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Legislation for expedited‐approval pathways and programmes for drugs, biologics or medical devices has been enacted for rapid commercialization of innovative products in the United States of America (USA) and the European Union (EU). However, less innovative products are increasingly benefitting from these expedited‐approval pathways, and obligations to collect and report post‐marketing data on approved products are being bypassed frequently. The Japanese government recently enacted legislation for a new conditional and time‐limited approval pathway dedicated to regenerative medicine products. The current study examines this new legislation and compares it with existing US and EU regulatory frameworks, with a particular focus on how it addresses the limitations of existing systems. Regulations, guidance documents and approval information were gathered from the websites of the respective authorities in the USA, the EU and Japan, and the systems were categorized through qualitative analysis. The pathways and programmes from each region were categorized into four groups, based on the requirement of pre‐ or post‐marketing clinical data. Expedited‐approval pathways in the USA and the EU provide similar qualification criteria, such as severity of target disease; however, such criteria are not specified for the new pathway in Japan. Only the Japanese pathway stipulates a time limitation on exceptional approval, requiring post‐marketing study for conditional and time‐limited products. Continuous improvement is necessary to solve previously addressed issues within the expedited‐approval pathways and programmes and to ensure that innovative medical products are rigourously screened, but also readily available to patients in need. The time limitation of conditional approval could be a potential solution to some of these problems. Copyright © 2017 The Authors. Tissue Engineering Regenerative Medicine published by John Wiley & Sons, Ltd.

Sheep pox and goat pox (SPGP) virus and lumpy skin disease (LSD) virus belong to the genus Capripoxvirus and cause disease with economic impacts in sheep/goats and cattle respectively. In 2013/14, outbreaks of SPGP were reported in sheep in Greece and Bulgaria and LSD outbreaks were reported in cattle in Turkey, Egypt and some countries in the Middle East. Clinical signs for both diseases include pox lesions, papules and scabs on the skin which may contain virus. This, together with the fact that Great Britain (GB) currently imports cattle hides, sheep skins and wool from European Union (EU) countries without the requirement for treatment prior to export, raises concern that capripoxviruses could be introduced into GB. A qualitative assessment presented here concluded that the current risk of entry of SPGP virus into GB through the importation of one untreated sheep skin, hide or wool bale from an EU Member State (MS) with similar flock prevalence to that in sheep in Greece in 2013/14 is low. In terms of SPGP virus levels, those infected sheep skins/hides entering GB are more likely to be from infected animals with normal skin (i.e., not showing lesions) and hence carrying lower levels of virus than those from animals showing papules and scabs which contain very high virus levels and are easier to detect. The predicted risk of importation of LSD virus per cattle hide/skin is also low (assuming LSD were to emerge in an EU MS with similar herd prevalence to that reported for SPGP in Greece in 2013/14). The levels of LSD virus on an infected cow's hide, if imported, may be very low. It is recommended that the risks for entry of capripoxviruses are recalculated if outbreaks occur elsewhere within the EU.

Melanie Piepenschneider untersucht die Rolle Deutschlands in der Europäischen Union, wobei sie die deutsche Einheit als Auslöser für weitere Vertiefungsschritte des europäischen Integrationsprozesses begreift. Nach der Vereinigung sieht sie die Gestaltung deutscher Europapolitik als schwieriger an. (HeLP/Editorial).

This article argues that the dominance of precise, linear borders as an ideal in the demarcation of territory is an outcome of a relatively recent and ongoing historical process, and that this process has had important effects on international politics since circa 1900. Existing accounts of the origins of territorial sovereignty are in wide disagreement largely because they fail to specify the relationship between territory and borders, often conflating the two concepts. I outline a history of the linearization of borders, which is separate from that of territorial sovereignty, having a very different timeline and featuring different actors, and offer an explanation for the dominance of this universalizing system of managing and demarcating space, based on the concept of rationalization. Finally, I describe two broad ways in which linearizing borders has affected international politics: by making space divisible in new ways; and underpinning hierarchies by altering the distribution of geographical knowledge resources.

This article argues that the dominance of precise, linear borders as an ideal in the demarcation of territory is an outcome of a relatively recent and ongoing historical process, and that this process has had important effects on international politics since circa 1900. Existing accounts of the origins of territorial sovereignty are in wide disagreement largely because they fail to specify the relationship between territory and borders, often conflating the two concepts. I outline a history of the linearization of borders, which is separate from that of territorial sovereignty, having a very different timeline and featuring different actors, and offer an explanation for the dominance of this universalizing system of managing and demarcating space, based on the concept of rationalization. Finally, I describe two broad ways in which linearizing borders has affected international politics: by making space divisible in new ways; and underpinning hierarchies by altering the distribution of geographical knowledge resources.

The paper examines the role of meso-level governance in the Hungarian political system focusing on the county self-governments. The objective of the author is to introduce the consequences of the lack of meso-level politics for the backslide of the democratic system. The paper focusing on Hungarian counties seeks to explore the three-decade-long process leading to the progressive elimination of these bodies from the public power arena. The Hungarian case demonstrates how the overall administrative and political centralisation process has contributed to the hollowing-out of meso-level political actors. The Hungarian case study underlines the complex interrelations between the macro-political system, and the territorial political governmental arenas from the aspect of the centre and periphery power relations. Many European regional governments are not only platforms for territorial interest representation but also a counterweight to the central level contributing to the quality and stability of democratic governance. The study reviewing the situation of Hungarian counties draws on the author's previous empirical research experiences and is a part of the ongoing research on governance issues of peripheral areas1. The results of the analyses discuss the implications of the hollowing-out of county governments on the electoral and party system, the modification of the institutional channels of interest representation. The Hungarian example appears to corroborate the analogy with the theory of second order elections. The theory of second order elections recognized the impact on the turnout and electoral preferences based on the changing role of different governance levels, by the same token, it seems that the weakening power position of the meso contributes to the decline of political competition and publicity by minimizing the interest of the public in general. The objective of the present study is to enrich the assessment of the relationship between territorial governance and democracy with some analytical options by demonstrating the implications of the "second order nature" of the meso.

Text guanyador del premi Catalunya-Europa de la Fundació Pasqual Maragall del 2018. ; Esta investigación se centra en las implicaciones de las políticas de solidaridad y redistribución de la Unión Europea (UE) en el proceso de integración desde una perspectiva de ciudadanía europea. Partiendo del análisis de distintos tipos de fuentes estadísticas, este estudio busca responder quienes son los grupos sociales beneficiados y perjudicados de la solidaridad europea, así como los efectos que estas políticas tienen en los procesos de transformación política y social. Para responder a estas preguntas, se desarrolla una perspectiva teórica sobre las políticas de solidaridad de naturaleza redistributiva y se realiza un análisis sistemático sobre el apoyo al proceso de integración en los últimos cuarenta años desagregado por grupos sociales. Asimismo, este estudio compara las políticas presupuestarias de la UE y los beneficiarios principales de estas, y evalúa la evolución de la desigualdad entre Estados Miembro. Los resultados indican que la integración basada solamente en criterios de mercado ha llevado a un gap entre la elite y el resto de los ciudadanos sobre sus perspectivas de la UE. Estas conclusiones implican que este proceso debería ir más allá de lo puramente económico y/o instrumental, lo cual representa importantes consecuencias para cuestiones normativas como la evolución de la UE y la coexistencia de diferentes identidades o demos a nivel europeo, nacional y regional.

The article argues that the democratic international trade union federations developed a keen interest in European economic co-operation after 1922, at first rejecting economic nationalism and advocating free trade; then, from the late 1920s onwards, stressing the need for an organised European economy. Remarkably, however, when discussing social issues, unions emphasised the national or universal level, as opposed to the regional one.

The advent of the computer and its associated devices has made office design, as well as furniture design, political issues; human discomfort and the resulting pressures from workers to alleviate it have spawned requests for improvements in the office environment. These have shaped union contracts and state regulations while stimulating demands forthe enactment of federal and state laws affecting the office.

The Western ideal of journalistic objectivity, influenced by liberal principles of the rulers' accountability to the ruled and the empirical skepticism of science, developed as an occupational response by journalists to marketplace competition among commercially or politically motivated suppliers of information and came to define the journalist's professional ethic of impartiality and independence. At the same time the term professionalism must be used advisedly. Journalism is a field with some but not all of the attributes of a profession. By the usual tests of the freedom of the practitioners to govern entry and exit from the field, to possess an exclusive right to carry on their trade, and to set the standards of performance, journalists are not as autonomous as, for example, physicians and attorneys. If they sought to close the shop to outsiders or to set standards of writing and reporting, they would be infringing upon the prerogatives of "management"—editors and publishers.