Analysis of healthy life expectancy and related socioeconomic influencing factors among the middle-aged and elderly in China, the United States, and the European Union / 中华流行病学杂志

Objective: To calculate and compare the healthy life expectancy (HLE) of the middle-aged and elderly in China, the United States, and developing and developed countries in the European Union(EU) and analyze the impact of socioeconomic factors on HLE in different countries or regions. Methods: Four surveys from 2010 to 2019 were brought into the research. The data were collected from the China Health and Retirement Longitudinal Study, Health and Retirement Study, and the Survey of Health, Ageing and Retirement in Europe. Developed and developing countries in the EU were divided into two groups for calculation. Education level, total family wealth, and work retirement status were selected to measure socioeconomic status, and activities of daily living were used as health status indicators. We used the multi-state life cycle table method to calculate the transition probability between different health states and estimate life expectancy and HLE. Results: A total of 69 544 samples were included in the study. In terms of age, the middle-aged and elderly in the United States and developed countries of the EU have higher HLE in all age groups. In terms of gender, only Chinese women have lower HLE than men. Regarding socioeconomic factors, the middle-aged and elderly with higher education levels and total family wealth level have higher HLE. In China, working seniors have higher HLE, while for USA women and developed countries of the EU, retired or unemployed seniors have higher HLE. Conclusions: Demographic and socioeconomic factors impact HLE in different countries or regions. China should pay more attention to the health of women and the middle-aged and elderly retired with lower education and less total family wealth.

Discussion on Technical Evaluation Requirements of Allergen Detection Reagent Pre-marketing / 中国医疗器械杂志

In the perspective of technical evaluation, the pre-marketing regulatory requirements of allergen detection reagents in China, America, European Union were compared, and the regulatory risks and performance requirements of this product were analyzed based on the monitoring of post-marketing adverse events, reference standards and domestic and foreign regulatory documents. In view of the "neck-stuck" problems such as the difficulty of clinical trials, the difficulty of finding comparable contrast reagents and the lack of clinical diagnostic gold standards, this paper discusses and gives regulatory suggestions, with a view to providing technical reference for product R&D, production, evaluation, approval and supervision in this field.

Research on the Necessity and Feasibility of Current Medical Device Supervision Legislation / 中国医疗器械杂志

This paper studies the necessity of the current legislation on the supervision of medical devices in China from the perspectives of strengthening administration according to law, protecting public health, perfecting the legal system of medicine and promoting the development of the medical device industry. This study analyzes and summarizes the legislative experiences and forms in the field of medical device regulation in the United States, the European Union, Japan and other countries and regions, at present, the conditions of carrying out the legislation of medical device supervision in China are quite mature, and some policy suggestions are put forward for the enactment of the law of medical device management in China.

Changes and Related Reflections on the European Union's in Vitro Diagnostic Medical Device Classification Supervision System / 中国医疗器械杂志

By analyzing and comparing the IVD product classification supervision system in the EU's new IVDR, old IVDD and related guidance documents, concepts of related regulatory reforms were analyzed and explored, to provide references for industrial personnel to understand and master the new EU IVD classification system, and for China's ongoing classification management reform.

Analysis on the Current Situation of Regulations and Standards for Home Photoepilators / 中国医疗器械杂志

This article introduces the safety risks of the novel light-based home-use hair removal device, and analyzes the differences in regulation among China, the United States and the European Union. In China, household intense pulsed light hair removal devices will also be supervised in accordance with medical device regulations. Therefore, the safety standards adopted in the absence of specific regulations are no longer applicable to the new regulatory requirements. It is imperative to adopt the new standards available to home photoepilators, so as to ensure the safety and effectiveness of the approved devices.

Brief Introduction about New Regulation of EU on IVDR / 中国医疗器械杂志

There are five-year transitional period for manufacturers after the issue of regulation(EU) 2017/746 on

Enlightenment of international pharmacovigilance system on establishment of pharmacovigilance system of Chinese medicine / 中国中药杂志

Pharmacovigilance system is an extension of the original adverse drug reactions monitoring and reporting system as well as an internationally recognized basic system that must be matched with the whole life cycle supervision of drugs. European Union(EU)pharmacovigilance system, World Health Orgnization(WHO) Uppsala Monitoring Center system and ICH system are internationally recognized pharmacovigilance systems. They all have their own pharmacovigilance characteristics and could provide guarantee for clinical safe drug use. With the deepening of international communication, pharmacovigilance has also been developed in China. Pharmacovigilance of Chinese medicine is a new concept based on the existing pharmacovigilance system of chemical medicine and the characteristics of Chinese medicine. In ancient China, Chinese medicine also had its own ways of early warning. Ancient medical books have records on the toxicity classification, clinical pharmacovigilance and intoxication rescue of Chinese medicine. With the increase of public recognition of Chinese medicine in recent years, especially since the government issued the 13 th Five-Year Plan for the development of Chinese medicine, the pharmaceutical industry in China has paid more and more attention to the pharmacovigilance of Chinese medicine.However, the pharmacovigilance system of Chinese medicine has not yet been established, and it still needs to be explored and improved.Therefore, it is very necessary to develop the system to standardize pharmacovigilance-related activities of Chinese medicine. In this context, this study analyzed and learned the characteristics of pharmacovigilance systems of EU, ICH, and WHO Uppsala Monitoring Center, so as to provide some enlightenment for the establishment and improvement of pharmacovigilance system of Chinese medicine.

MIXed plastics biodegradation and UPcycling using microbial communities: the NSFC-EU 2019 project MIX-UP to help achieve "carbon neutrality" / 生物工程学报

With the transformation and revolution of the global plastics recycling system, recycling and upcycling of mixed plastics waste not only reduces the carbon emissions of plastics during its life cycle, but also addresses its potential ecological and environmental hazards. This article summarizes an international cooperation project, "MIXed plastics biodegradation and UPcycling using microbial communities" (MIX-UP) which was funded by the National Natural Science Foundation of China and the European Union (NSFC-EU) in 2019. The consortium of MIX-UP consists of 14 partners from European Union and China. Focusing on the global issue of "plastics pollution", this Sino-European MIX-UP project took the mixed waste of petroleum-based plastics (PP, PE, PUR, PET and PS) and bio-based plastics (PLA and PHA) as starting materials for biotechnological conversion into value-added, sustainable biomaterials. MIX-UP has three subprojects: 1) identification of plastics biodegradation pathway and design & engineering of key degrading elements, 2) construction and functional regulation of microbial consortia/enzyme cocktails with high-efficiency for degradation of plastics mixtures, 3) strategy of design and utilization of plastics degradation products for production of high value materials. Through NSFC-EU complementary and cross-disciplinary cooperation, MIX-UP proposes the engineering of a new-to-nature biological route for upcycling, a low carbon and sustainable bio-treatment that is different from the traditional physico-chemical treatment, which will empower the recycling industry to a new dimension. The implementation of the project will not only help to promote innovation and development in the field of biotechnology in China, but also contribute to the achievement of China's carbon neutral goal.

Mutual Recognition Agreement for Nursing Professionals: Policy Issues and Alternatives / 간호행정학회지

Brief Introduction to Regulatory Documents of European and American Drug-Device Combinations and Enlightenment / 中国医疗器械杂志

This paper briefly introduces the recent regulatory regulations issued by the European Union and the United States on the drug-device combinations. The contents include the definition of drug-device combinations, the attribute definition process, the registration requirements, the review and approval procedures, the management of production systems, and the post-marketing safety supervision. Some inspirations have been obtained from them for reference by the regulatory authorities.

Governança global, regulamentação flexível e os ensaios clínicos na medicina regenerativa no Reino Unido e na União Europeia / Global Governance, Flexible Regulation and Clinical Trials in Regenerative Medicine in the United Kingdom and the European Union

Resumo A medicina regenerativa encontra-se em fase de desenvolvimento dos ensaios clínicos em terapias celulares (TC), na sua manufatura e na sua adoção gradual dentro dos sistemas de saúde. Entretanto, há uma série de lacunas e contradições na governança e regulamentação na área e o objetivo principal deste artigo é sua discussão dentro das tendências globais, já que esses processos afetam de modo substantivo a saúde coletiva global e encontram-se ainda escassamente resolvidos. O texto foca nos processos prevalentes nos ensaios clínicos com TC em duas lideranças internacionais, o Reino Unido e a União Europeia, utilizando a análise bibliográfica e de conteúdo. O texto conclui com uma discussão das principais vantagens e desvantagens para a saúde coletiva global da transição de um modelo científico de comprovação das novas terapias celulares para, eventualmente, outro baseado na inovação médica ou clínica. O último procede desde a fase pré-clínica com animais à aplicação das novas terapias a grupos pequenos de pacientes e, logo a seguir, a sua inserção no mercado. Muitas vezes, esse modelo se associa a flexibilidades regulatórias, a serem ilustradas no artigo, e especialmente desenhadas para aumentar a rapidez no desenvolvimento e aplicação das terapias.

Abstract Regenerative medicine is at present in a stage of development of clinical trials in cell therapies (CT), their manufacture and gradual adoption by health systems. However, there are several gaps and contradictions in governance and regulation in the area and the main aim of this article is their discussion within global trends, as these processes remain still ill- resolved while substantively affecting collective global health. The text focuses on an analysis of prevailing processes in clinical trials with CT by two leading actors, the United Kingdom, and the European Union, and is based upon bibliographical and content analyses. The article concludes with a discussion of the main advantages and disadvantages for collective global health of the transition from a conventional scientific model to test the new therapies to, eventually, one based on medical or clinical innovation. The latter proceeds from the pre-clinical research phase with animals to clinical trials with small groups of patients and subsequently, to the entrance of cell therapies into the market. Often this model is associated to flexible regulations, to be illustrated in the article, which are specifically designed to diminish time-lags between therapy development and its full application.

Axial Spondyloarthritis after bariatric surgery: a 7-year retrospective analysis

Abstract Background: In recent decades, obesity has become a public health problem in many countries. The objective of this study was to evaluate the main joint and extra-articular manifestations related to spondyloarthritis (SpA) after bariatric surgery (BS) in a retrospective cohort. Methods: Demographic, clinical, laboratory and imaging data from nine patients whose SpA symptoms started after a BS have been described. Modified New York (mNY) criteria for ankylosing spondylitis (AS) and the Assessment of Spondyloarthritis International Society (ASAS) criteria for axial (ax-SpA) and peripheral (p-SpA) spondyloarthritis were applied. Results: The mean weight reduction after BS was 49.3 ±21.9 kg. The BS techniques were Roux-en-Y gastric bypass (n =8; 88.9%) and biliopancreatic diversion with duodenal switch (n = 1; 11.1%). Four (44.4%) patients had no axial or peripheral pain complaints before BS, while the other four (44.4%) had sporadic non-inflammatory back pain that had been attributed to obesity. One patient (11.1%) had persistent chronic back pain. In all nine cases, patients reported back pain onset or pattern (intensity or night pain) change after BS (mean time 14.7 ± 18 months). In addition, 8 of them (88.9%) were human leukocyte antigen (HLA)-B27 positive. All nine patients could be classified according to ASAS criteria as ax-SpA and five (55.6%) patients were classified as AS, according to the mNY criteria. Conclusion: Our data highlight a temporal link between SpA onset symptoms and the BS, suggesting a possible causal plausibility between the two events.

Protecting and Utilizing Health and Medical Big Data: Policy Perspectives from Korea / 대한의료정보학회지

OBJECTIVES: We analyzed Korea's data privacy regime in the context of protecting and utilizing health and medical big data and tried to draw policy implications from the analyses. METHODS: We conducted comparative analyses of the legal and regulatory environments governing health and medical big data with a view to drawing policy implications for Korea. The legal and regulatory regimes considered include the following: the European Union, the United Kingdom, France, the United States, and Japan. We reviewed relevant statutory materials as well as various non-statutory materials and guidelines issued by public authorities. Where available, we also examined policy measures implemented by government agencies. RESULTS: In this study, we investigated how various jurisdictions deal with legal and regulatory issues that may arise from the use of health and medical information with regard to the protection of data subjects' rights and the protection of personal information. We compared and analyzed various forms of legislation in various jurisdictions and also considered technical methods, such as de-identification. The main findings include the following: there is a need to streamline the relationship between the general data privacy regime and the regulatory regime governing health and medical big data; the regulatory and institutional structure for data governance should be more clearly delineated; and regulation should encourage the development of suitable methodologies for the de-identification of data and, in doing so, a principle-based and risk-based approach should be taken. CONCLUSIONS: Following our comparative legal analyses, implications were drawn. The main conclusion is that the relationship between the legal requirements imposed for purposes of personal information protection and the regulatory requirements governing the use of health and medical data is complicated and multi-faceted and, as such, their relationship should be more clearly streamlined and delineated.

The Occurrence and Risk Assessment of Exposure to Aflatoxin M₁ in Ultra-High Temperature and Pasteurized Milk in Hamadan Province of Iran

OBJECTIVES: Aflatoxins are a category of poisonous compounds found in most plants, milk and dairy products. The present research was carried out to detect the presence of aflatoxin M₁ (AFM₁) in samples of milk collected from Hamadan province, Iran. METHODS: Twenty five samples of ultra-high temperature (UHT) and 63 samples of pasteurized milk were collected and the amount of AFM₁ was measured by an Enzyme-Linked Immunosorbent Assay method. In addition, the estimated daily intake (EDI) and hazard index (HI) of AFM₁ was determined by the following equations:(EDI= mean concentration of AFM₁ × daily consumption of milk/body weight; HI=EDI/Tolerance Daily Intake). RESULTS: AFM₁ was detected in 21 (84%) UHT milk samples and in 55 (87.30%) pasteurized milk samples. Seven (28%) samples of UHT and 21 (33.33%) pasteurized milk samples had higher AFM₁ content than the limit allowed in the European Union and Iranian National Standard Limits (0.05 μg/kg). None of the samples exceeded the US Food and Drug Administration limit (0.5 μg/kg) for AFM₁. EDI and HI for AM₁ through milk were 0.107 ng/kg body weight/day, and 0.535, respectively. CONCLUSION: A significant percentage of milk produced by different factories in Iran (84% of UHT and 87.3% of pasteurized milk) was contaminated with AFM₁. Therefore, more control and monitoring of livestock feeding in dairy companies may help reduce milk contamination with AFM₁. As the HI value was lower than 1, it can be assumed that there was no risk of developing liver cancer due to milk consumption.

Comparison of work environment and occupational injury in direct and indirect employment in Korea and Europe

BACKGROUND: To investigate the risk of injury for indirect employment in Korea, we compared work environment, workplace exposure, and injury risk according to the type of employment contract between Korea and European Union (EU) countries. METHODS: We analyzed data of blue-collar workers from the fourth Korean Working Conditions Survey (2014) and the sixth European Working Conditions Survey (2015) and compared workplace risk factors and preventive factors for occupational injuries. Multiple logistic regression analysis was conducted to identify the relationship between occupational injury and the type of employment contract after adjusting for age and sex. RESULTS: For descriptive characteristics, a relatively older age, lower income, lower proportion of full-time work, greater proportion in small-sized companies, and fewer unionizations were noted in indirect employment in Korea than in direct employment. Workplace exposure was significantly higher in indirect employment in both Korea and Europe. Among safety-related factors, indirect employment in both Korea and Europe lacked the support of company education, coworkers, and supervisors. Indirectly employed blue-collar workers had a significantly higher risk of occupational injury than those directly employed in Korea (odds ratio [OR]: 1.876), whereas there was no significant difference between directly and indirectly employed workers in EU countries (OR: 1.038). CONCLUSIONS: Indirectly employed blue-collar workers have an increased risk of occupational injury in Korea.

Health Promotion at Work: A Comparison of Policy and Practice Across Europe

BACKGROUND: Promoting healthy lifestyles at work should complement workplace safety programs. This study systematically investigates current states of occupational health and safety (OHS) policy as well as practice in the European Union (EU). METHODS: OHS policies of EU member states were categorized as either prevention or health promotion provisions using a manifest content analysis. Policy rankings were then created for each prevention and promotion. Rankings compared eight indicators from the European Survey of Enterprises on New and Emerging Risks-2 data on prevention and promotion practices for each member state using Chi-square and probit regression analyses. RESULTS: Overall, 73.1% of EU establishments take preventive measures against direct physical harm, and about 35.4% take measures to prevent psychosocial risks. Merely 29.5% have measures to promote health. Weak and inconsistent links between OHS policy and practice indicators were identified. CONCLUSION: National OHS policies evidently concentrate on prevention while compliance with health and safety practices is relatively low. Psychosocial risks are often addressed in national policy but not implemented by institutions. Current risk assessment methods are outdated and often lack psychosocial indicators. Health promotion at work is rare in policy and practice, and its interpretation remains preventive. Member states need to adopt policies that actively improve health and well-being at the workplace.

Comparison of Approval Process for Nonprescription Drugs in Different Countries

Nonprescription drugs have become increasingly important in Korean healthcare. By leveraging lower-cost drugs and reducing expenditure associated with fewer physician visits, the nonprescription segment can deliver tremendous value to individual consumers and the Korean healthcare system. Many countries have provided simpler and more rapid routes to market entry for qualifying nonprescription drug products, using the established data on drug safety and efficacy, as well as public and professional opinion. In US, the FDA waived the pre-approval process for over-the-counter (OTC) drugs marketed through the OTC Monograph Process. In Australia and Canada, different OTC product application levels are defined, with a reduced level of assessment required when the risks to consumers are considered low. Japan established a new OTC evaluation system in 2014 to facilitate the Rx-to-OTC switch process. The legislative framework for medicinal products in the European Union allows for drugs to be approved with reference to appropriate bibliographic data for old active substances with well-established uses. Through a comparison of the regulatory framework and the requirements for nonprescription approval process in different countries, several ways to improve regulatory practice for the evaluation of nonprescription drugs in Korea have been suggested.

Isotretinoin exposure in pregnant women in Korea

OBJECTIVE: Isotretinoin is a notorious teratogen otherwise used for the treatment of acne vulgaris. Some countries, including those in North America and the European Union, implemented the pregnancy prevention program (PPP); however, no PPP has yet been established in South Korea. So the aim of this study was to evaluate the rate of pregnant women exposed to isotretinoin among the callers of the Korean Mother Safe Counseling Center. METHODS: This is a prospective cohort study. We evaluated the demographic characteristics, obstetric history, and isotretinoin exposure of pregnant women based on the mother safe registry from April 2010 to July 2016. RESULTS: Among 22,374 callers, 650 (2.9%) pregnant women were exposed to isotretinoin. The mean age was 29.0±4.4 years in the isotretinoin-exposed group and 32.0±4.2 years in the unexposed group (P < 0.001). Moreover, the incidence of pregnancies within 30 days after isotretinoin discontinuation or during isotretinoin intake was 78.9% (513/650). The median duration of isotretinoin exposure was 18 (1–4,231) days. Furthermore, from 2011 to 2015, the incidence of isotretinoin exposure was 2.9±1.2 pregnancies per 10,000 births in South Korea. CONCLUSION: Approximately 80% of pregnant women are exposed to isotretinoin within the recommended 30 days of contraception or during pregnancy. Therefore, the PPP has to be established in South Korea.

Survival in clinical stage I endometrial cancer with single vs. multiple positive pelvic nodes: results of a multi-institutional Italian study / 부인종양

OBJECTIVE: To investigate survival outcomes in endometrioid endometrial cancer (EEC) patients with single vs. multiple positive pelvic lymph nodes. METHODS: We performed a retrospective evaluation of all consecutive patients with histologically proven International Federation of Gynecology and Obstetrics (FIGO) stage IIIC1 EEC who underwent primary surgical treatment between 2004 and 2014 at seven Italian gynecologic oncology referral centers. Patients with pre- or intra-operative evidence of extra-uterine disease (including the presence of bulky nodes) and patients with stage IIIC2 disease were excluded, in order to obtain a homogeneous population. RESULTS: Overall 140 patients met the inclusion criteria. The presence of >1 metastatic pelvic node was significantly associated with an increased risk of recurrence and mortality, compared to only 1 metastatic node, at both univariate (recurrence: hazard ratio [HR]=2.19; 95% confidence interval [CI]=1.2–3.99; p=0.01; mortality: HR=2.8; 95% CI=1.24–6.29; p=0.01) and multivariable analysis (recurrence: HR=1.91; 95% CI=1.02–3.56; p=0.04; mortality: HR=2.62; 95% CI=1.13–6.05; p=0.02) and it was the only independent predictor of prognosis in this subset of patients. Disease-free survival (DFS) and disease-specific survival (DSS) were significantly longer in patients with only 1 metastatic node compared to those with more than 1 metastatic node (p=0.008 and 0.009, respectively). CONCLUSION: The presence of multiple metastatic nodes in stage IIIC1 EEC represents an independent predictor of worse survival, compared to only one positive node. Our data suggest that EEC patients may be categorized according to the number of positive nodes.

Treatment outcomes of patients with stage II pure endometrioid-type endometrial cancer: a Taiwanese Gynecologic Oncology Group (TGOG-2006) retrospective cohort study / 부인종양

OBJECTIVE: Choice of hysterectomy and adjuvant treatment for International Federation of Gynecology and Obstetrics (FIGO) 2009 stage II endometrioid endometrial cancer (EEC) is still controversial. Aims of this study were to evaluate survival benefits and adverse effects of different hysterectomies with or without adjuvant radiotherapy (RT), and to identify prognostic factors. METHODS: The patients at 14 member hospitals of the Taiwanese Gynecologic Oncology Group from 1992 to 2013 were retrospectively investigated. Patients were divided into simple hysterectomy (SH) alone, SH with RT, radical hysterectomy (RH) alone, and RH with RT groups. Endpoints were recurrence-free survival (RFS), overall survival (OS), disease-specific survival (DSS), adverse effects and prognostic factors for survival. RESULTS: Total of 246 patients were enrolled. The 5-year RFS, OS, DSS and recurrence rates for the entire cohort were 89.5%, 94.3%, 96.2% and 10.2%, respectively. Patients receiving RH had more adverse effects including blood loss (p < 0.001), recurrent urinary tract infections (p = 0.013), and leg lymphedema (p = 0.038). Age over 50-year (HR = 9.2; 95% confidence interval [CI], 1.2–70.9) and grade 3 histology (HR = 7.28; 95% CI, 1.45–36.6) were independent predictors of OS. Grade 3 histology was an independent predictor of RFS (HR = 5.13; 95% CI, 1.38–19.1) and DSS (HR = 5.97; 95% CI, 1.06–58.7). Patients receiving adjuvant RT had lower locoregional recurrence (p = 0.046), but no impact on survival. CONCLUSION: Different treatment modalities yield similar survival outcomes. Patients receiving SH with RT had lower locoregional recurrent with acceptable morbidity. Age and tumor grading remained significant predictors for survival among patients with FIGO 2009 stage II EEC.