13 May 2024
The vision of a unified European HTA is by no means a new endeavor. At its core are the publicly declared ambitions to harmonize assessments of clinical data within the EU and avoid the duplication of efforts. Not surprisingly, these ambitions are pu...
Following the adoption of the Kunming-Montreal Global Biodiversity Framework (KM-GBF) under the Convention on Biological Diversity, the European Union (EU) introduced an EU Nature Restoration Regulation. This study systematically compares the restora...
The focus of manufacturers preparing for implementation of the EU HTA Regulation (HTAR) in 2025 has understandably been on their market access teams, and how they can be best equipped to adapt to this significant change. Considering the critical natu...
The European Union’s Artificial Intelligence Act (EU AI Act) is expected to be a major legal breakthrough in an attempt to tame AI’s negative aspects by setting common rules and obligations for companies active in the EU Single Market. Gl...
Twenty-one years after Directive 2001/82/EC regulating veterinary medicinal products (VMPs) came into force, a new veterinary regulation will apply from 28 January 2022. Future applicants will have to follow the requirements of Regulation (EU) 2019/6...
Aiming at reducing CO2 emissions from shipping at the EU level, a system for monitoring, reporting, and verification (MRV) of CO2 emissions of ships was introduced in 2015 with the so-called ‘MRV Regulation’. Its stated objective was to p...
A new LED rear light for automotives is proposed and demonstrated for EU ECE R07 regulation. The full rear light is a combination of a position lamp and a braking lamp, and LED light bars and micro-prisms are involved as their essential components. T...
As an empirical investigation of firm support for circular economy regulation in the European Union (EU) context, this paper is the first to connect the research field on corporate political activity with the growing research field on the circular ec...
The European Health Technology Assessment (HTA) regulation (HTAR) came into effect in January 2025 and impacts the HTA process in all European Member States. Member States must give due consideration to the joint clinical assessment (JCA) report. Thi...
The European Union (EU) has put forward a new regulatory framework for batteries through the EU Batteries Regulation (2023/1542), which sets a series of minimum thresholds of recycled materials for electric vehicle (EV) batteries sold on the EU marke...
Non-food geographical indications (GIs) are emerging as strategic policy instruments in the European Union after Regulation (EU) 2023/2411 extended protection to craft and industrial products. While the literature on agri-food GIs is extensive, empir...
Conceived as institutions funded by the public purse and intended to exist devoid of political influence, the mandate of public service media (PSM) entities is to disseminate reliable news content and high-quality audiovisual productions to all demog...
This explorative study aims to shed light on the ways in which Forest Stewardship Council (FSC) certification interacts with the implementation of the EU Timber Regulation (EUTR) in Romania. To this end, the EUTR implementation process is examined, a...
The dynamic nature of infectious diseases introduces inherent challenges to the design of vaccine clinical trials, which consequently makes vaccine indirect treatment comparisons (ITCs) and meta-analyses (MAs) more challenging compared with regular p...
Romania has some huge ferrous slag stockpiles that are secondary resources of minerals. Although a sizable portion of ferrous slags is recycled for use in building roads and other infrastructure, a sizable portion is still dumped. By November 2026, M...
The Nagoya Protocol on Access to Genetic Resources and Fair and Equitable Sharing of Benefits Arising from their Utilization came into force in October 2014. In the European Union (EU), new legislation had to be developed in order to apply the mandat...
Illegal logging and the associated deforestation have serious consequences for biodiversity, the climate, the economy and society. The EU Timber Regulation (EUTR) prohibits the placing of illegally harvested timber or timber products on the market. T...
The Biocidal Products Regulation (BPR) contains several provisions for nanomaterials (NMs) and is the first regulation in the European Union to require specific testing and risk assessment for the NM form of a biocidal substance as a part of the info...
Illegal logging has always been considered as a major environmental and social global concern, as it is directly associated with deforestation and climate change. Nowadays, EU Regulation No 995/2010 has been successfully enforced to impede the placem...
After almost every economic crisis and corporate scandal, political actors announce the need for stricter regulatory measures for financial markets and companies, in an attempt to appease their voters and defend their political agenda. Regarding the...
24 September 2025
The implementation of the European (EU) Health Technology Assessment (HTA) Regulation 2021/2282 (EU HTAR) offers many opportunities, aimed at harmonizing HTA procedures and improving access to innovations; it also represents a significant challenge f...
E-commerce has progressed within Europe before, on the basis of the pre-pandemic raise, with COVID-19 determining an explosion of its evolution. The European e-commerce market is very important, linking together more than 500 million consumers. This...
Building a common EU framework for sustainable finance undoubtedly implies the integration of sound and sustainable processes and skills across the whole structure and governance of financial institutions. Consequently, a new financial paradigm is go...
Unmanned aircraft systems (UAS) have rapidly become more common in various applications. At the same time, the need for a safe UAS operation is of great importance to minimize and avoid risks that could arise with the deployment of this technology. W...
18 November 2024
Many countries around the world use health technology assessment (HTA) to inform reimbursement and pricing decisions. HTA is often split into two steps, called assessment and appraisal. While the term HTA itself has been defined by international cons...
Sustainability and corporate social responsibility (CSR) strategies of companies delineate the health and the welfare of the communities across the globe. The two major goals of this study are (1) To explore the relationship between the environmental...
This scoping review examines the evolving landscape of European Union (EU) legislation, as it pertains to the implementation of artificial intelligence (AI) in smart grid systems. By outlining the current regulatory landscape, including the General D...
With the European Union (EU) Health Technology Assessment (HTA) regulation, Joint Clinical Assessments (JCA) are now required for oncological and advanced therapy medicinal products. The JCA assessment scope is determined through the PICO framework (...
The first objective of this paper was to provide an inventory of developments of certification schemes for sustainable biomass production, following recent EU legislation (both formalized and under development). One main pillar is the EU Timber Regul...
The paper addresses the interplay between the 1980 Child Abduction Convention and the Regulation (EU) 2019/1111, briefly presenting the main novelties contained in Chapter III of the Regulation devoted to international child abduction, and then focus...
This research examines the role of preserving the vernacular cultural landscape in sustainable tourism, with a focus on the Stara Planina area in Serbia. The goal was to determine how the perception of cultural heritage preservation, the use of resou...
Hydroxyapatite nanoparticles (HAP-NP) are incorporated in oral care products such as toothpastes and mouthwashes to treat dental sensitivity or to promote enamel remineralisation. Despite the good performance of HAP-NP in this application, it is impo...
Multimodal travel planning services allow travelers to plan their journey by combining different transport modes: air, rail, waterborne, coach, public transport, demand responsive transport, walking, cycling, etc. The European Union is fostering the...
Literature has suggested metallic nanomaterials (NMs) for a multitude of applications in cosmetic products, either as active ingredients or excipients. Alike most high-paced industrial sectors, cosmetology continues to capitalize on its unique proper...
Green and blue infrastructure, nature-based solutions, and cultural and built heritage play a key role in enhancing ecosystem services provision and shaping urban quality and communities’ wellbeing calling for an integrated approach to ecosyste...
The Green Deal of the European Union defines extremely ambitious climate targets for 2030 (−55% emissions compared to 1990) and 2050 (−100%), which go far beyond the current goals that the EU member states have agreed on thus far. The que...
Background: Port congestion contributes significantly to operational inefficiency and environmental impact in maritime logistics. With tightening EU regulations such as the Emissions Trading System (EU ETS) and FuelEU Maritime, understanding and miti...
While there has been considerable research related to Koroneiki cultivar in different areas in Greece, no systematic work has been carried out on olive oil analysis from one of the most important olive-growing regions in Greece, located southwest of...
The objective of this paper is to describe the process of transition from the Farm Accountancy Data Network (FADN) to the Farm Sustainability Data Network (FSDN), a European survey that gathers yearly data about agricultural holdings at microeconomic...
The integration of Artificial Intelligence (AI) and the Internet of Things (IoT) in Building Energy Management Systems (BEMSs) offers transformative potential for improving energy efficiency, enhancing occupant comfort, and supporting grid stability....
Animal agriculture is shifting toward larger farms and regional agglomerations in many countries. In step with this development, manure nutrients have started accumulating regionally, and are leading to increasing eutrophication problems. Nevertheles...
Background: Honey is a beekeeping product with high nutritional value, considered a bio-indicator of environmental pollution. The aim of this study was to determine the mineral content in honey by analyzing toxic metals in accordance with EU regulati...
Background/Objectives: This report examines the future of academic studies involving investigational therapeutic radiopharmaceuticals within the framework of Regulation (EU) No. 536/2014. It discusses the impact of Good Manufacturing Practice (GMP) r...
When possible, choosing materials with a low quartz content is the most effective and cost-efficient way to prevent the respirable quartz exposure of workers and other end users of powdery products. Therefore, methods are needed to analyze low amount...
Biocontrol agent (BCA) plant protection active substances composed from microorganisms, semiochemicals and substances from natural origins are increasing in Europe, since their entry into force of Regulation (EC) 1107/2009, in number and as a percent...
On 21 April 2021, the European Commission presented its long-awaited proposal for a Regulation “laying down harmonized rules on Artificial Intelligence”, the so-called “Artificial Intelligence Act” (AIA). This article takes a critical look at the pro...
A new, highly efficient curved reflex reflector is proposed to meet the requirement of EU ECE (Economic Commission for Europe) regulations based on the commercial design provided by an automotive company which has been in mass production. We used dou...
Since the implementation of Regulation (EC) No 1924/2006 on nutrition and health claims (NHCR) made on food, only 261 health claims have been authorised, suggesting that the regulation creates challenges for the food industry. This study looks at the...
A total of 209 samples of various cereal crops (maize, wheat, barley, rye and oats) grown in Croatian fields during 2016 and 2017 were collected to analyze and determine the occurrence and co-occurrence of EU regulated mycotoxins in cereals (AFB1, AF...
21 March 2017
The objective of this study was to investigate the aquatic-toxic effects of glyoxal-containing cellulose ether with four different glyoxal concentrations (0%, 1.4%, 2.3%, and 6.3%) in response to global chemical regulations, e.g., European Union Clas...
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