Many well-known hospitals buying undocumented reagents for clinical diagnostic reagents | | | without a license _ news
Original title: "undocumented" reagents with "scientific" why the coat can be used?
ComicsRecently, people in the industry to the South are reporters reflect, Thermo Fisher Scientific (China) Limited (hereinafter called "Meg Seymour flew") sold a number of unregistered in vitro diagnostic reagents for clinical diagnosis, more than Beijing, Shanghai, Nanjing and other medical and research institutions are involved.
Why the reagent "naked without a license?"
According to the relevant regulations of the State, allergen reagents such as failure to obtain in vitro medical device registration certificate only as a research reagent, cannot send a diagnostic report, results for physicians only. "Card can be used as diagnostic, no certificate is scientific research," said one industry insider. Why such over the years to "naked without a license"?
Reporters combed nearly a decade in the South the relevant provisions on administration of registration of in vitro diagnostic reagents found the clue.
Adopted by the State food and drug administration in April 2007, the measures for the administration of registration of in vitro diagnostic reagents (for trial implementation) (food drug armed [2007]229) 15th section "only for research, not for clinical diagnostic products exempted from the registration requirement, but its specifications and package labels must be marked" only for research, not for clinical diagnosis of "message". For reagents that are not registered at the time leaves a "hole". Until June 2014, this new revised registration regulation of in vitro diagnostic reagents are deleted.
In 7 years, manufacturers make use of the article, the production of in vitro diagnostic reagents is not registered, and only on the box marked "only for research, not used in clinical diagnosis." This reagent is not fully compliant to the "scientific" name was sold to secondary or even tertiary health institutions, and for clinical diagnosis.
On March 13, 2014, the national Office concerning medical devices issued "treatment of five" special action programme of the notifications, clear the use the product without a license punishment basis. Use the undocumented in vitro diagnostic reagents for medical institutions, in accordance with the supervision and administration of medical devices Ordinance 42nd penalty and inform health authorities at the same level.
Director of the information Office of the Anhui provincial food and drug Bureau Sun Binyuan has said publicly, and only after rigorous clinical testing and technical review of the State food and drug administration, after you confirm that it is safe and effective, these reagents to obtain medical device registration and listing.
Why enterprises do not apply for a certificate?
According to the current territory of the third class and of import medical device registration practices, within the third category and import category II and class III medical devices registration includes reception, administrative approval and technical reviews, approvals made four links, by the State food and drug administration and related departments.
Now that you have applied for registration mechanism, why not to apply for the certificate?
One industry source said the time and money required to request a certificate costs. "Each of these allergens to get the registration certificate, the market is not such a big demand, cost exceeds the benefit, that's why Thermo not to register. "Quality is the fundamental, but also by economic interests.
Hospital, why take the risk?
Since the State banned, why many well-known hospitals risk purchasing agent without a license and for clinical diagnosis?
A Hunan pharmaceutical testing agency staff told the South reporter, because the existence of clinical requirements, third-party testing agency market. In his view, the meaning of in vitro testing is if you can accurately detect the allergens, patients can avoid as far as possible in their daily lives to reduce pain.
The body's immune system to foreign substances naturally present a barrier, when harmful substances enter the body, the body's immune system will react immediately, to ward off or destroy it. However, once the reaction is beyond the normal range, launched attacks against harmless substances, formed the so-called "allergy".
Allergy is a kind of allergic reaction, is the body's immune response to foreign substance enters the body beyond the scope of. If the lack of targeted prevention and treatment, can easily lead to repeated illness, severe cases might cause damage to normal tissues. Thus, doctors often allergy patients are normally advised to do allergen screening tests in order to fundamentally solve the problem.
One medical test in the telecommunications industry to the South are journalists, traditional allergen detection methods include patch and two prick, are allergens or suspect allergenic substances through the skin and mucous membranes into the body, induce local allergic reactions, in order to screen for allergens.
In vitro testing, serum of patients by definition is drawn, in vitro testing. By looking at the body's antibody IgE to find allergens.
One industry insider told the South reporter close to Thermo, referred to in the foregoing cases of allergen detection in vitro reagent application effect is good, "high sensitivity of Phadia, (allergen) can be measured. "Another laboratory doctor also said the safety of in vitro test higher, had little effect on the human body.
However, it should be noted that current national certification of allergen detection in vitro reagents and items are limited, most test items can only be used for scientific research or statistical etiology and cannot be used for clinical diagnosis. A senior physician said subject to the reagent certificate, many projects with clinical significance is still not normal at the hospital.
"The clinic, patients need to check, if you have no choice. How should we do? "Said a long-term concern of investors in the pharmaceutical industry in the country, Thermo allergen reagents to make more comprehensive testing, of which few obtain a registration certificate, therefore there are hospital beyond use.
Case
Peking Union Medical College Hospital was fined 352,800
Enterprises involved the suspension of "undocumented" reagents, have not been found illegal
Public information displays, early 2016, Beijing, two renowned public hospital, for allegedly using Meg Seymour company investigation without registration of in vitro diagnostic reagents, are still pending. In 2014, 2015, Peking Union Medical College Hospital, children's Hospital of Shanghai, Chinese Academy of Medical Sciences Institute of skin diseases, are also local drug administrations using Thermo reagents that are not registered, Peking Union Medical College Hospital was also an administrative punishment 352,800.
Investigation of the market according to the Shanghai Pudong new area administration, Thermo direct customers are mainly divided into three types: one is the medical device business, two research units, three are medical institutions. January 2013 to September 2014, Meg Seymour to these clients with unregistered, for "scientific" diagnostic reagent sales amounted to RMB more than 14.11 million Yuan.
South reporter found that these reagents can be used to test human allergy induced by factors of in vitro diagnostics, is a part of Thermo p Hadia allergy diagnostic reagents. According to the regulation on registration of in vitro diagnostic reagents, and allergic reactions (allergens) reagents belonging to the highest degree of risk related to the third category of products, in accordance with the medical device management, access to medical device registration certificate can only be used in the clinic.
By October 2014 applicable registration regulation of in vitro diagnostic reagents (trial) provides that only for research, not for clinical diagnostic reagents products do not need to apply for registration, but its specifications and package labels must be marked "only for research, not used in clinical diagnosis."
South Reporter gets a record show, former Vice President of Thermo Zhangjiang Hi-Li had told law enforcement officials surveyed, Thermo sale "for research only" reagent, will issue a written notice to allow customers to sign to acknowledge receipt, the company will be advised in writing as a research agreement.
However, sometimes illegal activities of a research agreement "coat". Shanghai food and drug supervision Bureau Jinan branch October 10, 2014, according to a survey by January 2013-August 2013-children's Hospital of Shanghai six times to buy allergy diagnostic reagents products from Thermo for research, however in the 2013 3-in June, the hospital charges against allergens in patients with diagnosis of each charge 160 Yuan, for a total fee of 262720 Yuan.
These reagents are also sold to Beijing. According to public reports, between January 2014 and May, Peking Union Medical College Hospital 200 buy allergen in vitro diagnostic reagents, 2484. Purchase 1 month later, 39, 97 reagents for clinical diagnosis in 4 month, charging standards for each 100 yuan per person, the hospital actually illegal earnings amounted to RMB 88,200. Peking Union Medical College Hospital was a warning, confiscate the illegal income of 88,200 Yuan, and 3 times the illegal proceeds fine 264,600 Yuan.
Zhang Jiang Li said in a transcript, after October 2014, Meg Seymour fly company suspended all has not obtained the registration certificate of medical devices Phadia allergen diagnostic reagent sales. October 2014 to January 2015, the total sales amount of 140,000 yuan, average monthly income fell sharply. Eventually, Meg Seymour company has not been found illegal.
Survey
Manufacturer:
Currently only sells certified reagents
South reporter wants to buy allergen reagent for the fly factory in Guangzhou, a principal contact game, the official said, Thermo are more than 600 species of allergen reagents, obtain a registration certificate only 28, so no matter what the purpose, can only sell the 28 species. "We're working on it, if you have a research project of the national project, and hospitals or scientific research units, you can go to a fight", the official said, the current food and Drug Administration investigation is very strict, even if the agreement is only used for research should not be sold.
"Because it can't differentiate, we have sold the hospital to, Hospital says scientific research, but is actually a clinical, be found we should also assume a great responsibility", the official said, which 28 kinds of registered agents for detecting the most common allergens, common foods, such as pollen, cat Mao Goumao, dust and so on.
Inspection body:
Door-to-door sampling done in vitro testing
South reporter by pediatric patients and the patients ' family members call the capital of each hospital and children's Hospital of Shanghai dermatologist asked whether in vitro allergy testing, the results are: the test is currently only used for scientific research, not clinical.
Reporter immediately in online search to a name for Kang St global medical special check group of detection institutions, call Kang Sheng global medical special check group subordinates 7 a medical detection center one of of Shanghai new culture Crystal medical laboratory asked body outside allergy original detection of project and the charges situation, staff Han Mr said the detection Center provides of body outside allergy original detection including dust mites, and cat hair, and cockroaches, and freshwater fish, 20 a project, full detection finished total needed 450 Yuan. When reporters in the hospital could not find related projects, the staff member that the Agency has cooperation with Shanghai in several hospitals in the city are, simply inform the patient's name, hospital and beds, you can provide door-to-door sampling and testing services. The staff member also said the current testing program open only to adults.
Responsible editor: Wang Hao
Article keywords:Reagents without clinical
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多家知名医院购买无证试剂用于临床诊断|试剂|无证|临床_新闻资讯
原标题：“无证”试剂披“科研”外衣缘何能被用于临床？
漫画 近日，有业内人士向南都记者反映，赛默飞世尔科技(中国)有限公司(以下简称“赛默飞公司”)出售的一批未经注册的体外诊断试剂被用于临床诊断，北京、上海、南京等多家医疗与研究机构均有涉及。
试剂缘何“无证裸奔”？
根据国家有关规定，体外过敏原试剂如未取得医疗器械注册证书就只能作为科研试剂，不能发诊断报告，结果仅供医生参考。“有证就可以作为诊断，没证就是科研，”一位业内人士说。这种试剂为何多年来能“无证裸奔”呢？
南都记者在梳理近十年对体外诊断试剂注册管理的相关条款时发现了端倪。
国家食品药品监督管理局于2007年4月通过的《体外诊断试剂注册管理办法(试行)》(国食药监械[2007]229号)第十五条规定，“仅用于研究、不用 于临床诊断的产品不需要申请注册，但其说明书及包装标签上必须注明“仅供研究、不用于临床诊断”的字样”。这等于在当时为未注册的试剂留下了一道“口子”。直到2014年6月，这一条才从新修订的《体外诊断试剂注册管理办法》中被删去。
在此7年间，有生产企业利用该条规定，所生产的体外诊断试剂并未注册，且仅在包装盒上标示“仅供研究、不用于临床诊断”字样。这种不完全合规的试剂以“科研”名义被销售给二级甚至三级医疗机构，进而用于临床诊断。
2014年3月13日，国家总局《关于印发医疗器械“五整治”专项行动方案的通知》明确了使用无证产品的处罚依据。针对医疗机构使用无证体外诊断试剂的，依照《医疗器械监督管理条例》第四十二条进行处罚，并通报同级卫生主管部门。
安徽省食药监局新闻办主任孙斌园曾公开表示，只有经过严格的临床试验和国家食药监总局的技术审评，确认其安全有效后，这些试剂才能取得医疗器械注册证并上市流通。
企业为何不申请证书？
依据现行的《境内第三类和进口医疗器械注册审批操作规范》，境内第三类和进口第二类、第三类医疗器械注册审批包括受理、技术审评、行政审批和批件制作四个环节，且均由国家食品药品监督管理总局相关部门负责。
既然已有申请注册的机制，为什么迟迟不去申请证书呢？
一位业内人士称，申请证书所需的时间和金钱成本巨大。“每一种过敏原都要拿到注册证，市场没有这么大的需求，成本超出了收益，这也是赛默飞没有去注册的原因。”质量是根本，但推广靠的还是经济利益。
医院为何铤而走险？
既然国家明令禁止，为何多家知名医院甘冒风险购进无证试剂并用于临床诊断？
一位湖南的医药检测机构工作人员告诉南都记者，因为临床需求的存在，第三方检测机构颇有市场。他认为，体外检测的意义在于如能精准地测出过敏原，患者就可以在日常生活中尽量规避，减少痛苦。
人体的免疫系统天然地对外来物质存在一道屏障，当有害物质进入人体，机体的免疫系统会立即做出反应，将其驱除或消灭。不过，一旦这种反应超出了正常范围，对无害物质也发起攻击时，就形成了所谓的“变态反应”。
过敏正属于变态反应的一种，是机体对进入人体的外来物质的超范围免疫应答。若缺乏针对性的预防和治疗，容易导致病情反复，严重者甚至会损害正常的身体组织。因而，医生通常会建议经常过敏的患者做过敏原筛查检测，以便从根本上解决问题。
一位从事医学检验的业内人士向南都记者透露，传统的过敏原检测手段主要有斑贴和点刺两种，均是将变应原或可疑致敏物质通过皮肤和黏膜进入机体，诱发局部的过敏反应，以此来筛查过敏原。
而体外检测，顾名思义就是将患者的血清抽出，在体外进行检测。通过查患者体内的特异性抗体IgE来寻找过敏原。
一位接近赛默飞的业内人士告诉南都记者，前述案件中提到的体外过敏原检测试剂实际应用效果良好，“Phadia的灵敏度非常高，(一般的过敏原)基本都能测出来。”另一名检验科医师也表示，体外检测的安全性确实更高，对人体几乎没有影响。
不过，值得注意的是目前获得国家颁发证书的体外过敏原检测试剂和项目很有限，大部分检测项目仅可用于科研或统计病原学，不能用于临床诊断。一名一线医师表示，受制于试剂证书，国内很多对于临床具有指导意义的项目至今还无法在医院正常展开。
“对于临床来说，病人有需求要检验，如果别无他选。怎么办呢？”一名长期关注医药行业的投资人表示，在国内，赛默飞的过敏原试剂能够做出比较全面的检测，然而其中获得注册证书的却不多，因此存在医院超范围使用的情况。
案例
北京协和医院被罚35.28万元
涉事企业停售“无证”试剂,未被认定违法
公开信息显示，2016年年初，北京两家知名公立三甲医院，因涉嫌使用赛默飞公司未经注册的体外诊断试剂被立案调查，目前仍未结案。2014年、2015年，北京协和医院、上海市儿童医院、中国医学科学院皮肤病研究所，也被当地药监部门发现使用赛默飞未经注册的试剂，北京协和医院还因此被行政处罚35.28万元。
据上海市浦东新区市场监督管理局调查，赛默飞直接客户主要分为三类：一是医疗器械经营企业，二是科研类单位，三是医疗机构。2013年1月至2014年9月，赛默飞向上述客户提供未经注册的、用于“科研”的诊断试剂销售总金额达人民币1411万余元。
南都记者调查发现，上述试剂主要用于检测诱发人体过敏的因素的体外诊断，是赛默飞P hadia过敏原诊断试剂中的一部分。据《体外诊断试剂注册管理办法》，与变态反应(过敏原)相关的试剂属于风险程度最高的第三类产品，按照医疗器械管 理，获得医疗器械注册证书后方能用于临床。
2014年10月以前适用的《体外诊断试剂注册管理办法(试行)》规定，仅用于研究、不用于临床诊断的试剂产品不需要申请注册，但其说明书及包装标签上必须注明“仅供研究，不用于临床诊断”。
南都记者获取的一份笔录显示，赛默飞前副总裁张江立在接受调查时曾告诉执法人员，赛默飞出售“仅供研究”的试剂时，会发出书面告知，让客户签字确认收到，公司将此书面告知视为科研协议。
然而，这样的科研协议有时只是违规活动的一件“外衣”。上海市食品药品监督局静安分局2014年10月10日的一份调查报告显示，2013年1月-2013年8月上海市儿童医院分六次向赛默飞购买过敏原诊断试剂系列产品用作课题研究，然而在2013年3-6月，该医院对过敏原诊断的患者开展收费，每次收费 160元，共计收费262720元。
这些试剂同样出售到北京。据公开报道显示，2014年1月至5月，北京协和医院购进过敏原体外诊断试剂 200种，共2484支。在购进1个月之后，39种、97支试剂在4个月内用于临床诊断，收取费用的标准为每人每项100元，该医院实际违法所得共计人民 币8.82万元。协和医院被处以警告处分，没收违法所得人民币8.82万元，并处违法所得3倍罚款人民币26.46万元。
张江立在笔录中表示，在2014年10月以后，赛默飞公司就暂停了所有未取得医疗器械注册证的Phadia过敏原诊断试剂的销售。2014年10月至2015年1月，销售总金额人民币14万元，月均收入大幅下降。最终，赛默飞公司没有被认定违法。
调查
生产厂家：
目前只销售有证试剂
南都记者以希望购买过敏原试剂为由，联系上赛默飞广州厂家一名负责人，该负责人表示，赛默飞有600多种过敏原试剂，获得注册证书的只有28种，因此无论是 什么用途，都只能卖这28种。“我们现在正在想办法，如果你有国家立项的科研项目，而且是医院或者科研单位，可以去争取一下”，该负责人表示，目前药监局的调查很严，即便协议承诺只用于科研也不能售卖。
“因为现在没法区分，我们也曾卖到医院去，医院说用于科研，但实际上是临床，被查到了我们也要负很大责任”，该负责人说，这28种已注册试剂可供检测最常见的过敏原，如花粉、常见食物、猫毛狗毛、粉尘等等。
检测机构：
可上门取样做体外检测
南都记者分别以患者和患儿家属身份致电首都儿科医院和上海市儿童医院皮肤科询问是否开展体外过敏原测试，得到的结果都是：该项测试目前仅用于科研，不用作临床应用。
记者随即在网上搜索到一家名为康圣环球医学特检集团的检测机构，致电康圣环球医学特检集团下属7个医学检测中心之一的上海新培晶医学实验室询问体外过敏原检 测的项目及收费情况，工作人员韩先生表示该检测中心提供的体外过敏原检测包括尘螨、猫毛、蟑螂、淡水鱼等20个项目，全套检测做完共需450元。当记者提出自己在三甲医院无法找到相关项目时，该名工作人员称该机构与上海市内多家医院均有合作，只需告知患者姓名、医院和床位号，就可以上门提供取样和检测服务。该工作人员还称，目前的检测项目仅对成年人开放。
责任编辑：王浩成
文章关键词： 试剂 无证 临床
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