1、Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been gi
2、ven support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, w
3、ater, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution,
4、 “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than
5、2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing t
6、imber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “
7、bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral
8、resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary Riv
9、er Bridge, running at full capacity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of
10、three railway marshalling yards in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivost
11、ok and the nahuo card on the sea, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Orienta
12、l Maginot line“ of the Japanese invading army Tiger underground fortress ruins, General Chi第一部分 药品管理（占 15%）第一章 药事与药事管理药事与药事管理的概念、宏观药事管理与微观药事管理。第二章 药品药品、药品质量、药品标准的概念所谓药事即是与药有关的事情。具体地讲，药事是与药品的安全、有效和经济、合理、方便、及时使用相关的研究与开发、制造、采购、储藏、营销、运输、交易中介、服务、使用等活动，包括与药品价格、药品储备、医疗保险有关的活动。药事管理的目的是保证公民用药安全、有效、经济、合理、方便、及
13、时。药事管理的意义：对公众是一种保障；对国家是一种责任；对药事组织是一种监督。宏观药事管理： 药品监督管理、基本药物管理、药品储备管理、药品价格管理、医疗保险用药与定点药店管理。微观药事管理：药品研究与开发质量管理、药品生产质量管理、药品经营质量管理、药学服务质量管理、药品储备管理、药品价格管理、医疗保险用药销售管理。药品是指用于预防、治疗、诊断人的疾病，有目的地调节人的生理机能并规定有适应症或者功能主治、用法和用量的物质。药品质量是指药品符合规定标准的程度。包括物理指标、化学指标、生物药剂学指标、安全性指标（毒性、不良反应、毒理学、配伍禁忌和相互作用等） 、有效性指标（药效学指标） 、稳定性
14、指标、均一性指标。药品标准是国家对药品质量规格及检验方法所作出的技术规定。第三章 药品监督管理1、掌握药品监督管理的四原则目的性原则、方针性原则限制性原则、方法性原则2、药品监督管理的主要内容药品管理（注册管理；生产、流通和使用管理；广告管理；监督查处）药事组织管理（许可证管理；条件与行为规范管理；监督查处）执业药师管理（注册资格认证；注册管理；继续教育管理；监督查处）3、熟悉药品监督管理法规体系宪法法律行政法规地方性法规自治条例和单行条例部门规章地方性规章国际条约3、熟悉药品监督管理法规体系宪法法律行政法规地方性法规Leaders: provincial agricultural work
15、Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the prov
16、ince of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territor
17、y is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded
18、by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the i
19、nternationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million c
20、ubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast
21、black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopo
22、litical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary River Bridge, running at full capacity th
23、e annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards in the
24、 far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivostok and the nahuo card on the sea, to r
25、each South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese invadi
26、ng army Tiger underground fortress ruins, General Chi2自治条例和单行条例部门规章地方性规章国际条约二、药品注册管理机构包括食品药品监督管理局药品注册司、国家药品审评中心、国家药典委员会、中国药品生物制品检定所。药品注册管理的主要内容1、药品名称（通用名与商品名、化学药品名称与中药名称、药品命名原则。 ）2、药品包装、标签、说明书内容3、药品包装4、药品（对药品的安全性、有效性、稳定性进行评价和审查。 ） 分为临床前研究和临床研究。期临床试验初步的临床药理学及人体安全性评价试验。观察人体对于新药的耐受程度和药物代谢动力学，为制定给药方案提供依
27、据。 期临床试验随机盲法对照临床试验。对新药有效性及安全性作出初步评价，推荐临床给药剂量。期临床试验扩大的多中心临床试验。应遵循随机对照原则，进一步评价有效性，安全性。期临床试验新药上市后监测。在广泛使用条件下的社会性考察疗效和不良反应（注意罕见不良反应） 。药品注册申请与审批程序（新药临床研究）进口药品注册申请 申请药品的条件必须获得生产国注册批准和上市许可，企业必须符合该国和我国的 GMP. 申请者条件国外厂商驻中国的办事机构或在中国的注册代理，并已在中国工商行政部门登记的合法机构。 审批原则必须按规定进行质量复核；在中国境内进行临床研究（包括生物等效性试验） ；根据复核和临床研究，以及资
28、料审查，符合要求的发给进口药品注册证 。特殊管理药品的管理一、特殊管理药品的概念特殊管理药品是指麻醉药品、精神药品、医疗用毒性药品、放射性药品。特殊管理药品属于处方药，而且是处方药中管制最严格的一类。二、特殊管理药品管理的必要性特殊管理药品具有特殊的药理、生理作用，管理、使用不当将严重危害病患者及公众的生命健康乃至社会的利益。处方药管理一、处方药的分类1、患者不可自行用药，必须由医师使用或在医院由医师监控使用且社会药店不可零售的处方药。2、患者不可自行用药，必须由医师、医疗技术人员使用，社会药店可零售的处方药。如注射给药的处方药。Leaders: provincial agricultural
29、 work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing XX municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to th
30、e province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX municipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the te
31、rritory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major industrial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was her
32、alded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of more than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in
33、 the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 mil
34、lion cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom and reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Nort
35、heast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third,
36、 geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km long border, with national road passenger and freight transport port, built on the border between China and Russia has the largest permanent boundary River Bridge, running at full capac
37、ity the annual cargo capacity of up to 2.6 million tons. Russia two (HABA and Marina), two cities (Iman and Lesozavodsk) is the Russian Far East in developed areas. Lesozavodsk is only 8 km from XX port corresponding to the port of markovo, Lu Rinuo station is one of three railway marshalling yards
38、in the far East, the far East-Siberian railway and a parallel road runs through the pass. By rail and road, to the North by HABA capital Khabarovsk, the Russian hinterland, radiation in the CIS and Eastern European countries; to the South through the port of Vladivostok and the nahuo card on the sea
39、, to reach South Korea, Japan and other Pacific Rim countries and regions. Four is rich in tourism resources. XX tourist resources types, many attractions, beautiful scenery of the Sino-Russian border-river-wusuli River, a famous treasure island, known as the “Oriental Maginot line“ of the Japanese
40、invading army Tiger underground fortress ruins, General Chi33、患者可按处方药和医嘱自行用药，社会药店可零售的处方药。如口服抗生素等。二、处方药的管理模式处方药的生产与批发必须由具有药品生产许可证或药品经营许可证的药品生产、经营企业依法进行。进入药品流通领域必须注明“ 凭医师处方销售、购买和使用！” 的警示语。禁止直接向患者推荐、销售处方药。注射给药的处方药应在医疗机构由医务人员使用。非处方药管理一、非处方药的概念又称为柜台发售药品（Over the counter drugs） ，习惯称为 OTC。二、非处方药的分类1、甲类非处方药
41、 只能在具有药品经营许可证 、配备执业药师或药师以上药学技术人员的社会药店、医疗机构药房零售的非处方药。2、乙类非处方药 除社会药店和医疗机构药房外，还可以在经过批准的普通零售商业企业零售的非处方药。指导思想安全有效、慎重从严、结合国情、中西并重。 （方便公众为目的，用药安全为依据）分类标准国际规定的管制药品及毒性中药均列入处方药的范围；给药途径一般为口服、腔道和皮肤外用；可自我诊断、自我治疗的轻微病症的用药； 无潜在滥用、误用可能的药品可列入非处方药范围。遴选原则：应用安全，疗效确切，质量稳定，应用方便。三、非处方药管理的一般原则1、非处方药登记管理已经获得药品批准文号的药品作为非处方药生产
42、销售使用前，必须经过药品监督管理部门的再一次安全性审查，经非处方药登记后，才成为合法的非处方药。2、对非处方药的包装、标签和说明书的管理必须印有国家指定的非处方药专有标识。标签和说明书的用语要科学、易懂、详细，用词准确，每个基本包装单元要附有标签和说明书。包装必须符合质量要求，方便储存、运输和使用。3、对非处方药广告宣传的管理非处方药经批准可在大众媒介上进行广告宣传。4、非处方药的流通、使用管理乙类非处方药可以在经批准的普通商业企业销售，也可以进入医疗机构。甲类非处方药的管理模式甲类非处方药的警示语是请仔细阅读药品使用说明书并按说明使用或在药师指导下购买和使用！必须具有药品经营许可证并配备驻店
43、执业药师或药师以上药学技术人员的零售药店，方可零售药品。医疗机构销售甲类非处方药，可以不凭医师处方。甲类非处方药与处方药应当分柜摆放。类普通商业连锁超市必须由连锁总部统一从合法的供应渠道和供应商采购、配送，分店不Leaders: provincial agricultural work Conference held in XX, which is our concern and love, will greatly promote XX agricultural and rural economic development. First of all, I am representing X
44、X municipal party Committee and Government, extend a warm welcome to the attending leaders! XX has been given support and assistance to the province of agriculture, provincial agricultural Office, and expressed heartfelt thanks to all the friends! below, I XX with a brief report. A basic XX of XX mu
45、nicipality located (cities, omitted). One is the superior ecological environment. XX blue, clear, green, water, air, 70% of land in the territory is covered with forests, grasslands, wetlands and waters, built 7 thousands of square kilometers of the total area of nature reserves. Within major indust
46、rial pollution sources, air quality at the national level, national levels, water quality, soil pollution, “pure land“ reputation, was heralded by the United Nations environmental officials “the most suitable place for human survival.“ Second, the enrichment of natural resources. A total area of mor
47、e than 5 million mu of arable land (which owned 1.53 million acres), the annual grain output of more than 2 million tons and is located in the internationally recognized gold “cattle“, there should be more than 400,000 acres of grazing grassland, developing animal husbandry conditions; a total area
48、of 4.1 million acres of forest land, rich in precious wood such as pine, ash, yellow pineapple, standing timber volume of more than 26 million cubic meters. Forest Xia has hundreds of species precious wildlife, more than 200 more species precious herbs, annual Super thousand tons of wild mushroom an
49、d reserves Super 100,000 tons of mountain dish; nectar plant throughout, can bee 100,000 group, is China “bee of Xiang“, and national Northeast black bee reserves and important of bee products production base; can using water 2.5 billion cubic metres, should be fishing water 460,000 acres, rich big salmon, and “three spent five Luo“, North cold water specialty fish; found and proved reserves of mineral resources has 36 species. Third, geopolitical advantages. XX open midpoint is located in the eastern part of the province along the border, 264 km
