Search

The European Artificial Intelligence Act (AI Act) has profound implications for technological innovation in the medical and health care sector, transcending the boundaries of existing legal frameworks such as the Medical Device Regulation (MDR) and the General Data Protection Regulation (GDPR). This paper examines basic regulatory choices of the AI Act relevant for the field of digital health innovations by contextualizing its main goals, key obligations, and addressed actors. In light of these considerations, we present a scoping literature review that identifies potential regulatory challenges for stakeholders engaged in research, innovation and healthcare. Building on this, we point to concepts and methodologies to overcome such challenges in a way fostering innovation while realizing key constitutional and societal interests at the same time.

The field of organ transplantation is experiencing a transformative shift with the rise of Advanced Therapy Medicinal Products (ATMPs), which include gene therapies, somatic cell therapies, and tissue-engineered products. These therapies offer new, potentially curative treatments for longstanding medical challenges, impacting numerous patients. However, their adoption is hindered by complex regulatory frameworks, high production costs, and inconsistent access across Europe. The ESOT ATMP Task Force’s position paper analyzes these challenges from research to clinical application, advocating for a coordinated strategy to position Europe as a leader in ATMP development. It proposes specific actions such as streamlining regulatory pathways to accelerate approvals, boosting funding for ATMP research, and creating specialized facilities for development and implementation. The paper also highlights the critical roles of patient engagement and real-world evidence in optimizing clinical and regulatory practices.

This study addresses FinTech implementation challenges in the banking industry in Palestine. This was accomplished by adopting qualitative research methods. Semi-structured interviews were conducted with interviewees from the Palestinian Monetary Authority, banks, and FinTech companies. Thematic analysis was conducted using NVivo 12 software to identify themes in the interview scripts. Research outcomes suggest that FinTech development in Palestine encounters a range of multifaceted challenges, which can be categorised using the TOE (technological, organisational, environmental) framework. On the technological front, issues such as underdeveloped IT and telecommunications infrastructure, restricted mobile frequencies due to Israeli occupation, limited IT expertise, cyber risks, low digital literacy, and minimal FinTech awareness hinder progress. Organizationally, resistance to change, inadequate agility, limited digital skills, and slow Sharia compliance updates in Islamic banking impede innovation. Environmentally, the absence of a dedicated FinTech framework, unclear regulatory guidance, limited market size, and strict AML/CFT regulations create uncertainties for non-bank entities and restrict investment opportunities. Addressing these interconnected barriers requires coordinated efforts across legal, financial, and technological sectors to foster FinTech integration and growth in Palestine.

Small Modular Reactors (SMRs) offer transformative potential for maritime propulsion by providing significant benefits such as reduced emissions, enhanced fuel efficiency, and greater operational autonomy. However, their integration into the maritime sector presents complex regulatory challenges due to the convergence of nuclear and maritime laws. A unified, harmonized regulatory framework is essential to ensure safety, radioactive waste management, and accident prevention. While initiatives led by the International Atomic Energy Agency (IAEA) and International Maritime Organization (IMO) are progressing, key gaps remain, particularly regarding maritime-specific risk assessments, emergency response protocols, and cross-border regulatory harmonization. Enhanced collaboration between regulatory bodies, pilot projects, and transparent engagement with stakeholders will be critical to refining safety protocols and accelerating regulatory alignment. Public acceptance remains a vital factor, requiring rigorous environmental impact assessments (EIAs) and transparent communication to build trust and align SMR-powered vessels with global sustainability objectives. While challenges persist, they also present opportunities for innovation and international cooperation. By addressing these regulatory and public acceptance challenges through coordinated efforts and policies, SMR propulsion can become a cornerstone of a more sustainable, efficient, and technologically advanced maritime sector. Successful deployment will position SMRs as a key component of the global energy transition, driving progress toward low-carbon shipping and a greener maritime industry.

Combination products, amalgamating drugs, biologics, and medical devices, have revolutionized the healthcare landscape with their potential for innovative therapies. However, the intersection of diverse components within these products presents a complex regulatory environment, demanding rigorous attention to safety and efficacy. This article delves into the intricate landscape of regulatory considerations, safety, and efficacy assessments pertaining to combination products—a category at the intersection of drugs, devices, and biologics. The regulatory framework, primarily governed by the U.S. Food and Drug Administration (FDA), necessitates a nuanced classification determining the regulatory pathway. Collaboration between diverse regulatory centers, such as the Center for Drug Evaluation and Research (CDER) and the Center for Devices and Radiological Health (CDRH), underscores the integrated approach required for these innovative healthcare solutions. Safety considerations unravel the potential risks and adverse events associated with combining diverse components, emphasizing the need for robust risk assessment and mitigation strategies. The evaluation of efficacy involves sophisticated methodologies, clinical trials, and post-market surveillance, with recent advancements incorporating digital technologies. This comprehensive exploration aims to contribute to the evolving understanding and best practices in the regulatory and scientific realms, fostering collaboration and innovation in the development and assessment of combination products.

Cancer remains a leading cause of death globally. Cancer patients often seek alternative therapies in addition to, or instead of, conventional treatments like chemotherapy, radiation, and surgery. The progress in medical advancements and early detection provides more treatment options; however, the development of cancer drugs requires a significant amount of time, demands substantial investments, and results in an overall low percent of regulatory approval. The complex relationship between patent protection and pharmaceutical innovation complicates cancer drug development and contributes to high mortality rates. Adjusting patent criteria for alternative cancer therapeutics could stimulate innovation, enhance treatment options, and ultimately improve outcomes for cancer patients. This article explores the potential of alternative cancer therapeutics, chemopreventive agents, natural products, off-patent drugs, generic unpatentable chemicals, and repurposed drugs in cancer treatment, emphasizing the mechanisms and therapeutic potential of these unconventional compounds as combinatorial cancer therapies. The biological pathways, therapeutic effects, and potential to enhance existing therapies are reviewed, demonstrating their cost-effective and accessible options as adjuvant cancer therapies.

This manuscript explores the use of nanostructured chitosan for intranasal drug delivery, targeting improved therapeutic outcomes in neurodegenerative diseases, psychiatric care, pain management, vaccination, and diabetes treatment. Chitosan nanoparticles are shown to enhance brain delivery, improve bioavailability, and minimize systemic side effects by facilitating drug transport across the blood–brain barrier. Despite substantial advancements in targeted delivery and vaccine efficacy, challenges remain in scalability, regulatory approval, and transitioning from preclinical studies to clinical applications. The future of chitosan-based nanomedicines hinges on advancing clinical trials, fostering interdisciplinary collaboration, and innovating in nanoparticle design to overcome these hurdles and realize their therapeutic potential.

Abstract The growing world population, public awareness of animal welfare, environmental impacts and changes in meat consumption leads to the search for novel approaches to food production. Novel foods include products with a new or specifically modified molecular structure, foods made from microorganisms, fungi, algae or insects, as well as from animal cell or tissue cultures. The latter approach is known by various names: “clean meat”, “in vitro meat” and “cell‐cultured” or “(cell‐)cultivated meat”. Here, cells isolated from agronomically important species are expanded ex vivo to produce cell biomass used in unstructured meat or to grow and differentiate cells on scaffolds to produce structured meat analogues. Despite the fast‐growing field and high financial interest from investors and governments, cultivated meat production still faces challenges ranging from cell source choice, affordable expansion, use of cruelty‐free and food‐grade media, regulatory issues and consumer acceptance. This overview discusses the above challenges and possible solutions and strategies in the production of cultivated meat. The review integrates multifaceted historical, social, and technological insights of the field, and provides both an engaging comprehensive introduction for general interested and a robust perspective for experts.

Recent coronavirus pandemic and its global socio-economic impact has re-emphasized the need for safe, fast, and efficient delivery of vaccines for humankind. With advent of technological advances, and to improve patient acquiescence, several techniques for fast, effective, and safe delivery of vaccines have been researched and published in the literature in last three decades. These delivery enhancement techniques include but are not limited to electroporation, microneedles (MN), ultrasound, iontophoresis, etc. This review aims at discussing the current research undergoing in vaccine delivery, specifically focusing on microneedles assisted, the historical background of microneedles and their introduction to drug delivery area, and a special focus on formulation challenges and stability in these systems. The review also sheds light on regulatory challenges one must keep in mind for bringing a successful microneedles-based vaccine delivery into market as well as a snapshot of current commercially available microneedles-based products in cosmetic and pharmaceutical industry.

The etiologies of several cardiovascular, inflammatory, neurological, hereditary disorders, cancer, and infectious diseases have implicated changes in the genetic set up or genetic mutations as the root cause. Nucleic acid based therapeutics (NBTs) is a new class of biologics that are known to regulate gene expression at the transcriptional and post-transcriptional level. The NBTs include oligonucleotides, nucleosides, antisense RNA, small interfering RNAs, micro RNA etc. In recent times, this new category of biologics has found enormous potential in the management of cardiovascular, inflammatory, neurological disorders, cancer, infectious diseases and organ transplantation. However, the delivery of NBTs is highly challenging in terms of target specificity (intracellular delivery), mononuclear phagocyte system uptake, stability and biodistribution. Additionally, management of the above mentioned disorders require regular and intrusive therapy making non-invasive routes preferable in comparison to invasive routes like parenteral. The nasal route is garnering focus in delivery of NBTs to the brain in the management of several CNS disorders due to the associated merits such as non-invasiveness, possibility of chronic delivery, improved patient compliance, avoidance of hepatic and gastrointestinal metabolism as well as ability to bypass the BBB. Hence in recent times, this route has been sought by the reserachers as an alternative to parenteral therapy for the delivery of several NBTs. This review shall focus on an array of NBTs delivered through nasal route, their challenges, applications and opportunities. The novel delivery systems for incorporating NBTs; their targeting strategies shall be critically reviewed. The challenges towards regulatory approvals and commercialization shall also be discussed at large. Comparison of learnings derived from the success and barriers in nasal delivery of NBTs will help in identification of futuristic opportunities for their translation from bench to bedside.

Background: Solubility properties of drugs intensify a crucial role during the formulation development process. Aqueous solubility is one of the most significant factors concerning drug bioavailability analysis. Cyclodextrins [CDs] are supportive, competent excipients, required an ever-rising way to disguise unwanted pharmaceutical characteristics, exclusively poor aqueous solubility. Main Text: CDs are actively useful in medicinal industries for copious purposes, including improving drug solubility, safety, physicochemical stability, and bioavailability. Different solubility enhancement methods can resolve several approaches to trouble insolubility. Conclusions: Among all, the reported one complexation technique has been incorporated as one of the imperative and the exigent concept, to enhance the solubility of poorly water-soluble drugs. The standard CDs and their explicit derivatives are quite essential in enabling pharmaceutical excipients, which improve the aqueous solubility of poorly soluble drugs, raise the permeability of drugs through the biological membranes, and advances the drug dissolution rate and bioavailability. This review discusses some of the findings and broad applications of CDs and their derivatives in various drug delivery areas. This review also addresses the aspects regarding the new CD-based therapeutics, possible future uses and issues, and regulatory perspective in the modern scenario.

The article provides a description of the Autonomous ship, studies existing relevant projects, and examines the related Operational, Regulatory, and Quality assurance challenges raised due to the development and actual deployment of such vessels in the near future. After reviewing the main operational procedures, existing regulations, and quality assurance standards, a number of possible solutions and approaches to overcome the identified challenges are indicated. Some of the conclusions may be used not only in the Autonomous ships but also in traditionally manned vessels.

The recent proliferation of mobile financial services in developing countries has increased access to financial services among underserved rural and low-income populations. Mobile credit is one emerging mobile financial service that allows consumers to quickly apply for and receive loans over mobile devices. Mobile credit services have achieved early success in Kenya and Tanzania, two mature markets for mobile financial services. While these new services have the potential to further promote financial inclusion, they also raise novel regulatory issues and do not fit neatly into pre-existing regulatory categories. This is due to the nature of mobile credit and the variety of entities and regulatory frameworks implicated in the business models found in these two markets. Policymakers and regulators will need to make choices about how to regulate mobile credit with respect to consumer protection, credit reporting and the use of mobile and mobile money services transactional data, a key input for credit evaluation decisions. These choices will need to take into account promotion of financial inclusion and protection of consumers while limiting disincentives for innovation and investment.