3月6日，记者在中国医药设备工程协会2013年年会上获悉，目前国家药品监督管理部门已初步确定，将以省为单位出具原料药出口欧盟证明文件，并对出口欧盟的原料药划定了监管范围，以应对今年7月2日正式实施的欧盟有关原料药进口的62号令，具体实施办法有望于3月底发布。 

On March 6,,Journalists in China medical equipment engineering association 2013 annual meeting,At present, the national drug supervision and administration department has preliminary determined,The API exports to the eu certificate issued in the provinces,And API defined scope of the regulation of exports to the eu,In response to this year on July 2, the formal implementation of the European Union relevant API imports of decree 62,Specific measures is expected to be released in late march. 

　　出口监管升级 

Export regulations 

　　2011年6月，欧盟通过了一项有关原料药进口的新指令2011/62/EU（62号令），要求出口到欧盟的原料药的国家或地区的监管部门必须出具生产企业每一批次产品均符合欧盟GMP标准的书面证明。该指令被国内原料药界视为具有重大“杀伤力”的外贸政策之一。 

In June 2011,The European Union adopted a new directive 2011/62 / EU about API imports(62 call to arms),Request API's country or region's exports to the eu regulators must provide each batch production enterprise products comply with eu GMP standard written proof.The directive by domestic industry as a significant API"lethality"One of the foreign trade policy. 

　　中国医药保健品进出口商会相关数据显示，目前，我国出口到欧盟的原料药数量约占医药商品年出口量的25%左右，欧盟是我国原料药贸易的主要市场之一，欧盟出口情况的变化对我国医药出口影响较大。 

Chinese medicine and health products import and export chamber of commerce data show,At present,Our country exports to the eu about the number of active pharmaceutical ingredients of pharmaceutical products in about 25% of exports,The eu is one of the main market of active pharmaceutical ingredients in China trade,The eu export conditions change medicine export influence to our country. 

　　一家原料药生产企业的相关人士表示，从海关统计数据来看，在我国原料药出口结构中，有相当一部分是化工企业生产的，由于未按药品生产规范生产，其生产成本较低，质量难以保证，这类产品的出口不仅扰乱了出口市场秩序，同时也形成了安全隐患，被国外所诟病。 

A relevant personage says API production enterprises,Statistics from the customs,API in the export structure in our country,There are quite a part of the chemical enterprise production,Because not according to pharmaceutical production specification production,Its production cost is low,Quality difficult to guarantee,This kind of product export export not only disrupted the market order,At the same time formed the safe hidden trouble,Be living abroad. 

　　据了解，在过去很长的时间里，原料药，尤其是中间体生产与化工企业有着千丝万缕的联系，在医药行业推进GMP认证过程中，国家药品监管部门也曾努力推进原料药企业GMP认证。由于监管权限所限，化工企业不进行相关认证，但它们生产原料药的情况仍大量存在。这部分产品在国际贸易中占据成本优势，对规范原料药出口造成一定冲击。 

We have learned,In the past for a long time,Active pharmaceutical ingredients,Especially connected intermediate production and chemical industry,In the process of the pharmaceutical industry to promote GMP certification,National drug regulatory department has also pushed for API GMP certification enterprises.Due to the limitation of authority,Chemical enterprise carries on the related certification,But they still exist in their production of active pharmaceutical ingredients.This part of the products occupy a cost advantage in international trade,A certain impact on standard API exports. 

　　目前，我国出口欧盟的原料药大约有3种类型的产品：第一类是既有《药品生产许可证》又有批准文号的原料药产品；第二类是有《药品生产许可证》，但没有批准文号，专供出口的原料药产品；第三类则是既没有《药品生产许可证》，也没有批准文号的出口产品，这部分出口产品集中在化工企业。 

At present,China's exports to the eu's API is about three types of products:The first is both[Pharmaceutical production license]Have approval number of the API product again;The second type is[Pharmaceutical production license],But there is no approval number,API products for export;The third kind is neither[Pharmaceutical production license],No approval number of export products,This part of the export products focused on the chemical enterprise. 

　　国家局药品安监司生产监督处处长翁新愚表示，未来国家药品监管部门将对前两类产品按照一定程序开具证明。不对第三类开具证明文件。 

Commissioner of country AnJianSi drug production supervision, weng new fool said,Before the future national drug regulatory authorities to two kinds of products according to certain procedures issued certificate.Issued by the third class documents. 

　　外贸供应链革命 

Foreign trade supply chain revolution 

　　有业内人士评价说，几年前国家药品监管部门就已决心着手整治原料药市场，之前也进行过全国原料药情况摸底调查。此次欧盟62号指令的实施只是加速了国家整治原料药生产经营的进程，对原料药出口欧盟出具证明文件也将从根本上净化国际贸易购销链条。 

Evaluation of the personage inside course of study says,A few years ago, the national drug regulatory department has determined to start renovation market API,And active pharmaceutical ingredients in China is also done before baseline survey.The implementation of the eu directive no. 62 is just speeded up the process of API production and operation of state regulation,Eu exports to API documentation will also be issued by purification fundamentally international trade procurement chain. 

　　众所周知，原料药出口是我国医药出口贸易的主力军，其起步较早，成绩斐然。尤其是在大宗原料药领域，我国已成为全球最主要的生产供应基地。然而，在国际贸易中，我国原料药却一直备受打压，同时国际社会对中国原料药存在假劣药的质疑也不绝于耳。 

As is known to all,API is the main force of China's pharmaceutical export trade export,The early start,Remarkable achievements.Particularly in the field of bulk active pharmaceutical ingredients,Has become the world's main production supply base in China.however,In international trade,Active pharmaceutical ingredients in China has been much maligned,At the same time the international community on China's API is JiaLie medicine also has doubts. 

　　“现在并不知道化工企业产品出口欧盟的具体数量，因此无法预测卡住化工企业的这部分出口会对市场产生怎样的影响。江浙一带是化工产业发达地区，许多企业涉及原料药的出口，实施证明文件管理，无疑会对该地区造成一定影响。”论坛上一家企业代表坦言。 

"Now do not know the specific quantity chemical enterprise products are exported to the eu,So we can not predict stuck this part of the chemical enterprise exports will what effect to the market.Developed areas in jiangsu and zhejiang area is the chemical industry,Many enterprises involved in the export of active pharmaceutical ingredients,Implementation of document management,Will no doubt cause certain influence to the region."A company representative said on BBS. 

　　事实上，出具证明文件的本质是，欧盟试图通过国家信用手段净化欧盟市场，提高进口产品的安全性。然而，对于我国监管部门来说，在未来监管中亟待破解的难题仍然很多。 

In fact,,Is the nature of the issue a certificate file,The eu tried to through the national credit means to purify the eu market,To improve the safety of imported products.however,For China's regulators,Regulation in the future the problem remains to be cracked in the lot. 

　　有业内专家表示，出口欧盟的原料药许多是通过转口贸易完成的，化工企业出不去的产品是否可能“借船出海”呢？在此情形下，文件防伪，确认其唯一性显得特别重要。另外，建立覆盖全国与海关联动的数据库也是杜绝化工产品出口的关键手段之一。 

Industry experts said,The API many eu exports by entrepot trade,Where chemical enterprise products if possible"By boat out to sea"??In this case,File security,Is very important to confirm its uniqueness.In addition,Set up covering the whole country and customs of database is one of the key means to put an end to the export of chemical products. 

　　中国医药保健品进出口商会相关数据显示，去年，我国医药外贸出口的一个重大变化是传统的大宗原料药出口强势品种表现不尽如人意：出口额排名前25位的西药原料药出口额同比下降18.9%；医药大省出口增速放缓，江苏、广东的医药出口分别增长4.7%、2.5%，山东下降0.2%，低于全国平均水平。该协会预测，随着医药外贸企业转型升级走向深入，国内市场由于新医改的实施而不断扩容，拉动进口增长，以及医药产品刚性需求带动等，2013年我国医药进出口增长率有望达12%。 

Chinese medicine and health products import and export chamber of commerce data show,Last year,,Chinese medicine export a significant change is one of the traditional export commodities API varieties of strong performance is not satisfactory:Exports of the top 25 western medicine API exports fell 18.9% year on year;Medical province slowing export growth,jiangsu/Guangdong pharmaceutical export growth of 4.7%, respectively/2.5%,Shandong fell by 0.2%,Below the national average.The association predicted,Along with the medicine to the deepening of foreign trade enterprise transformation and upgrading,The domestic market are expanding due to the implementation of the new health care reform,Pull the import growth,And pharmaceutical products rigid demand, etc,Our country medicine import and export rate is expected to reach 12% in 2013. 

　　东药集团进出口公司高级文件经理徐禾丰表示，药监部门对出口欧盟原料药出具证明文件措施的实施，将对我国原料药出口购销供应链进行全面梳理，使之最终走向透明，这对于监管部门和企业来说都是一个挑战。但从长远来看，此举有利于净化我国原料药市场，增强我国原料药的国际竞争力。 

DongYao senior file manager xu said wellhope group import and export corporation,Issued by the agency for exports to the eu API documentation on the implementation of the measures,The API export procurement supply chain to conduct a comprehensive combing to our country,Finally to transparent,For the regulatory authorities and enterprises is a challenge.But in the long run,The move is conducive to purify API market in our country,Enhance the international competitiveness of China's active pharmaceutical ingredients. 

　　翁新愚强调，国家局还在认真研究具体实施细则，其实施原则是，属于医药监管范围的一定要管好，不属于监管范围的药监部门不会开具相关证明文件。具体内容以发布细则为准。

Weng new foolish emphasize,Specific implementation details, country is still in serious research,Its implementation principle is,Falls within the scope of medical supervision must manage,Do not belong to the scope of regulation issued by the agency won't related documents.Specific content to release detailed rules shall prevail.