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Genome editing in agriculture and food is leading to new, improved crops and other products. Depending on the regulatory approach taken in each country or region, commercialization of these crops and products may or may not require approval from the respective regulatory authorities. This paper describes the regulatory landscape governing genome edited agriculture and food products in a selection of countries and regions.

Biological therapies have transformed high-burden treatments. As the patent and exclusivity period for biological medicines draws to a close, there is a possibility for the development and authorization of biosimilars. These products boast comparable levels of safety, quality, and effectiveness to their precursor reference products. Biosimilars, although similar to reference products, are not identical copies and should not be considered generic substitutes for the original. Their development and evaluation involve a rigorous step-by-step process that includes analytical, functional, and nonclinical evaluations and clinical trials. Clinical studies conducted for biosimilars aim to establish similar efficacy, safety, and immunogenicity, rather than demonstrating a clinical benefit, as with the reference product. However, although the current knowledge regarding biosimilars has significantly increased, several controversies and misconceptions still exist regarding their immunogenicity, extrapolation, interchangeability, substitution, and nomenclature. The development of biosimilars stimulates market competition, contributes toward healthcare sustainability, and allows for greater patient access. However, maximizing the benefits of biosimilars requires cooperation between regulators and developers to ensure that patients can benefit quickly from access to these new therapeutic alternatives while maintaining high standards of quality, safety, and efficacy. Recognizing the inherent complexities of comprehending biosimilars fully, it is essential to focus on realistic approaches, such as fostering open communication between healthcare providers and patients, encouraging informed decision-making, and minimizing risks. This review addresses the regulatory and manufacturing requirements for biosimilars and provides clinicians with relevant insights for informed prescribing.

Invasive plant taxa are generally regulated at the species level, without considering infra- or interspecific variation. However, cultivars or hybrids can pose a lower risk of invasion, for example, due to sterility. We evaluate six general approaches to regulating cultivars and hybrids: (1) Globally Guilty by Association; (2) Nationally Guilty by Association; (3) Guilty until Proven Innocent; (4) Negotiated Guilt; (5) Claimed to be Innocent; and (6) Innocent until Proven Guilty. We discuss these approaches in the context of South Africa (which has a typified Negotiated Guilt approach). Following negotiations since 2001 between the South African horticultural industry/green industry and legislators, an unofficial consensus list of “presumed sterile” cultivars and hybrids was produced in 2014 containing 187 entities from 34 taxa. In 2020, this was reduced to 157 entities from 16 taxa. But the evidence supporting the original lists and the subsequent revisions was not published. To address this issue, we developed a generic pro forma (template) for reporting sterility based on observations and/or experiments on: flowering, fruiting, pollen, and seeds; the potential for vegetative propagation; and the potential for genetic changes (including hybridization and reversion to fertility). We recommend that such information be incorporated into risk analyses conducted specifically for infra- and inter specific entities, and only if the risk of a harmful invasion is demonstrated to be acceptably low or can be easily mitigated should such entities be exempted from regulation. This will be time-consuming, but, by setting out the evidence clearly, the approach is transparent and provides a clear route for stakeholders to seek exemptions for entities of importance. In conclusion, although we suspect the simplicity of the Negotiated Guilt approach is desirable to many stakeholders, and is the approach currently adopted in South Africa, we recommend a shift toward the Guilty until Proven Innocent approach.

This introductory article outlines three fundamental regulatory developments in the EU’s legislation addressing digitalization and automation of decision-making: One is that across many acts we see a move towards more complex multi-level composite procedures, involving not only public structures with agencies, EU bodies, national agencies, but also co-regulation through standardisation in combination with – in several areas – audited self-regulation. A second feature of much of the current legislation in digital matters is that obligations imposed therein require an increased attention to information management – from sourcing to use, dissemination, sharing. This is a requirement for both public and private actors imposing ever more ‘granular’ knowledge and reporting of information flows in economic operators. A third is the growing role of interoperability which is being firmly established as a tool to create data exchange possibilities The diverse regulatory tools and methods are creating complex networks of legal relations and obligations which appear difficult to submit to oversight and compliance without strong protection of individual rights and procedural structures ensuring their enforcement.

Adrenic acid is a 22-carbon unsaturated fatty acid that is widely present in the adrenal gland, liver, brain, kidney and vascular system that plays a regulatory role in various pathophysiological processes, such as inflammatory reactions, lipid metabolism, oxidative stress, vascular function, and cell death. Adrenic acid is a potential biomarker for various ailments, including metabolic, neurodegenerative and cardiovascular diseases and cancer. In addition, adrenic acid is influenced by the pharmacological properties of several natural products, such as astragaloside IV, evodiamine, quercetin, kaempferol, Berberine-baicalin and prebiotics, so it is a promising new target for clinical treatment and drug development. However, the molecular mechanisms by which adrenic acid exerts are unclear. The present study systematically reviewed the biosynthesis and metabolism of adrenic acid, focusing on intrinsic mechanisms that influence the progression of metabolic, cardiovascular and neurological disease. These mechanisms regulate several key processes, including immuno-inflammatory response, oxidative stress, vascular function and cell death. In addition, the present study explored the potential clinical translational value of adrenic acid as a biomarker and therapeutic target. To the best of our knowledge, the present study is first systematic summary of the mechanisms of action of adrenic acid across a range of diseases. The present study provides understanding of the wide range of metabolic activities of adrenic acid and a basis for further exploring the pathogenesis and therapeutic targets of various diseases.

Background Uganda, like other United Nations (UN) member states, has undertaken to achieve Universal Health Coverage (UHC) by 2030 in line with Sustainable Development Goal (SDG) 3 targets. However, if this target is to be achieved, efforts will need to be increased, as full coverage of essential services remains an issue. Access to quality, acceptable and affordable healthcare remains an illusion for many Ugandans. Artificial Intelligence can be a valuable tool in achieving UHC as it can increase access to health facilities in hard-to-reach areas. AI tools have also been reported to perform faster than humans at certain key health tasks like diagnosis. However, for AI to be effective in delivering its benefits, context-specific regulatory approaches are key, as needs and opportunities differ. In this paper, I argue that the regulation of AI can help make it an effective tool for achieving UHC in Uganda if the right regulatory approach and framework are adopted, as regulation shapes outcomes. This will tackle the risk of poor regulation hindering AI development and AI reinforcing inequalities. Methods The paper employs a doctrinal methodology to analyse the two prominent regulatory approaches to AI in the EU and UK, which have adopted a risk-based and principles-based approach, respectively. It investigates whether these approaches are suitable for regulating AI in Uganda’s healthcare and achieving UHC. The strengths and weaknesses of each approach are examined. The paper advocates for considering a human rights-based approach that can be integrated with the principles-based approach. Results Regulation is a double-edged tool that can positively or negatively shape health outcomes. Good regulation has the potential to emancipate ordinary people’s lives. Therefore, Uganda should leverage the positive aspects of principles-based and human rights-based approaches to regulation to ensure that AI’s potential to achieve UHC is effective. Conclusion The hybrid approach to AI regulation is best suited to serve Uganda’s healthcare needs. The foremost priority for Uganda is to attain Universal Health Coverage. A hybrid approach will contribute to this however, it is not the silver bullet. Uganda needs to supplement efforts to achieve UHC with other non-regulatory strategies.

Animal agriculture faces unprecedented challenges, including the need to increase productivity to meet increasing demands for high quality protein while combating increasing pest and disease pressures, improving animal welfare, adapting to a changing climate, and reducing the environmental impact of animal agriculture. Genome editing, in concert with other existing technologies, has the potential to accelerate these efforts. The U.S. Department of Agriculture (USDA) supports research focused on delivering scientific solutions to these national and global agricultural challenges and transferring these solutions to farmers. Genome editing, along with a broad range of other tools, provides an opportunity for scientists, breeders, farmers, and ranchers to meet these challenges and provides additional benefits for society, including healthier and more resilient livestock, while reducing agriculture’s impact on the environment. Farmers and ranchers need a full toolbox of existing and innovative options. However, they will not be able to access these tools unless flexible approaches are in place that encourage innovation and allow safe innovations to be used on farms. Genome editing can help us achieve these goals only if global regulatory and policy approaches allow their use in agricultural breeding programs and deployment to farms. The global regulatory landscape for products of genome editing is rapidly evolving, with an increasing number of countries focusing more on characteristics of products and whether they could be achieved by conventional breeding, rather than the technologies used to create them. The livelihoods of people along the agricultural value chain depend upon countries’ regulatory and policy choices; regulatory approaches and how they are applied have a dramatic impact in determining what products are developed and who can afford to use these new biotechnologies. We need to step forward and continue the momentum towards regulatory approaches that encourage innovation to ensure continued access to a safe, abundant, and affordable food supply for future generations.

Restrictions on second-generation anticoagulant rodenticides (SGARs) in the United States, which were partially implemented in 2011, prohibit the sale of SGAR products through general consumer outlets to minimize use by non-professional or non-agricultural applicators. This study analyzed liver tissue from four species of birds of prey admitted to a wildlife clinic in Massachusetts, USA, from 2012–2016 for residues of anticoagulant rodenticides (ARs). Ninety-four birds were analyzed; 16 were symptomatic for AR toxicosis, and 78 asymptomatic. Ninety-six percent of all birds tested were positive for SGARs: 100% of those diagnosed with AR toxicosis ante-mortem and/or post-mortem and 95% of subclinically exposed birds. Brodifacoum was found in 95% of all birds. Sixty-six percent of all birds contained residues of two or more SGARs. A significant increase in exposures to multiple SGARs occurred in later years in the study. Pesticide use reports (PURs) filed with the Massachusetts Department of Agricultural Resources were reviewed to determine the frequency of use of different ARs by pest management professionals (PMPs) across five years. This study finds that the three SGARs favored by PMPs—bromadiolone, difethialone, brodifacoum—were present in combination in the majority of birds, with increases in multiple exposures driven by increased detections of bromadiolone and difethialone. Continued monitoring of AR residues in nontarget species following full implementation of sales and packaging restrictions in the US is needed in order to elucidate the role of PMP use of SGARs in wildlife exposures and to evaluate the effectiveness of current mitigation measures.

Reducing the rate, extent, and negative impacts associated with poaching is a priority for diverse stakeholders including conservation practitioners and, increasingly, law enforcement agencies. The purpose of this paper is to explore local stakeholders' perceptions of poaching rules, and motivations for compliance and noncompliance, using focus groups and interviews in Namibia. We found no difference between participants' perception of the ability of regulatory and normative models to explain motivations to comply with wildlife rules; however, we found differences in the ability of moral and legitimacy-based normative models to explain compliance. Participants identified a diversity of motivations to poach; a number of motivations went beyond subsistence (\"cooking pot\") and economic (\"pocket book\") explanations of poaching. We suggest the criminological community capitalize on opportunities to collaborate with conservationists and others on exploring the various dimensions of poaching in order to reduce risks and environmental harm by minimizing rule breaking in conservation.

Nanomedicines are highly complex products and are the result of difficult to control manufacturing processes. Nonbiological complex drugs and their biological counterparts can comprise nanoparticles and therefore show nanomedicine characteristics. They consist of not fully known nonhomomolecular structures, and can therefore not be characterized by physicochemical means only. Also, intended copies of nanomedicines (follow-on similars) may have clinically meaningful differences, creating the regulatory challenge of how to grant a high degree of assurance for patients' benefit and safety. As an example, the current regulatory approach for marketing authorization of intended copies of nonbiological complex drugs appears inappropriate; also, a valid strategy incorporating the complexity of such systems is undefined. To demonstrate sufficient similarity and comparability, a stepwise quality, nonclinical and clinical approach is necessary to obtain market authorization for follow-on products as therapeutic alternatives, substitution and/or interchangeable products. To fill the regulatory gap, harmonized and science-based standards are needed.