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Heliyon Jul 2023Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly... (Review)
Review
Cities in the global south, constrained by limited resources, face challenges in delivering efficient transportation infrastructure and services to support their rapidly growing urban populations. Dhaka, serves as an example, as it grapples with the increasing demand driven by population growth, exacerbated by factors like land and resource scarcity, as well as intricate geopolitical dynamics. Despite the construction of a metro rail and other similar mass transit options, Dhaka continues to face difficulties in meeting the increasing transportation demand, posing a persistent challenge. Multiple institutions, including a coordination authority, are working to provide improved transportation services by implementing diverse strategic approaches focusing on infrastructure development, and formulating policies aimed at facilitating better mobility and accessibility. Over the past fifty years, the institutional arrangement and roles within the transportation system have changed. This study examines the institutional arrangements and how they have evolved, along with reviewing transportation development policies during this period. The findings indicate the involvement of multiple organizations in the city's transportation system performing distinct activities-- administrative, coordinating, legislative, regulatory, construction and management, and law enforcement. These authorities often encounter challenges fulfilling their responsibilities stemming from differences in vision, organizational structure, jurisdiction and most notably, lack of coordinatoon, resulting in ineffective infrastructure development and duplicated activities. To improve the transportation system, this study recommends better equipping the existing coordinating authority and expanding its jurisdiction to include other institutions. This approach aims to enhance coordination and address the challenges faced by Dhaka's transportation system, ultimately facilitating improved mobility and accessibility for the city's growing population.
PubMed: 37456001
DOI: 10.1016/j.heliyon.2023.e17887 -
Transnational Legal Theory 2022This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as...
This article puts forward an approach to account for the evolution of transnational private rule-makers. Morphing of organisations, procedures, and rules is suggested as a key strength of various forms of private authority. Directing attention towards evolutionary dynamics, and their impact on the goals pursued by transnational private regulators, as well as on the implications for targets and beneficiaries of their rules, brings forward various implications of transnational private regulators. These implications include tensions between the complementary and competitive relations between public and private authority, and question the capacity of the former to effectively enrol, steer and influence the latter. The article discusses the role of regulatory and organisational crises as catalysts for the emergence and evolution of transnational private rule-makers, and how crises affect the relation between public and private regimes. Finally, we reflect on possible competitive challenges that emerge by employing a dynamic perspective to transnational private regulation.
PubMed: 36999165
DOI: 10.1080/20414005.2023.2178143 -
Advanced Healthcare Materials Dec 2023New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal...
New and innovative nanomedicines have been developed and marketed over the past half-century, revolutionizing the prognosis of many human diseases. Although a univocal regulatory definition is not yet available worldwide, the term "nanomedicines" generally identifies medicinal products that use nanotechnology in their design or production. Due to the intrinsic high structural complexity of these products, the scientific and regulatory communities are reflecting on how to revise the regulatory framework to provide a more appropriate benefit/risk balance to authorize them on the market, considering the impact of their peculiar physicochemical features in the evaluation of efficacy and safety patterns. Herein, a critical perspective is provided on the current open issues regarding regulatory qualification and physicochemical characterization of nanosystems considering the current European regulatory framework on nanomedicine products. Practicable paths for improving their quality assurance and predicting their fate in vivo are also argued. Strengthening the multilevel alliance among academic institutions, industrial stakeholders, and regulatory authorities seems strategic to support innovation by standard approaches (e.g., qualification, characterization, risk assessment), and to expand current knowledge, also benefiting from the new opportunities offered by artificial intelligence and digitization in predictive modelling of the impact of nanomedicine characteristics on their fate in vivo.
Topics: Humans; Nanomedicine; Artificial Intelligence; Nanotechnology; Europe
PubMed: 37718353
DOI: 10.1002/adhm.202301956 -
Clinical Therapeutics Aug 2022For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International... (Review)
Review
For more than a decade, the World Health Organization, Pan American Health Organization, Pan-American Network or Drug Regulatory Harmonization, and the International Conference of Drug Regulatory Authorities, have encouraged regulators to adopt reliance and recognition pathways to reduce duplication, improve efficiency and efficacy, and strengthen regulatory capabilities, in order to facilitate marketing authorization approval, thereby maintaining supply chain integrity. Several factors have limited the more widespread implementation of reliance pathways in Latin America, among which is having the appropriate legal tools in place between and among agencies. Key among these tools are the Memorandum of Understanding (MOU) and cooperation agreements. Herein we have reviewed the content and the characteristics of MOUs and cooperation agreements available on the official websites of the regulatory agencies of the region (we found 11 multilateral MOUs and 8 cooperation agreements published), signed by Latin American agencies and interregional organizations. In this commentary, common characteristics are identified and recommendations for further implementation are made to promote communication, information sharing, and trust, thereby supporting the broader use of reliance pathways in the region.
Topics: Humans; Latin America; Organizations; Pan American Health Organization
PubMed: 35798570
DOI: 10.1016/j.clinthera.2022.06.005 -
Chinese Medicine 2018Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for... (Review)
Review
Internationalization of Traditional/Complementary Medicine (T&CM) products is important for initiating and sustaining developments in this field. Particularly for traditional Chinese medicines (TCMs), the global market continues to expand due to an interest in the potential clinical benefits of traditional approaches that are largely considered lower risk and lower cost than many conventional treatments. While the benefits of internationalization hold clear advantages for the business of T&CM products, keeping abreast of regulatory processes in different countries and regions that regularly revise market entry requirements is challenging. At present, the regulations of T&CM products are country specific and largely based on a risk-based assessment with a focus on protecting the consumer. To date, systematic analysis of these regulatory differences between countries and regions is limited. Publically available information about the legal requirements for the market entry of T&CM products were obtained from the relevant regulatory authority's websites for selected countries and regions (Macau-China, Hong Kong-China, Singapore, Australia, Canada, the European countries and the US). The market entry requirements in terms of quality, safety and efficacy of T&CM products for each country were analyzed and compared. Major differences were identified in the classification of T&CM products, market entry pathways, requirements of compliance with Good Manufacturing Practices; and level of evidence to demonstrate safety and efficacy based on historical use, non-clinical and clinical studies. Variations in the evaluation standards adopted by regulatory authorities pose a number of barriers and opportunities for the internationalization of T&CM products and have great implications for internationalization of TCMs from the sponsors' and the regulators' perspectives.
PubMed: 30337951
DOI: 10.1186/s13020-018-0209-6 -
Journal of Pharmaceutical Sciences May 2022Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC)... (Review)
Review
Recent advancements in data engineering, data science, and secure cloud storage can transform the current state of global Chemistry, Manufacturing, and Controls (CMC) regulatory activities to automated online digital processes. Modernizing regulatory activities will facilitate simultaneous global submissions and concurrent collaborative reviews, significantly reducing global licensing timelines and variability in globally registered product details. This article describes advancements made within the pharmaceutical industry from theoretical concepts to utilization of structured content and data in CMC submissions. The term Structured Content and Data Management (SCDM) outlines the end-to-end scientific data lifecycle from capture in source systems, aggregation into a consolidated repository, and transformation into semantically structured blocks with metadata defining relationships between scientific data and business contexts. Automation of regulatory authoring (termed Structured Content Authoring) is feasible because SCDM makes data both human and machine readable. It will offer health authorities access to the digital data beyond the current standard of PDF documents and, for a review process, SCDM would "enrich the effectiveness, efficiency, and consistency of regulatory quality oversight" (Yu et al., 2019). SCDM is a novel solution for content and data management in regulatory submissions and can enable faster access to critical therapies worldwide.
Topics: Commerce; Data Management; Drug Industry; Humans
PubMed: 34610323
DOI: 10.1016/j.xphs.2021.09.046 -
The Milbank Quarterly Jun 2022Policy Points Only a small minority of new drugs in "nonprotected" classes are widely covered by Part D plans nationwide in the year after US Food and Drug...
UNLABELLED
Policy Points Only a small minority of new drugs in "nonprotected" classes are widely covered by Part D plans nationwide in the year after US Food and Drug Administration (FDA) approval. Part D plans frequently apply utilization management restrictions such as prior authorizations to newly approved drugs in both protected and nonprotected classes. Drug price influences both formulary inclusion (in nonprotected classes) and coverage restrictions (in both protected and nonprotected classes), while other drug characteristics such as therapeutic benefits are not consistently associated with formulary design. Plans do not seem to favor the minority of drugs that are determined to offer added therapeutic benefit over existing alternatives.
CONTEXT
Medicare Part D is an outpatient prescription drug benefit for older Americans covering more than 46 million beneficiaries. Except for mandatory coverage for essentially all drugs in six protected classes, plans have substantial flexibility in how they design their formularies: which drugs are covered, which drugs are subject to restrictions, and what factors determine formulary placement. Our objective in this paper was to document the extent to which Part D plans limit coverage of newly approved drugs.
METHODS
We examined the formulary design of 4,582 Part D plans from 2014 through 2018 and measured (1) the decision to cover newly approved drugs in nonprotected classes, (2) use of utilization management tools in protected and nonprotected classes, and (3) the association between plan design and drug-level characteristics such as 30-day cost, therapeutic benefit, and the US Food and Drug Administration (FDA) expedited regulatory pathway.
FINDINGS
The FDA approved 109 new drugs predominantly used in outpatient settings between 2013 and 2017. Of these, 75 fell outside of the six protected drug classes. One-fifth of drugs in nonprotected classes (15 out of 75) were covered by more than half of plans during the first year after approval. Coverage was often conditional on utilization management strategies in both protected and nonprotected classes: only seven drugs (6%) were covered without prior authorization requirements in more than half of plans. Higher 30-day drug costs were associated with more widespread coverage in nonprotected classes: drugs that cost less than $150 for a 30-day course were covered by fewer than 20% of plans while those that cost more than $30,000 per 30 days were covered by more than 50% of plans. Plans were also more likely to implement utilization management tools on high-cost drugs in both protected and nonprotected classes. A higher proportion of plans implemented utilization management strategies on covered drugs with first-in-class status than drugs that were not first in class. Other drug characteristics, including availability of added therapeutic benefit and inclusion in FDA expedited regulatory approval, were not consistently associated with plan coverage or formulary restrictions.
CONCLUSIONS
Newly approved drugs are frequently subject to formulary exclusions and restrictions in Medicare Part D. Ensuring that formulary design in Part D is linked closely to the therapeutic value of newly approved drugs would improve patients' welfare.
Topics: Aged; Drug Costs; Humans; Medicare Part D; Prescription Drugs; United States; United States Food and Drug Administration
PubMed: 35502786
DOI: 10.1111/1468-0009.12565 -
Frontiers in Sociology 2022This article discusses similarities between the finance industry and the gambling industry. It considers empirical studies from both fields and compares both industries...
This article discusses similarities between the finance industry and the gambling industry. It considers empirical studies from both fields and compares both industries with regard to possible substitution effects. Afterwards, the current regulatory approach to gambling and financial markets is discussed. Based on this literature review, the author points out that regulators need to acknowledge the fact that both markets possess addictive properties and attract certain risk-seeking individuals. Moreover, the regulators need to find a way to align their fundamentally different objectives to find common solutions to cross-industry problems. Finally, an increased cooperation between (state) authorities is necessary. This cooperation could help to protect traders from developing gambling-related problems, provide significant insights for industry-wide and product-specific regulation and lead to a more informed use of technology for harm prevention purposes. The most important similarities and differences of both markets and the resulting regulatory implications are briefly summarized.
PubMed: 36479159
DOI: 10.3389/fsoc.2022.1023307 -
The AAPS Journal Sep 2022This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of... (Review)
Review
This publication provides some industry reflections on experiences from the Chemistry, Manufacturing, and Controls (CMC) development and manufacture and supply of vaccines and therapies in response to the COVID-19 pandemic. It integrates these experiences with the outcomes from the collaborative work between industry and regulators in recent years on innovative science- and risk-based CMC strategies to the development of new, high-quality products for unmet medical needs. The challenges for rapid development are discussed and various approaches to facilitate accelerated development and global supply are collated for consideration. Relevant regulatory aspects are reviewed, including the role of Emergency Use/Conditional Marketing Authorizations, the dialogue between sponsors and agencies to facilitate early decision-making and alignment, and the value of improving reliance/collaborative assessment and increased collaboration between regulatory authorities to reduce differences in global regulatory requirements. Five areas are highlighted for particular consideration in the implementation of strategies for the quality-related aspects of accelerated development and supply: (1) the substantial need to advance reliance or collaborative assessment; (2) the need for early decision making and streamlined engagement between industry and regulatory authorities on CMC matters; (3) the need to further facilitate 'post-approval' changes; (4) fully exploiting prior and platform knowledge; and (5) review and potential revision of legal frameworks. The recommendations in this publication are intended to contribute to the discussion on approaches that can result in earlier and greater access to high-quality pandemic vaccines and therapies for patients worldwide but could also be useful in general for innovative medicines addressing unmet medical needs.
Topics: COVID-19; Humans; Pandemics; Vaccines
PubMed: 36168002
DOI: 10.1208/s12248-022-00751-9