2015 年江苏省药品注册分析报告

江苏省药物研发势头强劲，药品注册申报量连年位居全国首位。重点分析2015 年及“十二五”期间江苏省药品注册情况，并提 出进一步完善我省药品注册管理工作的措施。     

提高注册人员素质维护制药企业利益

概述药品注册申报人员的职业要求及其在制药企业中的作用,分析目前药品注册工作存在的问题,并强调加强药品注册申报人员能力建设,使其在制药企业发挥出重要的作用。     

注册分类改革视角下药品数据保护制度效应分析

在国际趋势的压力下,兼受跨太平洋伙伴关系协定（TPP）影响,我国实施药品数据保护制度已成大势所趋。鉴于药品数据保护与药品注册审批体系紧密相关,我国化学药注册分类改革后,药品数据保护对医药产业发展必然会带来不同影响。结合我国分类注册改革新标准,在理论上对数据保护制度实施效果进行研究,进而探讨新注册分类下数据保护的实施对1至4类药品及医药产业的影响。     

2014年江苏省药品注册年度报告

通过相关数据资料的统计与分析,对2014年江苏省药品注册管理情况进行总结,以提升全省药品注册管理能力,为企业研发、管理人员提供相关参考。     

新时期提高药品生产质量管理水平的有效策略研究

药品是人们对抗疾病的重要武器,药品质量的好坏关系到医疗水平的高低,关系到人们的生命安全,因此做好药品生产质量管理工作是药品企业发展的重中之重。就现阶段来说,药品生产质量管理工作中尚存在着医药行业制度不规范、医药生产人员素质偏低、药品材料选择不规范、药品生产管理水平低等问题,这会严重影响药品质量。因此给予有针对性药品生产质量管理有效策略,能有效提高药品生产管理水平,保证药品质量。     

“创新药物研发高层论坛”专家观点

对2015年1月30日召开的“创新药物研发高层论坛”的专家报告内容进行归纳总结,旨在为从事药品注册、创新药及仿制药研发、 药物临床试验质量管理规范（GCP）及药品非临床研究质量管理规范（GLP）工作的人士提供信息参考。     

药品研发质量管理问题研究

伴随我国经济的快速发展,医疗卫生事业在我国也得到了长足的进步,其中,药品的研发与生产质量得到了广泛的重视。药品研发工作对于药品的后续生产及使用有重要影响,因此,做好药品研发的质量管理工作就具有重要的现实意义。本文将对药品质量管理加以简述,并在此基础上探讨药品研发质量管理的相关问题。     

多尼培南研究综述

本文对多尼培南的临床应用包括已上市药品的适应症、市场销售、注册报批方面进行了综述,指出了开发多尼培南前景广阔,利润巨大。     

原料药FDA注册中残留溶剂研究的基本原则

美国药监局实行FDA认证,并要求药品进入美国市场前,必须进行文件注册。在DMF文件"3.2.S.3.2原料药物特性确认"中,对残留溶媒的研究是一个重要内容。山东鲁抗医药拳头产品大观霉素、泰乐菌素系列产品都通过了FDA认证。笔者结合FDA认证注册较丰富的经验和ICH Q3C(R5)对残留溶剂的指导原则,总结了原料药FDA注册中残留溶剂研究的基本原则。     

保健食品注册与备案管理办法亮点解读

《食品安全法》于2015年新修订,将保健食品归为特殊食品类管理并首次引入备案制,为了进一步细化保健食品规范管理工作,维护保健食品行业的良好发展,2016年2月原国家食品药品监督管理总局颁发了《保健食品注册与备案管理办法》并于2016年7月1日起施行。本办法强化保健食品生产经营者义务和法律责任,规范保健食品注册备案工作,为完善保健食品行业的有序运行提供了制度上的保障。本文对保健食品注册与备案办法的亮点进行解读。     

美国孤儿药开发的政策、策略与实践

简述了罕见病及孤儿药的定义和研发意义,重点介绍了美国针对孤儿药开发的现有制度法规、激励政策及管理经验,并以实例 分析从研发、注册和上市等角度探讨了美国孤儿药开发的策略,旨在为从事孤儿药开发工作的人士提供参考。     

The 1986 United Nations convention on the conditions for registration of vessels and the question of open registry

Abstract

On February 7, 1986, the United Nations Convention on Conditions for Registration of Ships was finalized. This represents the culmination of efforts to define the necessary elements for the registration of vessels in a national registry. Its provisions include references to the genuine link, ownership, management, registration, accountability and the role of the flag state. This article examines each issue separately and focuses on the most important elements of ship's registration: the concept of genuine link and beneficial ownership.

The main reason behind the drive for the establishment of strict regulations on registration was the proliferation of open registries, their equation with substandard and hazardous conditions and efforts from developing countries to participate equally in the management of maritime transport. The conclusion is that the convention failed to clarify the most critical issues and reinforced the status quo of open registries.     

北京市公立医院试点医事服务费调查

北京市在公立医院试点医药分开,取消药品加成、挂号费和诊疗费,收取医事服务费。对试点医院门诊调查发现,医院改变传统管理和经营模式,从关注创收转变为控制成本,从多开药转变为合理用药,门诊患者数量明显增多,多数患者对现行的医事服务费政策支持并感到满意。部分医院管理者认为采用医事服务费并取消药品加成没有真正切断医生和药品之间的利益关系,对医院和医护人员长期影响有待进一步观察。     

Advancing Drug Innovation for Neglected Diseases—Criteria for Lead Progression

The current drug R&D pipeline for most neglected diseases remains weak, and unlikely to support registration of novel drug classes that meet desired target product profiles in the short term. This calls for sustained investment as well as greater emphasis in the risky upstream drug discovery. Access to technologies, resources, and strong management as well as clear compound progression criteria are factors in the successful implementation of any collaborative drug discovery effort. We discuss how some of these factors have impacted drug discovery for tropical diseases within the past four decades, and highlight new opportunities and challenges through the virtual North–South drug discovery network as well as the rationale for greater participation of institutions in developing countries in product innovation. A set of criteria designed to facilitate compound progression from screening hits to drug candidate selection is presented to guide ongoing efforts.     

Identification of patient's requirements in quality management system in health care institutions

AimTo present the solutions implemented in health care institution in the context of identification of patient's requirements, and evaluation of the level of patients’ satisfaction in accordance with the requirements of ISO norm 9001:2008 based on the experience of GPCC.BackgroundThe fundamental mechanisms behind the free market, such as competition, start applying also to the public health sector. Health service providers are gradually realising that patients are actual clients of health care institutions, with physicians, nurses, supporting personnel, registration officers and other staff responding to patients demand for medical and auxiliary services (e.g. exam registration, provision of information).Material and methodsPN-EN ISO 9001:2009 “Quality Management Systems. Requirements”, relevant literature and documentation of quality management system from the GPCC.The review of relevant literature and legal requirements; interpretation of provisions in relation to the functioning of health care institutions.ResultsModel of identification of patient's requirements and satisfaction in accordance with the requirements of ISO 9001:2008 has been elaborated and implemented in the GPCC.ConclusionThe identification of patient's requirements is much more complicated than evaluating the same parameters in manufacturing companies. In the context of medical services one should be aware of the subjectivity of patient's feelings, the psycho-social status and the general state of health during his or her treatment. Therefore, the identification of patient's requirements and satisfaction must be carefully thought out, implemented and regularly improved.     

Brands, costs and registration status of antimalarial drugs in the Kenyan retail sector

Background

Although an important source of treatment for fevers, little is known about the structure of the retail sector in Africa with regard to antimalarial drugs. This study aimed to assess the range, costs, sources and registration of antimalarial drugs in the Kenyan retail sector.

Methods

In 2002, antimalarial drug registration and trade prices were established by triangulating national registration lists, government gazettes and trade price indices. Data on registration status and trade prices were compared with similar data generated through a retail audit undertaken among 880 randomly sampled retailers in four districts of Kenya.

Results

Two hundred and eighteen antimalarial drugs were in circulation in Kenya in 2002. These included 65 "sulfur"-pyrimethamine (sulfadoxine-pyrimethamine and sulfalene-pyrimethamine (SP), the first-line recommended drug in 2002) and 33 amodiaquine (AQ, the second-line recommended drug) preparations. Only half of SP and AQ products were registered with the Pharmacy and Poisons Board. Of SP and AQ brands at district level, 40% and 44% were officially within legal registration requirements. 29% of retailers at district level stocked SP and 95% stocked AQ. The retail price of adult doses of SP and AQ were on average 0.38 and 0.76 US dollars, 100% and 347% higher than trade prices from manufacturers and importers. Artemether-lumefantrine, the newly announced first-line recommended antimalarial drug in 2004, was found in less than 1% of all retail outlets at a median cost of 7.6 US dollars.

Conclusion

There is a need to ensure that all antimalarial drugs are registered with the Pharmacy and Poisons Board to facilitate a more stringent post-marketing surveillance system to ensure drugs are safe and of good quality post-registration.     

2015 年江苏省医药产业发展报告

江苏省作为传统医药大省,是全国医药产业发展的重要组成部分。通过资料查询,从产业规模与体系、研发创新、产业潜能、人 才队伍、科研机构和专利发明等多方位,分析江苏省医药产业发展现状,并与其他医药产业重点省份进行比较,揭示目前全省医药产业 发展中的主要问题所在,为全省医药产业健康发展建言献策。     

某省级医院执行《江苏省医保药品目录》

目的 分析某省级三甲医院对《江苏省基本医疗保险药品目录》的执行效果。方法 选取江苏省某省级三级医院为研究对象,比较分析城镇职工医保患者和自费患者的药品使用情况。结果 新版《医保药品目录》能基本满足该院临床治疗需求;对门诊医保患者费用控制具有显著作用,但对住院医保患者的药品费用控制效果不明显,对不同疾病药品费用控制效果不一。结论 建立和完善严格的用药考核制度,需加强中高档药物使用的监管,并增加相应的适应症限制,应考虑将临床治疗可供选择、药价适应的药品纳入目录。