大型制药企业，庆幸：中国的目标是，加快批准新吃药

StephenW

3. Big Pharma, rejoice: China aims to speed up approvals for new meds
      By Emily Wasserman     

Relations between China and foreign drugmakers have been thawing for a while, with the country announcing late last year that it would toss out restrictive price caps and streamline drug approvals for U.S. companies. Now, China is throwing multinational drugmakers another bone with plans to reduce lengthy approval times for innovative drugs.

Companies can now apply to speed up approvals for much-needed new meds--including those for AIDS, cancer and rare illnesses--as long as their prices aren't higher in China than in the originating country or comparable markets, according to guidelines set out by China's State Council seen by Bloomberg. The country is also loosening its belt on clinical trial regulations for new drugs. Under the new policy, foreign companies can run clinical trials in China at the same time as overseas trials, and use data from international clinical trials to apply to bring their meds into the country.

That's a big win for multinational companies, which once had to jump through more hoops to bring their meds to market. In the past, foreign companies could only apply to import a drug to China after it had been approved and marketed in another country, the Bloomberg article notes. And drugmakers also had to run trials on Chinese patients before they got a marketing OK.

The move comes as welcome news to foreign drugmakers, which have struggled to get their meds approved in the country. China's restrictive approval process has resulted in a backlog of new drug applications, with 21,000 awaiting review and approval with a staff of just 120 to sift through them, Wu Zhen, vice minister of the China Food and Drug Administration, told the news outlet.

But the country wants to reverse that trend, shooting to eliminate its backlog of drug applications by the end of 2016, according to guidelines seen by Bloomberg. "Our attitude is very clear, we welcome innovative drugs to China, to come early, the sooner the better," Zhen said, according to Bloomberg.

Still, multinational companies could face an uphill battle as they bring their drugs to market. Growth in China's pharma market "slowed meaningfully" in Q2, Bernstein analyst Tim Anderson said earlier this month, falling to 4.6% growth from 15.1% in Q1. Companies have blamed the slowdown on everything from government cost cuts to restrictive policies toward volume growth. But a shift to lower-priced--typically local--generics could also be taking its toll, Anderson wrote in a note to clients.

- read the Bloomberg story

StephenW

3.大型制药企业，庆幸：中国的目标是，加快批准新吃药
  艾米莉沃瑟曼

中国和外国制药公司之间的关系已经解冻了一段时​​间，该国宣布去年年底，它会折腾出严格的价格上限，简化药品审批为美国公司。现在，中国是扔的跨国制药商的另一个骨计划，以减少冗长的审批时间为创新药物。

现在，企业可以申请，以加快审批新的急需吃药 - 包括艾滋病，癌症和罕见疾病 - 只要他们的价格并不比在原产国或类似的走高在中国，根据指引成立由中国国务院看到彭博社。该国还放宽对临床试验规范新药的皮带。根据新政策，外国公司可以在同一时间，因为海外的试验运行在中国的临床试验，并用数据来自国际临床试验申请，使他们吃药进入该国。

这是一个巨大的胜利为跨国公司，曾经有过更多的篮球跳，使他们吃药推向市场。在过去，外国公司只能申请进口药品到中国后，已批准并在另一个国家，彭博社的文章指出销售。而制药公司也不得不对中国患者的运行试验中，他们得到了一个营销OK（确定）。

此举是因为好消息的外国制药企业，其一直在努力让他们的吃药批准的国家。中国的严格的审批程序已导致新药申请的积压，21,000正在等待审查和批准使用的只有120来淘汰他们的工作人员，吴镇，中国食品药品监督管理局副局长，告诉新闻媒体。

但该国希望扭转这一趋势，射击，以消除药物的应用，到2016年年底的积压，根据看到彭博社的指导方针。 “我们的态度是非常明确的，我们欢迎创新药物来中国，来早，越早越好，”珍说，根据彭博。

尽管如此，跨国公司可能会面临一场艰苦的战斗，因为他们把他们的药物推向市场。在中国的医药市场在第二季度“放缓有意义”的增长，Bernstein分析师蒂姆·安德森说，本月初，从15.1％下降第一季度4.6％的增长。公司指责的事情，从政府成本削减对销量增长的限制性政策放缓。但转向价格较低的 - 通常是本地 - 仿制药也造成了伤害，安德森在一份给客户的。

- 读彭博新闻

9病成医

替诺审批了几年？明明外国人吃了效果很好的药，中国人就不能吃，还要几年的临床试验，几年的审批，当然目的可能是保护中国药企的利益，但考虑中国病人的利益了吗？医药管理部门是为药企服务的还是为病人服务的？药企可能会对管理者“公关”，但病人不会，这恐怕才是问题的原因吧？

MP4

9病成医 发表于 2015-8-20 17:11
替诺审批了几年？明明外国人吃了效果很好的药，中国人就不能吃，还要几年的临床试验，几年的审批，当然目的 ...

什么不能吃，国产替诺已经批准上市了。
中国人吃了效果很好的药，美国人不一样得临床试验么，几年审批么？

yelanglms

不知道何时有比替诺更好的药物产生？