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Post-approval changes (PACs) to the control and manufacturing processes of medicines and vaccines are routinely undertaken and critical to enable both innovation and secure sustained supply. In a world of global supply chains, the existence of divergent national PAC requirements (with additional countries introducing new requirements with potential differences) and other factors including document preparation and response timelines, can lead to long delays in approval (of up to 3–5 years) increasing the risk of disruption and shortages. We undertook an Industry survey in 2023 to assess implementation of ICH Q12, PAC procedures (change categorisation and review timelines) and use of reliance mechanisms across different countries (9 selected ICH Members and 19 Observers). Although this survey revealed limited implementation of Q12 in ICH Member countries, when comparing the data collected with those of a previous survey performed in 2020, we observed a broader adoption of risk-based approaches to variation categorisation (in all countries). This, however, was not reflected in improved timelines for approval. With regards to ICH Q12 adoption, the uptake of Post-Approval Change Management Protocols (PACMPs) was unchanged (with only one country reporting in-use) and implementation gaps were evident for Established Conditions (EC) and the Product Life Cycle Management document (PLCM). The survey found greater awareness of ICH Q12 and its tools compared to 2020, potentially illustrating the positive impact of training efforts. This illustrates the challenges being faced to broaden its implementation and use globally. In the same Industry survey, we also assessed PAC processes across different international countries. Long unpredictable timelines were the major concern across the countries surveyed together with limited capacity of the regulators. Four different CMC changes were selected and categorized by the respondents according to current knowledge of national classifications and timelines in the selected countries and compared with a reference classification and timeline from the European Medicines Agency and the World Health Organisation. This highlighted the lack of harmonisation of many countries with EU/WHO requirements, especially within the ICH Observer group. Last, this survey showed that some use of unilateral forms of reliance to Reference Authorities for PACs is starting. This is a mechanism all countries can employ, regardless of convergence of requirements and expertise, to enhance capacity building and reduce duplication of reviews, streamline variations approval, whilst accelerating patient access to innovation and securing supply. [ABSTRACT FROM AUTHOR]

This paper analyses how regulatory convergence in different categories of technical barriers to trade (TBTs) imposed on imports of goods in information and communications technology (ICT) globally affected the values, volumes and unit values of imported goods during the period 1996–2019. Keywords cited in TBTs that are notified to the World Trade Organisation (WTO) give an indication of the regulatory objectives behind the imposition of TBTs. MAST also classifies TBTs based on their applicability, procedural and administrative uses, factors which will also be taken into consideration in the analysis. However, the objectives of TBTs may provide better insights to policymakers. TBTs are non-discriminatory measures that are imposed unilaterally on all trading partners and on domestic producers. It is not feasible to analyse unilateral TBTs in a gravity setting, as they are excluded by the introduction of country-product-time fixed effects that control for multilateral resistances. However, regulatory convergence in TBT categories is a bilateral time-varying variable that is analysed in a gravity model in this paper. The empirical results suggest that regulatory convergence between trading partners in some TBT categories stimulates import values and volumes. However, the impact is very heterogeneous across TBT objectives and classes and across ICT product categories. [ABSTRACT FROM AUTHOR]

Regulatory harmonization and convergence have been identified as the key driver in promoting efficient evaluation of medicines, reducing workload, and supporting earlier access to medicines on the African continent. There has been great progress to date in enhancing regulatory harmonization and convergence on the African continent via the Regional Economic Communities (RECs) and with the establishment of the Africa Medicines Agency (AMA). In this article, the International Federation of Pharmaceutical Manufacturers and Associations (IFPMA) Africa Regulatory Network (ARN) presents its perspective based on the available literature review and results from a survey conducted with innovative biopharmaceutical companies to gather experiences using regional joint assessment procedures (JAPs) in Africa, such as the East African Community Medicines Regulatory Harmonization (EAC-MRH), the West African Medicines Regulatory Harmonization (WA-MRH), and the Southern African Development Community Medicines Regulatory Harmonization (SADC-MRH) initiative through the ZAZIBONA Collaborative Procedure for Medicines Registration (ZaZiBoNa), and provides best practices in this evolving landscape. The article also assesses other collaborative registration pathways available to facilitating registration of pharmaceutical products in African countries, such as WHO Collaborative Registration Procedures (CRP), Swissmedic’s Marketing Authorisation for Global Health Products (MAGHP) and EU Medicines for All (EU-M4ALL). Benefits and challenges of each of the existing pathways are discussed in this article. Main benefits include building more expert capacity and improved collaboration amongst experts, as well as shorter review timelines in some cases. Key challenges include the lack of predictability in the adherence to procedural timelines as defined per guidelines, lengthy timeline to achieve national marketing authorization following joint assessment, the lack of dedicated personnel, administrative issues during the submission process as well as additional country-specific requirements on top of JAP-specific requirements. Our recommendations for improvements include harmonization of requirements across countries and regions and with international standards, appropriate resource allocation for JAP activities to ensure adherence to timelines, use of JAPs throughout the entire product lifecycle and all product categories, adequate use of digital technologies, and improved communication and transparency with applicants. These improvements will allow industry to better plan their filing strategies for the region which will lead to overall improved usability of the JAPs in Africa and enable faster patient access.

The COVID-19 pandemic has shown itself to be an unprecedented challenge for vaccines which are widely recognized as the most important tool to exit this pandemic. We have witnessed vaccine scientists, developers, manufacturers, and stakeholders deliver several vaccines in just about a year. This is an unprecedented achievement in an environment that was not ready to manage such a global public health crisis. Indeed, the pandemic has highlighted some hurdles that need to be addressed in the system in order to streamline the regulatory processes and be in a situation where life-saving pharmaceutical solutions such as vaccines can be delivered quickly and equitably to people across the globe. More precisely, trade-offs had to be made between the need for regulatory flexibility in the requirements for manufacturing and controls to enable rapid availability of large volumes of vaccines vs the increased stringency and the lack of harmonization in the regulatory environment for vaccines globally. It is also characterized by a high heterogeneity in terms of review and approval processes, limiting equitable and timely access. We review and highlight the challenges relating to several topics, including process validation, comparability, stability, post-approval-changes, release testing, packaging, genetically modified organisms and variants. We see four areas for accelerating access to vaccines which provide solutions for the regulatory concerns, (1) science- and risk-based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. These solutions are not new and have been previously highlighted. In recent months, we have seen some progress at the health authority level, but still much needs to be done. It is now time to reflect on the first lessons learnt from a devastating pandemic to ultimately ensure quick and wide access to medicines and vaccines for the citizens and patients. [ABSTRACT FROM AUTHOR]

Vaccine discovery and vaccination against preventable diseases are one of most important achievements of the human race. While medical, scientific & technological advancements have kept in pace and found their way into treatment options for a vast majority of diseases, vaccines as a prevention tool in the public health realm are found languishing in the gap between such innovations and their easy availability/accessibility to vulnerable populations. This paradox has been best highlighted during the unprecedented crisis of the COVID-19 pandemic. As part of a two series publication on the vaccine industry's view on how to accelerate the availability of vaccines worldwide, this paper offers a deep dive into detailed proposals to enable this objective. These first-of-its-kind technical proposals gleaned from challenges and learnings from the COVID-19 pandemic are applicable to vaccines that are already on the market for routine pathogens as well as for production of new(er) vaccines for emerging pathogens with a public health threat potential. The technical proposals offer feasible and sustainable solutions in pivotal areas such as process validation, comparability, stability, post-approval changes, release testing, packaging, genetically modified organisms and variants, which are linked to manufacturing and quality control of vaccines. Ultimately these proposals aim to ease high regulatory complexity and heterogeneity surrounding the manufacturing & distribution of vaccines, by advocating the use of (1) Science and Risk based approaches, (2) global regulatory harmonization, (3) use of reliance, work-sharing, and recognition processes and (4) digitalization. Capitalizing & collaborating on such new-world advancements into the science of vaccines will eventually benefit the world by turning vaccines into vaccination, ensuring the health of everyone. [ABSTRACT FROM AUTHOR]

Background: To promote the efficiency and quality of registration for medical products, the Asia-Pacific Economic Cooperation (APEC) Regulatory Harmonization Steering Committee (RHSC) has implemented a 2020 roadmap to promote the concept of GRM since 2011. Key outcomes of this roadmap are discussed in this article to provide recommendations for improved regulatory practices and accelerated regulatory convergence. Methods: Adoption of relevant guidelines and delivery of training programs from the APEC Training Centers of Excellence for Regulatory Science (CoEs) have played a key role to promote capacity building, cooperation and convergence in good review practices (GRevPs) and good submission practices (GSubPs) for medical products among APEC economies. A key performance indicator (KPI) survey among the drug regulatory authorities (RAs) of APEC economies was conducted to understand the progress of this roadmap. Results: The CoE programs have provided a unique opportunity to promote dialogues between regulatory authorities and industry and efficiently disseminated the concept of GRM among APEC economies. The results of the KPI survey indicated significant progress in the status of implementing GRevPs over the last ten years. Conclusions: To accelerate regulatory convergence among APEC economies, it is necessary to promote mutual trust and cooperation in approval of medical products over the time. Continuous training in GRevPs and GSubPs through the CoE platform would set the stage to achieve the goal in the next decade. [ABSTRACT FROM AUTHOR]

Purpose: Regulatory convergence and cooperation among medical product regulatory authorities are essential to delivering safe and efficacious products quickly to patients. The COVID-19 pandemic highlights the urgent need for streamlined regulatory approval processes—which can be achieved in part through regulatory convergence and cooperation—both to accelerate availability of COVID-19 vaccines, treatments and diagnostics and to maintain the availability of the existing medical products unrelated to COVID-19. Methods: The Asia–Pacific Economic Cooperation (APEC) Life Sciences Innovation Forum (LSIF) established the Regulatory Harmonization Steering Committee (RHSC) in 2008 to advance regulatory convergence among APEC's 21 member economies. Key performance indicators (KPIs) were developed in 2018 to measure convergence. Results: This paper reports survey results collected from KPI tracking in March 2020 from medical product regulatory authorities in all 21 APEC economies concerning areas of regulatory practice in which they could converge and cooperate. For example, from 2008 to 2020, there was a 14.3% increase in the number of APEC member economy regulatory authorities sharing Good Manufacturing Practices (GMP) Certificates and a 28% increase in the number of regulatory authorities accepting multisite licenses in that same period. In addition, this paper explores how APEC economies could realize a maximum level of regulatory convergence and cooperation. Conclusions: Convergence efforts within APEC can accelerate availability of medical products including that related to COVID-19 vaccines, treatments and diagnostics, while maintaining the availability of the existing medical products unrelated to COVID-19 vaccines and treatment. New KPIs and capability building are to be considered to enable a new era of innovation ushered in by COVID-19. [ABSTRACT FROM AUTHOR]

A comparison of the regulations and guidelines from 33 countries, across different regions, on the requirements and procedures for the management of chemical, manufacturing and control (CMC) changes for vaccines, also known as post- approval changes (PACs), reveals significant variability and lack of predictability of timelines for regulatory review and approval. These shortcomings imply that multiple data packages have to be prepared for submission to different authorities, generating a complex regulatory environment. Moreover, the timelines for approval by individual national regulatory authorities are variable, which results in manufacturers keeping various stocks of vaccines produced in accordance with the various approved specifications and procedures, in the different countries. This can seriously affect timely availability of vaccine in those countries. The World Health Organization (WHO) guidelines on procedures and data requirements for changes to approved vaccines provide a consensual framework for alignment, but are still underused. Reliance on both the review and approval by the regulatory authority in the country of manufacturing, or on the review performed by other national regulatory authorities, recognized by WHO as stringent, or on WHO prequalification dossier, offer alternative ways forward. These and other options to improve the management of post-approval changes during the product lifecycle of vaccines are discussed in this report, and aimed at improving guidelines alignment and regulatory convergence to advance immunization equity and coverage.

Vaccines continue to play a central role in our ability to prevent disease, save lives, and improve health. The scientific community, including our own researchers, are driven by a shared purpose to improve vaccine technologies and bring the benefits of immunization to everyone, regardless of where they live – as soon as possible, especially when the medical need is considerable. Vaccine developers and manufacturers (sometimes referred to as "study sponsors" or "applicants") are exploring technological advancements to translate breakthrough discoveries into novel vaccines which have the potential to provide protection from life-threatening and debilitating infectious diseases. Developing new vaccines is a lengthy process regulated by guidance provided by independent organizations, National Regulatory Authorities (NRAs) and the World Health Organization. As most infectious diseases can span a considerable area of the world, clinical trials are often conducted across different countries and regions. Regulatory requirements for clinical trials (both Chemistry Manufacturing & Controls – CMC, nonclinical and clinical) vary significantly between the different countries and regions adding to the complexity of vaccine development and leading to significant delays in the development of novel vaccines and ultimately equitable access for populations to these innovations. Without progress in terms of regulatory convergence and harmonization the benefits from these scientific advancements will not be fully realized. There is an urgent need by global bodies such as WHO to partner with and the NRAs to establish and implement. 1. a common, global set of requirements for Clinical Trial Application (CTAs) per Phase of Development. 2. a parallel ethical committee and regulatory authority review rather than sequential reviews. 3. clear and transparent assessment timelines and commitment to these timelines. 4. a focus on reduced regulatory burden overall for NRAs, Ethics Committees (ECs) and vaccine developers. [ABSTRACT FROM AUTHOR]

Background: This study sought to identify criteria and current practices for implementing an abridged review process and understanding barriers and enablers in utilizing reliance models and to offer recommendations for the implementation of an abridged review process in South Africa based on good reliance practices (GRelP). Methods: A questionnaire was completed by six national regulatory authorities (NRAs) to determine criteria and current practices for implementing an abridged review process. In addition, two focus group discussions were conducted on the practical implementation of an abridged review process based on GRelP. Results: Participating NRAs indicated that reliance would be placed on one reference agency. Applications submitted to NRAs for an abridged review had to be identical to those submitted to the reference agency. Unredacted reference agency assessment reports would be required to facilitate the abridged review process. A full technical dossier would also be required, but only parts would be assessed during the abridged review. Focus groups indicated that abridged review elements had been identified and should be considered in implementing GRelP. Conclusions: NRAs strive to improve regulatory performance and accelerate approval times; however, many continue to face challenges due to resource constraints. Increasing workloads, advancing technologies, and limited expertise require NRAs to leverage regulatory convergence initiatives, collaborative registration procedures, and functional regional, continental and international networks to fulfil regulatory mandates. Recommendations for the implementation of an abridged review process and a framework for GRelP have been made with a view to optimise regulatory review processes in South Africa. [ABSTRACT FROM AUTHOR]

The Developing Countries' Vaccine Manufacturers Network, joined by global health organizations, held its 20th meeting celebrating two decades of vaccine innovations for global public good. Health leaders from industry, academia and global health organizations reviewed efforts to accelerate innovation, improve access to vaccines, overcome inequalities and strengthen technological and public-health management capabilities. Discussion topics included World Health Organization's immunization strategy, Pan American Health Organization's system-strengthening efforts, Gavi's evaluation of vaccine coverage in middle income countries and developments on public-market intelligence. Health market trends, delivery gaps, integration of system-wide needs, costs and benefits, and implications for stakeholder decision-making were areas of focus. Novel thinking was discussed on integration of policy, financing, regulatory pathways and alignment of innovation priorities to improve efficiency in vaccine development pathways. The Vaccine Innovation Prioritization Strategy collaboration presented nine global innovation priorities, and many other partners and members presented updates on their priorities. Novel technologies and platforms, such as RNA-based vaccines, adenoviral vectors, bioconjugation, blow-fill-seal and two-dimensional barcodes, provided opportunities to accelerate vaccine innovations. Challenges in planning and operations at global level included those in health security, polio eradication, re-emergence of diseases, disparities between forecasts and orders and heterogeneous regulatory requirements. Manufacturers were urged to accelerate innovation and prequalification of high-impact vaccines, such as pneumococcal, human papillomavirus and rotavirus vaccines, to strengthen immunization globally. [ABSTRACT FROM AUTHOR]

The number of international agreements purporting to liberalise trade, mainly focused on reducing protectionist measures through the imposition of general principles, has increased greatly over the last 25 years. More recently, the United States and the European Union (EU) concluded comprehensive agreements covering trade in goods, trade in services, and foreign investment. This article inquires whether, and the extent to which, such agreements represent a departure from previous practice. It focuses on (a) the instruments employed to address domestic regulation affecting trade in services and (b) three specific agreements concluded between 2016 and 2018: the EU-Canada Comprehensive Economic and Trade Agreement, the Comprehensive and Progressive Agreement for Trans-Pacific Partnership, and the United States-Mexico-Canada Agreement. While these recent Preferential Trade Agreements put forward novel approaches to regulatory diversity affecting trade in services, it is too early to ascertain whether these will have any ground-breaking impact in terms of services trade liberalisation. [ABSTRACT FROM AUTHOR]

More than one-third of the World Trade Organization-notified services trade agreements that were in effect between January 2008 and August 2015 involved at least one South or Southeast Asian trading partner. Drawing on Baier and Bergstrand's (2004) determinants of preferential trade agreements and using the World Bank's database on the restrictiveness of domestic services regimes (Borchert, Gootiiz, and Mattoo 2012), we examine the potential for negotiated regulatory convergence in Asian services markets. Our results suggest that Asian economies with high levels of preexisting bilateral merchandise trade and wide differences in services regulatory frameworks are more likely candidates for services trade agreement formation. Such results lend support to the hypothesis that the heightened “servicification” of production generates demand for the lowered services input costs resulting from negotiated market openings.

Since the early 2000s, the United States and European Union have discussed the development of bilateral and regional trade agreements. The TTIP – Trans-Atlantic Trade and Investment Partnership was announced in February 2013 and is currently under negotiation. The initiative aims at establishing a trade agreement between the two blocs, removing all trade barriers, including the non-tariff ones, in a wide range of economic sectors. The paper looks at several key elements that the bilateral negotiations are set to challenge from the European Union perspective. We focus on the main causes for resistance within the EU towards establishing the agreement, seeking to understand the future framework for international trade for the European states. While the EU continues integration to establish a functioning internal market, still continuing the process of diminishing and eliminating non-tariff barriers among the member states, we examine whether liberalisation of trade and investment between the US and the EU will benefit the EU as a whole, considering the current socio-economic trends at the Union’s level.

Several regulatory convergence efforts for biologics are underway globally, with the goal of ensuring global standards are applied consistently across regulatory agencies. Training and capacity building will ensure convergence through fostering international collaborations between agencies and ensure harmonized standards are applied, which will bring products to market faster and cheaper. [ABSTRACT FROM AUTHOR]

Asia-Pacific is a region of fast growing opportunity for biomedical research and marketing of new health products by pharmaceutical and medical device companies. While national regulatory authorities have the responsibility to ensure timely access to innovative, effective, and safe therapies, many face capacity and resource constraints that limit their ability to guarantee a robust regulatory system capable of licensing and monitoring novel medicines and medical devices, and tackling substandard and falsified products. The region’s regulatory landscape is also fragmented with country-specific requirements that create barriers to entry for new health products. To help address these challenges, the Duke-National University of Singapore’s (Duke-NUS) Centre of Regulatory Excellence (CoRE) was established in 2014 with the strategic goals to strengthen the region’s regulatory agencies through capacity development, regulatory convergence, work sharing, and nurturing networks for leadership and systems innovation. A smart and mature regulatory system in Asia-Pacific is pivotal to promote biomedical innovation and enhance equitable, sustainable access of populations to quality health products that are safe and efficacious. [ABSTRACT FROM AUTHOR]

This article compares the copyright laws of Botswana, Lesotho, Mozambique, South Africa, Swaziland and Zimbabwe governing music as against the Berne Convention with a view to determine similarities which are necessary in the Internet age. The findings point to divergence in the standards of protection, thereby calling for harmonisation of laws in the Southern African region. In addition, the article recommends the ratification of the WIPO Internet treaties to respond to the new forms of infringement posed by the advent of the Internet and advancements in technology. [ABSTRACT FROM AUTHOR]

The divergence of regulatory requirements and processes in developing and emerging countries contributes to hamper vaccines’ registration, and therefore delay access to high-quality, safe and efficacious vaccines for their respective populations. This report focuses on providing insights on the heterogeneity of registration requirements in terms of numbering structure and overall content of dossiers for marketing authorisation applications for vaccines in different areas of the world. While it also illustrates the divergence of regulatory processes in general, as well as the need to avoid redundant reviews, it does not claim to provide a comprehensive view of all processes nor existing facilitating mechanisms, nor is it intended to touch upon the differences in assessments made by different regulatory authorities. This report describes the work analysed by regulatory experts from vaccine manufacturing companies during a meeting held in Geneva in May 2017, in identifying and quantifying differences in the requirements for vaccine registration in three aspects for comparison: the dossier numbering structure and contents, the application forms, and the evaluation procedures, in different countries and regions. The Module 1 of the Common Technical Document (CTD) of 10 countries were compared. Modules 2–5 of the CTDs of two regions and three countries were compared to the CTD of the US FDA. The application forms of eight countries were compared and the registration procedures of 134 importing countries were compared as well. The analysis indicates a high degree of divergence in numbering structure and content requirements. Possible interventions that would lead to significant improvements in registration efficiency include alignment in CTD numbering structure, a standardised model-application form, and better convergence of evaluation procedures. [ABSTRACT FROM AUTHOR]

• SPS regulatory convergence reduces but not outweigh SPS trade costs in dairy trade. • Trade frictions remain even after harmonisation to EU SPS standards. • Convergence to EU SPS rules only reduce trade costs to highly competitive exporters. • Experience reduces trade costs but not as much as regulatory convergence. With its influence on the world stage, the EU's Farm to Fork initiative seeks to extend sustainable and fair food production practises globally, in part, by encouraging convergence with EU food standards (i.e., sanitary and phytosanitary measures-SPS). Harmonisation clauses have been found empirically to encourage trade, but no quantifiable estimates exist on the trade effects of SPS regulatory convergence. This paper examines this issue for the dairy industry, a highly regulated sector with significant sustainability concerns attached. Furthermore, the cost-saving effects arising from closer regulations and 'experience' (i.e., accumulated years of foreign trade track-record), are compared. Employing a 3-year interval panel starting in 2010, a structural gravity equation that includes domestic trade is estimated with a flexible empirical approach that evinces asymmetric trade impacts for specific bilateral trade routes. Results indicate a trade depressing effect for SPS measures, estimated as a global average 10.4% Ad-valorem Equivalent (AVE). Moreover, at the global level, converging regulatory frameworks generate larger trade gains than experience, where a 1% rise in regulatory convergence is equivalent to 5 years of positive trade and a 14% reduction of the AVE. The reduction of trade frictions prompted by harmonisation and experience does not, however, outweigh SPS trade costs. Exporters to the EU face a higher SPS AVE than that faced by the EU (10.1% vs 9.3%). On average, exporters to the EU also benefit from a 9% saving due to experience, although cost savings from regulatory convergence are only reported for larger exporters to the EU, whose consolidated position in EU markets also grants them even greater than average benefits from years of accumulated experience. [ABSTRACT FROM AUTHOR]

The Developing Countries Vaccine Manufacturers’ Network (DCVMN) gathered leaders in immunization programs, vaccine manufacturing, representatives of the Argentinean Health Authorities and Pan American Health Organization, among other global health stakeholders, for its 17th Annual General Meeting in Buenos Aires, to reflect on how vaccines are shaping global health. Polio eradication and elimination of measles and rubella from the Americas is a result of successful collaboration, made possible by timely supply of affordable vaccines. After decades of intense competition for high-value markets, collaboration with developing countries has become critical, and involvement of multiple manufacturers as well as public- and private-sector investments are essential, for developing new vaccines against emerging infectious diseases. The recent Zika virus outbreak and the accelerated Ebola vaccine development exemplify the need for international partnerships to combat infectious diseases. A new player, Coalition for Epidemic Preparedness Innovations (CEPI) has made its entrance in the global health community, aiming to stimulate research preparedness against emerging infections. Face-to-face panel discussions facilitated the dialogue around challenges, such as risks of viability to vaccine development and regulatory convergence, to improve access to sustainable vaccine supply. It was discussed that joint efforts to optimizing regulatory pathways in developing countries, reducing registration time by up to 50%, are required. Outbreaks of emerging infections and the global Polio eradication and containment challenges are reminders of the importance of vaccines’ access, and of the importance of new public-private partnerships. [ABSTRACT FROM AUTHOR]

Since the summer of 2013, the European Union (EU) and the United States (US) are negotiating the Transatlantic Trade and Investment Partnership (TTIP). Especially for the EU, this is one of the policy priorities for the present term. TTIP is supposed to bring much-needed growth and jobs and to enable the EU to remain a global standardsetter, all without lowering EU levels of regulatory protection. Opponents of the agreement, however, fear that TTIP would lead to a regulatory race-to-the-bottom. This article scrutinizes these claims through a detailed document analysis complemented with a number of interviews. It is embedded in the political-economic literature on the trade-regulation nexus as well as on exporting standards and secondary literature on past EU-US regulatory cooperation attempts. We argue that the effects of TTIP are dependent on the concrete mode of regulatory convergence chosen in the agreement. If, as seems presently most plausible, the negotiators opt for bilateral mutual recognition as their preferred mode for regulatory convergence, the plausibility that TTIP would lead to global standards is reduced. The risk of running into a regulatory race-to-the-bottom increases in that case, but will ultimately depend on the number of sectors where this mode is applicable and under which conditions this is applied. We conclude that the probability is low that the TTIP agreement being negotiated will lead either to a significant increase in global standards or to a direct large-scale race-to- the-bottom. [ABSTRACT FROM AUTHOR]

Purpose – This paper aims to examine the issues faced by the World Trade Organization (WTO) dispute settlement system in disputes involving questions of regulatory convergence. The traditional focus of the WTO has been on increasing market access and eliminating discrimination in trade. Now, as tariffs have been all but eliminated and Members rarely impose obviously discriminatory trade barriers, attention increasingly turns to questions of regulatory convergence. Leaving aside questions as to the overall benefits of regulatory convergence between markets, these developments pose a significant challenge to the organs of the WTO dispute settlement – and it is here that this paper focuses. Design/methodology/approach – While General Agreements on Tariffs and Trade (GATT)/WTO law has fairly well-developed tools for identifying discrimination in trade, the tools necessary for assessing whether regulatory measures maintain the requisite balance or proportionality between sovereign/domestic concerns and trade concerns are less clear. The paper discusses this latter point. Findings – The WTO agreements are frequently not clear on where or how this balance between sovereign/domestic concerns and trade concerns is to be determined. To date, WTO panels and the Appellate Body have preferred to focus on whether they can identify any discriminatory aspects of a measure. However, they will increasingly be called to pronounce on non-discriminatory regulatory policy choices of Members. Originality/value – This paper contributes to the literature on the Appellate Body, and argues that Members will need to develop a credible and consistent balance between policy space and trade restrictiveness. [ABSTRACT FROM AUTHOR]

Since the early 2000s, the United States and European Union have discussed the development of bilateral and regional trade agreements. The TTIP -- Trans-Atlantic Trade and Investment Partnership was announced in February 2013 and is currently under negotiation. The initiative aims at establishing a trade agreement between the two blocs, removing all trade barriers, including the non-tariff ones, in a wide range of economic sectors. The paper looks at several key elements that the bilateral negotiations are set to challenge from the European Union perspective. We focus on the main causes for resistance within the EU towards establishing the agreement, seeking to understand the future framework for international trade for the European states. While the EU continues integration to establish a functioning internal market, still continuing the process of diminishing and eliminating non-tariff barriers among the member states, we examine whether liberalisation of trade and investment between the US and the EU will benefit the EU as a whole, considering the current socio-economic trends at the Union's level. [ABSTRACT FROM AUTHOR]

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Is globalization promoting regulatory convergence in agricultural biotechnology policies in the South? This article examines the nature and limits of regulatory convergence in the field of agri-biotechnology and investigates the effects that international forces have on biotechnology and biosafety policies in developing countries. Based on detailed case studies of Mexico, China and South Africa this article shows that these three leading biotechnology countries in the South are exposed to powerful international influences but are responding to the regulatory challenges of genetically modified organisms (GMO) adoption in distinctive ways. The existing regulatory polarization between US and EU biotechnology approaches has not forced a convergence around either of these two international models. GMO policies in the South do not simply follow the binary logic of the US–EU regulatory conflict. Instead, they integrate elements from both regulatory approaches and are steering a course that suggests substantial regulatory diversity in the South. The globalization of biotechnology thus goes hand in hand with regulatory diversity in the developing world. Furthermore, regulatory polarization between the EU and US has helped to open up political space in key developing countries. [ABSTRACT FROM AUTHOR]

This paper highlights the remarkable convergence that has happened throughout the world in the field of corporate governance since the Cadbury report in the UK and the Vienot report in France, which makes the application of the Sarbanes-Oxley Act of 2002 to non- US companies particularly strange. But the difference is not and never has been so much at the level of principles, and it is in the implementation of regulatory principles that the major divergence of approaches between countries lies. No country has the monopoly on the best rules, but most now recognise that the role of the Board of Directors requires a mix of independence, relevant experience and expertise that together form the indispensable key to the efficient functioning of capital markets: investor confidence. The main issue will be a convergence in implementation through a reinforcement of regional and international cooperation, particularly through the enhancement of the International Organization of Securities Commissions. [ABSTRACT FROM AUTHOR]