Search Results (61)

Background: China’s pharmaceutical regulatory framework is undergoing a pivotal shift from a traditional “command-control” model to a “lifecycle regulation” approach, aiming to balance drug safety, innovation, and accessibility. This study systematically examines the evolution, achievements, and challenges of China’s regulatory reforms, offering insights for global pharmaceutical governance. Methods: Using a mixed-methods approach integrating historical analysis, policy text mining, and case studies, we reviewed the pharmaceutical laws and regulations enacted since 1949, supplemented by case studies (e.g., COVID-19 vaccine emergency approvals) and a comparative analysis with international models (e.g., U.S. FDA and EU EMA frameworks). The data were sourced from authoritative platforms such as the PKULAW database, criminal law amendments, and international regulatory texts. Results: China’s regulatory evolution is categorized into four phases: Emergence (1949–1984), Foundational (1985–2000), Deepening Reform (2001–2018), and Lifecycle Regulation (2019–present). The revised Drug Administration Law (2019) institutionalized risk management, dynamic GMP inspections, and post-market surveillance, marking a transition to holistic lifecycle oversight. Key milestones include the introduction of the Vaccine Management Law (2019) and stricter penalties under the Criminal Law Amendment (XI) (2020). Conclusions: China’s lifecycle regulation model demonstrates potential to harmonize safety and innovation, evidenced by improved API export compliance (e.g., 15% increase in international certifications by 2023) and accelerated approvals for breakthrough therapies (e.g., domestically developed PD-1 inhibitors). However, challenges persist, including uneven enforcement capacities, tensions between conditional approvals and risk mitigation, and reliance on global supply chains. These findings provide critical lessons for developing countries navigating similar regulatory dilemmas. Full article

Background: Since the effectiveness of primary DM care (PDMC) is influenced by both health-care-related and external factors, its indicator set must include indicators that are easy-to-understand for all stakeholders, such as composite indicator-based ranking. Objectives: Our study aimed to prepare a composite PDMC indicator, which is adjusted with the GP-independent characteristics of a GMP, in order to evaluate the usefulness of composite indicators in performance-improving programs. Methods: Using indicators standardized by age, sex, and eligibility for exemption certificates (on hemoglobin A1C, lipid status, serum creatinine, and ophthalmological examination, and on influenza vaccination) for Hungarian adult DM care, factor analysis was applied to create a composite DM care quality indicator (CDMI). It was adjusted (ACDMI) by a multivariable linear regression model of the association between structural characteristics of GMPs and the CDMI. Results: There were 516,052 DM patients provided for by 4784 GMPs. The CDMI exhibited significant associations with patients’ lower education (β = −0.139, 95%CI: −0.182; −0.095), GPs’ age over 65 (β = −0.083, 95%CI: −0.109; −0.056), GMPs with more than 2000 adult patients (β = −0.059, 95%CI: −0.090; −0.027), and urban location (β = 0.096, 95%CI: 0.058; 0.134). The average difference in GMPs’ ranks by the CDMI and ACDMI was 583. Extreme poor (N = 147) and extreme good (N = 176) performances of GMPs were identified, and those were categorized further by the role of GP-independent factors in causing the extreme performances (N_{healthcareunrelated} = 84; N_{healthcarerelated} = 239). Conclusions: Our findings suggest a stepwise and widely communicable process for PDMC monitoring, which starts with the evaluation of the CDMI and ACDMI to identify the GMPs requiring interventions, making a distinction between extreme GMPs requiring health-care-related interventions and those requiring non-health-care-related interventions. Full article

Achieving a Foot-and-Mouth Disease (FMD)-free status without vaccination marks a significant milestone for Brazil, a major agricultural powerhouse with extensive cattle herds and vast borders. This certification represents not only a scientific and logistical achievement but also an opportunity for enhanced market access and strengthened biosecurity. However, transitioning to this status involves challenges, including maintaining stringent monitoring and surveillance, managing porous border regions, and mitigating risks from neighboring regions with varying FMD statuses. This review explores the expectations surrounding Brazil’s new status, including the anticipated economic benefits, the influence on Brazil’s international trade position, and the role of sustainable disease management practices. We also discuss potential risks, such as accidental reintroduction and surveillance gaps, which could impact livestock health and trade dynamics. With a focus on effective biosecurity, regional cooperation, and advanced diagnostic capabilities, Brazil’s journey to maintaining FMD-free status highlights both the opportunities and complexities of disease control in a nation deeply reliant on its agricultural sector. This status demands ongoing surveillance to support Brazil’s agricultural economy and ensure the long-term health security of its livestock industries. Full article

Background: The COVID-19 pandemic has necessitated changes in European healthcare systems, with a significant proportion of COVID-19 cases being managed on an outpatient basis in primary healthcare (PHC). To alleviate the burden on healthcare facilities, many European countries developed contact-tracing apps and symptom checkers to identify potential cases. As the pandemic evolved, the European Union introduced the Digital COVID-19 Certificate for travel, which relies on vaccination, recent recovery, or negative test results. However, the integration between these apps and PHC has not been thoroughly explored in Europe. Objective: To describe if governmental COVID-19 apps allowed COVID-19 patients to connect with PHC through their apps in Europe and to examine how the Digital COVID-19 Certificate was obtained. Methodology: Design and setting: Retrospective descriptive study in PHC in 30 European countries. An ad hoc, semi-structured questionnaire was developed to collect country-specific data on primary healthcare activity during the COVID-19 pandemic and the use of information technology tools to support medical care from 15 March 2020 to 31 August 2021. Key informants belong to the WONCA Europe network (World Organization of Family Doctors). The data were collected from relevant and reliable official sources, such as governmental websites and guidelines. Main outcome measures: Patient’s first contact with health system, governmental COVID-19 app (name and function), Digital COVID-19 Certification, COVID-19 app connection with PHC. Results: Primary care was the first point of care for suspected COVID-19 patients in 28 countries, and 24 countries developed apps to complement classical medical care. The most frequently developed app was for tracing COVID-19 cases (24 countries), followed by the Digital COVID-19 Certificate app (17 countries). Bulgaria, Italy, Serbia, North Macedonia, and Romania had interoperability between PHC and COVID-19 apps, and Poland and Romania’s apps considered social needs. Conclusions: COVID-19 apps were widely created during the first pandemic year. Contact tracing was the most frequent function found in the registered apps. Connection with PHC was scarcely developed. In future pandemics, connections between health system levels should be guaranteed to develop and implement effective strategies for managing diseases. Full article

This report reviews national data from all Member States on measles, rubella, and congenital rubella syndrome (CRS) elimination in the Region of the Americas during 2019–2023. It includes an analysis of compliance with vaccination coverage, surveillance indicators, and measles outbreaks, as well as an analysis of the response capacity of the laboratory network and a country case study that meets all indicators. The sources of information were the integrated epidemiological surveillance system for measles and rubella of the Pan American Health Organization (PAHO)/World Health Organization (WHO) and the Joint Reporting Form (eJRF), among others. From 2020 to 2022, regional coverage with first (MMR-1) and second doses (MMR-2) decreased to rates below 90%. The regional suspected case notification rate was maintained above the minimum expected 2.0 suspect cases per 100,000 population, except in 2021. During 2019 to 2023, 18 countries experienced outbreaks, with two of the outbreaks resulting in re-established endemic transmission. In conclusion, two countries in the Americas have not maintained measles elimination, but by the end of 2023 no country showed endemic measles transmission. One of the countries that lost its certification of elimination in 2018 managed to be reverified in 2023; the other is pending reverification. All countries maintained rubella elimination. Despite these challenges, the sustainability of the elimination of these diseases remains a health priority in the Region. Full article

The impact of COVID-19 measures on airport performance is obvious, and there have been numerous studies on this topic. However, most of these studies discuss prevention measures, the effects on airport operations, forecasts of economic impacts, changes in service quality, etc. There is a lack of research on the effects of various prevention measures on airport operations and the interrelationships between these measures. This study focuses on addressing this gap. In this study, an integrated approach is devised that combines the decision-making trial and evaluation laboratory (DEMATEL) method and interpretive structural modeling (ISM). This integrated method is useful for exploring the relationship between pandemic measures and airport performance as well as the complex relationship between them, and the combination of methods improves upon the shortcomings of the original models. This study reveals that mandating vaccination certificates for entry into a country is the most significant measure affecting airport performance. Additionally, aircraft movement at the airport has the greatest overall impact and can be considered the most crucial factor influencing airport performance from an operational standpoint. The findings show that both factors directly influence financial performance, as reflected in the net income. Some management implications are provided to mitigate the consequences of the measures taken to counter the pandemic crisis. This integrated approach should also assist authorities and policy-makers in planning cautious action for future crises. Full article

As the Global Polio Eradication Initiative (GPEI) strategizes towards the final steps of eradication, routine immunization schedules evolve, and high-quality vaccination campaigns and surveillance systems remain essential. New tools are consistently being developed, such as the novel oral poliovirus vaccine to combat outbreaks more sustainably, as well as non-infectiously manufactured vaccines such as virus-like particle vaccines to eliminate the risk of resurgence of polio on the eve of a polio-free world. As the GPEI inches towards eradication, re-strategizing in the face of evolving challenges and preparing for unknown risks in the post-certification era are critical. Full article

Background and Objectives: This study delves into the attitudes, beliefs and determinants influencing the uptake of the COVID-19 vaccine among the Lithuanian population. Materials and Methods: Utilizing a cross-sectional study design, a total of 3166 respondents were surveyed. Results: The findings reveal a significant disparity in vaccination rates based on socio-demographic factors, with higher uptake observed among individuals with a university degree, urban residents and those in higher income brackets. Personal beliefs, particularly regarding the vaccine’s efficacy in pandemic management, played a pivotal role in vaccination decisions. This study also highlights the influence of external factors, such as the activity of the “anti-vaxxer” movement and the introduction of vaccination certificates. Conclusions: The results emphasize the need for targeted educational interventions and comprehensive public health campaigns to address vaccine hesitancy and promote widespread immunization. Full article

The COVID-19 pandemic led to widespread restrictions globally, prompting governments to implement measures for containment. Vaccines, while aiding in reducing virus transmission, have also introduced the challenge of identifying vaccinated individuals for the purpose of easing restrictions. The European Union (EU) addressed this through the “digital COVID-19 certification” system, allowing citizens to travel within the EU based on their vaccination, recovery, or negative test status. However, the system’s digital format poses challenges for those who are not digitally proficient, such as seniors and those with low educational or socioeconomic status. This study aims to propose enhancements to the current system, considering the mobility needs of all citizens. The methodology involves reviewing literature on digital literacy, the digital divide, and information systems related to vaccination and certification. The paper presents straightforward recommendations to make the COVID-19 certificate more accessible to digitally excluded individuals. These proposals may serve as a valuable starting point for healthcare executives to evaluate and adapt the certification scheme to be inclusive of a broader range of stakeholders. Full article

To reduce the number of COVID-19 cases, vaccines were rapidly made available worldwide. For a strategically targeted response to the COVID-19 pandemic, population vaccination coverage was to be maximized. The target groups also included healthy children. In this context, it is important to understand the determinants and beliefs that lead parents to favor or oppose COVID-19 immunization in children. This study aimed to investigate parents’ COVID-19 vaccination willingness in Germany for children aged 5–11 years in 2021/2022. For this purpose, the determinants and beliefs behind parents’ vaccination decisions were examined. Descriptive analysis and bivariate correlations were performed on COVID-19 vaccination willingness and parents’ mental health status, general vaccination attitudes, and SARS-CoV-2 politics perceptions. In total, 2401 participants fully participated in this cross-sectional study. The COVID-19 vaccination uptake (71.4%) outweighed the vaccination refusal (19.4%). Correlations revealed higher vaccine acceptance in parents presenting full vaccination certificates (90.9%), COVID-19 immunizations (99.9%), or increased COVID-19 fear (93.6%). Vaccination-refusal was associated with higher perceived pressure by COVID-19 vaccination campaigns (87.7%), higher experienced restrictions due to COVID-19 protective measures in parents’ social environment (83.6%), and engagement against COVID-19 protective measures (51.6%). Besides general anxiety, no significant correlations were observed between parents’ mental health variables and vaccination willingness. Although several factors are ultimately associated with vaccination willingness, future vaccination campaigns should prioritize reducing pressure, increasing trust, and considering parents’ differentiation between familiar and unfamiliar pathogens during their vaccination decision-making process. Full article

Horses are transported in the United States more than any other livestock species and co-mingle at various events; therefore, they are considered to be at an increased risk for infectious disease transmission. The fragmented movement of horses combined with numerous sites of co-mingling makes tracing the potential spread of a disease outbreak a necessary part of an infection control plan, both locally and nationally. The cross-movement of personnel with horses and the persistence of endemic diseases make biosecurity implementation an ongoing challenge. Although many of the risks for infection are known, there is limited documentation about the usefulness of prospective control measures. The objective of this survey was to determine horse owners’ understanding and knowledge of biosecurity practices for preventing infectious diseases in the United States. Questions covered owner demographic information, including horse use which was divided into 10 categories as follows: Pleasure/Trail Riding, Lessons/School, Western Show, English Show, Breeding, Farm/Ranch, Retired, Racing, Driving and Other. The survey was distributed by sending requests to a list of horse owner organizations, which then sent emails to their members. The email request described the survey and provided a website link to start the survey. A total of 2413 responses were collected. Analysis of the results included cross-tabulation to identify significant differences in biosecurity knowledge and awareness by horse use. Significant differences by horse use were identified for vaccination, biosecurity planning, use of isolation, disease risk, monitoring for diseases, co-mingling of horses, sanitation, medical decision making and health record requirements for horse events. In summary, the results suggest that most owners are not highly concerned about the risk of disease or the use of biosecurity. There are several biosecurity applications and techniques which can be increased and will benefit horse health and welfare. These include reliance on temperature monitoring, isolation of new horses at facilities, risks of horse mingling, entry requirements such as vaccination and health certificates at events, and an emphasis on having biosecurity plans for facilities and events where horses co-mingle. The information from this study will be used to create tools and information that horse owners and veterinarians can use to implement appropriate biosecurity practices for different types of horse uses and events. Full article

Worldwide, conjugated pneumococcal vaccines (PCVs) have proven effective against invasive pneumococcal disease, but non-invasive pneumonia is a major cause of mortality in young children and serotypes vary geographically, affecting effectiveness. We analyze nationwide death certificate data between 2003–2017 to assess the impact of PCVs on pneumonia mortality among young children from Peru. We report descriptive statistics and perform timeseries analysis on annual mortality rates (AMRs) and monthly frequencies of pneumonia deaths. Children under 5 years of age accounted for 6.2% (n = 10,408) of all pneumonia deaths (N = 166,844), and 32.3% (n = 3363) were children between 1–4 years of age, of which 95.1% did not report pneumonia etiology. Comparing periods before and after PCV introduction in 2009, mean AMRs dropped 13.5% and 26.0% for children between 1–4 years of age (toddlers/preschoolers), and children under 1 year of age (infants), respectively. A moderate correlation (Spearman’s r = 0.546, p < 0.01) in the monthly frequency of pneumonia deaths was estimated between both age groups. Quadratic regression suggests a change in direction around 2005 (highest pneumonia mortality) for both age groups, but percentage change analysis identified an inflection point in 2013 for infants only, not for toddlers/preschoolers, suggesting that the impact of PCVs might be different for each age group. Full article

The recent COVID-19 pandemic situation highlights the importance of digital vaccine certificates. In response, the European Union (EU) developed EU Digital Vaccine Certificates to enable proof of non-infectivity and completed vaccinations. However, these solutions suffer from several shortcomings, such as ineffective certificate holder identification and a high violation of user privacy with the disclosure of sensitive information. In this work, we present a novel solution for privacy-preserving EU Digital Vaccine Certificates. Our solution solves the aforementioned privacy and security shortcomings and is in line with current EU legislation, i.e., the General Data Protection Regulation (GDPR), the upcoming revision of the electronic IDentification, Authentication, and trust Services (eIDAS), called regulation eIDAS 2.0, and the new tools that it envisages to be led by European digital identity. This identity is intended to allow citizens to prove their identity to access online services, share digital documents, or simply prove specific personal characteristics such as age without revealing their identity or other personal information. The core of our proposal is built on our novel attribute-based credential scheme, which can be easily implemented on various handheld devices, especially on Android smartphones and smartwatches. However, due to the lightweight nature of our scheme, it can also be implemented on constrained devices such as smart cards. In order to demonstrate the security, privacy, and practicality inherent in our proposal, we provide the security analysis of the cryptographic core along with a set of experimental results conducted on smartphones and smart cards. Full article

The first reported infections from COVID-19 were in 2019 and, since then, an outbreak has spread rapidly to other parts of the world, resulting in many deaths. As a result, governments began to implement border restrictions and quarantine measures, bringing the travel industry to a halt and plunging the global economy into a severe contraction. Many regions chose to coexist with COVID-19 and gradually eased their border restrictions with certain conditions, such as using personal health status certificates, vaccination certificates, etc. Digital certificates are becoming a global trend, and Taiwan has invested in developing related tools. This paper presents a technical evaluation from the government’s point of view. Taiwan uses the European Union (EU) Digital COVID Certificate as a basis to build a digital certificate that can fully meet the residents’ current international business and tourism needs. The government hopes that this digital proof will promote the public’s return to normal life and overcome the inconveniences brought about by the COVID-19 pandemic. In the post-pandemic era, finding a way to coexist with the virus while gradually relaxing border and community epidemic-prevention policies without impacting our Taiwan’s medical capacity is a significant challenge. Providing key technological solutions to assist in risk stratification is essential in addressing this issue. Full article

Background/Objective: Little is known about the impact of the COVID-19 pandemic on mortality from COPD at the population level. The objective was to investigate COPD-related mortality throughout different epidemic waves in Italy before and after the vaccination campaign, which started in late December 2020 and initially targeted the population aged ≥80 years. Methods: Death certificates of residents in Veneto (Northeastern Italy) aged ≥40 years between 2008 and 2021 were analyzed. Age-standardized morality rates were computed for death certificates with any mention of COPD. Generalized estimating equation (GEE) models were fitted to estimate the expected mortality during the pandemic. The results were stratified by age groups of 40–79 and ≥80 years, main comorbidities, and place of death. Results: COPD was mentioned in 3478 death certificates in 2020 (+14% compared to the 2018–2019 average) and in 3133 in 2021 (+3%). Age-standardized mortality rates increased in all age and sex groups in 2020; in 2021, mortality returned to pre-pandemic levels among the elderly but not in the population aged 40–79 years (+6%). GEE models confirmed this differential trend by age. COPD-related mortality peaks were observed, especially in the first pandemic waves, with COVID-19 identified as the underlying cause of death in a relevant proportion (up to 35% in November 2020–January 2021). Mortality with comorbid diabetes and hypertensive diseases slightly increased during the pandemic. Conclusion: COPD-related mortality increased at the beginning of the pandemic, due to deaths from COVID-19. The start of the vaccination campaign was associated with an important decline in COPD-related mortality, especially among the elderly, who first benefited from COVID-19 vaccines. The study findings show the role of mass vaccination in reducing COPD-related deaths during the later phases of the pandemic. Full article