Drug approval salesman only 70 people a variety of new drugs in China is listed by card | | approval _ drug news
Original title: China drug approval "traffic jam"
Reporter Zhang Shu
Lift the drug approval system in our country, the first words that appear in people's minds is "slow". Approval progress "slow, inefficient, resulting in many new drugs in China is in processing the traffic jams, much industry criticism. Drug approval, China pharmaceutical development, China has become the biggest stumbling block.
"Cancer drugs to go to the United States, and India to buy, that are no longer in China is nothing new. "Headquartered in Switzerland's Novartis pharmaceutical company CEO Jiang Muzhong smiling sigh, this phenomenon reflects China's drug review slow and overstocking, examination and approval of chronic illness. "The drug is a rotting bones. ”
Drug approval is universal around the world of drug supervision and management system in China by the food and Drug Administration (hereinafter "the food and drug administration").
But because of long processing time, programs, miscellaneous, China's drug approval system has been highly criticized.
For approval of new drugs, 16 years
2015 years on August 18, the State Department released the opinion on the reform of review and approval system for drugs and medical devices (hereinafter referred to as the views).
The opinions and released the same day, the State food and Drug Administration Deputy Director Wu Zhen said publicly at a news conference, Chinese drugs review backlog is still serious, review drugs up to 21,000, while the State has increased the level of drug standards and quality certification, but "pharmaceutical standards high enough to compare and backward management, review and approval system is not suitable, mechanisms are not reasonable" and other issues still outstanding.
"With the current review speed, China has developed good medicine on the patients to eat, get approval number we had for 16 years. "This experience has always been Cheng Zengjiang haze," too slow! ”
Cheng Zengjiang is a head of drug research and development. Frustration like this slow approval of new drugs in China, in the pharmaceutical industry has become a very public event.
In China, the approval of new medicines is divided into two main processes, namely the clinical trials of new drugs and new drug approvals.
According to the food and drug administration of public figures, in 2014, 1.1, 3.1 class of new drugs drugs and 6 average review time for new drugs for 42 months, 42 and 25 months, reporting the average review time for clinical 14 months and 28 months and 28 months.
Under the same conditions, from 2003 to 2013, United States, European Union, Japan approved new drug application time is 304 days, 459, and 487 days.
Approval for a change challenge, in 2007, the food and Drug Administration issued the regulation on drug registration, provides for each time limit for approval, where the clinical trial of new drug approval time shall not exceed 90 days, technical review of new drug approval takes 150 days.
"But in practice, was dragged a few years is normal. "Cheng Zengjiang said, because approval time is starting to deal with starting material," but when dealing with material, arrangement depends on the food and drug administration. ”
Get the clinical trial of new drug approvals, drug companies, are only a start.
"Approval of new drug approvals took longer. "CPPCC National Committee member, Chinese Academy of Sciences, academician of CAs, Shanghai Science and Technology Association Chairman Chen Kaixian is blunt," we are on a drug to the clinical, Labs done, to get to the hospital to use, evaluate, from phase I to phase III, this process of approval once every period. ”
Meanwhile, in front of him, every day, a large number of cancer patients die, but may be able to save their lives but still in the approval of new drugs on the way.
"The United States has a melanoma drug a few years ago, completed only 3.5 months to approve, and this cannot be achieved in China. "Chen Kaixian is always unable to let go," our animal experiments began in 2005, now in the second phase I clinical trial stage. "He is expected to, at least at the end of 2017 to put this new drug application.
This period is for 12 long years.
The quality of generic drugs is grim
Drug approval, in addition to new drugs, generic drugs accounted for China market.
"Now we have 21,000 species, 90% are drugs generic drugs, including 8 varieties, more than 100 companies to declare at the same time. "Status of the mentioned drugs review backlog, Zhen Wu quote a series of numbers. "The review backlog is largely because Chinese generic standards are not high, and repeated declarations of enterprises is serious. ”
For a long time, China's independent research and development ability of drugs, domestic pharmaceutical companies can only be copied in other countries has been a patent medicine of the patent protection period, the production of alternative medicine.
But according to the quality standards of China's long-standing generics, generics only and the original drugs active ingredients, appearance, shape, route of administration, dose, conditions of use and the requirements of clinical effect is not clear.
"If they cannot find the original drugs, pharmaceutical companies can already listed other generic drugs as a generic object. "Tsinghua University law school Dean Wang chenguang had told the media that," low-standard "led directly to poor drug quality, drug companies low barriers to entry.
In 2007, the food and drug administration new drug registration regulation, requires that the generic drugs and generic drugs have the same active ingredients, route of administration, dosage form, specifications, and the same treatment.
The standard generic generic standard, but implicit generic is a generic object must be the original drugs and still provides "the changed dosage form of drugs already on the market, changing the route of administration, adding new indications for drug registration in accordance with the new drug application procedures apply to."
"Changing the route of administration, changed dosage form arguably is not new, but according to the new procedures apply, take up a drug evaluation Center of a great deal of manpower and resources. "Wang chenguang said.
Subsequently, in 2007 the drug registration procedures prior to the implementation of generic drugs, food and Drug Administration has been launched in 2012 "quality evaluation of conformity", but about "consistency" issue persists.
This explains Wang chenguang, consistent quality evaluation starts now, progress has been very slow, one reason is that many generics simply "could not find the original drugs".
"These drugs before generic object may be other generic drugs, countries without the required original drugs or reference list of medicines. "Wang chenguang admitted that" many drug companies do not know who the original drugs. ”
Review of fuzzy
And this situation is the standard of review is not transparent.
"Standards are not transparent, and one reason for the repeated declarations. "Nantong Miao Bao ying, Deputy Director of the food and Drug Administration said," because they do not know the standard, some declarations are queuing up for obvious defects. But in fact, these materials should be early in the first period of the audit to be filtered out. ”
Review standards touched clue, mode of communication between enterprises and review Center, started the "informal" modes. In order to spy on the review scale, companies think of ways and even sent people "waiting" in the review Center in Beijing's yuyuantan South Road.
In fact, on the review of public importance of standards, food and Drug Administration is not known.
Early in 2007, the new drug registration regulation of the press conference, spokesman for the food and Drug Administration has said publicly at a news conference, public, devoted several articles of the provisions to public review, public review standards, open review process and schedule, open review results.
However, nearly 7 years later, the current food and drug official website to review standards of the general public is still very limited. Publicly lined up its website for some time, and somehow was not updated.
"The food and drug administration closed the review standards, but also they have some wiggle room. ”
"Sometimes they are very difficult", Zhu was involved in a drug review, because pharmaceutical companies have spent great efforts to public relations, assessment of no way, "had to find an expert to deny."
In response, Cheng Zengjiang says, United States food and Drug Administration has a dedicated Orange Book, the list of generic drugs, "a drug can refer to the who-like, what standards, rules are very clear. ”
"Even if we do not establish the Orange Book system, to which varieties are not approved generic public notice in a timely manner. "Cheng Zengjiang recommends said a generic input, or at least millions," with the public, enterprises would not have unnecessary investment. ”
Dilemma solved
"Approval system reform for many years, but it seems people are still difficult". View of the future direction of the drug approval system, medicines evaluation board expert Zhu said.
According to public data shows that China's medicines market approval responsibility undertaken by the food and drug administration, but the specific approval, devolved upon the Center for drug evaluation.
"The immediate cause of the food and drug administration departments, in the programme on the establishment of 120 people. "Zhu Xun said," but in fact for a long time only 50, most recently in the series will be prepared make up another 70. ”
The 120 people, including a number of administrative positions, "the real business personnel for review, only about 70 people." Zhu Xun said.
In contrast, as a United States drug review Center reviews research center, Center for Biologics Evaluation Research (CBER) has about 2000 staff who have a professional background and experience, its under review Office are also the focus of CDER's Office of new drugs, there are 6 Office is responsible for the review of the different types of drug.
Source: rule of law weekend
Responsible editor: Wang Hao
Article keywords:Drug approval
I want feedback
Save a Web page
Legal network-legal journal
中国药品审批业务员仅70人 多种新药被卡难上市|药品|审批_新闻资讯
原标题：中国药品审批“大塞车”
记者 张舒
提起我国药品审批上市制度，出现在人们脑海中的第一个字便是“慢”。审批进度“慢”、效率低，致使我国许多新药被堵在审批路上，备受业界诟病。中国式药品审批已经成了中国医药发展的最大绊脚石。
“抗癌新药要去美国、印度才能买到，这在中国已不再是什么新鲜事。”总部位于瑞士的制药公司诺华CEO江慕忠曾笑叹，而这一现象正折射出中国药品审评慢、积压多、审批难的痼疾。“可谓一药功成万骨枯。”
药品审批是全球各国普遍实行的药物监督管理制度，在中国由食品药品监督管理总局(以下简称“食药监总局”)负责。
但因为审批时间长、程序冗杂，我国药品审批制度一直备受诟病。
为新药批准文号等过16年
2015年年8月18日，国务院正式发布《关于改革药品医疗器械审评审批制度的意见》(以下简称《意见》)。
《意见》发布当天，国家食品药品监督管理总局副局长吴浈在新闻发布会上公开表示，目前中国药品审评积压仍旧严重，待评审药品达21000件，尽管国家已经提高了药品标准和质量认证水平，但“药品标准不够高，管理方式比较落后，审评审批体制不顺，机制不合理”等问题依然突出。
“以目前的审评速度，中国患者要吃上已经研发好的药，光拿批准文号我们等过16年。”这段经历始终是程增江心头的阴霾，“实在太慢了！”
程增江是一家药品研发机构的负责人。而像这样对中国新药审批慢的不满情绪，在药品行业早已成为一个公开的话题。
在中国，新药审批主要分为两个流程，即新药临床试验审批和新药生产审批。
根据食药监总局公开的数据显示，2014年，中国1.1类新药、3.1类新药及6类新药的平均审评时间为42个月、42个月和25个月，申报临床的平均审评时间为14个月、28个月和28个月。
相同情况下，2003年至2013年间，美国、欧盟、日本新药申报生产获批时间依次为304天、459天和487天。
为改变审批速度难题，2007年，食药监总局发布《药品注册管理办法》，对每个审批环节的时限作出规定，其中，新药临床试验审批的时间不得超过90天，新药生产审批需要150天的技术审评。
“但在实际操作中，被拖个几年再正常不过。”程增江介绍称，因为审批时限是从开始处理材料起算，“但是什么时候处理材料，就要看食药监局的安排了。”
而拿到新药临床试验批文，对于药企来说，也仅仅只是一个开始。
“新药生产审批的批文耗时会更久。”全国政协委员、中科院院士、上海市科协主席陈凯先对此直言，“我们现在一个药要上临床，实验室做完后，要拿到医院去使用、评价，从一期到三期临床，这个过程每期都要审批一次。”
与此同时，在他面前，每天都有大量恶性肿瘤病人死亡，但或许能够挽回他们生命的新药却还在审批的路上。
“美国前几年有一个治疗黑色素瘤的药物，只用了三个半月就审批完成，而这在国内目前还无法实现。”陈凯先对此始终无法释怀，“我们从2005年开始做的动物实验，到现在还在二期临床阶段。”而在他的预计里，这一新药至少要在2017年底才能投入应用。
这期间是漫长的12年。
仿制药质量堪忧
在药品审批中，除新药外、仿制药占据了中国大部分市场。
“现在我们手上在审的21000个品种，90%是化药仿制药，其中有8个品种，100多家企业在同时申报。”提及药品审评积压的现状，吴浈报出了一系列数字。“审评积压很大程度上是因为中国仿制药标准不高，且企业重复申报现象严重。”
长期以来，由于中国自主研发药品能力弱，国内药企只能仿制其他国家已经过了专利保护期的专利药，生产替代药品。
但根据中国推行已久的仿制药质量标准，仿制药只需和原研药在活性成分、外观、形状上一致，对于给药途径、剂量、使用条件和临床效果的要求则不明确。
“如果找不到原研药，药企可以国内已经上市的其他仿制药作为仿制对象。”清华大学法学院院长王晨光曾对媒体表示，“低标准”直接导致了药品质量差，药企进入门槛低等问题。
2007年，食药监总局公布新版《药品注册管理办法》，要求仿制药与被仿制药具有相同的活性成份、给药途径、剂型、规格和相同的治疗作用。
该项标准提高了仿制药的仿制标准，但未言明仿制药的仿制对象是否必须是原研药，且仍规定“对已上市药品改变剂型、改变给药途径、增加新适应症的药品注册按照新药申请的程序申报”。
“改变给药途径、改变剂型按理说不算新药，但按照新药的程序申报，占用了药品评审中心大量的人力、物力。”王晨光表示。
其后，对于2007年《药品注册管理办法》实施前的仿制药，食药监总局已于2012年启动“质量一致性评价”，但关于“一致性”的争议一直存在。
王晨光对此解释道，质量一致性评价启动到现在，进展非常缓慢，一个重要原因是很多仿制药根本“找不到原研药”。
“这些药品之前的仿制对象可能是其他仿制药，国家没有法定的原研药或参比药品目录。”王晨光坦言，“很多药企也不知道谁是原研药。”
审评标准模糊
而这一弊病则是审评标准的不透明。
“标准的不透明，也是企业重复申报的一个原因。”南通食品药品监督管理局副局长缪宝迎称，“因为不知道标准，一些存在明显缺陷的申报材料也在排队。但其实这些材料，应该早在前期的审核中就被过滤掉。”
审评标准摸不着头绪，企业和审评中心之间的沟通模式，就启动了“非正式”模式。为了打探审评尺度，企业想出各种办法，甚至派人“守候”在位于北京玉渊潭南路的审评中心。
其实，关于审评标准公开的重要性，食药监部门也并非不知。
早在2007年，新版药品注册管理办法的发布会上，食药监总局发言人就曾在新闻发布会上公开表示，对于公开，专门有几个条款做了规定，要公开审评事项、公开审评标准、公开审评过程和进度、公开审评结果。
然而，近7年过去了，目前食药总局官网对审评标准的公开依旧非常有限。有一段时间在其网站曾经公开排队，也不知何故后来未再更新。
“食药总局不公开审评标准，也是为了他们有一些回旋空间。”
“有时候他们也很为难”，在朱讯曾参与的一个药品评审中，因为药企花了大力气公关，评审部门没办法，“只好找专家来否定”。
对此，程增江介绍道，美国食品药品监督管理局专门设有一个橙皮书，即仿制药目录，“某个药可以参照谁仿，什么标准，规则非常透明。”
“即便我们做不到建立橙皮书制度，也要对哪些品种不批准仿制及时公示。”程增江建议称，一个仿制药的投入，至少也在上百万，“有了公示，企业就不会无谓投入了。”
多重困境待解
“审批制度改革喊了很多年，但看起来人依旧是难点”。针对我国药品审批制度未来发展方向，药品评审委员会专家朱讯说到。
据公开资料显示，中国的药品入市审批之责，由食药监总局承担，但具体审批工作则落在药品审评中心身上。
“而这个食药监总局直属的事业部门，在方案上的编制人数是120人。”朱迅表示，“但事实上长期以来只批了50个，最近中编办才把另外70个编制补上。”
而这120人中，还包括若干行政性岗位，“真正进行审评的业务人员，只有70人左右”。朱迅直言。
与此相对，作为美国药物审评研究中心最大的审评中心，生物制品审评研究中心(CBER)拥有约2000位具有专业背景和经验的工作人员，其下设的新药审评办公室亦是CDER的重点办公室，有6个办公室负责对不同类别的新药进行审评。
来源：法治周末
责任编辑：王浩成
文章关键词： 药品 审批
我要反馈
保存网页
法制网-法制日报