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This paper reviews the experiences of Viet Nam in improving its approach to regulatory management. Since 1986, Viet Nam promulgated and amended a number of laws and regulations to regulate economic activities in line with market-oriented reforms. A side effect of more laws and regulations has been the increasing compliance costs of the business community. Viet Nam then gradually introduced good regulatory practices, including regulatory impact assessment, online publication of draft, regulatory planning, etc. Numerous efforts were also sought to simplify and control administrative procedures, the most notable of which were under Project 30 since 2007 and Resolution 19 since 2014. Both Project 30 and Resolution 19 produced quick and material outcomes. Further meaningful reforms of administrative procedures depend on whether Viet Nam can build up sufficient confidence of stakeholders in the process. As the key lessons from Project 30 and Resolution 19, further improvement of regulatory management requires strong political will, involvement of relevant stakeholders, and enactment of separate bodies with a clear mandate and sufficient capacity.

In recent years, a growing emphasis on safety has driven various industries, both in manufacturing and service, to implement a Safety Management System (SMS) in their organisations. SMSs have also been widely implemented in aviation due to both regulatory requirements and voluntary implementation with the aim of decreasing incidents and accidents whilst reducing inefficiencies and costs stemming from the repercussions of safety failures. The aviation industry involves various players for the provision of services ranging from airline operations, maintenance, aerodrome operations, air traffic services, aircraft and component design, manufacturing, and training. Not all organisations in the aviation industry have implemented SMSs. Furthermore, SMS is currently not regulated for all aviation organisations. Whilst technology has played a key role in driving down the number of accidents and incidents in aviation, the growth in air traffic demands having programs in place to further drive down accident rates. In this context, this article provides an investigation to the regulatory framework for the implementation of SMSs in aviation, including the requirements stipulated by the International Civil Aviation Organisation (ICAO) and the status of SMS regulation of key National Aviation Authorities (NAA) and Military Aviation Authorities (MAA), with a focus on organisations involved in airworthiness including initial and continuing airworthiness. This article also investigates the challenges of implementing SMSs in organisations involved in Airworthiness, as well as the benefits that could be gained by service providers as well as NAA&rsquo ; s or MAA&rsquo ; s through SMSs.

Regulatory management refers to the systematic appraisal of the impacts of proposed legislative rules and the sustained maintenance of existing laws and regulations. Regulation, used here in the broad sense of the verb 'to regulate', means the use of legal instruments to give effect to a government policy intervention. All countries have their own unique systems for developing, deploying, and reviewing legislation and regulations. Increasingly, they are introducing regulatory management policies and strengthening their institutions to make regulatory systems more effective. Individual regulations do not operate in isolation but interact as part of a system. The framework underpinning this toolkit suggests that a high-performing regulatory system needs to have four key components: 1) regulatory quality tools, such as regulatory impact analysis or administrative burden reduction; 2) regulatory practices and processes, such as consultation and international regulatory cooperation; 3) regulatory institutions through a regulatory oversight body; and 4) a regulatory strategy or overarching policy, such as good practice regulatory principles. Regardless of the differences in underlying regulatory management systems, all countries face the same range of choices about adopting regulatory quality tools, practices, strategies, and institutions.

Transnational regulatory networks play important roles in multi-level regulatory regimes, as e.g, the European Union. In this paper we analyze the role of regulatory networks from the perspective of the economic theory of legal federalism. Often sophisticated intermediate institutional solutions between pure centralisation and pure decentralisation can help to solve complex tradeoff problems between the benefits and problems of centralised and decentralised solutions. Drawing upon the insights of the political science literature about regulatory networks, we show that regulatory networks might be an institutional innovation that can fulfill a number of functions (rule-making, best practices and policylearning, effective enforcement, conflict resolution) that might allow for a better intermediate solution between centralised and decentralised regulatory powers. We apply our approach in three case studies to very different regulatory networks, the Body of European Regulators for Electronic Communication (BEREC), the European Competition Network (ECN), and the International Competition Network (ICN). An important result is that regulatory networks might not only be a temporary phenomenon but part of long-term institutional solutions in European multi-level regulatory regimes.

Ensuring access to essential medicines is a key objective of all health systems, and is an integral component of the progress towards universal health coverage (UHC). Despite global and national efforts to improve access and affordability of medicines, millions of people – particularly in low- and middle-income countries – still remain without access to quality-assured and affordable medicines. This study aims to contribute to existing knowledge on regulatory systems and harmonization efforts in Southeast Asia. Focusing on five member states of the Association of Southeast Asian Nations (ASEAN) – Indonesia, Malaysia, the Philippines, Thailand, an Vietnam – this study gives an overview of pharmaceutical markets and key pharmaceutical policies in the region, provides a cross-country comparison of medicines regulatory systems, and details harmonization efforts, opportunities, and challenges.

Indonesia's miners are adept at scaling the country's rugged regulatory landscape. But their legendary resilience may be put to the test in 2014. Written by Dharma Djojonegoro, President Director of Indonesian mining services provider PT Multi Nitrotama Kimia (MNK).

Dieses Buch sammelt Fallstudien aus unterschiedlichen Policybereichen zur Rechtsdurchsetzung in mehrstufigen Regulierungssystemen, einem Phänomen der postmodernen Gesellschaft. Es sind komplexe Rechtssysteme, die sich durch mehrere Ebenen der Gesetzgebung (national, europäisch/supranational, international) auszeichnen und in denen nationale, supranationale und internationale Akteure zusammenwirken. Die Herausforderungen bezüglich Rechtsdurchsetzung werden in verschiedenen Rechtsdisziplinen und aus politikwissenschaftlicher Sicht analysiert, mit Schwerpunkt auf der EU. Die Vielfalt ermöglicht es, gemeinsame Schlussfolgerungen zu konzeptionellen Herausforderungen solcher Systeme zu ziehen und allgemein anwendbare Lösungen vorzuschlagen. Mit Beiträgen von Chrysa Alexandraki, Ioannis Asimakopoulos, Kelly Blount, Kei Hannah Brodersen, Giovanni Chiapponi, Nicole Citeroni, Simona Demková, Dimitrios Kafteranis, Katalin Ligeti, Pier Mario Lupinu, Branimir Stanimirov, Igor Tkalec, Carsten Ullrich und Panagiotis Zinonos.

Intro -- FrontMatter -- Reviewers -- Acknowledgments -- Contents -- Boxes, Figures, and Tables -- Acronyms and Abbreviations -- Summary -- 1 Introduction -- 2 Regulatory Systems, Global Health, and Development -- 3 Global Efforts to Strengthen Regulatory Systems -- 4 The Role of the National Government -- 5 The Role of the Regulatory Agency -- Appendix A: Committee Member Biographies -- Appendix B: Public Meeting Agendas -- Appendix C: Call for Comments -- Appendix D: Ensuring Safe Foods and Medical Products Through Stronger Regulatory Systems Abroad.