中印联合抵制欧洲原料药新进口法， 以下是原文

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India, China plan to jointly oppose EU regulation on API at WTO forum
Joseph Alexander, New Delhi
Monday, August 06, 2012, 08:00 Hrs  [IST]  

India and China may together move the World Trade Organisation (WTO) against the European Union (EU) regulation on bulk drugs which may affect the current exports of Active Pharmaceutical Ingredients (APIs) from both the countries to Europe.

EU has changed the rules for importing active substances into EU for medicinal products for human use and the amended regulation would come into effect fully by July 2013. It would make mandatory the current good manufacturing practices (cGMP) certificate from the local authority for all bulk drugs exports.

Sources said the Commerce Ministry had already taken up the matter with the EU authorities as the directive is expected to pose serious challenge to the API exports and is meant to secure the EU pharma supply chain.

Under the technical barrier to trade (TBT) provisions, India can raise the issue at the WTO forum and it is learnt that India would all possibly make a joint statement with China at the next meeting of the WTO. China Chamber of Commerce had already written to Pharmaceutical Export Promotion Council of India (Pharmexcil) on the possibility of making joint representation, it is learnt.

China’s share in EU’s API imports is 12 per cent while India commands only two percent share in the API imports into the EU. Hence, China is going to be affected more than India.

The Commerce Ministry has also sought the opinion of the Bulk Drug Manufacturers Association over the issue.

Meanwhile, the industry representatives are also trying to take up the issue with Drugs Controller General of India (DCGI). Industry had pointed out that the DCGI was not authorized or conversant enough with EU GMP standards to issue certification. The companies will have to produce such certificates even after their manufacturing facilities and products (meant for exports) get all regulatory clearances directly from the EU drug regulatory authorities in that case.

青松

印度，中国计划联合反对欧盟监管API在WTO论坛
约瑟夫·亚历山大，新德里
8月6日，2012年08:00 [IST]   

印度和中国可以共同推动世界贸易组织（WTO）对欧盟（EU）的规定，可能会影响目前的出口活性药物成分（API）从国家到欧洲的原料药。

欧盟已经改变了规则导入活性物质进入欧盟人用医药产品和修订规例来2013年7月全面生效。这将作出强制性地方当局的所有原料药出口的现行良好生产规范（cGMP）证书。

消息人士称，商务部已经采取了与欧盟当局的指令的API预计将构成严重的挑战为了确保出口和欧盟医药供应链

贸易（TBT）规定的技术壁垒，印度提出的问题，在WTO论坛，据悉，印度将可能使中国在未来的联合声明中世界贸易组织的会议。中国商会已经已经书面医药出口促进委员会印度（Pharmexcil）联合表示的可能性，这是教训。

中国占欧盟的API进口的份额是12％，而印度命令只有2％份额的API进口加入欧盟。因此，中国将超过印度受到影响。

商务部还征求了意见，在此问题上的原料药制造商协会。

同时，业界代表还试图把印度药品管理的问题（ DCGI）。业内人士指出，DCGI没有被授权或不够熟悉欧盟GMP标准，颁发认证。该公司将不得不产生这样的证书，即使在他们的生产设施和产品（指出口）获得监管机构的批准，在这种情况下，直接从欧盟药品监管部门。

简单生活

希望中印能联合行动成功,期待着结果

惜姌

原文看不懂啊~~~

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惜姌 发表于 2013-3-21 11:18
原文看不懂啊~~~

一楼不是有翻译么？？？、

惜姌

平淡映 发表于 2013-3-26 08:54
一楼不是有翻译么？？？、

哦哦！⊙０⊙~~

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惜姌 发表于 2013-3-26 09:29
哦哦！⊙０⊙~~

伤不起。。。。。。。。。。。。。。。。。