【直报网1月29日讯】（东方今报）疫苗审批申报了5年仍未见答复，只能看着价值3000多万元的疫苗过期销毁。去年，河南省人大代表、依生生物制药有限公司董事长张译实名举报国家食品药品监督管理总局 (以下简称“食药监总局”)。昨日，张译向记者透露，他已将食药监总局告上法庭，目前法院已判决食药监总局超时审批违法。

CNDSN January 29th news (Orient today) vaccine approval to declare for 5 years with no answer, can only look at the vaccine expiration value of about 30000000 yuan of destruction. Last year, the Henan Provincial People's Congress, mutualist pharmaceutical limited company chairman Zhang Yi to real-name reporting/real-name whistleblowing State Administration of food and Drug Administration (hereinafter referred to as the "food and Drug Administration"). Yesterday, Zhang Yi discloses to the reporter, he has the food and Drug Administration on the court, the current food and drug administration court judgement has been approving illegal timeout.

【讲述】新药审批被拖了5年

[about] approval of new drugs to be dragged on for 5 years

昨天，来郑州参加河南省两会的张译向记者透露，他之所以会选择实名举报也是无奈之举，因为食药监总局在疫苗批签发上屡屡超期，给他的企业造成了巨大损失。

Yesterday, to Zhengzhou to participate in the Henan province NPC and CPPCC Zhang Yi disclosed to reporters, he can choose real-name reporting/real-name whistleblowing is upset, because the food and Drug Administration in the vaccine batch release repeatedly extended, caused huge losses to his business.

“2008年5月至8月，我们公司向食药监总局下属的中国食品药品检定研究院(以下简称‘中检院’)送检25批共253431人份狂犬疫苗，但过去5年时间了，中检院还没有做出任何审批结果。”张译告诉记者，因为审批拖延时间太长，那批狂犬疫苗早已失效，最后只能销毁，造成损失3300万元。

"From May to August 2008, our company subordinate to the food and Drug Administration Chinese food and Drug Inspection Institute (hereinafter referred to as the 'Inspection Institute') submitted 25 batch of a total of 253431 copies of rabies vaccine, but over the past 5 years, in the inspection institute have not made any examination result." Zhang Yi tells a reporter, because the examination and approval of the delay is too long, the number of rabies vaccine has failure, finally can only be destroyed, resulting in the loss of 33000000 yuan.

据介绍，根据我国《生物制品批签发管理办法》等相关法律规定，疫苗类制品生产的每批次产品都需送中检院检验，然后获得食药监总局批签发的合格证明，才能最终上市销售。“疫苗的有效期一般是3年，根据《生物制品批签发管理办法》规定，检测机构应当在55日内完成批签发工作。”张译表示，最近几年里他们公司遇到的疫苗审批被拖延的事还有多起。

According to the introduction, in accordance with the provisions of the relevant laws of our country "release of biological products management approach", each batch of products the production of vaccines are required to send Inspection Institute test, then get the food and Drug Administration approved certificate issued, before the final listing sales. "The period of validity of vaccine is generally 3 years, according to the" release of biological products management measures "provisions, the detection institution shall, within 55 days of completion of the issuance of work group." Zhang Yi said, their company encountered vaccine approval was delayed in the recent years there are many things.

据张译讲述，2010年的时候，他们开始申请仿制药灭菌注射用水项目，在完成现场生产检查及抽样药品注册送检后，2011年4月15日国家药品审评中心收到新报资料，并于当年6月30日正式启动审评工作。但过去3年多了，该项目还在审评过程中。“按照《药品注册管理办法》规定的技术审评工作时间，对已上市药品改变剂型和仿制药的申请为160日。”

According to Zhang Yi tells the story, in 2010, they began to apply for generics Sterile Water for Injection project, upon completion of the production site of inspection and sampling for drug registration inspection, in April 15, 2011 the National Center for drug evaluation of new data is received, and in June 30th the same year officially started the review work. But in the past 3 years, the project is still in the review process. "In accordance with the" measures "provisions of drug registration management technology review time for drugs already on the market, change the formulation and generic application for 160 days."

【欣慰】法院判决食药监总局违法

[happy] Court Food and Drug Administration Law

张译告诉记者，除了实名举报外，他还对食药监总局和中检院提起了行政诉讼，而目前5起诉讼案件中有3起都有了结果。“法院在判决书中很明确地称‘食药监总局超期审批违法’”。

Zhang Yi told reporters, in addition to real-name reporting/real-name whistleblowing, he also filed administrative proceedings on the food and Drug Administration and Inspection Institute, at present 5 cases in 3 are the results of. "The court in its judgement is explicitly called 'food and Drug Administration extended approval of illegal'".

张译表示，2012年底到2013年8月，他们公司一共向中检院申请了120批次的狂犬疫苗批签发。“2013年七八月份的时候，中检院通知我们说有3批疫苗无菌检查不合格，但没有通知其他批次的检验结果。”直到2013年12月底，中检院才发通知，以风险持续存在为由，对其他117批疫苗“不予以签发”。

Zhang Yi said, at the end of 2012 to 2013 August, they were to inspection institute applied for 120 batches of rabies vaccine batch release. "When in 2013 seven or eight month, notify us in Inspection Institute said 3 batches of vaccine sterile examination is not qualified, but did not inform the other batches of test results." Until 2013 12 at the end of the month, in the inspection institute to notice, to risks persist on other grounds, issued 117 batches of vaccine "can't be".

“如果是检验不合格，我们一定会马上销毁，但这样不予以签发，是没有依据的。”张译告诉记者，去年9月份的时候，他们将中检院起诉到了北京市东城区人民法院，去年11月份，他们收到了法院的行政裁定书，裁定书上说中检院不具有行政职权，同时法律亦未规定授权其履行行政职责，故其做出的《通知》不是具体行政行为。“这不是典型的超范围审批是啥？”

"If it is failed the inspection, we will immediately destroyed, but it will be issued, there is no basis." Zhang Yi told reporters, last September, they will be in inspection institute prosecution to the Beijing Dongcheng District people's court, in November last year, they received a court administrative rulings, ruled that the book says in inspection institute does not have administrative powers, while the law nor the provisions of authorized to perform administrative duties, so it made the "notice" is not a specific administrative act. "It is a typical super scope of approval?"

【呼吁】政府部门应加强依法行政

[appeal] government departments should strengthen the administration according to law

在采访中，张译告诉记者他们公司主要从事的就是疫苗的研发、生产和销售，因为在国内审批较慢，他在无奈之下在新加坡和美国也设立了公司。“在国内几年还没审批下来的药品，在新加坡三四个月就全部审批完成了。这样一来，这些药再回到国内销售的话就成了进口药，价格也要比在国内生产高得多”。

In the interview, Zhang Yi told reporters that their companies mainly engaged in is the vaccine research and development, production and sales, because in the domestic approval is slow, in his desperation in Singapore and American has set up a company. "In the domestic several years have not approved drug, in Singapore for three or four months on all approval completed. Thus, these drugs back to the domestic sales of the word on the imported drugs, prices are also much higher than the production in china".

张译告诉记者，在美国、印度等国家新药审批时间仅为一个月，但在我们国家新药审批时间却要长上很多，这主要原因便是我们的相关政府部门没有依法行政。“其实我们很多新药在最开始申报的时候，在国际上也是比较领先的，但就是因为审批太慢了，才被别的国家赶超了。”

Zhang Yi told reporters, in America, countries such as India new drug approval time is only a month, but in our country the new drug approval time is to long for many, the main reason is the relevant government departments in our administrative not in accordance with the law. "In fact, many of our new drug at the beginning of the declaration, in the world is more leading, but because of the approval is too slow, only by other countries to catch up and surpass."

“创新药品临床审批艰难，药品价格居高不下。这不仅危害新药研发企业的积极性，更损害了人民群众的切身利益。”张译表示，他希望通过自己的较真和呼吁，能为国家的医药创新去除人为壁垒。▲

"Innovation medicine clinical examination difficult, high drug prices. This is not only harmful to the enthusiasm of new drug research and development of the enterprise, the more damage the vital interests of the people." Zhang Yi said, he hope that through their own hard and appeal, can remove artificial barriers to pharmaceutical innovation country. *

（原标题：新药审批5年未见答复 河南省人大代表状告食药监总局）

(original title: new drug approval for 5 years no reply National People's Congress of Henan province sued the food and Drug Administration)

责任编辑：宝蓝

Editor: Blue