“新药审批为啥这么慢？”

"New drug approval, why so slowly?"

　　“这我不同意，新药审批快不起来。”

"This I don't agree with,New drug approval quickly."

　　这是今日全国人大浙江代表团会场爆发的一场交锋。擦出火星的是一个问题：“怎样才能让13亿中国人用上国产药？”

This is today's zhejiang delegation of the National People's Congress of party a.Wipe out the Mars is a question:"How to make the 1.3 billion Chinese people using Chinese medicine?"

　　说起这个，一年卖药上亿元的全国人大代表胡季强也忍不住激动了起来。

Speaking of the,Sell medicine to hundreds of millions of dollars a year in the National People's Congress to represent Hu Jijiang also cannot help but excited to get up.

　　“外国药已经占据了中国人用药的半壁江山。”这位浙江康恩贝制药股份有限公司的董事长发现，在大医院，进口药的比例逐年提高，进口药主要销往医疗资源集中的大医院，而他们造出的国产药，在零售药店、小医院等低端市场的销量占了四成。

"Foreign medicine has occupied half of the Chinese application."The zhejiang kahn bei pharmaceutical co., LTD., chairman of discovery,In a big hospital,The proportion of JinKouYao increase year by year,JinKouYao medical resources are mainly sold to big hospital,And they made out of Chinese medicine,In the retail pharmacy/Small hospitals and other low-end market sales accounted for forty percent.

　　“这是一个大事情。如果国产药不能占领我们自己的市场，就永远都给外国药当垫底。”这位研发药物出身的企业家说。

"This is a big thing.If the domestic medicine cannot occupy our own market,, I never give foreign medicine be at the bottom."The drug was born entrepreneur said.

　　“现在，国内企业的6000多种药都压在政府部门，就是排队等着审批。很大程度上，是因为药审中心人员严重不足。”全国人大代表、浙江华海药业股份有限公司董事长陈保华说。

"now,Domestic enterprises more than 6000 kinds of medicines on the government,Is in line waiting for approval.largely,Because of shortage of human medicinal center staff."The National People's Congress/Zhejiang huahai pharmaceutical co., LTD., chairman of Chen Baohua said.

　　全国政协委员、复星集团董事长郭广昌今年就拿出了一个有关仿制药注册审批的提案。

The national political consultative conference (CPPCC)/Fosun chairman guo guangchang this year will come up with a generic drug registration for examination and approval of the proposal.

　　郭广昌告诉记者，如果能够推动到期仿制药的尽快上市，将大大减轻患者的医疗费用，降低医保基金费用支出。但是，现在专利到期新药的仿制太慢了，慢就慢在审评审批程序上。我国2007年出台的《药品注册管理办法》规定，新药临床试验的技术审评需要90个工作日，实际操作时限往往在8个月以上，如果再加上排队受理期，前后可能长达一年以上。

Mr Guo told reporters,If you can push generics due listed as soon as possible,Will greatly reduce the patients' medical costs,Reduced medicare fund expenses.but,Now off patent drugs to generic is too slow,Slow is slow on the examination and approval procedures for the review.Introduced in 2007 in China[Drug registration management measures]provisions,New drug clinical trials of technical review to 90 working days,Actual operation often over eight months,If plus line acceptance period,Before and after could last more than a year.

　　在美国、欧洲、印度等国家和地区，这个时限一般是一到两个月。而对于专利到期化学制剂仿制的注册审批周期，现在还无法根据《药品注册管理办法》的进度实施，注册周期更是漫长。

In the United States/The European/India and other countries and regions,The time is usually one to two months.For patents expire chemicals generic registration approval cycle,Now also can't according to[Drug registration management measures]The progress of the implementation,Registration cycle is long.

　　“在药品审批上，我国曾有一段时间审批过快过滥，造成不少问题。”郭广昌说，但现在有些矫枉过正了。要把居民用药负担降下来，加快仿制药的审批是重要的举措。当然，这并不是说要以牺牲质量为代价。

"On the drug approval,There was a time for examination and approval in China too excessive,Cause many problems."Mr Guo said,But overdoing it now.To cut down the residents medical burden,Speed up for examination and approval of generic drugs is an important measures.Of course,,This does not mean to sacrifice quality for price.

　　在我国的药品市场上，一个“怪现象”存在了多年。

Medicines on the market in our country,a"Strange phenomenon"There for many years.

　　那些已经过了专利保护期的药品，在中国依然享受着单独定价的特权，价格高高在上。在国际上，某家药企研发了一种新药并获得专利后，一般可以享受20年的专利保护。在这20年中，别的药厂不可以进行仿制。但一旦专利保护期过了，别的药厂就可以进行仿制，从而导致该药品的价格迅速跳水。但在我国，这些已经过了专利保护期的药品却依然在享受定价特权。

Those who have passed the patent protection to medicine,In China still enjoy the privilege of separate pricing,High above the price.In the world,A drug firms have developed a new drug and patented,General can enjoy 20 years of patent protection.In the twenty years,Other companies can not to copy.But once the patent protection,Other companies can be generic,Which may lead to a plunge in the price of the medicine quickly.But in our country,The patent protection of the drugs have passed but still enjoying the privilege price.

　　“戴市场的帽子，拿政府的鞭子，坐行业的轿子，收企业的票子，供官员兼职的位子。” 这是全国政协委员朱征夫对行政审批异化的评论。今天的会场里，浙江省人民检察院检察长陈云龙代表大声把它念了一遍。

"Hats in the market,With the government's whip,Sat sedan chair industry,Collect business ticket,Part-time job for officials." This is the CPPCC national committee Zhu Zhengfu of alienation of administrative examination and approval.In today's meeting,Zhejiang province people's procuratorate chief procurator Chen Yunlong represent loudly read it again.

　　听着这么多意见，作为国家中医药管理局的药品评审专家，全国人大代表女以建敏坐不住了。“药厂是一定要推销更多药的，而医学专家希望控制质量，减少乱象。现在中国市场药物生产和药品是过剩的，药企也良莠不齐。”

Listen to so many opinions,As the state administration of traditional Chinese medicine drug evaluation experts,The National People's Congress representative female to build min sit not to live."Pharmaceutical industry is a must to sell more drugs,The medical professionals hope to control the quality,Reduce the mess.Now the Chinese market is excess drug production and drug,Drug companies are good and bad are intermingled."

　　“大大小小的药企，同样性质的药有很多重复。如果真的是自己研发的新药，解决了国际医学都没能解决的问题，我们是批得很快的。”

"Large and small companies,There are a lot of repeat nature of the same medicine.If it is his own research and development of new drugs,Solved the international medical has failed to solve the problem,We are group of very fast."

　　女以建敏的矛头，指向中国药创新不足。

Women to build sensitive target,Pointing in the direction of China's drug innovation is insufficient.

　　这又把另一个代表丁列明“激”了起来。他是浙江贝达药业有限公司盐酸埃克替尼研发团队首席研究员、国家“千人计划”特聘专家。

This and another representative list"excitation"To get up.He is zhejiang beida pharmaceutical co., LTD. Hydrochloric acid for ek's r&d team lead researcher/countries"One thousand plan"Distinguished experts.

　　“中国并非没有创新药。我是2002年创业的，已经有一种抗癌新药通过了审批。大家都感觉创新药很难，投入大、周期长、审批难。我同意其他企业的发言，国家政策非常重要。”

"China is not without innovation.I am a business in 2002,Have a cancer drug has passed the examination and approval.Everyone feel the innovation medicine is difficult,In large/Cycle is long/Approval is difficult to.I agree with other businesses,National policy is very important."

　　女以建敏又摇了摇手。“这个在美国是绝对不能批的，研究同样的产品，美国就要20多年。美国没批肿瘤新药，但是中国批了。”

Women to build quick shook to shake a hand again."This is absolutely not in the United States,The same product,The United States is more than 20 years.The United States didn't batch of cancer drugs,But the China group."

　　全国人大财政经济委员会副主任委员、全国人大代表吕祖善一直听得很认真。这时候，这位浙江前省长忍不住好奇：“能控制肺癌，为啥不批？”

Finance and economic committee of the National People's Congress, deputy director of the committee/The National People's Congress lv zhushan always listened carefully.At this time,The former zhejiang provincial governors couldn't help but wonder:"To control lung cancer,Why not group?"

　　女以建敏答得飞快。“中国抗癌药确实能延长生存期，但是不能治愈。美国的医学观念是这种药不进入国家医药系统。而且医生对新药也不一定信任。”

Women to build quick answer very fast."Chinese anticancer drugs really can prolong the survival period,But cannot be cured.Medical concept of the United States is this kind of medicine does not enter the country's medical system.Of new medicines and doctors may not trust."

　　中国老百姓怕“中国药”里有假，胡季强也很清楚。

Chinese people afraid of"The Chinese medicine"In the false,Hu Jijiang very clearly as well.

　　他的母亲曾经就是受害者。有一次，她看了虚假广告买了一种“保健品”假药，吃了以后出现低血糖休克，“差点救不回来了”。

His mother was a victim.once,She bought a false advertisement"Health care products"Counterfeit drugs,When I had eaten it appear hypoglycemia shock,"Almost can't save back".

　　“这个非常可恶，就像温总理讲的，企业家身上要流淌着道德的血液，不能坑蒙拐骗、欺骗消费者。因为药品是人命关天的，你卖假药就是谋财害命。”

"This is very hateful,As premier wen to say,Entrepreneurs should flow the blood of morality,Can't're incapable/Cheat consumers.Because drugs are human life,Do you sell fake drugs is thuggery."

　　“我们提议修改药品管理法，建议国家要加大对造假的惩治力度，让造假者倾家荡产，严重的需要杀一儆百。”胡季强说。

"We propose to modify pharmaceutical administration law,Suggested that countries should intensify punishment to fraud,Let the counterfeiters,Serious need to scare others."Hu Jijiang said.

　　随着“战火”扩大，“看病贵”问题摆上桌面。中间休息时，女以建敏一出门，陈保华、胡季强马上跟了出来。事关中国人健康的大问题，讨论还在持续。

as"The fighting"expand,"See a doctor expensive"Issues on the table.When the interval,Women go out to build an,Chen Baohua/Hu Jijiang with out immediately.About the Chinese big problems of health,Discussion continues.