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Background: Access to medicine is crucial for the effective functioning of healthcare systems. A robust regulatory framework is necessary to ensure the safety, effectiveness, and availability. However, weak regulatory frameworks persist in many low- and middle-income countries, leasing to the circulation of falsified and substandard medicines as well as anti-competitive restrictions on registering poor-quality medicines, which poses a significant public health threat. This study evaluated the evolution of Zanzibar's medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level. Methods: This study was conducted at the Zanzibar Food and Drug Agency (ZFDA) in Unguja, Zanzibar, using a retrospective cross-sectional review and qualitative approach. It thoroughly reviewed relevant regulatory documents, including Acts, policies, guidelines, and assessment reports. Data were collected using a standardised checklist and analysed to uncover patterns and insights regarding the evolution of Zanzibar's medicine regulatory system. Results: This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities. Conclusion: Zanzibar's medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. Future efforts should address the remaining challenges and foster collaboration with regional and international bodies to ensure the continued evolution and effectiveness of Zanzibar's medicine regulatory framework. [ABSTRACT FROM AUTHOR]

Genetically modified (GM) crops are the most important agricultural commodities that can improve the yield of African smallholder farmers. The intricate circumstances surrounding the introduction of GM agriculture in Africa, however, underscore the importance of comprehending the moral conundrums, regulatory environments, and public sentiment that exist today. This review examines the current situation surrounding the use of GM crops in Africa, focusing on moral conundrums, regulatory frameworks, and public opinion. Only eleven of the fifty-four African countries currently cultivate GM crops due to the wide range of opinions resulting from the disparities in cultural, socioeconomic, and environmental factors. This review proposed that addressing public concerns, harmonizing regulations, and upholding ethical standards will improve the adoption of GM crops in Africa. This study offers ways to enhance the acceptability of GM crops for boosting nutrition and food security globally. [ABSTRACT FROM AUTHOR]

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa's current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template. [ABSTRACT FROM AUTHOR]

Supply chain resilience involves creating diverse and redundant sources for raw materials, optimizing logistics, and employing advanced forecasting techniques to anticipate and mitigate potential shortages. Manufacturing resilience focuses on adopting scalable and adaptable production technologies, enhancing quality control measures, and establishing contingency plans for production disruptions. Regulatory resilience entails the capacity to navigate and comply with evolving regulatory landscapes swiftly, fostering collaborations with regulatory agencies to expedite approval processes during emergencies. Innovation and research resilience are crucial for sustaining drug development and responding to emerging health threats. This involves investing in cutting-edge technologies, fostering partnerships for collaborative research, and maintaining a pipeline of new therapies and treatments. Pharmaceutical resilience also requires effective communication and coordination among stakeholders, including pharmaceutical companies, healthcare providers, governments, and international organizations. By enhancing these components, the pharmaceutical sector can better withstand and recover from disruptions, ensuring continuous access to essential medications and safeguarding public health. This abstract emphasizes the multifaceted approach needed to build and sustain resilience within the pharmaceutical industry, ensuring its capacity to meet both current and future challenges effectively. [ABSTRACT FROM AUTHOR]

This article examines the critical role of life insurance in India's economic development, focusing on its growth, contributions, and challenges. The life insurance sector in India has experienced significant expansion due to government initiatives like the Pradhan Mantri Jan Dhan Yojana (PMJDY) and Pradhan Mantri Jeevan Jyoti Bima Yojana (PJJBY), which have improved market penetration and accessibility. Key findings include the importance of a robust regulatory framework, the impact of financial inclusion, and the necessity of enhancing public awareness and trust. The study also highlights future research directions, such as exploring technological innovations, evaluating government schemes, and understanding consumer behavior. The article concludes by emphasizing the sector's role in fostering financial stability and economic growth, while addressing ongoing challenges and identifying opportunities for further development. [ABSTRACT FROM AUTHOR]

This opinion paper evaluates the potential of porcine islets as a promising alternative in beta cell replacement therapy for Type 1 Diabetes (T1D), juxtaposed with the current limitations of human donor islets. It analyzes the compatibility of pig islets with human glucose metabolism, their prospects as a limitless and high-quality source of beta cells, and the unique immunogenic challenges they present in xenotransplantation. Additionally, the paper discusses the regulatory and ethical considerations pertinent to the use of porcine islets. By synthesizing current research and expert perspectives, the paper highlights both the opportunities and significant barriers that need addressing to advance pig islets as a viable therapeutic option. The findings advocate for a balanced and forward-looking approach to the integration of pig islets in T1D treatment, underscoring the need for continued research and dialogue in this evolving field. [ABSTRACT FROM AUTHOR]

Repurposing generic drugs as new treatments for life-threatening diseases such as cancer is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. Nonprofit organizations and other non-manufacturers have been ramping up efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these nonmanufacturers find it difficult to obtain regulatory approval in the U.S. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs. This limits the broad clinical adoption of these drugs and patient access. In this paper, we explore the regulatory landscape for repurposing of small molecule generic drugs within the U.S. We describe case studies of repurposed drugs that have been successfully incorporated into clinical treatment guidelines for cancer without regulatory approval. To encourage greater adoption of generic drugs in clinical practice-that is, to encourage the repurposing of these drugs-we examine existing Food and Drug Administration (FDA) pathways for approval of new uses or indications for generic drugs. We show how non-manufacturers, who are generally more active in generic drug repurposing than manufacturers, could utilize existing regulatory authorities and pathways, and we describe the challenges they face. We propose an extension of the existing 505(b)(2) new drug application (NDA) approval pathway, called a "labeling-only" 505(b)(2) NDA, that would enable non-manufacturers to seek approval of new indications for well-established small molecule drugs when multiple generic products are already available. It would not require new chemistry, manufacturing, and controls (CMC) data or introducing new drug products into the marketplace. This pathway would unlock innovation broadly and enable patients to benefit from the enormous potential of low-cost generic drugs. [ABSTRACT FROM AUTHOR]

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients' quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a "medical device lag," where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA). [ABSTRACT FROM AUTHOR]

Genetically modified (GM) crops are the most important agricultural commodities that can improve the yield of African smallholder farmers. The intricate circumstances surrounding the introduction of GM agriculture in Africa, however, underscore the importance of comprehending the moral conundrums, regulatory environments, and public sentiment that exist today. This review examines the current situation surrounding the use of GM crops in Africa, focusing on moral conundrums, regulatory frameworks, and public opinion. Only eleven of the fifty-four African countries currently cultivate GM crops due to the wide range of opinions resulting from the disparities in cultural, socioeconomic, and environmental factors. This review proposed that addressing public concerns, harmonizing regulations, and upholding ethical standards will improve the adoption of GM crops in Africa. This study offers ways to enhance the acceptability of GM crops for boosting nutrition and food security globally.

The relevance of the article is due to the insignificant contribution of microfinance to the development of the Russian economic system, especially in the context of supporting small and medium-sized businesses. However, the regulator sees it as a promising sector of the financial market and considers its progressive development necessary. The purpose of the work is to study the current state and identify trends in the development of the microfinance market in Russia. The methodological basis of the study includes empirical observation and analysis. During the work, official statistical data and scientific publications on the topic of microfinance have been used. The article provides a review of current legislative documents regulating the microfinance sector, and analyses the state of the market based on statistical data. It is substantiated that some elements of the monetary and financial policies pursued in the Russian Federation can be applied for the successful development of the microfinance sector, contribute to its effective and balanced work, and improve accessibility and sustainability. In the course of the work, key directions for the development of the microfinance market are formed: improving regulation and supervision; promoting financial literacy of the population; application of digital technologies; expansion and diversification of the product portfolio, development of partnerships, social entrepreneurship, which contribute to the sustainable development of this segment of the financial market. Particular attention is paid to a detailed analysis of improving the regulatory framework for microfinance in Russia from the point of view of legislation on bankruptcy of individuals, stimulating innovation and digitalisation, and supporting social entrepreneurship.

Abstract This article examines the critical role of life insurance in India's economic development, focusing on its growth, contributions, and challenges. The life insurance sector in India has experienced significant expansion due to government initiatives like the Pradhan Mantri Jan Dhan Yojana (PMJDY) and Pradhan Mantri Jeevan Jyoti Bima Yojana (PJJBY), which have improved market penetration and accessibility. Key findings include the importance of a robust regulatory framework, the impact of financial inclusion, and the necessity of enhancing public awareness and trust. The study also highlights future research directions, such as exploring technological innovations, evaluating government schemes, and understanding consumer behavior. The article concludes by emphasizing the sector's role in fostering financial stability and economic growth, while addressing ongoing challenges and identifying opportunities for further development.

The article outlines the provisions of the modern regulatory framework that regulates the work of health spa (sanatorium) organizations and the use of natural healing resources for therapeutic purposes. The legislative innovations, the main tasks and problems of the development of the spa and resort industry from a medical point of view are described. The historical background of the development of the spa and resort medical industry in the context of natural resources is presented. It describes the development of health resort business in Russia from the emergence of the first sanatorium to the present day.

Abstract Background Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use, however due to their special properties the availability of approved radiopharmaceuticals is limited. For this reason, they can be produced on a small scale outside the marketing authorization process. Main body The in-house radiopharmaceutical preparations represent an important source of these special medicines for routine nuclear medicine practice. However, a lack of harmonization in Member States’ regulations leads to extreme differences in the use and availability of radiopharmaceuticals across Europe. The aim of this work is to provide an overview of the different national regulatory frameworks in which Directive 2001/83/UE is adopted on the preparation of radiopharmaceuticals outside the marketing authorization track in Europe. Nine different national regulations have been studied to describe how unlicensed radiopharmaceuticals are prepared. Special attention is paid to reflect the minimum standards that these preparations should meet as well as the educational requirements to be a radiopharmacist in charge of them. Conclusion The rapid development of new radiopharmaceuticals used in radiometabolic therapy requires a common regulation that allows balance between the use and preparation of licensed and unlicensed radiopharmaceuticals. The absence of a harmonized regulation for the radiopharmaceutical small-scale preparation and the implementation of Good Manufacture Practices, leads to extreme differences in the use, quality assurance and availability of radiopharmaceuticals in Europe.

The purpose of this article is to investigate the factors that influence the authenticity of heritage hotels in popular tourist destinations. Using the Greek island of Santorini as a case study, the following three (3) factors, which have not been systematically studied so far, are examined and appear to have a significant impact on authenticity in the conversion of a heritage architectural building into a heritage hotel: (a) its structural characteristics, (b) the influence of the star classification system and (c) the extent to which each business promotes authenticity elements and heritage identity. For the purposes of this study, a threefold methodological approach was conducted, which includes archival research in the registry of the Hellenic Chamber of Hotels for all the heritage hotels in Santorini (69 units), research in the accounting data of the island’s heritage hotels certified with the national star ranking system for their services and amenities and research analysis of the information regarding the promotion of the heritage hotels through their official websites. Additionally, a cartographic representation of the locations of these hotels was created and their positioning was compared to the boundaries of traditional or non-traditional settlements. The results validated the basic finding of the literature review, that the authenticity of a heritage hotel is a construction under constant negotiation, influenced by a multitude of factors. The conversion of a historic building into a heritage hotel is a multidimensional process that requires a delicate balance between preserving cultural value and adapting to the needs of modern tourism, as well as a continuous evaluation and review of the policies in place.

Background Ethiopia’s potato seed system is currently hindered by a disjointed regulatory framework, insufficient quality assurance processes, and a lack of collaboration among stakeholders, which collectively impede agricultural productivity and food security. The regulatory environment is characterized by inconsistent seed certification practices and a dependence on informal seed sources, negatively affecting the quality of potato seeds available to farmers. Although potatoes play a crucial role in global food security by providing high yields compared to other staple crops, the sector grapples with significant challenges due to bureaucratic inefficiencies, limited technical expertise, and the widespread presence of counterfeit seeds throughout the value chain. Methods To tackle these challenges, this mini-review outlines potential improvements, stressing the necessity for a unified regulatory framework tailored to the unique issues of vegetatively propagated crops. For this reason, we have used different literature source from web of science, Pubmed, Google Scholar, ResearchGate and other scientific websites. We have documented the most relevant information focusing on potato seed system, regulatory frameworks, quality assurance bottlenecks and pathways for improvement across the seed value chain. Results our paper highlights key recommendations that includes enhancing training for regulatory staff, investing in research for disease-resistant varieties, and bolstering public-private partnerships to encourage innovation and resource sharing. Furthermore, improving traceability in the seed supply chain is essential for maintaining seed quality and integrity. Conclusions This review calls for a comprehensive strategy that fosters stakeholder engagement and promotes sustainable practices to rejuvenate Ethiopia’s potato seed system, thereby supporting the livelihoods of millions of smallholder farmers and strengthening national food security through integrated seed sector development and capacity improvement of the seed regulatory body as well as smallholder farmers.

Background: Radiopharmaceuticals have been considered a special group of medicines in Europe since 1989. The use of radiopharmaceuticals that have marketing authorization should always be the first option in clinical use, however due to their special properties the availability of approved radiopharmaceuticals is limited. For this reason, they can be produced on a small scale outside the marketing authorization process. Main body: The in-house radiopharmaceutical preparations represent an important source of these special medicines for routine nuclear medicine practice. However, a lack of harmonization in Member States' regulations leads to extreme differences in the use and availability of radiopharmaceuticals across Europe. The aim of this work is to provide an overview of the different national regulatory frameworks in which Directive 2001/83/UE is adopted on the preparation of radiopharmaceuticals outside the marketing authorization track in Europe. Nine different national regulations have been studied to describe how unlicensed radiopharmaceuticals are prepared. Special attention is paid to reflect the minimum standards that these preparations should meet as well as the educational requirements to be a radiopharmacist in charge of them. Conclusion: The rapid development of new radiopharmaceuticals used in radiometabolic therapy requires a common regulation that allows balance between the use and preparation of licensed and unlicensed radiopharmaceuticals. The absence of a harmonized regulation for the radiopharmaceutical small-scale preparation and the implementation of Good Manufacture Practices, leads to extreme differences in the use, quality assurance and availability of radiopharmaceuticals in Europe. [ABSTRACT FROM AUTHOR]

As the global financial ecosystem undergoes a paradigm shift toward sustainability, platforms emerge as instrumental intermediaries, connecting diverse stakeholders, facilitating information flow, and catalyzing impactful investments. This paper analyses the evolving landscape of sustainable finance and investigates the role of platforms in fostering its growth. Sustainable finance platform-based enablers were determined using a systematic literature review and bibliometric techniques on a sample of papers retrieved from the SCOPUS database, and included crowdfunding platforms, impact investment platforms, peer-to-peer (P2P) lending platforms, blockchain-based financing platforms, and ESG data platforms. The analysis showed that platform-based solutions act as accelerators of sustainable finance mobilization, by enhancing transparency of the processes, and by improving dissemination and accessibility of the funds needed. Thus, platform-based solutions help a broader set of stakeholders direct the potential of platforms to accelerate the transition toward a more sustainable and inclusive global financial system. [ABSTRACT FROM AUTHOR]

The management of drinking water treatment plant (DWTP) sludge is challenging for water treatment facilities. Previous studies reported mainly on handling sludge through landfilling, release into water bodies, discharge into wastewater treatment plants, onsite disposal, and incineration methods for the treatment of sludge. The limitations of these sludge-handling methods are well documented. This article focuses on the hierarchical approach as an alternative and comprehensive method for handling DWTP sludge. The core of hierarchical management streamlines the minimization of the generated DWTP sludge; treatment of DWTP sludge to reduce toxicity; changing of the physicochemical form of DWTP sludge; and finally, the reuse, recycling, and recovery of DWTP sludge. The premise is to achieve zero landfilling of DWTP sludge, establish a circular economy, generate job opportunities, and preserve the environment. Thus, this study also proposes two main technologies, which are gravity-based sludge separators for fractionating the sludge and photocatalytic membrane reactors (PMRs) as a technology for the treating and/or recovery of nutrients and minerals from DWTP sludge. Until the chemical deductive or minus approach becomes a reality in water treatment, the use of PMRs and gravity-based sludge separators will enhance the management of DWTP sludge when incorporated into the hierarchical approach. [ABSTRACT FROM AUTHOR]

The purpose of this article is to investigate the factors that influence the authenticity of heritage hotels in popular tourist destinations. Using the Greek island of Santorini as a case study, the following three (3) factors, which have not been systematically studied so far, are examined and appear to have a significant impact on authenticity in the conversion of a heritage architectural building into a heritage hotel: (a) its structural characteristics, (b) the influence of the star classification system and (c) the extent to which each business promotes authenticity elements and heritage identity. For the purposes of this study, a threefold methodological approach was conducted, which includes archival research in the registry of the Hellenic Chamber of Hotels for all the heritage hotels in Santorini (69 units), research in the accounting data of the island's heritage hotels certified with the national star ranking system for their services and amenities and research analysis of the information regarding the promotion of the heritage hotels through their official websites. Additionally, a cartographic representation of the locations of these hotels was created and their positioning was compared to the boundaries of traditional or non-traditional settlements. The results validated the basic finding of the literature review, that the authenticity of a heritage hotel is a construction under constant negotiation, influenced by a multitude of factors. The conversion of a historic building into a heritage hotel is a multidimensional process that requires a delicate balance between preserving cultural value and adapting to the needs of modern tourism, as well as a continuous evaluation and review of the policies in place. [ABSTRACT FROM AUTHOR]

Background: This study critically assesses the regulatory challenges faced in Brazil for mechanical ventilators amid the COVID-19 pandemic. It evaluates the effectiveness of expedited regulatory actions, compares strategies with other countries, and proposes future optimization in emergency conditions. Methods: Premarket submissions of mechanical ventilators were surveyed, involving accompanying certification documentation, rejections, approvals, and cancellations. Postmarket occurrences were surveyed until June 2023, evaluating their incidence and presence of certifications. Regulatory pathways in other countries were reviewed for comparison. Results: Brazil's regulatory strategy increased its ventilator supply capacity 17 times in 10 months. However, the absence of essential certifications in 95.52% of the premarket submissions, such as the Certificate of Conformity issued by the Brazilian Conformity Assessment System (CC-SBAC), raised safety and performance concerns. Among temporarily approved ventilators, the main cause of cancellation (76.92%) was the absence of certifications after the temporal approval, notwithstanding the already installed devices maintaining authorization for use in health services. Postmarket alerts lacked CC-SBAC issuance in 75% of the cases when sponsors reported the occurrences. It highlighted the importance of ongoing technical assistance and monitoring, particularly for devices lacking proper certifications. Conclusions: The extraordinary regulatory conditions in Brazil significantly impacted ventilator premarket evaluation. However, lacking essential certifications led to post-approval cancellations. Postmarket occurrences emphasized necessary vigilance, with most alerts involving uncertified devices. Improved premarket evaluation, considering component shortages and real-world usage scenarios, as collaborative efforts from other countries and international bodies, is crucial for ensuring the safety and effectiveness of ventilators in public health emergencies. [ABSTRACT FROM AUTHOR]

Net metering (NM) is among the potent regulatory tools used globally for supporting distributed generation and renewable energy sources. This paper examines the trajectory of NM in a developing country such as Pakistan, analyzing the impact of regulatory changes, confidence-building strategies, hindering factors, and technical/financial issues. The three-stage methodology involves three components, namely techno-economic analysis, stakeholder engagement surveys, and impact analysis of financing mechanisms. This study emphasizes the importance of clear regulatory and financial frameworks, grid upgrades, and public–private partnerships for technology distribution in the context of a developing country with weak grid utilities and an import–export energy ratio. It also explores the role of financial incentives, such as tax breaks and subsidies, to encourage investment in NM systems from the perspective of lucrative rates, impact on paybacks, and return on investments, and proposes concrete solutions to enhance financial inclusion for ambitious renewable energy goals. Until April 2023, over 56,000 NM/distributed generation facilities were commissioned, with an installed capacity of 950 MW. By May 2024, the number of NM consumers reached ~100,000, with a 1950 MW capacity, nearly doubling. However, the import and export ratio of IESCO changed most, with 61% exports and 39% imports, directly impacting the revenue stream. A total of 60% of banks have adopted actions linked with green banking criteria, aiming to limit their environmental impact. The change in tariff will result in reduced ROI for NM consumers to 20%, and increase the payback period from less than 4 years to 13 years. Government subsidies, tax breaks, and green financing frameworks are proposed to encourage investment, but have been abruptly halted, and were previously at a 6% interest rate. This research aims to provide insights into effective market evaluation methodologies for NM programs and offer policy recommendations to strengthen legislative and institutional frameworks governing NM. [ABSTRACT FROM AUTHOR]

The travel and tourism industry in India is one of the country's most vibrant sectors, significantly contributing to economic growth, employment generation, and cultural exchange. Despite its immense potential, the industry faces numerous challenges that hinder its sustainable development. This paper critically examines the challenges of travel and tourism management in India, including infrastructural deficits, environmental concerns, regulatory complexities, seasonality, lack of skilled workforce, and the impact of socio-political factors. It explores how these challenges affect the tourism sector's growth and offers insights into potential solutions and strategic approaches for effective management. The study draws on data from various reports, academic literature, and case studies to provide a holistic understanding of the multifaceted issues plaguing the industry. In conclusion, the paper emphasizes the need for a collaborative effort between government, private sector, and community stakeholders to overcome these challenges and ensure the sustainable development of tourism in India. [ABSTRACT FROM AUTHOR]

Childhood cancer is a leading cause of death in children, and the increasing availability of digital healthcare data, coupled with rapid progress in artificial intelligence (AI), brings a transformative opportunity to revolutionise its diagnosis, treatment and ultimately improve patient outcomes by leveraging diverse data resources. However, the effective application of AI in childhood cancer requires strict adherence to regulatory and best practice guidelines for patient data preparation and AI model development. Currently, there is a lack of such regulatory and methodological guidance specifically tailored for the paediatric community. This review seeks to address this gap. Beginning with an overview of existing regulatory frameworks, it examines the types of data currently in use or with potential use in developing AI applications for childhood cancer. This encompasses data from traditional sources, such as patient data and electronic health records (EHRs), as well as emerging sources like social media data and social determinants of health. This review also outlines the rules and criteria for collecting, processing, and sharing these data. Informed consent and re-consent are required for data collection and re-use, and data quality, privacy, and security as well as data standardisation, harmonisation and interoperability are important for data processing. Additionally, this review clarifies the essential requirements and methodologies for developing AI models in childhood cancer and healthcare. It also emphasises the importance of AI being trustworthy, protecting privacy, and being accountable and validated in clinical settings. By systematically addressing these key components, this review aims to provide comprehensive knowledge and practical tools for the reliable application and implementation of AI in paediatric cancer to enhance AI acceptance and promote its widespread integration within the childhood cancer community. This, in turn, will lead to improved diagnosis, treatment and outcomes for children with cancer.

Background Access to medicine is crucial for the effective functioning of healthcare systems. A robust regulatory framework is necessary to ensure the safety, effectiveness, and availability. However, weak regulatory frameworks persist in many low- and middle-income countries, leasing to the circulation of falsified and substandard medicines as well as anti-competitive restrictions on registering poor-quality medicines, which poses a significant public health threat. This study evaluated the evolution of Zanzibar’s medicine regulatory system over the past two decades and identified the key factors contributing to its success by elaborating on the Zanzibar Food and Drug Agency, seeking the expertise of regional, continental, and global experts to assess its regulatory capacity and maturity level.Methods This study was conducted at the Zanzibar Food and Drug Agency (ZFDA) in Unguja, Zanzibar, using a retrospective cross-sectional review and qualitative approach. It thoroughly reviewed relevant regulatory documents, including Acts, policies, guidelines, and assessment reports. Data were collected using a standardised checklist and analysed to uncover patterns and insights regarding the evolution of Zanzibar’s medicine regulatory system.Results This study revealed substantial legal provisions, organisational development, strategic planning, and resource allocation improvements. Notable achievements include establishing a structured organisational framework, developing a comprehensive strategic plan, and implementing a Quality Management System (ISO 9001:2015 certified). The ZFDA also addressed human resource limitations by creating job descriptions and a staff scheme of service, enhancing financial resources through revised fee regulations and government support, and improving infrastructure with new office and laboratory facilities.Conclusion Zanzibar’s medicine regulations have evolved significantly, with marked regulatory capacity and infrastructure improvements. Future efforts should address the remaining challenges and foster collaboration with regional and international bodies to ensure the continued evolution and effectiveness of Zanzibar’s medicine regulatory framework.

Broad consent is permitted by the South African National Department of Health Ethics Guidelines but appears to be prohibited by section 13(1) of the Protection of Personal Information Act 4 of 2013. Additionally, the Act mandates that all personal data (including biobank sample data) be collected for lawful, explicit, and clearly defined purposes. There is possibility for ambiguity in interpretation because of this discrepancy between the two instruments. Given the association between the transfer of samples and data, the long-term nature of biobanking, which makes it impractical to provide too much or enough information because it is simply not available at the time of sample collection, and the various ways that the Protection of Personal Information Act 4 of 2013 have been interpreted, we aim to demonstrate that South Africa’s current regulatory framework should appropriately permit broad consent use for biobank research where the transfer of samples and their associated data are contemplated. In summary, the proposed amendments include removing regulatory ambiguity regarding broad consent use, ensuring adequate safeguards for research participants by specifying rules for data access and personal information processing, and incorporating consent form information requirements into the national Consent Template.

This opinion paper evaluates the potential of porcine islets as a promising alternative in beta cell replacement therapy for Type 1 Diabetes (T1D), juxtaposed with the current limitations of human donor islets. It analyzes the compatibility of pig islets with human glucose metabolism, their prospects as a limitless and high-quality source of beta cells, and the unique immunogenic challenges they present in xenotransplantation. Additionally, the paper discusses the regulatory and ethical considerations pertinent to the use of porcine islets. By synthesizing current research and expert perspectives, the paper highlights both the opportunities and significant barriers that need addressing to advance pig islets as a viable therapeutic option. The findings advocate for a balanced and forward-looking approach to the integration of pig islets in T1D treatment, underscoring the need for continued research and dialogue in this evolving field.

Repurposing generic drugs as new treatments for life-threatening diseases such as cancer is an exciting yet largely overlooked opportunity due to a lack of market-driven incentives. Nonprofit organizations and other non-manufacturers have been ramping up efforts to repurpose widely available generic drugs and rapidly expand affordable treatment options for patients. However, these non-manufacturers find it difficult to obtain regulatory approval in the U.S. Without a straightforward path for approval and updating drug labeling, non-manufacturers have relied on off-label use of repurposed drugs. This limits the broad clinical adoption of these drugs and patient access. In this paper, we explore the regulatory landscape for repurposing of small molecule generic drugs within the U.S. We describe case studies of repurposed drugs that have been successfully incorporated into clinical treatment guidelines for cancer without regulatory approval. To encourage greater adoption of generic drugs in clinical practice–that is, to encourage the repurposing of these drugs–we examine existing Food and Drug Administration (FDA) pathways for approval of new uses or indications for generic drugs. We show how non-manufacturers, who are generally more active in generic drug repurposing than manufacturers, could utilize existing regulatory authorities and pathways, and we describe the challenges they face. We propose an extension of the existing 505(b)(2) new drug application (NDA) approval pathway, called a “labeling-only” 505(b)(2) NDA, that would enable non-manufacturers to seek approval of new indications for well-established small molecule drugs when multiple generic products are already available. It would not require new chemistry, manufacturing, and controls (CMC) data or introducing new drug products into the marketplace. This pathway would unlock innovation broadly and enable patients to benefit from the enormous potential of low-cost generic drugs.

Agriculture has a strategic role in providing food for the population. This causes significant government intervention in this sector, and therefore the development of high-quality approaches to this process remains relevant. This study aimed to provide recommendations for this process in Ukraine, particularly in the context of economic digitalisation. To achieve this, graphical analysis, modelling, abstraction, and the method of logical reasoning were used. The role of digital technologies in achieving more effective results in the context of improving the efficiency of agricultural development was described in detail in the paper. In addition, a conclusion was made about the necessity of cooperation between the state and enterprises in this area. This is primarily associated with the challenges that may arise in companies implementing such practices. Understanding the presence of these challenges, the likelihood of further implementation of such type of technologies in enterprises decreases. Several approaches were proposed in the paper to reduce the negative impact on agricultural companies. Given the consequences of the full-scale Russian invasion of Ukraine, particular attention was paid to non-financial approaches, as well as to the problems existing within the current legislative framework. Furthermore, separate conclusions were drawn based on statistical data regarding the development of science and education in Ukraine overall. The study’s practical value lies in that the findings will enhance the efficiency of the state sector’s functioning in Ukraine in agricultural regulation

Abstract Seeds, as the initial products in agricultural systems, play a pivotal role in ensuring quality, fundamental to national food security and sustainable agricultural development. This study introduces a concept integrating public governance and evolutionary game theory to construct a quadripartite evolutionary game model involving seed companies, certification agencies, farmers, and governmental departments. It considers the strategic choices of these stakeholders under varying economic motivations and market mechanisms, as well as the influence of external regulation and incentives on game strategies. The existence conditions for evolutionarily stable strategy combinations are determined using the Lyapunov first method, and MATLAB is employed for numerical simulation analysis to validate the game analysis under initial conditions. The simulation results reveal two potential equilibrium points corresponding to different strategic choices among stakeholders. The study finds that producing high-quality seeds and the refusal of certification agencies to engage in rent-seeking are crucial for ensuring seed quality. Additionally, the cost–benefit ratio of seed companies, the speculative cost of certification agencies, and the rights-protection cost of farmers are key determinants in the evolution of seed quality assurance strategies. This research also holds practical significance in enhancing seed quality assurance mechanisms and fostering sustainable development in agriculture.

The management and reconstruction of critical-sized segmental bone defects remain a major clinical challenge for orthopaedic clinicians and surgeons. In particular, regenerative medicine approaches that involve incorporating stem cells within tissue engineering scaffolds have great promise for fracture management. This narrative review focuses on the primary components of bone tissue engineering—stem cells, scaffolds, the microenvironment, and vascularisation—addressing current advances and translational and regulatory challenges in the current landscape of stem cell therapy for critical-sized bone defects. To comprehensively explore this research area and offer insights for future treatment options in orthopaedic surgery, we have examined the latest developments and advancements in bone tissue engineering, focusing on those of clinical relevance in recent years. Finally, we present a forward-looking perspective on using stem cells in bone tissue engineering for critical-sized segmental bone defects. [ABSTRACT FROM AUTHOR]

Seeds, as the initial products in agricultural systems, play a pivotal role in ensuring quality, fundamental to national food security and sustainable agricultural development. This study introduces a concept integrating public governance and evolutionary game theory to construct a quadripartite evolutionary game model involving seed companies, certification agencies, farmers, and governmental departments. It considers the strategic choices of these stakeholders under varying economic motivations and market mechanisms, as well as the influence of external regulation and incentives on game strategies. The existence conditions for evolutionarily stable strategy combinations are determined using the Lyapunov first method, and MATLAB is employed for numerical simulation analysis to validate the game analysis under initial conditions. The simulation results reveal two potential equilibrium points corresponding to different strategic choices among stakeholders. The study finds that producing high-quality seeds and the refusal of certification agencies to engage in rent-seeking are crucial for ensuring seed quality. Additionally, the cost–benefit ratio of seed companies, the speculative cost of certification agencies, and the rights-protection cost of farmers are key determinants in the evolution of seed quality assurance strategies. This research also holds practical significance in enhancing seed quality assurance mechanisms and fostering sustainable development in agriculture. [ABSTRACT FROM AUTHOR]

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbalbased treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An indepth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM. [ABSTRACT FROM AUTHOR]

Geothermal energy exploration, development, and research have been ongoing in Canada for several decades. The country's cold climate and the push to develop renewable energy sources have driven interest in geothermal energy. Despite this drive, regulatory complexities and competition with other relatively inexpensive energy sources with existing infrastructure have hindered development. As such, interest has grown and waned with changes in the energy economy over several decades, leaving many projects at a standstill. As of January 2023, there are currently no operational geothermal power projects in Canada. Many hot spring pool and spa complexes remain active, and Canada is a leading country in the installation of ground source heat pumps (GSHPs; also called geo-exchange systems). However, in the last decade, the interest in deep geothermal systems has renewed, with many new projects starting up across several provinces and territories. Moreover, projects that had shown limited progress for many years—such as Mount Meager in British Columbia—have begun to renew their development efforts. Research is also expanding within prominent research groups and universities. The areas of focus include both building upon previous studies (such as thermal gradients and the heat flow in sedimentary basins) and researching new methods and resources (such as GSHPs, closed-loop systems, integrated geothermal operations, and hybrid systems, including heat storage). The development is supported by federal, provincial, and territorial governments through grants and the development of regulatory frameworks. Although challenges still remain for Canada to develop its geothermal energy resources, several power, thermal, and co-production projects, ongoing research, funding, and regulatory acts are all moving forward to support geothermal development. This paper aims to study Canada's geothermal energy update in 2023 regarding the aspects mentioned above. [ABSTRACT FROM AUTHOR]

Transitioning to renewable energy is an urgent global goal. Wind energy is a promising renewable source with contentious obstacles. Using the Yatir Wind Farm project in Israel as a case study, we explore the potential of framing in identifying and mitigating obstacles in a wind farm project. The cognitive and strategic frames employed by stakeholders were elicited through 18 semi-structured interviews and more than 100 documents. This analysis highlights three conflicting issues: potential or perceived harm to neighboring residents, protecting birds and bats, and adapting to changing regulations throughout the process. Regarding residents' opposition to feared harm from the project, initial cautious curiosity was followed by distrust and deep disappointment due to a lack of transparency and a sense of abandonment facing perceived existential threats to their health and homes. This led residents to conduct legal battles, which resulted in their claims being rejected. It also led to the breakdown of relationships among neighbors opposing and promoting the wind farms. In the case of bird and bat protection, stakeholders initially framed concerns emotionally until the dialogue shifted to scientific discourse, resulting in the successful refinement of mutually agreed upon regulatory guidelines. The structural appeal mechanisms effectively addressed evolving regulations, overcoming the lack of mutual understanding and resulting in the adoption of the majority of the new regulatory requirements. The analysis underscores the importance of understanding stakeholders' frames for effectively working through the complex and transdisciplinary nature of sustainability transitions and achieving successful outcomes. It also reveals the need for formal mechanisms to validate stakeholder needs and integrate them into decision-making processes. Recommendations include early and meaningful public involvement, process improvement for stakeholder engagement, and enhanced transparency in decision-making processes. [ABSTRACT FROM AUTHOR]

Agriculture has a strategic role in providing food for the population. This causes significant government intervention in this sector, and therefore the development of high-quality approaches to this process remains relevant. This study aimed to provide recommendations for this process in Ukraine, particularly in the context of economic digitalisation. To achieve this, graphical analysis, modelling, abstraction, and the method of logical reasoning were used. The role of digital technologies in achieving more effective results in the context of improving the efficiency of agricultural development was described in detail in the paper. In addition, a conclusion was made about the necessity of cooperation between the state and enterprises in this area. This is primarily associated with the challenges that may arise in companies implementing such practices. Understanding the presence of these challenges, the likelihood of further implementation of such type of technologies in enterprises decreases. Several approaches were proposed in the paper to reduce the negative impact on agricultural companies. Given the consequences of the full-scale Russian invasion of Ukraine, particular attention was paid to non-financial approaches, as well as to the problems existing within the current legislative framework. Furthermore, separate conclusions were drawn based on statistical data regarding the development of science and education in Ukraine overall. The study's practical value lies in that the findings will enhance the efficiency of the state sector's functioning in Ukraine in agricultural regulation. [ABSTRACT FROM AUTHOR]

Dermal injections of hyaluronic acid gel for aesthetic skin rejuvenation are becoming increasingly popular nowadays. Although these products are classified as medical devices, the regulations on their administration by licensed practitioners are still weak, whereas their manufacturers increasingly highlight and advertise the cellular effects that underpin the efficacy of these injections. In this review, we discuss all current knowledge on the mode of action of dermally injected hyaluronic acid and the potential toxicological implications, especially from crosslinked gels, in conjunction with the current global regulations. We also highlight the urgent need for further research to elucidate the therapeutic implications and underscore the imperative need for robust regulatory frameworks to safeguard public health. We conclude that dermal injections of hyaluronic acid have several therapeutic implications that warrant further research and that strict regulations must be applied to their manufacture/quality control and the required qualifications of licensed aesthetic injectors. [ABSTRACT FROM AUTHOR]

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This study explores the policy process in the Namibian Electricity Supply Industry in relation to the development of the Modified Single Buyer market model. The research employs the Advocacy Coalition Framework as a theoretical framework wherein actors within a policy subsystem are conceptualized as forming advocacy coalitions based on shared beliefs and engaging in coordinated efforts over time to influence policy direction. The analysis has uncovered the existence of two prominent coalitions: the progressive coalition is advocating for market liberalisation, while the conservative coalition is seeking to preserve the status quo and resist the adoption of the new electricity market model. The study concludes that powerful actors in the Electricity Supply Industry, although equipped with enormous economic resources and strong political ties, could not prevent the regulator from implementing comprehensive changes in the electricity sector. However, the conservative coalition has managed to negotiate for a phased implementation of the policy to ensure minimal disruption in the industry and to guarantee the security of the electricity supply in the long run. The phased implementation also allows sufficient time for this coalition to realign their business strategies within the new regulation policy and maintain their status as relevant and critical actors.

Touristic islands around the world are facing crucial energy challenges, including fossil fuel dependency, high electricity costs, high environmental impact and vulnerability to EU climate change targets and policies. On May 18, 2017, fourteen EU countries signed a “Political declaration on clean energy for EU islands” with the aim of accelerating the clean energy transition on more than 2,700 islands in Europe, supporting islands in reducing their energy import dependency, maximizing distributed energy generation near consumption and adopting innovative energy solutions. However, most of the population on EU islands is concentrated in the Mediterranean Sea, in Spain, Italy and Greece. More specifically, six islands account for the majority of the island's population (approximately 10.78 million): Sicily, Sardinia, the Balearic Islands, the Canary Islands, Crete and Corsica.Realising the importance of the role of local and regional authorities in the islanded Energy Transition, the EU has triggered and supported the creation of the Covenant of Mayors (CoM) for Climate & Energy and the initiative for Clean Energy of EU Islands. These instruments have promoted energy transition awareness among the municipalities and the importance of the bottom-up approach (from local to national). This paper proposes, based on a review of state-of-the-art energy models and methodologies, to identify the main gaps in specific energy indicators capable of easily modelling, assessing and monitoring progress towards the energy transition for policy makers. Furthermore, it presents the main barriers and constraints identified in island areas of Italy, Spain and Greece.

This study is devoted to the analysis of transformations in the use of monetary surrogates within the Ukrainian banking system from 2015 to 2023. Through an extensive examination of financial data, key factors driving the rising prevalence of electronic money and cryptocurrencies have been identified. This phenomenon unfolds against a backdrop of profound technological shifts and economic volatility, compounded by regulatory challenges. The findings underscore a strong interconnection between technological advancements, changes in consumer behavior, and the evolution of the regulatory framework. A notable increase in the volume of electronic money transactions, coupled with the significant expansion of the cryptocurrency market, points to a paradigm shift from traditional banking services towards novel financial instruments. Specifically, electronic money, cryptocurrencies, and digital tokens are emerging as prominent alternatives to conventional currency, offering users avenues for conducting transactions and preserving value amid economic instability. The research also provides an in-depth analysis of the regulatory hurdles confronting financial institutions and government agencies, particularly regarding adherence to anti-money laundering (AML) protocols and know-your-customer (KYC) regulations, alongside the imperative to safeguard consumer rights amid heightened cryptocurrency market volatility. Furthermore, this study addresses the potential long-term ramifications of the proliferation of monetary surrogates on Ukraine’s banking system, including shifts in conventional banking practices, potential risks to financial stability, and implications for monetary policy. Despite notable progress in the integration of new financial technologies, several unresolved challenges persist, particularly concerning the provision of adequate regulatory support for innovation while maintaining the stability of the financial system. In conclusion, this research offers a valuable contribution to the understanding of how technological development and socio-economic changes are reshaping financial systems in emerging economies, with a particular focus on Ukraine. The insights derived from this study may prove instrumental for policymakers and financial institutions as they navigate the evolving conditions and challenges of a rapidly transforming financial landscape.

India has the credit of running the second largest higher education system in terms of institutions worldwide, despite having only 26.3% Gross Enrollment Ratio (GER), including vocational education. It aspires to achieve a target of 50% GER by 2035. It means it would require a larger number of higher education institutions (HEIs), public and private, in addition to huge fiscal resources. At present about 75% of the HEIs are privately managed with about 66% of student enrolment. Though there is no provision of for-profit higher education institutions in India, many non-profit private HEIs are actually working as for-profit. They are growing fast and are visible too. Therefore, it is high time now to think seriously about the pros and cons, causes and consequences of for-profit and non-profit private HEIs in India. India provides a big market for non-profit and for-profit higher education to domestic and foreign stakeholders.  Already 160 foreign universities are working in collaboration with public or private limited companies in India. This essay provides an analysis of issues related to for-profit and non-profit HEIs, including desirability, size, funding, transparency, accountability, quality, feasibility and sustainability, government policies, regulation, foreign collaborations, private investments, and incentives. The methodology adopted is analytical, comparative, and empirical.

The topic of the research related to capital accounting in commercial enterprises is relevant, as the harmonization of this process in accordance with the requirements of International Financial Reporting Standards (IFRS) becomes an integral component for attracting investment, increasing the transparency of financial reporting, and maintaining competitiveness in the global market. The purpose of the study is to develop and implement the methodology of capital accounting in the accounting activities of commercial enterprises of the Republic of Azerbaijan. Among the methods used, analytical method, statistical method, functional method, method of system analysis, method of deduction, method of synthesis and method of comparison were applied. The research was aimed at in-depth analysis of the essence of capital accounting in Azerbaijani commercial enterprises in the context of modern conditions of market economy. The main attention was paid to the study of the legal and regulatory framework, peculiarities of the authorized capital of limited and joint stock organizations. Within the framework of the research, the key elements of development of financial accounting of capitals complying with IFRS requirements were identified. In addition, specific examples of synthetic accounting of business transactions for capital formation at commercial enterprises are provided, as well as the rules of their reflection in the financial statements are outlined. Special attention is paid to the fundamentals of new accounting rules developed to meet IFRS requirements. As a result of the study, solutions have been proposed to eliminate problems related to capital accounting in accordance with IFRS requirements in the activities of Azerbaijani commercial enterprises. These solutions are oriented to harmonize accounting practices with international standards, improve transparency of financial statements and increase attractiveness for potential investors. The results can be used for Azerbaijani commercial enterprises, contributing to the improvement of financial transparency, attractiveness for investors and harmonization of accounting practices with global standards

In the following article, a study is carried out on the accounting treatment of tax on income according to the provisions of the National Accounting Standards (NAS) and the International Financial Reporting Standards (IFRS). The research aims to identify the specific aspects of the application of NAS and IFRS for income tax accounting. The following scientific research methods are used in the study: analysis of the normative framework governing the study, synthesis of information, comparison to identify distinctive features.. The results of the research identified the existence of a different approach to income tax accounting according to NAS applied in the Republic of Moldova and IFRS (IAS 12). The result of the study shows that public interest entities that must apply IFRS require a more complex approach to tax on income versus entities that apply the provisions of the national accounting regulatory framework (NAS) of the Republic of Moldova.

Nuclear security has been emphasized to ensure the safety of the environment and humans, as well as to protect nuclear materials and facilities from malicious attacks. With increasing utilization of nuclear energy and emerging potential threats, there has been a renewed focus on nuclear security. Korea has made efforts to enhance the regulatory oversight processes, both for general and specific legislative systems. While Korea has demonstrated effective nuclear security activities, continuous efforts are necessary to maintain a high level of security and to improve regulatory efficiency in alignment with international standards.In this study, the comprehensive regulatory oversight framework for the security of Korean nuclear facilities has been investigated. For reference, the U.S. regulatory oversight frameworks for nuclear facilities, with a focus on nuclear security, and the motivations of changes in regulatory oversight framework have been identified. By comparing these regulatory programs and frameworks, insights and considerations for enhancing nuclear security regulations have been identified. A comprehensive security inspection program tailored for the Korean regulatory oversight framework has been proposed, and has been preliminarily applied to hypothetical conditions for further discussion.

This study examines the regulatory and policy framework for social housing in Latvia, focusing on its current state and future directions. Through comprehensive policy analysis and document review, the research traces the historical development of social housing policies, evaluates the existing regulatory landscape, and compares Latvian approaches with EU best practices. The study reveals significant challenges in Latvia’s social housing sector, including limited stock, inadequate funding mechanisms, and policy gaps in addressing the needs of vulnerable populations, particularly the elderly. Despite these challenges, recent initiatives and proposed reforms indicate a growing recognition of the importance of social housing in addressing demographic shifts and economic disparities. The findings highlight the need for a more robust and adaptive policy framework that aligns with EU standards while addressing Latvia’s unique socio-economic context. The study proposes policy recommendations aimed at enhancing the accessibility, affordability, and quality of social housing, with a particular emphasis on age-friendly housing solutions. By identifying key areas for improvement and potential innovative approaches, this research contributes to the ongoing discourse on social housing policy in Latvia and offers insights for policymakers, urban planners, and housing stakeholders.

Abstract Background Nuclear medicine has made enormous progress in the past decades. However, there are still significant inequalities in patient access among different countries, which could be mitigated by improving access to and availability of radiopharmaceuticals. Main body This paper summarises major considerations for a suitable pharmaceutical regulatory framework to facilitate patient access to radiopharmaceuticals. These include the distinct characteristics of radiopharmaceuticals which require dedicated regulations, considering the impact of the variable complexity of radiopharmaceutical preparation, personnel requirements, manufacturing practices and quality assurance, regulatory authority interfaces, communication and training, as well as marketing authorisation procedures to ensure availability of radiopharmaceuticals. Finally, domestic and regional supply to ensure patient access via alternative regulatory pathways, including in-house production of radiopharmaceuticals, is described, and an outlook on regulatory challenges faced by new developments, such as the use of alpha emitters, is provided. Conclusions All these considerations are an outcome of a dedicated Technical Meeting organised by the IAEA in 2023 and represent the views and opinions of experts in the field, not those of any regulatory authorities.

Medical devices play a crucial role in human health. These are instruments, machines or even software programs used to diagnose, treat, monitor or prevent health conditions. They are designed to help improve patients’ quality of life and range from simple items, such as thermometers, to more advanced technologies, such as pacemakers. In order to guarantee the safety and efficacy of medical devices intended for use on patients, the establishment of appropriate regulatory frameworks is crucial to ascertain whether devices function as intended, comply with safety standards and offer benefits that outweigh the associated risks. Depending on the country, different regulatory agencies are responsible for the evaluation of these products. The regulatory landscape for medical devices varies significantly across major markets, including the European Union, the United States of America and Japan, reflecting diverse approaches aimed at ensuring the safety and efficacy of medical technologies. However, these regulatory differences can contribute to a “medical device lag,” where disparities in approval processes and market entry timelines driven by strict regulatory requirements, increasing device complexity and the lack of global harmonization, result in delays in accessing innovative technologies. These delays impact patient access to cutting-edge medical devices and competitiveness in the market. This review aims to address the regulatory framework of medical devices and the approval requirements by the European Commission (EC), the Food and Drug Administration (FDA) and Pharmaceuticals and Medical Device Agency (PMDA).