National Regulatory Authorities Research Articles

Translational pathway of a novel PFF2 respirator with chitosan nanotechnology: from the concept to the practical applications

Introduction:Translational Health Research (THR) is a tool aimed at assisting in the transformation of basic and/or applied scientific research into a health technology ready for commercialization. The aim of this study is to present the translational pathway in wich our research group developed a Personal Protective Equipment (PPE) called VESTA® Facial Respirator with chitosan nanotechnology for protection against viruses, bacteria, and fungi. The aim of this study is to present the process of THR applied to a health technology research.Methods:The theoretical-methodological process of THR was applied to the Research and Development (R&D) of the respirator. This method is characterized by subsequent phases, as follow: T (0)—Concept, T (1) Pre-Clinical, T (2) Clinical, T (3) Industrial Scale Production, and T (4) Characterized by subsequent phases, as follow: Technological Evaluation.Results:Applying the THR process in the development and production of the Particulate Filtering Facepiece class 2 (PFF2) respirator with chitosan nanotechnology, University of Brasilia was able to transform the research idea into a respirator approved by the National Regulatory Agency for industrial-scale production within 24 months. The THR process is not a linear action; this flexibility allows essential activities for transforming research into a marketable product.Discussion:The integration among various stakeholders right from the genesis of research is a driving force for the effective utilization of results. The maturity of the country’s industrial sector is crucial for converting university research into a marketable product, and governments need to prioritize these products in healthcare system incorporations. The academic culture of scientific research needs to intensify the technological transfer phase of its inventions. Conclusion: In less than 24 months, the University of Brasilia translated research on a new PPE into the market by applying the THR method.

Traditional herbal medicine regulatory implementation in Ethiopia: a qualitative study.

Background: Approximately 80% of the Ethiopian population predominantly depends on herbal medicines (HMs) for their primary healthcare needs. Nevertheless, worries regarding the safety, efficacy, and standard of herbal-based treatments have been escalating due to the lack of strong regulatory frameworks. Therefore, the study aimed to assess the presence of regulatory frameworks for traditional herbal medicines and their enforcement in Ethiopia. Methods: The qualitative-phenomenological study design was conducted from November 2021 to March 2022 G.C. The study included 25 regulatory official key informants (KIs) who work for national and regional medicine regulatory agencies, and 15 traditional herbal medicine (THM) practitioners who work at the regional level were purposefully selected for an in-depth interview (IDI). An in-depth interview guide was developed through the purposive sampling technique. The collected data were analyzed using thematic content analysis techniques. Results: The study found that the current national medicine proclamation is deemed inadequate in the regulation of THM. Both conventional and traditional herbal medicines are regulated by a single agency. Weak legal enforcement, a lack of government commitment and support, resource constraints, and inadequate regulatory tools are the main challenges faced in THM regulation. Conclusion: Overall, the study found inadequate legal frameworks and weak THM regulatory implementations in Ethiopia. Consequently, it is critical for all regulatory authorities in Ethiopia to exert their utmost efforts to effectively regulate THM.

Enforcing ethical standards to safeguard the credibility and legitimacy of public media corporations: The role of News Ombudspersons in Spain and France

This study introduces a cross-country comparative analysis of the role of News Ombudsperson in the public media corporations in Spain and France. It investigates the specific media self-regulatory processes established to reduce reputational risks and increase the trust and credibility of the media organisations. It aims to fill in the gaps in prior research by applying a qualitative framework developed using indicators derived from scholarly work on regulation and governance and media management. The variables selected for the analysis are extracted from prior interdisciplinary research and focus on media self-regulatory processes, complaints management mechanisms, election, reporting procedures, checks and balances, roles, visibility and transparency of News Ombudspersons in two countries which represent the Polarised Pluralist media system category. Research questions are raised in relation to the main variables identified for the comparative analysis. Data were collected from multiple publicly available international sources, including public media organizations databases, national media regulatory authorities, and academic studies. Results reveal cross-country variations. The systematic investigation of different forms of self-regulatory procedures might lead to concrete recommendations and best practice models for media organizations beyond the European Union. Further research could address the role of media audiences as relevant stakeholders in media governance processes.

Identifying and costing common gaps in Central and West Africa pharmaceutical regulation.

Regulatory systems strengthening is crucial for catalyzing access to safe and effective medical products and health technologies (MPHT) for all. Identifying and addressing common regulatory gaps through regional approaches could be instrumental for the newly incepted African Medicine Agency. This original study sheds light on common gaps among 10 national regulatory authorities (NRAs) and ways to address them regionally. The study used NRA self-assessment outcomes to identify common gaps in four critical regulatory pillars and estimate the cost of addressing them from regional perspectives that aimed at raising the maturity level of regulatory institutions. A cross-sectional study, using the WHO Global Benchmarking Tool (GBT), was conducted between 2020 and 2021 with five NRAs from ECCAS and ECOWAS member states that use French and Spanish as lingua franca. The 10 NRAs operated in a non-formal-to-reactive approach (ML1-2), which hinders their ability to ensure the quality of MPHT and respond appropriately to public health emergencies. Common gaps were identified in four critical regulatory pillars-good regulatory practices, preparedness for public health emergencies, quality management systems, and substandard and falsified medical products-with overall cost to address gaps estimated at US$3.3 million. We elaborated a reproducible method to strengthen regulatory systems at a regional level to improve equitable access to assured-quality MPHT. Our bottom-up approach could be utilized by RECs to address common gaps through common efforts.

Balancing reputational strategies in the European administrative space: how private actors and agencies talk about regulation

ABSTRACT The reputational perspective on agencies has sparked fruitful research. We argue that this perspective can also be applied to private actors in regulatory governance. As they are incorporated into governance because of their expertise, we hypothesise that a technical reputation dominates private actors´ regulatory talk. Furthermore, we test whether agencies have a more multi-dimensional reputational strategy than private actors. We analyse documents of private actors, national regulatory agencies (NRAs) and a European agency (ACER) in energy market regulation. We code rule drafts and agency decisions, and show that private actors not only use technical, but also legal and performative arguments. However, NRAs and ACER have a more balanced reputational strategy. They balance the reputational mix of the private actors when approving rule drafts, adding to the reputational dimensions that private actors neglect. Thus, our article shows how private actors and agencies differ in their regulatory talk within one rulemaking process.

The process of ratifying the treaty to establish the African Medicines Agency: perspectives of national regulatory agencies.

The vision of the African Medicines Agency (AMA) is to ensure that all Africans have access to affordable medical products that meet internationally recognized standards of quality, safety and efficacy for priority diseases/conditions. The AMA is being established by a treaty which had to be ratified by a minimum of 15 African countries. Although there was no deadline, the ratification process has been slower than expected. This study therefore analysed the rationale, perceived benefits, enabling factors and challenges of the AMA's establishment. This study was a qualitative, cross-sectional, census survey of the national medicines regulatory authorities (NRAs) of 45 African countries. The Heads of NRAs and a senior NRA staff member were contacted to complete self-administered questionnaires. The existence of mature NRAs, the desire to have harmonized regulatory systems, the presence of strong political will and appropriate advocacy to expedite treaty signing are all enabling factors for AMA treaty signing. The challenges reported include the fact that the process is slow and there is limited understanding of the process. Competing national priorities, changes in office bearers in the public system and stagnation of the process at the ministerial level were also challenges reported. This study has improved the understanding of the treaty signing and ratification process and the perceived benefits and enabling factors of signing and ratification from African NRAs' perspective. NRAs also highlighted challenges encountered in the process. Addressing these challenges will result in effective medicines regulation by galvanizing technical support, regulatory expertise and resources at a continental level.

Assessing media mergers and acquisitions: The power pyramids of regulatory cooperation

Due to the media goods’ dual economic and cultural role, merger and acquisition (M&A) assessments are complex and differ from M&As in other sectors. An additional layer of complexity is added to the assessment when various authorities are involved. An even more complicated matter is when the authorities have different remits. These authorities mostly comprise National Competition Authorities that enforce competition law, focused on economic considerations, and National Regulatory Authorities that enforce and oversee the application of media law, focused not only on setting rules and limitations on the media market but also on considering non-economic elements such as plurality. In certain countries, ministries and government authorities can intervene in these assessments. There have been discussions on the need for cooperation between authorities, however, mostly at the international level. Thus, little is known about the current cooperation procedures at the national level. The article proposes a typology of cooperation at the EU member states level and the United Kingdom and introduces the concept of the ‘power pyramid’ to represent the hierarchical relationships between authorities. Cooperation proves that competition policy and media-specific regulation are intertwined and are complementary. Furthermore, the article shows that having more than one authority assessing media M&As leads to media pluralism being more often explicitly one of the criteria used in the assessments, and thus providing a more holistic approach.

AI in education risk assessment mechanism analysis

ABSTRACT Artificial intelligence (AI) has had a significant impact on several sectors and fields. Failure Modes and Effects Analysis (FMEA) is a powerful risk management and prevention tool that can help companies identify and address any weaknesses in their practices. The Risk Priority Number (RPN) approach has been criticized for its flaws since it calculates the product of severity, occurrence, and detection ratings of threats. By considering a variety of criteria and aspects, and by thoughtfully and carefully combining expert perspectives, the proposed FMEA model may more accurately evaluate the risks associated with AI in Education. Picture Fuzzy Sets (PFSs) and Grey Relational Analysis-TOPSIS (GRA-TOPSIS) are combined to achieve this. The goal of this research is to use an updated FMEA model to assess and rank the risk hierarchy of the seven identified hazards. According to the data, algorithmic risk is the most significant issue that requires urgent attention. Relevant constraints and suggestions are also provided to encourage research on the dangers of AI in Education. Suggestions include creating a national or international regulatory authority to control the use of artificial intelligence in education, promoting the use of the FMEA technique as a common framework for assessing the risks connected to AI in Education.

Towards the Greening of Banking: A Comparison of the Polish and Czech Financial Markets

Abstract The role of the banking system in promoting and implementing the Sustainable Development Goals in Europe has recently become very significant. As an important part of the financial sector, green banking helps to achieve the goals of sustainable development, which, in times of global financial, economic, climate, and social crises and of war, is very important. The authors aim to present the general approach to ‘green banking’ in Poland and the Czech Republic as represented by the banking sectors themselves and the national regulatory and supervisory authorities, with reference to the EU legal framework. They posit that ‘green banking’ is an increasingly important trend in the development of the Polish and Czech financial markets and conclude that EU regulations are the biggest driver of change in green finance, resulting in an increased awareness of environmental, social, and corporate governance (ESG) factors. What is required, however, is greater systemic involvement of the institutions that constitute the financial safety net, especially central banks. The research has used a theoretical and dogmatic-legal method, based on content analysis and the availability of source information, i.e. theoretical-legal publications, overview sector reports, and, in particular, legal regulations key to the topic.

Approaches to Design an Efficient, Predictable Global Post-approval Change Management System that Facilitates Continual Improvement and Drug Product Availability.

The complexity and inter-connectedness of operating in a global world for drug product supply has become an undeniable reality, further underscored by the COVID-19 pandemic. For Post-Approval Changes (PACs) that are an inevitable part of a product's commercial life, the impact of the growing global regulatory complexity and related drug shortages has brought the Global PAC ManagementSystem to an inflection point in particular for companies that have their products marketed in many countries.This paper illustrates through data analyzed for the first time from 145,000 + PACs for 156 countries, collected by 18 global pharma companies over a 3-year period (2019-2021), how severe the problem of global regulatory complexity is. Only PACs requiring national regulatory agency (NRA) approval prior to implementation were included in the data set. 1 of the 156 country NRAs approved all submitted PACs within a period of 6months. The 6-month timeline was chosen because it is the recommended review timeline for major changes in the WHO guidance for vaccines and biotherapeutic products. 10 out of the 156 (6%) countries had no more than 10% of the PACs reviewed and approved in > 6 months. In 33 (22%) countries more than half of the PACs took > 6 months for approval. It is rare that the same PAC is approved globally within 6 months as individual NRAs take from a few months to years (in some cases > 5 years) for their review.The global PAC management complexity has steadily grown over the past 20years. Attempts thus far to solve this problem have not made any meaningful difference. Senior leaders and decision-makers across the interdependent components of the complex Global PAC Management System (industry and regulators) must come together and collaboratively manage the problem holistically with the objective of ensuring global drug product availability instead of continuing with distinct stakeholder or country-focused solutions, which can tend to worsen the problem.In this paper, the Chief Quality Officers (CQOs) from 18 of the largest innovator pharma companies (see Acknowledgements) are speaking with One-Voice-of-Quality for PACs (1VQ for PACs Initiative). They are recommending a set of 8 approaches to activate a holistic transformation of the Global PAC Management System. This article presents their view on the problem of global regulatory complexity for managing PACs, it's impact on continual improvement and the risk to drug product supply, as well as approaches that can help alleviate the problem.

[Health alerts for substandard, falsified, and unregistered medical products at the onset of the COVID-19 pandemic in the AmericasAlertas de saúde para produtos médicos abaixo do padrão, falsificados e não registrados no início da pandemia de COVID-19 nas Américas].

Identify and analyze incidents of substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic. Detailed search of the websites of regulatory authorities in the Americas. Identification of incidents of substandard, falsified, unregistered, and stolen medicines and medical devices (including in vitro diagnostics). The types of products were determined, as were the stages in the supply chain where they were detected, and the actions taken by authorities. A total of 1 273 incidents were identified in 15 countries (1 087 substandard, 44 falsified, 123 unregistered, and 19 stolen products). The largest number of incidents involved medical devices, disinfectants, and antiseptics. The most frequently reported point in the supply chain was online purchasing. The principal measures taken by the regulatory authorities were: alerts, prohibition of use, prohibition of advertising and manufacture, recall, and monitoring of adverse events. A substantial number of incidents involving substandard, falsified, unregistered, and stolen medical products at the onset of the COVID-19 pandemic were identified. Shortages of supplies, easing of regulatory requirements, and increased demand are factors that may have led to an increase in the number of incidents. The national regulatory authorities of reference reported more frequent detection of incidents and more frequent application of health measures. A regulatory strategy is needed in order to address online sales and ensure the safe distribution of medical products.

Mapping the emergence of the theme of corruption in the area of corporate governance: a bibliometric review of the literature

Objective: Despite the evident theoretical importance of corporate governance as a mechanism for controlling corrupt practices, as far as we know there are no review articles that relate these themes. In this sense, the objective of this article is to map the emergence and evolution of corruption in the area of corporate governance and present the state of the art and trends in future studies on these topics.
 Method: This article is a bibliometric review, it is a statistical analysis method that provides a quantitative understanding of the academic literature on a given scientific field. The bibliometric techniques used are cocotation analysis and bibliographic matching analysis. In other words, we sought to understand the theoretical roots and identify the frontiers of knowledge.
 Results: In the co-citation analysis, 4 theoretical clusters (theoretical bases) were identified and in the pairing, 6 theoretical clusters (frontiers of knowledge) were identified. It is clear from the graphic mappings that current research (frontiers) has more congruence between the different themes, while the research that forms the theoretical bases is more idiosyncratic.
 Originality/Relevance: As far as we know, this is one of the first articles to store knowledge about corruption in the area of corporate governance and cluster it into theoretical bases and boundaries.
 Theoretical/methodological contributions: The pairing analysis identified the following main topics in vogue: Disclosure of sustainability reports; Institutional Theories; Political connections; Corporate Governance Control Mechanisms; National culture; Foreign investments; Organizational performance; Financial paper; Factors determining bribery; and role of national and international regulatory agencies.

Limited availability of methods for the detection of xenotransplantation-relevant viruses in veterinary laboratories.

The German Xenotransplantation Consortium is in the process to prepare a clinical trial application (CTA) on xenotransplantation of genetically modified pig hearts. In the CTA documents to the central and national regulatory authorities, that is, the European Medicines Agency (EMA) and the Paul Ehrlich Institute (PEI), respectively, it is required to list the potential zoonotic or xenozoonotic porcine microorganisms including porcine viruses as well as to describe methods of detection in order to prevent their transmission. The donor animals should be tested using highly sensitive detection systems. I would like to define a detection system as the complex including the actual detection methods, either PCR-based, cell-based, or immunological methods and their sensitivity, as well as sample generation, sample preparation, sample origin, time of sampling, and the necessary negative and positive controls. Lessons learned from the identification of porcine cytomegalovirus/porcine roseolovirus (PCMV/PRV) in the xenotransplanted heart in the recipient in the Baltimore study underline how important such systems are. The question is whether veterinary laboratories can supply such assays. A total of 35 veterinary laboratories in Germany were surveyed for their ability to test for selected xenotransplantation-relevant viruses, including PCMV/PRV, hepatitis E virus, and porcine endogenous retrovirus-C (PERV-C). As comparison, data from Swiss laboratories and a laboratory in the USA were analyzed. Furthermore, we assessed which viruses were screened for in clinical and preclinical trials performed until now and during screening of pig populations. Of the nine laboratories that provided viral diagnostics, none of these included all potential viruses of concern, indeed, the most important assays confirmed in recent human trials, antibody detection of PCMV/PRV and screening for PERV-C were not available at all. The situation was similar in Swiss and US laboratories. Different viruses have been tested for in first clinical and preclinical trials performed in various countries. Based on these results it is necessary to establish special virological laboratories able to test for all xenotransplantation-relevant viruses using validated assays, optimally in the xenotransplantation centers.

Impact Assessment of Divergence on Post-Approval Changes Classifications of Latin America Region With Europe and the United States, and Propositions to Harmonize Classification Based on Risk as a Path to Build the Trust Between National Regulatory Agencies

The lack of harmonization in the post-approval changes (PACs) classifications for pharmaceutical products may have an impact on the efficient implementation of PACs and in the supply of medicine, jeopardizing the continuity of therapies, especially in the case of chronic diseases. The percentage of similarity between the PACs classifications existing between countries of Latin America (Mexico, Brazil, Colombia, Venezuela, Argentina, Chile, Ecuador, Peru, and Central America) versus Europe and the United States (US) has been calculated, focused on the PACs for chemical products and on the minor and moderate variations as defined in the European Union (EU)1,2 and US3 regulations. Even though Mexico, Colombia, Brazil, and Argentina implemented a risk-based PACs classification, a wide diversity is observed, with a high percentage of variations classified as major or high risk for these countries and the rest of the Latin American countries, except for Venezuela (which previously adopted and recognized the EU classification). In addition, we identified a group/subset of PACs that are not categorized in the regulations of Mexico, Brazil, Chile, and Central America countries. Considering that Mexico, Brazil, and Argentina are members or observers of the International Council for Harmonization of Technical Requirements for Pharmaceuticals for Human Use4 and the Pharmaceutical Inspection Co-operation Scheme,5 these countries could further align their PACs classification with the EU and US regulations. This could also be an opportunity for other countries of the Latin America region to recognize and adopt PACs classifications aligned to the EU or United States, which would also support the inclusion of reliance processes in their regulation for already considered/recognized reference countries. This would guarantee more health authority efficiency and optimization as well as more uniform implementation of PACs globally.

Assessment of pharmacovigilance guidelines in the Southern African Development Community: A document review.

Lack of harmonization in pharmacovigilance (PV) practice in resource-limited states in Africa has led to differentiation and marginalization, thus creating an environment where weak or absent PV systems may benefit from regional guidelines. To compare the PV guidelines of Southern African Development Community (SADC) member states to international guidelines and identify areas for improvement for aligning PV practice within the SADC region. We utilized a 73-item checklist to assess the PV guidelines of the SADC member states. Checklist parameters were rated using binary scoring. Only seven (Botswana, Mauritius, Namibia, South Africa, Tanzania, Zambia, and Zimbabwe) of the 16 SADC member states had guidelines to assess. Of these, only four had supporting legislation. All seven national medicines regulatory authorities (NMRA)'s guidelines required reporting of local serious adverse drug reactions (ADRs). Four NMRAs implemented device vigilance; none specified submission timelines for ADRs associated with substandard or falsified medicines. Only three NMRAs required electronic transmission of individual case safety reports in the E2B format. Five NMRAs mandated safety monitoring during interventional clinical trials. Five NMRAs required aggregate reporting through periodic safety update reports. Only two NMRAs required submission of the development safety update report. Regarding risk management, four NMRAs required notification of actions taken by foreign NMRAs and four NMRAs expected to review Dear Healthcare Professional Letters before distribution by the marketing authorization holder. Areas for improvement of guidelines to establish common process standards and allow for synchronized submissions of comparable data to SADC NMRAs are provided.

Good manufacturing practice in low‐ and middle‐income countries: Challenges and solutions for compliance

AbstractApproximately 2 billion people globally have limited access to essential medicines, particularly those living in low‐ and middle‐income countries (LMICs). In addition, there is a higher prevalence of substandard and counterfeit medicines in LMICs, which may cause antimicrobial resistance and therapeutic failure. Good manufacturing practice (GMP) is key to ensuring access to high‐quality, safe and effective medicines, including active pharmaceutical ingredients and excipients used for manufacturing finished dosage forms. Compliance with GMP standards saves resources for both manufacturers (e.g. avoiding expensive product recalls) and governments (e.g. minimising compliance inspections). Concerted collaborations among different countries to harmonise GMP standards and procedures have occurred, and the World Health Organisation (WHO) GMP is commonly used in LMICs. However, barriers to GMP compliance remain apparent, particularly in LMICs. Pharmaceutical manufacturers in LMICs face several barriers such as inadequate resources and infrastructure, inefficient or weak regulation, a shortage of skilled people and limited training opportunities for manufacturing personnel. Although national regulatory authorities (NRAs) have been established in LMICs, most NRAs are not fully independent and are placed within the health department. NRAs in LMICs are not able to fully utilise international and regional reliance mechanisms and collaborations. Therefore, both NRAs and pharmaceutical manufacturers must be adequately supported through resources, infrastructure and capacity‐building opportunities. NRAs must be suitably empowered with assured functional independence. A comprehensive guideline for managing conflicts of interest among pharmaceutical manufacturers, procurement agencies and NRAs is needed. NRAs must liaise with other NRAs, participate in joint GMP inspections and leverage the expertise of regional or international collaborations. Pharmaceutical manufacturers in LMICs can leverage WHO GMP standards to improve GMP compliance and expand their market. However, as these solutions may have cost implications, prioritising key gaps for GMP compliance and optimisation of available resources are essential.

Analysis, residue behaviour and risk assessment of combination product of iprovalicarb + copper oxychloride in representative fruiting vegetables, cucurbit and in soil using LC-MS/MS and ICP-MS.

Combination product of two herbicides, i.e. iprovalicarb and copper oxychloride, is a new formulation. There is paucity of data on the dissipation pattern and risk assessment of this combination product in crops. To understand the dissipation behaviour/kinetics of this product, a supervised field trial was undertaken on cucumber and tomato. Method validation for a QuEChERS-based method for analysis of these pesticides from cucumber and tomato matrices reveals that all the parameters were within the acceptance range in accordance with SANTE. The limit of quantitation (LOQ) for iprovalicarb in cucumber and tomato fruits, and in soil matrices when analysed on LC-MS/MS was established at 0.01mgkg-1. Similarly, the LOQ for copper oxychloride (as copper) on ICP-MS was established at 0.5mgkg-1 in cucumber and tomato fruits and 5.0mgkg-1 in soil. Dissipation of iprovalicarb was slower in tomato fruits as compared to cucumber fruits. The initial accumulation of the residues of iprovalicarb was 0.073 and 0.243mgkg-1 in cucumber and 0.214 and 0.432mgkg-1 in tomato fruits at standard and double dose, respectively. Similarly, copper oxychloride residues were 3.51 and 6.45mgkg-1 in cucumber and 1.26 and 2.56mgkg-1 in tomato fruits at standard and double dose, respectively. The residues were below LOQ in cucumber fruits, tomato fruits and soil at the time of harvest. The residues of copper oxychloride persisted till harvest time in cucumber fruits and in soil. A preharvest interval (PHI) of 3day is recommended on safer side for the combination product of iprovalicarb + copper oxychloride. Theoretical maximum daily intake (TMDI) is less than maximum permissible intake (MPI) for iprovalicarb and copper oxychloride at both the doses from 0day and onward. The results from the present study can be of immense importance for establishing label claims, maximum residue limits (MRLs) and risk assessment by national and international regulatory agencies.

Breaking the iron triangle around nuclear safety regulation: The cases of France, Japan, and India

AbstractThe International Atomic Energy Agency asserts that the regulation of the safety of civil nuclear power requires national regulatory agencies to be effectively independent. However, in the early years of national civil nuclear power programs national nuclear industries were dominated by iron triangles or subgovernments of powerful actors with an interest in promoting the industry. The creation of an independent safety regulator requires a radical restructuring of the national governance framework. Windows of opportunity or critical junctures for such reform occur only occasionally. This paper examines the cases of France, Japan, and India to identify the factors that determine the degree of success in attempts to break the power of nuclear iron triangles or subgovernments and create an effectively independent regulator. This analysis shows a serious nuclear accident can create the opportunity to dismantle an iron triangle. The extent and speed with which reforms can be implemented depend greatly on pre‐existing and prevailing conditions. Key determinants include the power structures and attitudes toward nuclear power in elite politics, the degree of engagement of civil society, and pressures from international organizations. Of these, the first, elite politics, appears to be the most important in these three cases.

Carbon Dioxide Uptake Estimation for Spanish Cement-Based Materials.

The Intergovernmental Panel on Climate Change (IPCC), which is the United Nations body for assessing the science related to climate change, has recently recognized the natural carbonation process as a way of carbon offsetting with mortar and concrete. Accordingly, this activity could be recognized as a carbon removal process for which certification should be granted. The aim of the certification of carbon removal is to promote the development of adequate and efficient new carbon removal processes. Therefore, the main objective of this study is to provide reliable results on carbon dioxide uptake by cement-based materials in Spain. Yearly, greenhouse gas emissions are reported to the United Nations Framework Convention on Climate Change (UNFCCC) by each country, and the natural carbonation should be added up to the carbon accounting. Therefore, natural carbonation should be included in the IPCC Guidelines for National Greenhouse Gas Inventories, and such accounting information should be made available promptly to the national regulatory authorities. This paper provides the results of carbon dioxide uptake by Spanish cement-based materials from 1990 to 2020 by using an easy method of estimating the net carbon dioxide emissions (simplified method) considering the carbon dioxide released by the calcination during clinker production (process emissions). The outcome of this study reveals that there was 93,556,000 tons of carbon dioxide uptake by the mortar and concrete manufactured in Spain from 1990 to 2020.

Harmonization of individual case safety reports transmission requirements among PAHO reference authorities: a review of their current regulation.

To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the 'Good Pharmacovigilance Practices for the Americas' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.