| 1. | International names for pharmaceutical substances inn
国际非专利药名 |
| 2. | At that time , there were no mechanisms to allow quick registration of generics
在那时，没有允许快速注册非专利药的机制。 |
| 3. | Thus , any company that wanted to launch a generic copy had to produce a complete package of data almost identical to that provided by the originator company
因此任何想上市非专利药的公司，都需要提供一套完整的数据，与原研厂商所提供的几乎相同的。 |
| 4. | Nothing particularly special about that , except for the fact that the us legislation allows the generic company 6 - months ' exclusivity before any competitors can launch
这看上去没有任何特别之处，只是美国法律授予该非专利药公司6个月的市场独占期，期间任何竞争者不得上市该非专利药。 |
| 5. | The world health organization ' s international nonproprietary names expert group works to develop international nonproprietary names for pharmaceutical medicinal substances for acceptance worldwide
翻译：世界卫生组织的国际非专利药名专家组制定了为全世界接受的药品成分的国际非专利药名。 |
| 6. | These deals are certainly within the letter of the law but run counter to its spirit and intention of promoting competition between generic companies and aggressive challenges to branded company patents
这些交易当然是在法律许可得范围之内的，但却与其支持非专利药公司之间的竞争、支持向原研公司的专利发起挑战的精神和主旨背道而驰了。 |
| 7. | In simple terms , the way that it works is that a branded company that is selling its product in the us grants a generic company the right to market a generic version of its product before any competitors launch a generic
简单说来它（授权的非专利药）就是，在任何竞争者上市非专利药之前，在美国销售品牌药的公司授权一个非专利药公司销售其产品的非专利药。 |
| 8. | They matter a great deal to generic companies active in the us generic markets because they represent another tool used by branded companies to prolong their period of market control as patent expiry approaches
授权的非专利药对于活跃在美国非专利药市场上的非专利药生产商非常重要，是因为它代表着品牌药公司在专利行将过期之时，所使用的另一种延长其市场控制期的方式。 |
| 9. | At present , very few clinical trials are conducted in children , partly because obtaining “ informed consent ” is hardly possible . ( the who hopes that countries can at least compare notes on how to get round that problem . ) this in turn deters pharmaceutical firms from researching and developing child - friendly medicines , and generic drug producers from producing low - cost versions
现在很少有临床试验是针对儿童的，部分原因是因为“告知同意”原则很难遵守（ who希望各国能够想办法绕过这个问题） ，这也给制药企业研发儿童用药，非专利药制造商生产廉价的仿制药制造了障碍。 |
