Reported food adulteration in the MENA region (2019–2024): A multilingual media and RASFF analysis of trends, hazard types and regulatory gaps

Purpose: To assess the regulatory compliance of operational processes at a British pharmaceutical manufacturing company (Company X). Provide remediation strategies for any compliance gaps identified to align operations with regulatory approvals. Ultimately, to assure Qualified Persons that finished pharmaceutical products released for sale are compliant with regulatory approvals and manufactured to current quality standards. Materials and methods: A gap analysis between regulatory-approved CTD sections and operational documentation is conducted for a single marketed product at Company X. Inclusion of CTD sections for review is determined according to those likely to contain Established Conditions (EC) as specified in the International Council for Harmonisation (ICH) of Technical Requirements for Pharmaceuticals for Human Use Q12 guideline. A three-tiered review process is used to identify Established Conditions and describe compliance. Tier 3 (Student) identifies Established Conditions by comparing like-for-like (compliant), equivocal (further assessment required) and opposing (non-compliant) terminology in the CTD sections compared to operational documentation. Tier 2 (Subject Matter Experts (SMEs)) reviews and approves Tier 1 outputs. Equivocal terminology is assessed as either compliant or non-compliant. Non-compliant conditions are assessed as regulatory gaps if they deviate from the CTD or quality gaps if they are compliant with the CTD but deviate from Good Manufacturing Practices (GMP). A risk assessment is conducted using a risk priority numbering (RPN) tool and remediation proposals are made. Tier 1 (Governance) reviews and confirms Tier 2 compliance gap outputs and ratifies a final adjudication and remediation strategy. Results and discussion: Data outputs for this study could only be generated at Tier 3 and Tier 2 levels due to time constraints. A total of 62 compliance-related Established Conditions (EC) were identified with 37 representing compliance gaps. 49% (30 conditions) related to regulatory compliance gaps, 40% (25 conditions) were compliant and 11% (7 conditions) were quality compliance gaps. Six categories of regulatory compliance gaps were identified with the most commonly observed being the unavailability of regulatory-approved CTD sections for review. Three categories of quality compliance gaps were identified with the most commonly observed being the misalignment of operational and validating documentation. Conclusions: Company X is presently in a state of non-compliance. The unavailability of regulatory-approved documentation emerges as the most common compliance issue suggesting insufficiencies in regulatory document control may currently exist. A root cause analysis coupled with a corrective and preventative action plan may be beneficial to support sustained compliance. Further work is required to remediate identified compliance gaps to bring operations into regulatory compliance.

During use of Electronic Cigarettes (ECs) and Heated Tobacco Products (HTPs), their ingredients and products formed during heating are aerosolized and inhaled. Hazard information is often unavailable. Our objective was to identify and classify substances in the ingredients or emissions of ECs and HTPs, based on scientific hazard classifications. Ingredient data were collected from the European Union Common Entry Gate (EU-CEG), a mandatory notification system for tobacco and related products in the EU. Substances in EC or HTP emissions were identified with a systematic literature review and classified into three categories based on existing health hazard classifications. Category 1 substances (highest potential health hazard) were regarded as high-priority substances for research and quantification. Categories 2 and 3 included potentially harmful substances and substances lacking sufficient toxicological data respectively. 134 of the 1740 identified substances were classified in Category 1. Several substances possess Carcinogenic, Mutagenic, or Reprotoxic properties, prohibited as tobacco additives. Most substances lacked sufficient toxicity data and were classified in Category 3. Our classification can be used for monitoring and enforcement, ensuring proactive management of potential risks. Therefore, we recommend strengthening the enforcement of existing bans. This study identifies and classifies 1740 substances found in the ingredients and emissions of ECs and HTPs, including, 134 hazardous chemicals, among which are carcinogens, mutagens and reproduction toxicants. This indicates regulatory gaps and the need for stricter enforcement of existing bans. The findings provide a valuable tool for policymakers and public health professionals for monitoring and mitigating risks.

Need for assessing the inhalation of micro(nano)plastic debris shed from masks, respirators, and home-made face coverings during the COVID-19 pandemic.

BackgroundMusculoskeletal disorders (MSD) are the most common nonfatal injuries in construction, occurring more frequently in construction than in most other industries. Construction safety programs typically focus on traumatic injuries and...

Hazards identification and creation of a safe working environment is a major challenge faced by management of many industries today. Hazard assessment is thus carried out in workplaces to identify dangerous events and conditions that may lead to accidents in the industries. Gap analysis on hazard identification alongside safety management in the industries was carried out in order to showcase the level of incompleteness in recent studied on the subject and the need to close the gaps in future studies. This study, which was carried out in both a petrochemical and an oil refining companies in Nigeria, identified industrial hazards and assessed safety measures in the Chemical Industry (CHI) of Nigeria. A well-structured questionnaire instrument was used for data collection. The study was carried out amongst technical staff and management staff of the chemical industry whose day-to-day duty is such that they are exposed to one form of hazard or the other in the industry. The questionnaire was administered to 96 technical staff and management staff in the CHI out of which 84 (88%) were completed and returned. The study focused on types of hazards, hazards and risk awareness, implementation of control measures and effectiveness of safety hazards and risk management programmes in the chemical industry of Nigeria. Modified Proportional Importance Index (PII) and a four-point Likert scale were adopted in data analysis. Results revealed that loud noise (PII = 3.2; respondents = 92%), working at heights (with PII = 3.1; respondents = 89%) machines and equipment vibration (PII = 3.0; respondents = 87%), high voltage areas (PII = 2.9; respondents = 84%) and chemical spills (PII = 2.5; respondents = 55%) are the highest ranking hazards in the chemical industry. A high level of safety hazard awareness was found among workers in the industry (p < 0.05, 95%Cl.; PII = 3.1 - 3.5). The outcome of the intervention showed that Chemical Industry Number 1 (CHI-1) improved from 87.90% to 98.09%, Chemical Industry Number 2 (CHI-2) improved from 81.53% to 95.54% on worker's knowledge on the identification and assessment of hazards and risk in the chemical industries. These hazards pose threats to the safety of workers and should be effectively controlled to reduce associated risks to as Low as Reasonably and Practically Achievable (ALARPA).

A gendered analysis of trends in the faith‐based provision of social services: Evidence from Egypt and Turkey

Antimicrobial resistance (AMR) is a growing global concern, influenced by antibiotic use in both human and veterinary medicine, especially in companion animals. In low- and middle-income countries, regulatory oversight on veterinary prescriptions is often limited, creating gaps that can accelerate AMR. This study aimed to characterize the use of antibiotics approved for human use that are prescribed by veterinarians for companion animals in Brazil, a country representative of broader regulatory challenges. We conducted a retrospective analysis of five years (2017-2021) of national sales data recorded by the National System for the Management of Controlled Products (SNGPC), maintained by the Brazilian Health Regulatory Agency (ANVISA). A total of 789,893 veterinary antibiotic prescriptions were analyzed over the five-year period, providing a comprehensive overview of prescribing patterns. The dataset included all oral and injectable antibiotics purchased in human pharmacies with veterinary prescriptions. Data wrangling and cleaning procedures were applied to extract information on volume, antibiotic classes, seasonal variation, and regional distribution. The results revealed a predominance of penicillins, first- and second-generation cephalosporins, and a marked increase in macrolide use, especially azithromycin. Notable regional disparities were observed, with the southeastern region leading in prescription volume. The findings, particularly the disproportionate use of azithromycin and the marked regional disparities, highlight the need for targeted monitoring policies and a stricter regulation of off-label antibiotic use in veterinary medicine. They also offer insights applicable to other countries facing similar AMR threats due to limited surveillance and regulatory frameworks.

In the distinguished spheres of private security industries, India and the UK confront a shared predicament—a conspicuous void in unambiguous wage regulation within their governing acts. This systemic lapse, diluting the safeguarding of employee rights and welfare, engenders concerns over wage inequalities, perpetuating a vulnerable workforce’s susceptibility to exploitation. This discord reverberates as an intricate dissonance in the tapestry of labour regulations, weaving threads of disparity, neglect and inequity, thereby underscoring a poignant disjunction between international ideals and the tangible hardships faced by the unsung custodians of security. The article will address these demands by embracing global labour standards, harmonizing legislative frameworks and their implementation and nurturing collaborations among stakeholders for equitable compensation.

This paper is a preliminary attempt to evaluate the regulatory gap for Unmanned aerial system (UAS) operations in Sri Lanka and to propose improvements to the regulatory framework. Data were collected on the existing distribution of UAS usage in the country. A sample of users of UASs was surveyed to determine current and intended future use of UASs. Using UAS regulations applied elsewhere in the world and other scientific studies, a list of criteria was established. The relative importance of the established evaluation criteria was determined based on the perception of both UAS operators and a sample of the general public. Using the identified criteria and newly imposed UAS regulations in Sri Lanka, the regulatory gap analysis was performed to evaluate the regulatory performance.

SummaryBackgroundIn Lao Peoples Democratic Republic, midwives are the main providers of primary reproductive, maternal, newborn, child and adolescent (RMNCAH) services. We analyzed to what extent practice regulations allow midwives to provide nationally defined essential RMNCAH services.MethodsStakeholder consultations and document reviews were conducted to identify the essential RMNCAH interventions and care tasks midwives are expected to provide without physicians. These were defined in: 1) the Essential Health Service Package (EHSP) and 2) 18 national standards and guidelines. We then mapped whether midwifery regulations, which provide the legal framework for clinical service provision, supported delivery of these standards to identify regulatory gaps. Data were used to update regulations.FindingsMidwives were expected to provide 39 RMNCAH interventions without physicians, representing 1100 care tasks. Midwifery practice regulations allowed eight of 39 interventions (20.5%) and 705 of 1100 care tasks (64.1%) at baseline. Of the 31 interventions not allowed for provision by midwives, 83.9% (26) required prescribing and giving medicines, 51.6% (16) ordering and conducting diagnostics, 38.7% (12) making a clinical diagnosis, and 22.6% (7) use of non-pharmacological interventions. The Ministry of Health convened a multi-stakeholder group to revise the midwifery practice regulations, which increased the legally supported interventions and care tasks to 37 (94.9%) and 1081 (98.3%), respectively.InterpretationThis novel methodology enabled systematic identification and quantification of regulatory gaps in midwifery practice and data-driven revisions. Consequently, regulatory support for delivery of primary RMNCAH interventions vastly improved. The approach can be applied to other clinical cadres, service areas and countries.FundingKorea Foundation for International Health Care (KOFIH) supported research operation.

This chapter is devoted to a systemic consideration of the preconditions for the emergence of modern Islamism in the Middle East. Since Islamism is spread almost in every country of the Middle East, it seems reasonable to formulate some ideas explaining its widespread influence in this part of the world through a comparative analysis of some developmental trends in this macroregion and in China and India. Such an analysis seems of vital importance since radical Islamism appears a powerful destabilizing force at the global and regional levels. We attend to the need to delineate between radical and moderate Islamisms, since in many Muslim societies the latter appears to be more a stabilizing force and not a destabilizing one. We maintain that the success of Islamism is strongly determined by the traditionally fragile statehood in the Middle East. At the same time, in certain respects, for example, in terms of language, ethnicity, and religion, the Middle East seems to be much more homogenous than, say, India which is one of the most multilingual states of the world. This homogeneity became the most important basis for internationalization of Islamism in the MENA region, which could then easily cross the state boundaries making them transparent.

Assessment of the Meetings, Incentives, Conventions and Exhibitions (MICE) Industry in the Philippines

The transition to hydrogen as an aviation fuel, as outlined in current decarbonization roadmaps, is expected to result in the entry into service of hydrogen-powered aircraft in 2035. To achieve this evolution, certification regulations are key enablers. Due to the disruptive nature of hydrogen aircraft technologies and their associated hazards, it is essential to assess the maturity of the existing regulatory framework for certification to ensure its availability when manufacturers apply for aircraft certification. This paper presents the work conducted under the Clean Aviation CONCERTO project to advance certification readiness by comprehensively identifying gaps in the current European regulations. Generic methodologies were developed for regulatory gap and risk analyses and applied to a hydrogen turbine aircraft with non-propulsive fuel cells as the APU. The gap analysis, conducted on certification specifications for large and normal-category airplanes as well as engines, confirmed the overall adequacy of many existing requirements. However, important gaps exist to appropriately address hydrogen hazards particularly concerning fire and explosion, hydrogen storage and fuel systems, crashworthiness, and occupant survivability. The paper concludes by identifying critical areas for certification and highlighting the need for complementary hydrogen phenomenology data, which are key to guiding future research and regulatory efforts for certification readiness maturation.

Chapter 27 - Commercializing Genetically Engineered Cloned Cattle

в данной статье представлен анализ риска несбалансированной ликвидности как ключевого инструмента повышения устойчивости российского банковского сектора в условиях кризиса. Исследование основывается на обширном обзоре научных публикаций и практических кейсов, акцентируя внимание на динамической природе ликвидности и её влиянии на финансовую устойчивость банков. Особое внимание уделяется взаимосвязи между уровнем задолженности, ценами на товары и услуги, а также денежной массой как факторам, влияющим на ликвидность. Рассматриваются риски, возникающие из-за невыплат по кредитам или отзывов депозитов, что делает банки уязвимыми к финансовым потрясениям. Отмечено противоречие между высокой ликвидностью и доходностью: стремление увеличить прибыль может привести к снижению ликвидности из-за инвестирования в более рискованные активы. Исследуется взаимодействие между ликвидными и неликвидными активами, что подчеркивает необходимость сбалансированного управления для минимизации рисков, связанных с дефицитом или избытком ликвидности. На основе проведенного анализа сделан вывод о важности эффективного управления ликвидностью, которое требует применения методов, таких как нормативный метод, стресс-тестирование, GAP-анализ и управление активами и пассивами (ALM). Предложен детальный разбор наиболее распространенных методов, а также разработка интегрированной модели оценки риска несбалансированной ликвидности, учитывающей внутренние и внешние факторы. Модель включает многоуровневую систему сбора данных, многомерный анализ и создание адаптивных стресс-сценариев с использованием машинного обучения для раннего предупреждения о потенциальных рисках. Данная работа подчеркивает необходимость комплексного подхода к управлению ликвидностью, что позволит повысить стабильность банковского сектора в условиях экономической неопределенности и обеспечить его устойчивое развитие. this article presents an analysis of the risk of unbalanced liquidity as a key tool for improving the stability of the Russian banking sector in a crisis. The study is based on an extensive review of scientific publications and practical cases, focusing on the dynamic nature of liquidity and its impact on the financial stability of banks. Special attention is paid to the relationship between the level of debt, prices of goods and services, as well as the money supply as factors affecting liquidity. The risks arising from non-payment of loans or withdrawal of deposits, which makes banks vulnerable to financial shocks, are considered. The contradiction between high liquidity and profitability is noted: the desire to increase profits can lead to a decrease in liquidity due to investing in riskier assets. The interaction between liquid and illiquid assets is investigated, which emphasizes the need for balanced management to minimize risks associated with a shortage or excess of liquidity. Based on the analysis, it is concluded that effective liquidity management is important, which requires the use of methods such as the regulatory method, stress testing, GAP analysis and asset and liability management (ALM). A detailed analysis of the most common methods is proposed, as well as the development of an integrated model for assessing the risk of unbalanced liquidity, taking into account internal and external factors. The model includes a multi-level data collection system, multidimensional analysis and the creation of adaptive stress scenarios using machine learning for early warning of potential risks. This work highlights the need for an integrated approach to liquidity management, which will increase the stability of the banking sector in conditions of economic uncertainty and ensure its sustainable development.