Regulatory Procedures Research Articles

Regulatory Quality in the International Circulation of Medicinal Products

Since 2014, the World Health Organization has been implementing a large-scale project to strengthen and develop national regulatory systems, which is aimed at increasing the availability of safe, effective and high-quality medicines and medical devices for the population of all countries, but primarily low- and middle-income countries. The project analyzes the maturity of national regulatory systems using a global benchmarking tool developed based on various regulatory authority assessment systems and has undergone extensive discussion and pilot testing; the results of national authorities that have reached high levels of maturity are published. A WHO List of Regulatory Authorities is also being formed, replacing the previously used concept of "stringent regulatory authorities". This List is recommended for use in regulatory reliance procedures by national regulatory authorities, purchasing structures of various levels and status: commercial, public, state or international. The regulatory quality of drug regulation is one of the critical factors of any national healthcare system. At the global level, it is directly related to goals 1,3,8,9 and 11 of sustainable development defined by the UN. The WHO project under consideration to assess maturity) of the regulatory system of the pharmaceutical sector is fundamentally different from similarly focused projects carried out in the past. First of all, the project focuses not on legal and regulatory/methodological documents, but on institutional and procedural aspects, i.e. on the structure and functions of regulatory bodies. Along with this, the project can have a significant impact on global pharmaceutical markets.

Analysis of registered clinical trials in Italy regarding dermatology (2003-2022): a cross-sectional study on historical trend and prospects for industry investments.

This cross-sectional analysis intends to evaluate trend and outlook of industry clinical research in Italy regarding dermatology and its prospects for the next few years. A computerized search of ClinicalTrial.gov database was carried out considering the 20-year period 2003-2022 using the following string: "Skin Diseases OR Skin cancer OR Skin Neoplasms OR Skin Infection OR Skin Lesion OR Skin Ulcer OR Skin Laxity OR Skin toxicity OR Dermatologic Complication OR Skin abnormalities". During the last 20 years 690 Industry Clinical Trials (IndCTs) were conducted in Italy regarding dermatological investigations, almost entirely funded by non-Italian pharmaceutical companies, involving 4497 centers, and recruiting an average of 13.0 subjects per site. The number of controlled and randomized studies has grown quite regularly and in the last 5 years they represented 79.6% of IndCTs initiated. Countries most frequently sharing with Italy international protocols were Spain (75.0%), Germany (71.8%), France (68.5%), the USA (67.4%), and the UK (54.8%). These data point to a historical involvement of Italy in dermatology IndCTs lower than in the major European countries. However, the war in Ukraine has deprived IndCTs of the contribution of Russia, Ukraine, and Belarus, meaning a mean of about 40 new IndCTs per year in a population of 200 million inhabitants. In contrast, many indicators point to Italy as a country with potential in dermatology wider than used in the past: an efficient health care system accessible to any citizen or resident, 4.6 million dermatological interventions per year, low density of IndCTs concerning dermatology, good production of scientific papers in indexed medical journals, relatively low cost of services and labour and geopolitical stability. The European Clinical Trials Information System's (CTIS), mandatory for the EU member states since early 2023 allows common, simplified, and harmonized regulatory procedures over the life cycle of clinical trials in Europe (EMA, 2023) and plays in favor of Italy's greater competitiveness in clinical research.

Інституціональний базис для регулювання ринку логістичних послуг в україні та її регіонах з боку держави

The transformation of the Ukrainian economy towards market relations has brought to light significant imbalances in the logistics sector. A lack of an adequate theoretical framework and a clear state policy in this area has led to several problems. These include insufficient information support of logistics processes, a limited number of large logistics operators, and a need for more research and development in logistics. These factors complicate the optimization of trade flows and reduce the competitiveness of Ukrainian enterprises, making it an urgent matter that requires immediate attention. This publication aims to provide a detailed study of the system architecture and the evolution of forms of state regulation in the logistics sector. The architecture of the state regulation system in logistics provides a structured and comprehensive approach to managing logistics processes at the state level. It includes several main components that interact to ensure the effective functioning of the logistics services market. It is necessary to implement modern approaches to the state regulation of logistics services to ensure the Ukrainian economy’s sustainable development and improve citizens’ quality of life. These approaches can potentially revolutionize the sector, bringing about significant improvements. In particular, the priority task is to create a single digital window platform that will combine all permitting procedures into a single electronic service. At the same time, the government should actively work on harmonizing Ukrainian customs legislation with European standards, which will significantly simplify customs formalities and speed up the movement of goods. Implementing these measures will help increase the competitiveness of Ukrainian businesses and attract foreign investment, paving the way for a brighter future for the Ukrainian logistics sector. It is crucial to ensure close cooperation between the state and business. Regular consultations, transparency of regulatory procedures, and flexibility of legislation are critical factors for attracting investment and stimulating innovation. Introducing special tax regimes, such as corporate tax rebates for companies investing in infrastructure development and support for start-ups and innovative companies, will help modernize the industry and increase efficiency. However, the most significant step is harmonizing Ukrainian legislation with European standards. This is not just a formality but a significant milestone that will facilitate Ukraine’s integration into the European Economic Area, opening new opportunities for the Ukrainian logistics sector and paving the way for its growth and development. Keywords: state regulation, institutionalism, institutional framework, logistics, logistics sector, logistics regulation.

Insights into Early Interactions on Innovative Developments with European Regulators.

The European Medicines Agency Innovation Task Force (ITF) acts as early point of contact for medicine and technology developers to enable innovation during early drug development stages through ITF briefing meetings. To reflect on the current pace of innovation and to assess the potential of ITF stakeholder interactions, a comprehensive analysis of the ITF briefing meetings held between 2021 and 2022 was conducted with a focus on individual questions raised by the developers and the related feedback provided by the European regulators. Questions raised during ITF briefing meetings were extracted and categorised into main and sub-categories, revealing different themes across the whole medicine development process such as manufacturing technologies, pre-clinical developments, and clinically relevant questions. There was positive feedback from regulators who gave initial guidance in 85% of the answers, provided concrete examples in 20% of the answers and recommended to continue discussions through additional regulatory procedures in 22% of the answers. This analysis frames the content and the type of topics discussed during ITF briefing meetings. Moreover, it describes the type of regulatory feedback provided to medicine developers and identified potential for improvement of these early interactions. Therefore, this analysis emphasises the role of ITF briefing meetings in fostering innovation in medicine.

A Comparative Analysis of Business Models and their Impacts on Selected Indigenous Communities in Aklan, Philippines: Towards Sustainable Practices in Ancestral Domains

This study investigates the impacts of various economic models on indigenous communities in Aklan, Philippines, with a special focus on sustainable practices within their ancestral lands. It examines the socio-economic, cultural, and environmental consequences of different business models. Additionally, it delves into the community members’ perspectives and aspirations regarding sustainable development, highlighting the primary challenges and opportunities they face. The study utilized a quantitative research approach, employing structured surveys to collect data from participants. The poll encompassed inquiries regarding demographic profiles, assessments of commercial effects, as well as the difficulties and possibilities encountered by the communities. A Pearson correlation analysis was performed to ascertain the association between demographic characteristics and perceived impacts. The study found that business models had a favorable effect on the socio-economic status, cultural preservation, and environmental conservation of indigenous groups. Diverse advantages were noted in the benefits offered by various business structures. Perceptions of these impacts were significantly related to age, educational background, career, and length of involvement in community activities. The main obstacles encompassed issues related to financial accessibility, infrastructure development, regulatory barriers, and educational deficiencies. Potential areas for development were recognized in eco-tourism, sustainable agriculture, partnerships with non-governmental organizations, market demand for indigenous products, and technology. The findings highlight the capacity of business models to improve the socio-economic, cultural, and environmental welfare of indigenous communities. It is essential to have customized company strategies that take into account the demographic variety. To achieve the successful adoption of sustainable business models, it is crucial to tackle financial, infrastructural, and regulatory obstacles. It is advised to improve financial assistance by providing grants and microfinance, investing in infrastructure, streamlining regulatory procedures, and establishing education and training initiatives. It is crucial to promote eco-tourism, enhance partnerships with non-governmental organizations (NGOs) and stakeholders, and utilize technology to implement sustainable practices. It is crucial to have policies that effectively combine economic growth with the preservation of culture and the sustainability of the environment. Keywords: Indigenous communities, sustainable development, business models, Aklan, socio-economic impacts

More than red tape: exploring complexity in medical device regulatory affairs.

This study investigates the complexity of regulatory affairs in the medical device industry, a critical factor influencing market access and patient care. Through qualitative research, we sought expert insights to understand the factors contributing to this complexity. The study involved semi-structured interviews with 28 professionals from medical device companies, specializing in various aspects of regulatory affairs. These interviews were analyzed using a mix of qualitative coding and natural language processing (NLP) techniques. The findings reveal key sources of complexity within the regulatory landscape, divided into five domains: (1) regulatory language complexity, (2) intricacies within the regulatory process, (3) global-level complexities, (4) database-related considerations, and (5) product-level issues. The participants highlighted the need for strategies to streamline regulatory compliance, enhance interactions between regulatory bodies and industry players, and develop adaptable frameworks for rapid technological advancements. Emphasizing interdisciplinary collaboration and increased transparency, the study concludes that these elements are vital for establishing coherent and effective regulatory procedures in the medical device sector.

Digital practices for consumer e-participation in economic regulation and the role of organisational capacity

ABSTRACT How do national regulatory agencies (NRAs) use digital practices to empower consumers for e-participation in regulatory processes? To address this question, we designed a novel framework to comprehensively capture digital practices adopted by NRAs across the key regulatory procedures, including consumer information provision, communication, education, and rule-making, which we conceptualise as two-way relational mechanisms. To measure the scope of digital regulatory practices, we derived composite digital scores for 236 NRAs across 42 EU and OECD countries, based on coding the regulators’ websites and social media accounts. We also developed a new multidimensional construct of organisational capacity to explain the variation in the adoption of digital regulatory practices among NRAs with sole – and multi-sectoral competencies in five economic markets, ranging from utilities to financial services. Our findings show significant regional divergence in the adoption of digital regulatory practices by NRAs from the old and new EU member states, as well as the significant effect of NRA’s reform experience, resources allocations, sectoral competencies, and in-house capabilities on their digital scores. This study offers implications for both improving the effectiveness of regulatory procedures through consumer-oriented digital transformation, as well as government initiatives for enhancing digital trust and e-participation in economic regulation among consumers.

Factors driving consumer adoption of smart and green building materials: the role of civil engineers and architects

ABSTRACT This study aims to investigate the role of civil engineers and architects in driving consumer adoption of smart and green building materials in Bengaluru, India. A mixed-method approach is employed, including quantitative surveys of 350 consumers and qualitative interviews with 30 civil engineers and architects. The data are analyzed using descriptive, Confirmatory Factor Analysis (CFA), Structural Equation Modeling (SEM), and thematic analysis. Income acts as a moderating variable influencing the consumers in adoption. Civil engineers and architects use innovative marketing strategies, public education campaigns, and consumer involvement in decision-making. However, various barriers such as initial costs, limited availability, lack of expertise, and complex regulations prevent widespread adoption. The qualitative analysis highlighted the environmental benefit as the most relevant factor, increasing awareness and providing education as the most powerful strategy. Conversely, the lack of a uniform rating system and certification system is the most critical challenge affecting the adoption of these materials from a consumer behaviour perspective. Therefore, the study recommended incentivising green building materials, promote knowledge via professional development, and expedite regulatory procedures to encourage widespread use. The study uses civil engineers and architects as consumer acceptability influencers to help policymakers create a smart and green building material consumption roadmap.

Managing Substance Use Disorders and Addiction: How to Integrate Professionalism and Ethics with the Complexity of Diagnosis and Therapy

Physicians and other healthcare staff who work with the patients having substance use disorders (SUDs) and addiction have to deal with different and complex scenario invariably in comparison to other healthcare providers dealing with regular medical services sought by the patients. Hence, the unconventional nature of practice regarding patients of SUDs and addiction and the diverse range of backgrounds among substance use workers, e.g., psychiatrist, general physician, nurse, psychotherapist, counsellor, social worker, and public health specialist highlights the universal relevance of being more professional and more ethical in practice. They are expected to demonstrate a variety of ethical and professional competences to safeguard themselves and others involved. Clinical team engaged in such activities requires specific ethical training that can help them face specific ethical dilemmas and guide through deeper consideration of those pressing and complex issues, using specific framework, professional guidelines, or institutional management approaches. Professional societies and accrediting institutions should apply their authority to establish practice standards, competencies, regulatory procedures, and codes of ethics to help guide practice and protect public trust and confidence. For the team involved in practice, it is important to become familiar with and adhere to the principles and values that define professionalism and ethical conduct in care for patients suffering from SUDs and addiction. The review paper aims to examine the intersection of professionalism and ethics with the complexity of diagnosis and therapy in this specific area of practice. Besides, some frameworks will be highlighted which may help healthcare providers to foster ethical decision making. It is also a modest effort to show some new insights for improving the quality of care in addiction and mental health by the professional team and healthcare organization from both clinical and operational viewpoint. Mugda Med Coll J. 2024; 7(1): 42-47

Producing labour stratification: how migration policies affect the working, living and housing conditions of migrant farmworkers

ABSTRACT Based on a long-term investigation of migrant farmworkers within the Sicilian agricultural districts, this paper aims to use the lens of migratory stratification to scrutinize the various changes that have occurred in the agricultural sector over the past decade. Drawing on ethnographic data from an empirical study conducted on the working and living conditions of migrant farmworkers, this paper will shed light on the economic and social stratification strategies fostered by EU migration policies. In line with the issues addressed in this special issue, the paper analyses how migrant regulatory procedures have resulted in the deterioration of migrant farmworkers’ working, living and housing conditions. Before the so-called ‘refugee crisis’, the stratification of migrant farmworkers was mainly based on country of origin and involved labourers due to different times of arrival and legal status; with the onset of the ‘refugee crisis’, the mechanisms of stratification and labour substitution mainly involved asylum seekers.

REGULATION OF FINTECH INNOVATIONS THROUGH POLICY FRAMEWORKS: ENSURING CONSUMER PROTECTION WHILST PROMOTING INNOVATION

The emergence of FinTech technologies has prompted the creation of extensive regulatory frameworks that safeguard consumer interests while promoting an atmosphere that is supportive of technical progress. This study explores the complex regulatory environments that shape FinTech advances, primarily emphasizing the need to find a careful balance between protecting consumer interests and promoting innovation. This paper investigates crucial steps intended to strengthen consumer protection by undertaking a thorough review of worldwide regulatory procedures, including variances among countries and the crucial roles of governmental agencies. These controls cover a wide range of tactics, from the application of know-your-customer (KYC) and anti-money laundering (AML) procedures to strict transparency requirements and strong privacy protections. The report also looks at the procedures in place in the FinTech industry for handling customer complaints and guaranteeing accountability. In addition, the study explores different approaches to innovation in the regulatory environment, including the creation of regulatory sandboxes and the encouragement of joint ventures between industry players and regulatory bodies. This paper illustrates both effective regulatory interventions and difficulties found in regulating FinTech developments through the analysis of relevant case studies. These observations are combined to provide a set of practical suggestions that legislators can use to successfully navigate the changing regulatory environment around fintech. The report also provides predictions for future developments in FinTech legislation, giving decision-makers the insight they need to adjust to the ever-changing FinTech landscape.

FOSTERING COMPETITIVE ENVIRONMENTS FOR ENTREPRENEURS: INSIGHTS AND BEST PRACTICES

Today, it is critical fostering competitive environments in nurturing entrepreneurial success. In an era characterized by dynamic market landscapes, this study delves into key insights and best practices that contribute to creating an ecosystem conducive to the growth and sustainability of entrepreneurial ventures. This research investigates the challenges and perspectives in fostering a competitive environment for entrepreneurship, focusing on individual and institutional barriers faced by entrepreneurs. Drawing on a combination of qualitative data from semi-structured interviews and insights from existing literature, the study identifies key constraints such as regulatory barriers, legal uncertainties, financial challenges, human resource management issues, and inner fears and insecurities among entrepreneurs. Through a systematic analysis, the research proposes recommendations for policymakers and stakeholders to address these constraints and create a conducive environment for entrepreneurial activity. These recommendations include simplifying regulatory procedures, enhancing financial support mechanisms, improving talent development programs, fostering a supportive organizational culture, and combating corruption effectively. The study emphasizes the importance of a holistic approach that addresses both individual and institutional barriers to entrepreneurship, highlighting the need for collaboration between the public and private sectors. By implementing these recommendations, countries can unlock entrepreneurial potential, drive innovation, and achieve sustainable economic development. Keywords: entrepreneurial activity, competitive environment, challenges, solution, Kazakhstan.

Dossier submission in the UK after Brexit

The withdrawal of the United Kingdom (UK) from the European Union (EU), commonly known as Brexit, occurred on January 31, 2020, triggering a transition period until December 31, 2020, during which the UK and EU negotiated their future relationship. Brexit has brought significant changes to regulatory frameworks, particularly in the pharmaceutical sector. This article examines the transition of dossier submission procedures in the UK following Brexit, focusing on the implications for marketing authorizations (MAs) and pharmacovigilance. The Medicines and Healthcare Products Regulatory Agency (MHRA) transitioned to an independent regulatory body, establishing new guidelines for pharmaceutical companies seeking MAs in the UK. Key changes in marketing authorization routes include the conversion of centrally authorized products (CAPs) to UK MAs, the introduction of the Decentralized and Mutual Recognition Reliance Procedure (MRDCRP), and the implementation of a 150-day assessment timeline for national procedures. This article compares dossier requirements before and after Brexit in the UK and highlights pharmacovigilance requirements post-Brexit, emphasizing adjustments to reporting obligations, Qualified Person for Pharmacovigilance (QPPV) responsibilities, and the establishment of UK-specific Pharmacovigilance System Master Files (PSMFs). Additionally, it addresses the dossier Module 1 administrative information requirements to provide a comprehensive overview of the changes in regulatory procedures in the UK pharmaceutical sector following Brexit. Overall, the article aims to serve as a valuable resource for industry professionals, regulatory experts, and other stakeholders seeking clarity on the regulatory changes and their implications for pharmaceutical products in the UK following Brexit.

Analisis Pengetahuan, Sikap Dan Motivasi Kepatuhan Dokter Spesialis Dengan Pengisian Rekam Medis Pasien di Instalasi Rawat Inap RS X Jakarta

Completeness in filling of medical record files by doctors will be able to facilitate other health workers in providing action or treatment to patients, and can be used as a source of data in the Medical Record section in data management and reports that will be used as useful information for hospital management in determining evaluation and development of health services. At this time at RS X based on the Quality of Medical Records, the completeness of filling in the Medical Records of inpatients for the period January –Desember 2023 is still 59%. The purpose of this study was to analyze the compliance analysis of doctors filling out patients Medical Records at the inpatient installation of RS X Jakarta in 2023.The study was conducted with a cross sectional design, using a sample of 60 specialist doctors at RS X. Data were analyzed by Chi Square. Sources of Data This research is primary data collected by the method of distributing questionnaires as a research instrument.The results of the study concluded that there was a significant relationship between age, gender, knowledge, attitudes and motivation of doctors with compliance in filling out medical records with p-value ˂ 0.05. There is no significant relationship between tenure and compliance in filling out medical records with p-value = 0.452 ˃ 0.05. The most dominant relationship in physician compliance in filling out medical records is Doctor's Knowledge and Motivation with p-value = 0.000 ˂ 0.05. Dominance of knowledge and motivation of doctors in filling out medical records. The suggestion is that the knowledge and motivation of doctors really need to be a concern and the hospital management should consider things related to improving the quality of doctors in filling out medical records. Knowledge improvement in regulatory updates, SOPs and procedures for filling out medical records is very important. The use of electronic medical records can provide great benefits for health services such as hospitals.

Incorporation of sediment- and soil-specific aspects in the Criteria for Reporting and Evaluating Ecotoxicity Data (CRED).

In environmental risk assessment either for registration purposes or for retrospective assessments of monitoring data, the hazard assessment is predominantly based on effect data from ecotoxicity studies. Most regulatory frameworks require studies used for risk assessment to be evaluated for reliability and relevance. Historically, the Klimisch methodology was used in many regulatory procedures where reliability needed to be evaluated. More recently, the Criteria for Reporting and Evaluating Ecotoxicity Data (CRED) have been developed for aquatic ecotoxicity studies, providing more detailed guidance on the evaluation and reporting of not only the reliability but also the relevance of a scientific study. Here, we discuss the application of the CRED methodology for assessing sediment and soil ecotoxicity studies, addressing important sediment- and soil-specific criteria that should be included as part of the CRED evaluation system. We also provide detailed recommendations for the design and reporting of sediment and soil toxicity studies that can be used by scientists and researchers wishing to contribute ecotoxicological data for effect assessments carried out within regulatory frameworks. Integr Environ Assess Manag 2024;20:2162-2174. © 2024 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

РИЗИКИ ЯКОСТІ АУДИТОРСЬКИХ ПОСЛУГ

Introduction. Today, more than a million subjects of economic activity in the world are certified according to the ISO 9001 standard - quality management system. The quality management system (QMS) is an integral part of management that follows both market norms and business rules. The practice of implementing QMS, along with the optimistic results of quality improvements, reveals the debatable aspects of such processes. Problem Statement. The International Quality Management Standards application (which is one of the main audit reform directions in Ukraine) is today complicated both by the active pace of the mentioned processes (insufficient time for the unification of quality policies and procedures) and the difficulty of international regulatory practical application policies and procedures regarding audit quality. Subjects quite often postpone their orders for conducting a mandatory audit during the period of martial law, which leads to the emergence of quality control risks. Purpose – coverage of modern trends in the audit quality risks identification and assessment, justification for an audit firm of an alternative internal quality management system as an integral operational management component, that will enable the systematic approach formation to conduct a competitive audit. Methods. General scientific and special methods are used: analysis, synthesis, grouping, description, comparison, theoretical generalization and abstract-logical. Results. The complex nature of quality risks in modern audit conditions, their impact on the validity, reliability and persuasiveness of the auditor's opinion is revealed. The quality risk is investigated based on a comprehensive risk assessment in terms of the audit company's “quality management system” components. Common errors of auditing companies in the quality management system organization, the significance of their impact on compliance with norms and goals of audit quality are given. Based on the conceptual rules and principles of the International Quality Management Standards, alternative components of the “Quality Management System” for the audit company, their structural and logical connections with the identification of the functional role are proposed. Based on the international practice of risk-oriented management, methodical approaches to the identification and risk assessment are proposed, alternatives for internal regulation and specified processes documentation are revealed. Conclusions. The quality management system does not have a simple cycle, its effectiveness lies in systemic regulatory and internal management development. The internal audit of the QMS cannot fulfill its function by declarative decisions only. Due to the established communication with the auditors, interest in the demand for his role, the person responsible for the company's QMS should raise his competence' level, work with quality risks “in advance”. Issues of audit quality risk management highlighted in the article are quite new and require the methodological and practical principles formation of regulation and conceptually unified mechanisms for the implementation of such processes by audit companies.

Synthetic polypeptides using a biologic as a reference medicinal product - the European landscape of regulatory approvals.

Recent advances in synthetic drug manufacturing have introduced a new dynamic to the European regulatory system, with chemically synthesized polypeptide products using biological originator products as their reference medicine. Whereas biosimilars are subject to a dedicated regulatory framework in the EU, synthetically produced follow-on products are not eligible for assessment through this pathway, requiring approval via the traditional generic pathway under Article 10 (1), or via the hybrid pathway under Article 10 (3). This review presents an overview of recent developments in the field of synthetic peptides referencing biological originators in the EU. The use of different regulatory procedures can have potential implications for regulatory assessments, clinical practice and pharmacovigilance. As more complex synthetic products referencing recombinant originator products are expected in the coming years, this study promotes more transparency as well as global alignment about regulatory procedures for chemically synthesised products referencing biological originator products to ensure approval of safe and high-quality generics.

Information Sovereignty of the Republic of Belarus and the Russian Federation: Directions for Ensuring and Ways to Improve them

The article discusses the main directions of ensuring information sovereignty in the Republic of Belarus and the Russian Federation, as well as ways to improve them. To date, some problems have been identified that relate to the security of the information sphere of the Russian Federation and the Republic of Belarus, which made it possible to create specific measures to resolve them.Aim. In the information sphere of countries such as the Republic of Belarus and the Russian Federation, various studies of a comprehensive plan were conducted by various scientists, politicians, as well as the military. Thanks to these studies, today there is a theoretical basis for improving the entire mechanism for protecting the information sovereignty of the two countries. However, due to the dynamism of the integration plan processes, changes in globalization, as well as due to the situation in geopolitics, it becomes necessary to conduct more and more analytical studies regarding the application of practical experience in ensuring national security in the information sphere.Tasks. Identification and justification of priority areas for improving the provision of information sovereignty of the Republic of Belarus and the Russian Federation as the basis of the information component.Methods. During the study, standard scientific methods of analysis and synthesis, expert-analytical, structural-logical, comparative and structural-functional methods, as well as a forecasting method were used.Results. The study showed that the information sovereignty of the Republic of Belarus and the Russian Federation ensures their political, economic, social stability and sustainable progressive development, since in the context of the globalization of the information space and key areas of public life, the influence on the information field increases and the importance of information security at the national levels increases for each state.Conclusions. It is expedient to consolidate the equal importance in the composition of the structural mechanisms for ensuring the information sovereignty of the Republic of Belarus and the Russian Federation, their constitutional and legal status and equivalent nature. The use of exclusively control and supervisory, regulatory and restrictive procedures in the information environment is not sufficient to maintain information sovereignty.

Evaluation of sustainability reporting of the food industry in Hungary from an EU taxonomy perspective

Compliance with green requirements is becoming increasingly important in assessing the performance of companies. The new CSRD legislation requires a wider range of companies to produce sustainability reports and their content is influenced by the EU's taxonomy regulation setting out the framework for sustainable finance. The disclosure of information affects the perception of companies' sustainability performance, which will affect their access to financial resources and development opportunities. The main question is, both in theory and in practice, how companies can comply with the legislation in the future. It is essential for the competitiveness of Hungary's food industry to keep pace with future environmental sustainability requirements, so we examined the sustainability reporting practices of the sector's key companies in terms of their contribution to the environmental objectives set out in the taxonomy regulation. The research fits well with the EU's overall green transition regulatory procedure and our study is gap-filling at macro-regional and sectoral levels. The sustainability reports were assessed by content analysis using a scoring method. The results show that the sustainability reporting practices of food processing companies in Hungary differ significantly. Furthermore, greater emphasis must be placed on reporting and the credibility of the reports to meet future expectations. Foreign-owned companies and companies with more than 500 employees attribute greater importance to reporting. In the food processing sector, the disclosure of information and data under the taxonomy objectives of mitigation of climate change, sustainable use of water and marine resources, and transition to a circular economy was most common.

Digital transformation in accounting: elevating effectiveness across accounting, auditing, reporting and regulatory compliance

Purpose The study aims to analyse the role of digitisation in accounting in enhancing the overall effectiveness of accounting functions. To achieve this, the study provides empirical evidence from the stakeholder’s perspective of digitisation of accounting, auditing, reporting and regulatory compliance procedures. Design/methodology/approach The study has applied a quantitative approach to identify the thoughts of auditors, accountants and academicians on the impact of digitalised accounting applications on accounting functions. The data was collected by administering an empirical study and a sample of 482 professionals from the accounting, auditing and academic sectors. To analyse and interpret data descriptive statistics, structured equation modelling and mediation analysis has been used. Findings The finding of the study signifies the relevance of digitalised accounting applications in accounting functions and reveals that there is a significant impact of digitalisation on accounting, auditing, reporting and regulatory compliance aspects of accounting functions. The outcome of the study explores that a digitalised accounting system reduces possible errors and improves the accuracy and transparency of the system. Research limitations/implications The study highlighted the importance of developing new methods and techniques that can be used in practice. This indirectly advocates the inclusion of such concepts in accounting curricula to emphasise the need to understand the challenges and opportunities created by digitisation. Furthermore, the study will become a motivation to scholars who intend to explore different areas through which new technologies can be adopted to transform traditional accounting systems. Practical implications The contributions of the current study have implications that the adoption of digitised accounting enhances economic efficiency through a reduction in accounting costs, and enhanced accuracy that leads to the elimination of penalties and litigations for non-compliance with regulatory authorities. This indirectly impacts positively on the financial health of the business organisations and economies at large. This implication becomes greater evidential support to the organisations which are yet to plan the adoption and implementation of digital tools in their organisation for accounting functions. Originality/value Digitalisation is a relevant part of the accounting function to improve efficiency and accuracy. Since accounting and auditing practitioners struggle to control the accuracy and efficiency of transactions. Furthermore, the outcome of the study assists organisations in gaining real-time access to financial data, transforms workflows and empowers management to make timely informed sound decisions, optimise resource allocation, efficient regulatory compliance and so on.