20141112 ECA新闻：源自日本的某些药品进口限制

20141112 ECA新闻：源自日本的某些药品进口限制  

2014-11-13 22:40:14|  分类： ECA新闻

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GMP News
12/11/2014

Import Restrictions for some Products from Japan

源自日本的某些药品进口限制

In 2011, the Fukushima Daiichi nuclear power plant was severely damaged after the Tsunami tragedy, followed by a radiation leak. Since that, European regulatory authorities have been working with international regulatory partners to ensure that appropriate measures are taken to monitor food and pharmaceutical products coming from Japan.

在2011年，福岛第一核能电厂在海啸灾难后严重受损，随后发生放射泄漏。自该事件后，欧洲法规当局已经与国际法规同行一起努力保证采取适当的措施对来自日本的食品和药品进行监控。

In the CMDh paper "Monitoring of medicines originating from Japan" it is stated that "to date, no risks from radioactive contamination have been identified in any medicines imported to the European Union (EU) and the likelihood of such contamination occurring is considered to be minimal." However in the interest of patient safety, the CMD(h) has issued the regulation (EU) 322/2014 defining measures to be put in place in the EU for food and animal feed.

在CMDh关于“来自日本的药品监控”文件中，声明“到目前为止，在已进口至EU的药品中还没有发现放射性污染风险，很有可能这类污染可以被认为是非常的小”。但是，为了患者安全着想，CMD已经签发了EU规定322/2014，其中指明了在EU内针对食品和动物饲料所要采取的措施。

As a consequence, the Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human (CMD(h)) (part of the Heads of Medicines Agencies) has now revised its document defining restrictions for medicinal products from certain areas in Japan. The following measures listed apply to all medicines "manufactured, partially manufactured, transited or stored in Japan with the exclusion of products" which have been manufactured after March 2011:

因此，人药互认和非集中程序协调组（CMD）（药品监管机构主管的一部分）现在已修订了其文件，对来自日本某些区域的药品进行了限制。以下所列措施适用于所有2011年3月后“在日本生产、部分生产、转港或存贮”的药品，有部分例外另行列出。

• "For medicines manufactured, partially manufactured, transited or stored in the prefecture of Fukushima, testing for the presence of radioactivity is still required."
• “在福岛辖区内生产、部分生产、转港或存贮的药品，仍需要检查放射性”
• "For medicines manufactured, partially manufactured, transited or stored in the prefectures of Gunma, Ibaraki, Tochigi, Miyagi, Saitama, Tokyo, Iwate, and Chiba and Kanagawa, testing is only required for medicinal products containing raw materials of fish, animal or vegetal origin sourced from these prefectures."
• “在群马、茨城、枥木、宫城、畸玉、东京、岩手、千叶和神奈川辖区内生产、部分生产、转港或存贮的药品，只需要测定含有产自这些辖区的鱼、动物、植物来源的原料的药品”
• "For medicines manufactured, partially manufactured, transited or stored in other Japanese prefectures, no additional testing for the presence of radioactivity is required."
• “在日期其它辖区生产、部分生产、转港或存贮的药品，不需要加测放射性物质”
• "Testing of cytotoxic products irrespective of origin is not requested in view of the potential risks to the operators and the minimal likelihood of radioactive contamination as confirmed by the data available to date."
• “从对操作人员的潜在风险来看，不需要进行与产地无关的细胞毒素测试，截至目前为止的得到的数据已确认放射性污染的可能性是很小的”
• "European Regulatory Authorities have, in addition, decided that medicines coming from manufacturing sites in any of the listed prefectures where satisfactory test results have been recorded are no longer requested to be tested."
• “另外，欧洲法规当局已经做出决定，凡来自上述所列辖区内生产场所的药品，如果之前已有记录合格的检测结果，则不需要再次检测”
  

As with the food measures, the approach is expected to be applicable until 31 March 2015 and will be reviewed again at that time.

关于食品方面的措施，预期在2015年3月31日会给出方案，那时将会再次进行审核。

The Co-ordination Group for Mutual Recognition and Decentralised Procedures - Human, CMD(h), has been set up in the revised Pharmaceutical Legislation (Directive 2004/27/EC amending Directive 2001/83/EC) for the examination of any question relating to marketing authorisation of a medicinal product in two or more Member States in accordance with the mutual recognition procedure or the decentralised procedure. The CMD(h) has started its activities in November 2005 and replaced the informal Mutual Recognition Facilitation Group, which was in operation over 10 years, to coordinate and facilitate the operation of the mutual recognition procedure.

CMD（h）是根据修订后的药品法（指令2004/27/EC修订2001/83/EC）建立的，目的是根据互认程序或非集中审批程序检查所有与2个或2个以上成员国内药品上市许可相关的问题。CMD已经在2005年开始其工作，以代替之前的互认推进组，该互认推进组运行了10多年，目的是协调和推进互认程序的运作。

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272014101333112900/

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好资料，谢谢