中成药欧盟注册分析

自2004年起，欧盟和美国分别发布了《传统植物药注册程序指令》和《植物药产品指南》，掀起了中药的新篇章，西方发达国家第一次在法律层面上认可中药作为药品的地位，现通过对欧盟植物药注册法规法律的探讨以及注册成功案例的分析，为我国中成药国际化注册提供一定参考。     

European survey of hepatitis B vaccination policies for healthcare workers: An updated overview

BackgroundThe risk of transmission of bloodborne pathogens, including hepatitis B virus (HBV) to healthcare workers (HCWs) is well known. In 2005 we performed a survey on HBV prevention in HCWs in the European Union (EU). An update of the 2005 survey deemed necessary as an EU Council Directive (2010/32/EU) on sharps injuries was to be implemented into national legislation by 11 May 2013 and more countries were starting universal HBV vaccination.MethodsWe performed an electronic survey in 2016, among national representatives from the Occupational Medicine section of the European Union of Medical Specialists (UEMS), to find out how policies have been put into practice in the European Union countries (plus Norway and Switzerland). The data were updated in 2019.ResultsAnswers were received from 21 countries (among them 19 EU Member States), representing 78% of the population and 60% of HCWs in the EU-28. HBV vaccination was mandatory for medical and nursing staff in 10 countries; for other paramedical staff, medical and nursing students in 9 countries; for paramedical students in 8 countries; for cleaning staff in 7 countries; and for technical staff in 5 countries; it was recommended in all but one of other countries. Serotesting before vaccination was done in 7 countries. The vaccination schedule most often used was 0, 1, 6 months (18countries), monovalent HBV vaccine was used in 14 countries, and combined (HAV + HBV) vaccine in 11 countries. Serotesting after vaccination was done in 18 countries and boosters were recommended in 14 countries. A non-responder policy was present in 18 countries. HBV vaccination coverage (5 countries) was 70–95%. Sharps injuries were reported in 13 countries, nationwide in 7 of them; European-wide reporting was not mentioned by respondents.DiscussionThese results show the variation in the implementation of EU legislation in the participating countries. More consultation between actors at EU level, including enhancing medical surveillance in occupational medicine could help to optimise policies in European countries in order to further reduce HBV transmission to HCWs.     

国外仿制药参比制剂选择简介及对我国的启示

目的：为完善我国仿制药一致性评价中参比制剂选择机制和程序提供参考,为仿制药企业在应用选择参比制剂时提供思路。方法：详细介绍了美国FDA有关参比制剂选择指南草案的最新描述,以及欧盟、日本和WHO对于参比制剂的相关要求。结合我国现阶段仿制药一致性评价工作实际,为完善参比制剂选择程序提出建议。结果与结论：美国详细规定了仿制药参比制剂的选择思路和实际操作程序,为我国仿制药参比制剂的选择提供了新的思路。我国正处于仿制药一致性评价参比制剂遴选的关键时期,制定全面、完善的参比制剂遴选体系和机制,有助于规范参比制剂的选择程序,加快一致性评价工作进程,提升我国仿制药一致性评价参比制剂选择的科学性和完整性。     

MACVIA-LR,Reference site of the European Innovation Partnership on Active and Healthy Ageing (EIP on AHA) in Languedoc Roussillon

The Région Languedoc-Roussillon is the umbrella organisation for an interconnected and integrated project on AHA covering the 3 pillars of the European Innovation Partnership on Active and Healthy Ageing. All sub-activities (A1: electronic pharmaceutical file, A2: falls prevention initiative, A3: frailty, B3: chronic respiratory diseases, chronic diseases with comorbidities, oral health and hepatitis virus C chronic infection, C2 and D4 active and independent living and handicap) are included in MACVIA-LR that has a strong political commitment and includes all stakeholders (public, private, patients, policy makers). It is one of the Reference Sites of the European Innovation Partnership on Active and Healthy Ageing built around chronic diseases, ageing and handicap. The framework of MACVIA-LR has the vision that the prevention and management of CDs is essential for AHA promotion and for the reduction of handicap. The main objective of MACVIA-LR is to develop innovative solutions for a network of Living Labs in order to improve the care of patients affected by CDs in the Languedoc-Roussillon area and to disseminate the innovation.     

丹参胶囊在欧盟药品注册中的可读性测试研究和实践

药品说明书是载明药品信息的法定文件,对指导公众合理用药起着至关重要的作用。在欧美药品的申报体系和指南中,均要求申请者在药品上市前必须完成药品说明书可读性测试研究,以保证说明书内容通俗易懂,指导公众合理安全用药,避免用药不当可能导致的风险。由于审评理念和标准的差距,目前中国在新药评审的过程中缺乏药品说明书可读性测试研究的要求、法规和指南。以国内申报欧盟成功的品种丹参胶囊注册上市实践为案例,分析欧盟对于药品说明书可读性测试研究的要求,以期为我国建立和实施药品说明书可读性研究的管理思路提供借鉴和参考。     

Potentially inappropriate medications among elderly people with neurocognitive disorders – A nationwide register-based study using 3 different explicit criteria

BackgroundThe use of potentially inappropriate medications (PIMs) is a problem since it might contribute significantly to adverse drug reactions and hospital admissions among elderly with major neurocognitive disorder (NCD). To assess the appropriateness of drug treatment, different explicit criteria have been developed.ObjectivesTo investigate and compare the prevalence of PIM users among elderly with major NCD on a nationwide basis using 3 different explicit criteria. Furthermore, the study aimed to investigate factors associated with the use of PIMs.MethodsThis nationwide register-based study included 35,212 people, 65 years or older, diagnosed with major NCD and registered in the Swedish registry for cognitive/dementia disorders up to June 30, 2017 and alive December 31, 2017. PIMs were identified using 3 different explicit criteria; the Swedish quality indicators, the EU(7)-PIM list and the AGS Beers Criteria. PIM use was defined as having collected a minimum of one PIM at least once between July 01 – December 31, 2017.ResultsThe numbers of people using one or more PIMs were 7629 (21.7%) according to the Swedish quality indicators, 11,838 (33.6%) according to the EU(7)-PIM list, and 12,002 (34.1%) according to AGS Beers Criteria. Antipsychotics, antithrombotic agents and anxiolytics were the most frequently used PIM class according to the different assessment tools, respectively. The use of PIMs was positively associated with vascular dementia and Lewy body dementia/Parkinson's disease dementia, regardless of the assessment tool used. However, the association between using at least one PIM and age, sex, MMT-value and frontotemporal dementia, differed depending on the criteria used.ConclusionsThe different results and included PIMs indicate the different perspectives on PIMs between criteria, which make it difficult to compare the results. However, psychotropic drug use requires further highlighting, as well as the association between PIM use and different types of major NCD.     

Risk analysis of main mycotoxins occurring in food for children: An overview

Mycotoxins are secondary metabolites produced by fungi contaminating the food chain that are toxic to animals and humans. Children up to 12 years old are recognized as a potentially vulnerable subgroup with respect to consumption of these contaminants. Apart from having a higher exposure per kg body weight, they have a different physiology from that of adults. Therefore they may be more sensitive to neurotoxic, endocrine and immunological effects. For these reasons, a specific and up-to-date risk analysis for this category is of great interest.In this review, an accurate analysis of the main mycotoxins occurring in food intended for children (deoxynivalenol, aflatoxins, ochratoxins, patulin and fumonisins) is presented. In particular, known mechanisms of toxicity and levels of exposure and bioaccessibility in children are shown. In addition, recent discoveries about the strategies of mycotoxins managing are discussed.