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【奥译言】欧盟判定:蔓越莓类产品不属医疗器械

阅读: 2017年06月06日

【奥译言】欧盟判定:蔓越莓类产品不属医疗器械

5月19日, 医疗器械欧盟监管委员会投票通过了欧盟委员会的决定,对于产品的基本预期用途为“基于蔓越莓提取物中的原花青素(PAC)以用于预防或治疗膀胱炎”,即俗称的膀胱发炎或感染,决定为“不属于医疗器械指令章节1(2)(a)中医疗器械的定义”。


在2016年2月的草案之后,欧盟人用医药产品委员会(CHMP)在去年7月发布了最终的决议,决议指出:“含有原花青素和/或蔓越莓作为物质或制剂,用于尿路感染(UTIS)的产品,目前在欧洲以食品增补剂,医疗器械和消费品各种形式在市场上销售。”


综合考虑委员会提供的信息、医疗器械的定义、CE指南文件、欧盟司法法院于2012年公布的一份裁决以及科学文献,CHMP发表以下观点:“总体数据表明,原花青素(PAC)的机械模式的作用机理是极不可能发生的,原花青素(PAC)的代谢产物和蔓越莓的其他成分展现的更可能是药理活性。”


2014年,法国阿科法玛(Arkopharma)企业的蔓越莓产品被法国的医疗产品监管机构(ANSM)取消其医疗器械资格,该产品之前基于临床数据为基础取得专利,并获取IIb类医疗设备资质。ANSM当时的说法是,阿科法玛企业缺乏数据来证明其属于医疗器械。


委员会的该决议将预计在今年夏天以后做最终采纳和发布。

英语原文  


European Commission: Cranberry Products Are Not Medical Devices

Posted 26 May 2017
By Zachary Brennan
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The European Commission's regulatory committee on medical devices on 19 May voted in favor of the commission's decision that products "whose principal intended action, depending on proanthocyanidins (PAC) present in cranberry extract, is to prevent or treat cystitis," also known as bladder inflammation or infection, "are not medical devices within the meaning of Article 1 (2) (a) of the Medical Devices Directive."

The final decision, following a draft decision in February 2016, comes as last July, the European Medicines Agency's Committee for Medicinal Products for Human Use (CHMP) noted: "Products containing proanthocyanidins and/or cranberry as substance or preparation for use in urinary tract infections [UTIs] are currently marketed differently across the EU as food supplement, medical device or consumer product."

While considering the information provided by the commission, the definition of a medical device, an EC guidance document, a ruling in the Court of Justice of the European Union from 2012 and the scientific literature, CHMP said in its opinion, "The totality of data suggests that a mechanical mode of action of PACs is highly unlikely. Metabolites of PACs and other constituents of cranberry exhibit most probably a pharmacological activity."

In 2014, the French company Arkopharma had its EU medical device status revoked by France's medical products regulator (ANSM) after obtaining Class IIb medical device status for its patented cranberry-based products based on clinical data. ANSM said at the time that Arkopharma lacked the data to justify its device status.

The formal adoption and publication of the commission's decision are expected later this summer.




内容来自:RAPS

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