仿制药品

除了TRIPs协议对专利仿制药品的平行进口有特殊规定外，在国际层面上基本没有调整平行进口的法律规定。

Except there is the special regulations about parallel importation of generic drug in TRIPs Agreement , most international conventions have no related previsions about parallel importation .

生物等效性研究对于保证受试药品（仿制药品）与参比药品（原创新药品）生物等效，具有相同的有效性和安全性，保证受试药品的质量是极其重要的。

Bioequivalence investigation is very important to ensure the bioequivalence between generic drug and innovator drug and make sure they have the same therapeutic efficacy and safty .

为了应对仿制药品生产商的竞争，美国和欧盟的药品工业在TRIPS协议谈判中发挥了重要的作用。

Reacting to competition from generic producers , the U.S. and E.U. pharmaceutical industries played a lead role in TRIPS Agreement negotiations .

国内企业精于廉价生产仿制药品。在1995年加入世贸组织（WTO）后，印度不得不修改其专利政策。

Domestic firms became masters at copying medicine and making it cheaply . After joining the World Trade Organisation ( WTO ) in 1995 , India had to change its patent policy .

但无论是仿制药生产厂商还是FDA都不会与被仿药物有所差异的仿制药品进行上市后研究。

But neither generic-drug manufacturers nor the FDA does post-marketing studies that might indicate patients are responding differently to a generic than to its brand-name counterpart .

国内企业精于廉价生产仿制药品。

Domestic firms became masters at copying medicine and making it cheaply .

指导原则解读系列专题（七）仿制药品质量研究及稳定性研究的技术要求

The technical requirements of quality and stability research

世卫组织推动使用仿制药品，反对为符合世卫组织标准的仿制产品的生产和国际贸易设置障碍。

WHO promotes generic medicines and opposes barriers to the production and international trade of generic products that meet WHO standards .

创记录数量的药品专利在未来几年将到期，这应该会提高仿制药品的竞争力并降低药品价格。

RECORD number of drug patents will expire over the next few years , which should heighten competition from generic drugs and force down prices .

世卫组织实行了许多规划，包括通过协助你们生产高质量、低成本的仿制药品的规划，坚定和持续地支持你们开展工作。

And this is a strong commitment of continuing support from many programmes at WHO , including those that facilitate your work in producing high-quality , low-cost generic medicines .

包括中国在内的许多国家，原创药品作为临床用药的先导，仿制药品均是人们医疗卫生用药的主体，同一品种往往有多家企业生产。

In Many countries like china , origin medicine is a leader of clinical medication , while imitation products is main body in medical treatment and public health , the same type of which is manufactured by many enterprises .

这座大楼的一侧驻扎着美国雅培公司，目前正忙于仿制药品的开发。该公司于2010年以37亿美元收购了印度制药公司皮拉马尔（Piramal）旗下的品牌仿制药业务，因而拥有了生产仿制药的特权。

In one part of the building , Abbott , an American firm , is developing generic drugs - a privilege it won when it bought the copycat business of Piramal , an Indian firm , for $ 3.7 billion in 2010 .

我国目前生物药品品种较少，大部分都不具有自主知识产权，长期以来以仿制外国药品为主。

China current biological drugs are less species , most of them do not have independent intellectual property rights , has long been dominated by generic drugs overseas .

长期以来以大量生产原料药和仿制外国化学药品为主的中国制药业，将加快对拥有自主知识产权的新药和新技术的开发。

China 's pharmaceutical enterprises , which mainly produce large amount of medicines used as raw materials and imitate foreign chemical medicines over a long period of time , will accelerate the development of new medicines and technologies with their own intellectual property rights .

目前，仿制已有国家标准药品的研制开发工作，在质量研究方面存在的差异较大。

Today , a large difference exists in quality study during the development of the chemicals of the obtained official standard .

如果允许他人自由仿制会大大损害药品发明创造人将有可能获得的利益以及再研发的积极性，所以对药品进行专利保护能够激发药品研发积极性，有助于有效药品快速问世。

Tolerance of free imitation will greatly damage the enthusiasm of drug R & D. so the pharmaceutical patent protection can promote drug development and contribute to the rapid advent of effective drugs .