《药学英语》PPT教学课件-unit 1

This meant opening an office in Beijing or Shanghai to sell their internationally approved products to the growing Chinese market.
中国制药行业的外资情况
尽管存在着文化、种族和法规的差异， 越来越多的外国公司开始在中国进行多个 实验中心的三期临床实验。
The basic means of China's absorption of foreign investments
1. Sino-foreign joint ventures 2. Cooperative businesses 3. Exclusively foreign-owned enterprises 4. Joint exploitation 5. Foreign-funded share-holding companies 6. New types of foreign investment
中国制药行业的外资情况
追溯到1980年，日本大冢制药有限公司在 中国创立了第一个中外合资制药企业：中国大 冢制药有限公司。紧接着，1982年，瑞典法玛 西亚制药公司在中国建立了第一个欧洲合资企 业：无锡中国瑞典制药公司。到1995年，根据 PJB出版的1997年中国制药市场指南统计：在 中国已经有1500家中外合资制药企业注册。
Eighteen of the top 20 global pharmaceutical giants have entered into these arrangements. Germany's Bayer has nine joint ventures in China, with a total investment of US $160 million investment. Switzerland Roche has seven, and a US $130 million investment.
中国制药行业的外资情况
现在的情况不是这样的了。“如果你对中国市场还 心存疑虑的话，你可以以一个完整的制药公司来中 国。”Ross Horsburgh这样说，他是捷利康中国医药 集团发展顾问公司北京区制药总监。该公司是英国捷 利康和中国医药集团总公司共同设立的合资企业。他 还说到：“你到中国来已经不能仅仅作为一个销售组 织或者分散产品的渠道了。”
• Clinical trial phase Ⅲ: patient groups: comparison with standard therapy FDA approval
• Clinical trial phase Ⅳ: general use: longterm benefit- risk evaluation
Name card:
Chairman: executive chairman Stockholder; CEO: chief executive office Inspector; Director Manager: general manager
vice manager
中国制药行业的外资情况
“当加拿大国有契约研究组织（CRO）MDS Harris于 1993年首次在中国设立办事处以来，美国和欧洲的制药 公司开始对此投入的关注远远超出了仅仅是在中国做一 些简单的四期临床实验以符合中国市场的最低要求”。 作为 CRO的主席和首席执行官（CEO）的James McClurg 博士说。“在过去的两年，这样的关注迅速扩大。今天， 在中国进行的临床实验水平，坦率地讲，已经超过了西 方标准。这将是世界各大制药企业广泛关注的事实。”
世界著名药厂标志
世界著名药厂标志
English Package Insert
Introduction
Chapter 1 The Structure of English Package Insert
❖ The purpose of studying this chapter
grasp the Structure of English Package Insert grasp the special language characteristics enlarge the special vocabulary students can read and translate the English
经历了短暂的犹豫之后，就在这些年， 西方制药公司纷纷涌入中国建立了其“基 地（办事处）”。这就意味着在他们在北 京、上海开辟一个办事处向不断增长的中 国市场销售他们国际认证的产品。
No longer. "If you are serious about the Chinese market, you have to come here as a full pharmaceutical company," says Dr. Ross Horsburgh, regional medical director for Beijing-based Zeneca SinoPharm Development Consulting Company, a joint venture between Britain' s Zeneca Pharmaceuticals and China' s Sino-Pharm. "You can' t come here just as a sales outfit or just as a distribution channel."
When MDS Harris, the Canadian-owned contract research organization, opened an office in China in 1993, the interest by US and European pharmaceutical companies in doing something more than a small Phase IV trial to meet China' s minimal licensing criteria was modest at best, says Dr James McClurg, the CRO's President and Chief Executive Officer.
❖ 中文：
四、The contents of Package Insert:
中国制药行业的外资情况
全球20家制药巨头中的18家已经都进入了 中国市场，德国的拜尔制药公司已经在中国 建立了9家合资企业，总投资大约在 160,000,000美金。瑞士的罗氏制药有限公司 在中国建立了7家合资企业，总投资大约是 130,000,000美金。
世界著名药厂
1. 辉瑞 （PFIIER） 2. 强生（johnson &johnson）
Clinical trials
• Clinical trial Phase Ⅰ: healthy subjects: effects on body functions, dose definition, pharmacokinetics
• Clinical trial phase Ⅱ: selected patients: effects on disease; safety, efficacy, dose, pharmacokinetics
In the past two years, the interest has "increased exponentially", he says. "Today, the interest in China, and in conducting clinical trials in China to the Western standard, is quite frankly overwhelming. It's a very broad interest by major drug companies everywhere in the world," he says.
❖ 2. Direction n. tell 方向 ② 说明 tell sb. to do sth.
❖ 3. Description 描写 种类，形状
❖ 4. Leaflet leaf + let (platelet血小板) ① 小叶，嫩芽 ② 散页，传单
❖ 5. Data sheet ❖ 6. Package Insert
Back in 1980, Tokyo's Otsuka Pharmaceutical created the first Sinoforeign pharmaceutical joint venture: China Otsuka Pharmaceutical. It was followed in 1982 by Sweden's Pharmacia, which set up the first European joint venture: Wuxi SinoSwed Pharmaceutical.
❖ Question：
（1）现阶段，广泛用来表示“药品说明书”
的是：
。
（2）曾经用来表示“药品说明书”的
是：
。
三、Definition of Package Insert：
❖ 英文：Package Insert which in each of the drug package can instruct doctor and patient how to use this kind of drug.
西安杨森 上海强生制药有限公司 3. 葛兰素史克制药(GLAXO-SHICO 4. 默克制药（MERCK) 5.诺华NOVARTIS：北京诺华制药有限公司 6. 雅培: 上海雅培制药有限公司 7. 阿斯利康制药有限公司 8. 礼莱LILLY 9. 施贵宝（SQUIBB） 10. 拜尔（BAYER）