27 resultados para Investigational New Drug Application
em Archive of European Integration
Resumo:
The team comprising Jean-Claude Juncker’s Commission was revealed on 10 September 2014: does it herald a new start for Justice and Home Affairs (JHA) cooperation in the EU? This essay outlines the main structural and thematic changes introduced by the new Commission, in particular those with direct or indirect relevance to EU JHA or the Area of Freedom, Security and Justice (AFSJ) policies. It also reflects on the new institutional configuration and what it means for the substantive work of the new Commission services and for their intra- and inter-institutional relations. The essay concludes with a set of proposed policy priorities for the new Commission.
Resumo:
The crisis in the eurozone– which became worse in Europe at the same time that the Lisbon Treaty entered in force at the end of 2009 – has presented the first test of the crisis management capabilities of the intergovernmental approach. As provided under the Lisbon Treaty, the European Council has been the true decision-making centre for the policies adopted in response to the financial crisis, with the Commission playing a technical role. This commentary finds, however, that this institutional set-up has been unsatisfactory and unable to overcome the three fundamental dilemmas of the integration process: the dilemma of veto power, the dilemma of enforcement of the agreements and the dilemma of decision-making legitimacy. While it remains to be seen whether the election of François Hollande as President of France signals the beginning of a new political cycle characterised by new ideas on the institutional future of the EU, if that were to materialise, this paper aims to contribute to the debate on those new ideas.
Resumo:
The proposal to move to a full banking union in the eurozone means a radical regime shift for the EU, since the European Central Bank will supervise the eurozone banks and effectively end ‘home country rule’. But how this is implemented raises a number of questions and needs close monitoring, explains CEPS CEO Karel Lannoo in this new Commentary.
Resumo:
Among the many foreign policy challenges the EU will have to address this year, such as cultivating workable ties with Ukraine, Russia and other neighbours in the east, reviving the transatlantic partnership in trade, rebalancing alliances with Asian countries, and pooling and sharing defence capabilities, the number one challenge that will take up most of the Foreign Affairs Council’s time is the Middle East. After months of half-baked unilateral attempts at resolving the foreign policy challenges posed by this troubled region, the moment has now come for the EU to take bold and concrete action, argues CEPS Senior Fellow Steven Blockmans in this new Commentary.
Resumo:
The crisis has contributed to a slowdown in global trade volumes, with trade virtually stagnant in the twelve months to July 2013. In this context, fruitful negotiations in the World Trade Organisation’s 9th Ministerial Conference in Bali are crucial to sustain the institution’s credibility and prove that multilateral negotiations can still deliver success. WTO trade talks are the only ongoing trade liberalisation process that has development at its core. The Doha mini-package under consideration at Bali is a collection of watered-down but deliverable elements of a deal comprising agriculture, trade facilitation and special and differential treatment/less developed country concessions. Post-Bali, the WTO should aim to reverse the current disenchantment with multilateral trade negotiations. This means formulating a relevant trade negotiating agenda with an understanding of global value chains at its core. However, the transition to the new agenda requires a closure of the ongoing Round. The easiest way to conclude the Doha Round would be to select another discrete set of deliverables that fulfills the development commitment of the Doha Development Agenda, thus paving the way for a new Round.
Resumo:
This book examines the Brazil-EU Strategic Partnership and is the result of a project that ‘twinned’ five sets of eminent Brazilian and European scholars to investigate themes of undoubted strategic significance: macroeconomics, trade policy, climate change, foreign policy and continental regionalism. Results show that while the two parties cannot claim to determine global policies, they can develop a specialist niche in global affairs, working together in the avant-garde of those searching for workable global solutions, seeking to bridge the frequent wide differences between the West and the rest, or North and South, or old powers and new ones.
Resumo:
This study analyzes the Turkish case as a model country for the state-building processes in the Arab world in the aftermath of the Arab revolts that took place in Tunisia, Egypt and Libya. To this end, it deals with the Turkish case in three phases: the founding of the Turkish Republic, political developments until 2002, and the post-2002 Justice and Development Party period. The study focuses on state-society relations manifested in the form of a secular-religious cleavage intertwined with problematic civil-military relations. Each phase of Turkey’s history is compared to cleavages and civil-military relations in Egypt, Tunisia and Libya. After analyzing the constitution-making processes in the latter three countries following the Arab revolts, the study concludes by discussing the viability of the Turkish model in the light of Turkey’s search for a new constitution.
Resumo:
In late 2006 and early 2007, relations between Russia and Belarus were hit by the most serious crisis in many years. In a setting of heightened tension, the Belarusian authorities decided to gradually modify their economic policy and thoroughly restructure the ruling class. The new situation created new, much more difficult challenges for the Belarusian opposition. The processes initiated by the authorities were not intended to bring about either the democratisation of public and political life or full economic liberalisation; their only purpose was to enable the regime to tackle new challenges and survive in the changing international context. Nevertheless, modernisation has been initiated in Belarus' authoritarian system of power, which until now was considered to be completely incapable of reform. This puts the country's main political and economic partners, including the European Union, in a new situation.
Resumo:
Against a backdrop of chaos and violence in the EU’s neighbourhood, Steven Blockmans acknowledges that the troubles of 2014 will cast a long, dark shadow over 2015. In this new CEPS Commentary the author attempts to predict some of the EU foreign policy developments that are likely to mark the New Year.