上海将建成中国药FDA评价中心，以加快药品审批

StephenW

SPOTLIGHT ON... CFDA eyes new Shanghai evaluation center to speed drug approvals

Shanghai will build a China FDA medicine evaluation center to speed drug approvals, CNTV said on its website, as part of efforts to keep and attract drug and device firms to the region. China has struggled with a backlog of more than 18,500 drugs awaiting approval by the end of 2014, an increase of 33% from the previous year, according to the China FDA's Center for Drug Evaluation in April. A timeframe was not immediately available for the new center. In May, the country hiked fees to register medicines and devices as part of efforts to fund faster approvals. According to CNTV, the CFDA says the process of clinical trial and production application takes 240 working days in total. But domestic and multinational companies complain the waits are often double. CNTV says one key reason for delays is that CFDA has around 120 staff handling evaluations, compared to thousands at the U.S. FDA.
Report
Introducing new medicines in China is a laborious and time-consuming process, which usually takes at least five to six years. The delay is sometimes so long new drugs become dated by the time they're finally approved. This burdensome mechanism has hindered the development of many pharmaceutical companies. But now Shanghai is trying to change the situation.

From lab to pharmacy counter, a new medicine has to go through clinical trial and market production application to get the approval of bringing it to the Chinese market. A pharmaceutical company in Shanghai has waited for over 10 years since it summited the application for its anti-cancer drug.

"We have waited for the approval for four and half years in the supervision department during these ten years. The new medicine are getting dated," Zhang Haizhou, researcher with Shanghai Cp Guojian Pharmaceutical Co., said.

China Food and Drug Administration is supervising the approval of new drugs in the country. It says the process of clinical trial and production application take 240 working days in total, much less than Zhang has waited.

"It only takes a few weeks to months to evaluate a new medicine. Most of these four and half years is only spent on queuing for evaluation and approvals. But the evaluation center is also busily evaluating other drugs," Chen Wei, president of Shanghai Zhangjiang Economic Research Institute, said.

To bring cheaper and more effective medicines to the Chinese market, new measures have been taken to speed up the medicine evaluation process. Pharmaceutical companies are also encouraged to set up their research centers in Shanghai.

There are around 120 staff in the Administration in charge of evaluation, while in the US there are thousands of personals doing this job. To share the workload and speed up the process, Shanghai will build a regional center of medicine evaluation under the China Food and Drug Administration.

"We want to change this situation and make Shanghai more competitive in attracting pharmaceutical companies investing here," Shou Ziqi, director of Shanghai Committee Of Science & Technology, said.

StephenW

聚焦... CFDA眼睛上海新评价中心，以加快药品审批

上海将建成中国药FDA评价中心，以加快药品审批，CNTV在其网站上，以努力保持和吸引药物和医疗器械公司，以该地区的一部分。中国一直在努力以超过18500药物正在等待批准的2014年，比上年增长33％，年底积压，根据中国FDA的药品评价中心在四月。一个时间表是没有立即对这个新的中心。今年五月，国家上调学费注册的药品和设备，以努力基金审批速度更快的一部分。据CNTV，CFDA的说，临床试验的过程和生产应用程序需要240个工作日总和。但是，国内企业和跨国企业抱怨等待往往是双。 CNTV说，一个关键的原因延迟是CFDA拥有大约120名员工处理的评价，比起在成千上万的美国FDA。
报告
在中国引入新的药品是一个艰苦和耗时的过程，通常需要至少五六年的时间。该延迟，有时只要新药成为由他们终于批准了时间约会。这种负担机制阻碍了许多制药公司的发展。但现在上海正在努力改变这种状况。

从实验室到药店柜台，一种新药要经过临床试验和市场生产中的应用得到将它带到了中国市场的认可。一家制药公司已在上海等了超过10年，因为它登顶申请的抗癌药物。

“我们已经等待和批准四个半年期间，这十几年监管部门的新药越来越过时，”张海洲，研究员，上海中信国健药业有限公司，说道。

中国食品药品监督管理局监督新药在国内批准。它说，临床试验和生产应用过程中需要240个工作日总，远低于张某等待。

“只需要几个星期到几个月来评价一个新药，其中大多数四年半只花费在排队进行评估和批准，但评价中心还忙着评估其他药物，”陈炜，上海总裁张江经济研究所说。

为了使更便宜，更有效的药物在中国市场，新的措施已经采取，以加快医药评估过程。还鼓励制药企业建立自己的研发中心在上海。

大约有120名员工在管理，负责评估，而在美国有数以千计的交友做这个工作的。为了分担工作量，加快的过程中，上海将建立药品评价根据中国食品药品监督管理局的区域中心。

“我们要改变这种状况，使上海在吸引制药企业在这里投资更具有竞争力，”守紫气，上海市委科技总监说。