem between these groups. The results also show that despite attempts by marketers to link the meanings of the two types of products, the themes in the definitions of natural and traditional products are different and overlap only sporadically. These findings serve as a step toward creating better academic conceptualizations and a more specific regulatory framework for natural and traditional products that will reduce the likelihood of misleading business practises and confusion among consumers and researchers.

The Future of L-Arginine Dietary Supplementation Research - The Impact on NOS Dependent and Independent Systems

Introduction: The consumption of L-arginine is of particular concern, due to the importance of dietary supplements in people’s daily life, continually increasing. Also, the counter position is the impact of adulterants, contaminants and undeclared constituents in L-arginine products, and consequently to health/wellness. Aim: To contextualize and provide new perspectives for L-arginine dietary supplement research, that would have an impact on the consumers, and patients, health/wellness. Method: The approach was to do a literature search in multiple online electronic academic open-source scientific databases. These covered, PubMed, Scopus, Google Scholar, Elsevier, Taylor & Francis, Sabinet, ScienceDirect, ClinicalTrials.gov, and The Cochrane Collaboration. The search terms covered  L-arginine, and the specific research related interest. Outcome: The role of L-arginine in inhibition and control of disease is essentially via the dependent or independent NO metabolic pathways. In L-arginine deficiency, the selective delivery is exogenously taking the amino acid. That there is an impact of dietary arginine containing supplements consumption (or in combination) on human performance (exercise), including effects on cognitive flexibility, and/or mental ability. That L-arginine supplementation is indicated for stress reduction, anxiety, and adaptogenic capabilities in the healthy. However, L-arginine is not lacking, in side effects, including drug-interactions when taken in combination. Gastrointestinal disturbances being the most common adverse effects. Conclusion: Of prominence is the potential benefit, pure L-arginine holds for the consumer. It is recommended that further scientific research scrutiny is warranted. This will provide awareness for an improved specific national regulatory framework, globally, but also set the tone for future research studies.

A multistep in vitro hemocompatibility testing protocol recapitulating the foreign body reaction to nanocarriers

The development of drug nanocarriers based on polymeric, lipid and ceramic biomaterials has been paving the way to precision medicine, where the delivery of poorly soluble active compounds and personalized doses are made possible. However, the nano-size character of these carriers has been demonstrated to have the potential to elicit pathways of the host response different from those of the same biomaterials when engineered as larger size implants and of the drugs when administered without a carrier. Therefore, a specific regulatory framework needs to be made available that can offer robust scientific insights and provide safety data by reliable tests of these novel nano-devices. In this context, the present work presents a multistep protocol for the in vitro assessment of the hemocompatibility of nanocarriers of different physicochemical properties. Poly (ethyl butyl cyanoacrylate) nanoparticles and lipid-based (LipImage™ 815) nanoparticles of comparable hydrodynamic diameter were tested through a battery of assays using human peripheral blood samples and recapitulating the main pathways of the host response upon systemic administration; i.e., protein interactions, fibrinogen-platelet binding, cytotoxicity, and inflammatory response. The data showed the sensitivity and reproducibility of the methods adopted that were also demonstrated to determine individual variability as well as to discriminate between activation of pathways of inflammation and unintended release of inflammatory signaling caused by loss of cell integrity. Therefore, this multistep testing is proposed as a reliable protocol for nanoparticle development and emerging regulatory frameworks.Graphical abstract

The Hitchhiker's Guide to Human Therapeutic Nanoparticle Development.

Nanomedicine plays an essential role in developing new therapies through novel drug delivery systems, diagnostic and imaging systems, vaccine development, antibacterial tools, and high-throughput screening. One of the most promising drug delivery systems are nanoparticles, which can be designed with various compositions, sizes, shapes, and surface modifications. These nanosystems have improved therapeutic profiles, increased bioavailability, and reduced the toxicity of the product they carry. However, the clinical translation of nanomedicines requires a thorough understanding of their properties to avoid problems with the most questioned aspect of nanosystems: safety. The particular physicochemical properties of nano-drugs lead to the need for additional safety, quality, and efficacy testing. Consequently, challenges arise during the physicochemical characterization, the production process, in vitro characterization, in vivo characterization, and the clinical stages of development of these biopharmaceuticals. The lack of a specific regulatory framework for nanoformulations has caused significant gaps in the requirements needed to be successful during their approval, especially with tests that demonstrate their safety and efficacy. Researchers face many difficulties in establishing evidence to extrapolate results from one level of development to another, for example, from an in vitro demonstration phase to an in vivo demonstration phase. Additional guidance is required to cover the particularities of this type of product, as some challenges in the regulatory framework do not allow for an accurate assessment of NPs with sufficient evidence of clinical success. This work aims to identify current regulatory issues during the implementation of nanoparticle assays and describe the major challenges that researchers have faced when exposing a new formulation. We further reflect on the current regulatory standards required for the approval of these biopharmaceuticals and the requirements demanded by the regulatory agencies. Our work will provide helpful information to improve the success of nanomedicines by compiling the challenges described in the literature that support the development of this novel encapsulation system. We propose a step-by-step approach through the different stages of the development of nanoformulations, from their design to the clinical stage, exemplifying the different challenges and the measures taken by the regulatory agencies to respond to these challenges.

Contemporary difficulties and challenges for the implementation and development of compressed earth block building technology in Argentina

The construction with compressed earth blocks (CEB) has provoked special worldwide interest in recent decades. In Argentina it has considerable experiences due to technical research, its use in public works and the development of some manufacturing units at different scales. The particular interest of its technology transfer to low income population sectors has been central and defines the social profile with which it has been implemented in the last time. However, its contemporary development has a low territorial impact due to the fact that problems are observed that hinder the implementation, dissemination, economic support of the manufacture and CEB commercialisation and the transfer of this technology. The aim of this article is to characterize and discuss the nature of the problems that hinder further development of CEB construction technology in Argentina. Local scientific production was analysed and the agents involved in the CEB production process were identified, who were surveyed and interviewed asking their assessment of the problems that affect the development of this technology today. The results show that the technical aspects involved in the CEB manufacturing stage are the ones that have received the most attention so far, much of the current difficulties to continue with its development are focused on the implementation, dissemination, and economic sustainability of the CEB manufacturing and commercialisation and the transfer of this technology. The lack of a specific regulatory framework for this technology is transversal to these problems mentioned. With regard to the scientific field, these issues need to be incorporated into research agendas, at least at the local level.

End-of-life management of solar PV waste in India: Situation analysis and proposed policy framework

Increasing energy demands and commitments in relation to climate change have accelerated the deployment of solar power globally, especially in India. Grid-connected solar capacity in the country has increased ∼11 times in just five years, from 2.6 GW in March 2014 to 28.18 GW in March 2019. However, this development has inevitably also led to the emergence of significant volumes of solar photovoltaic (PV) waste, which will only increase in the upcoming years, a considerable challenge for its waste management system. The environmental and human health risks associated with the unscientific dumping of solar PV waste have been well established in the existing literature, presenting the need to develop an effective strategy to manage this emerging waste stream. This paper presents a review of literature about India's solar PV waste management sector with a view to understanding the ground realities and identifying challenges and barriers that hinder the adoption of a regularised strategy for its management using the DPSIR framework approach. It goes on to propose a regulatory framework aimed at mainstreaming the end-of-life (EOL) management of solar PV waste in India after evaluating strategies that have already been used worldwide. In line with the Extended Producer Responsibility (EPR) concept, a multistakeholder, multi-sectoral and systematic approach has been adopted to develop a specific regulatory framework for India. The framework was subjected to a SWOT analysis to evaluate its functionality. The SWOT analysis indicates that one of the critical strengths of the framework is that it is based on a participatory approach to be adopted by all stakeholders for managing this emerging waste stream.

CONSUMERS’ AWARENESS AND KNOWLEDGE OF NANOFOOD IN MALAYSIA

The integration of engineered nanomaterials (ENMs) in the food and agriculture industry is now common and rampant among giant food manufacturers to enhance the quality, functionality, and physicality of food products. However, consumers have not been consulted and informed on the use of ENMs in food despite various potential safety and health risks associated with oral exposure of ENMs illustrated from scientific studies. In the European Union, the food law was amended to include provisions on nanotechnology after conducting a public consultation to explore public awareness and perception of nanotechnology. In the absence of a specific regulatory framework for nanofood in Malaysia, this study aims to analyse consumers’ awareness and knowledge of nanofood. The result from the study serves as an invaluable input to the regulatory authority in framing any regulatory reform to regulate nanofood. A survey was conducted using a closed-ended questionnaire distributed online. The result indicates that the awareness and understanding of nanofood are still lacking and not satisfactory.

Teledermatology: The New Normal?

Teledermatology: The New Normal?

Brain safety concerns of nanomedicines: The need for a specific regulatory framework

There is growing interest in using nanomaterials as carriers for the delivery of drugs in diseases such as cancers and central nervous system (CNS) disorders. Although several nanomaterial-based products have been approved, the regulatory framework for their use in humans remains limited. Nanomedicines (NMs) are usually not designed to cross the blood–brain barrier (BBB). Given the lack of a comprehensive set of standardized methods to assess their in vivo fate, there is an urgent need to characterize NM biodistribution as well as the toxicity that could result from their interaction with the CNS. Here, we discuss the risks of potential unwanted BBB crossing and brain toxicity of nanocarriers (NCs), along with the safety assessment and current regulatory challenges related to NMs.

A Comparative Analysis of Unfair Terms in Consumer Contracts in Malaysia and Singapore

The inclusion of welfarist ideology in the consumers’ trade derived from the ideal of paternalism is a paradigm change from the doctrine of freedom of contract. Regulatory and legislative steps must be taken to support and attract consumers to the industry. Judicial and legislative actions must be taken to correct the market flaws that create consumers’ vulnerability while trading in the global market. As one of ASEAN members’ founders, Malaysia is moving towards people-centered economic endeavours to balance both industry and consumer interests through exclusion clauses to prevent unfair practices in consumer contracts. Legal intervention is one of the ways to curbing the issues that arise from exclusion clauses. Before 2010, the non-existence of a specific regulatory framework to limit exclusion clauses usage in contracts involving consumers further increases consumers’ vulnerability. Traditional judicial approaches in the battle against coercion and unethical behaviour of traders before 2010 did not engross consumer rights and interests. This sign is, in fact, the modern age of customer contracts, the enforcement of unfair terms. This article used the content analysis technique and analysed the evolution of legislative interference and judicial approaches in interpreting exclusion clauses in contracts involving consumers in Malaysia and Singapore.

Use of the Term "Citizen" In Online Media Reports On Mostar's Local Elections

The specific regulatory framework under which the local elections in Mostar in 2020 were held, and especially the fact that the elections in this city were held after 12 years, puts in the focus of communication research the media treatment of the relationship between citizens and political parties in local communities organized under a mortgage of war ethnic and territorial divisions. Having in mind the influence of online media, both independent and relying on traditional media productions, this paper primarily deals with reporting on the results of local elections in Mostar, questioning the focus of reports in the context of relations between citizens, as a universal political category, and political candidates competing for the management of public affairs at the local level. Also, in additional elements of the research, the paper deals with the analysis of identification of participants in political processes, on the one hand, a citizen, who in the public discourse of Bosnia and Herzegovina is often treated as a member of an ethnic group, and a political party on the other, usually treated in media reports as a representative of national categories, and not as a performer of public affairs concerning the achieved election results.