20150326 ECA新闻：EU数据库中GDP证书和WDA---需要改进

20150326 ECA新闻：EU数据库中GDP证书和WDA---需要改进  

2015-03-26 23:12:44|  分类： ECA新闻

来源：http://zhuyujiao1972.blog.163.com/blog/static/986947272015226111244326/

GMP News
26/03/2015

GDP Certificates and WDAs in the EU Database - Improvement Needed

EU数据库中GDP证书和WDA---需要改进

  The revised Good Distribution Practice Guide in the EU which was introduced in March 2013 was triggered by the so called Counterfeit Directive. This was of course never the official name, but it was the intention of the European Commission to ensure a secure Supply Chain and to prevent illegal/counterfeit medicinal products from entering into the legal supply chain.

2013年3月公布的修订后的欧盟GDP指南是由所谓的防伪指令引发的。这当然并不是官方给定的指令名称，并其目的是欧盟委员会要保证供应链安全，防止非法/假药进入合法供应链。

A number of cases have been identified where illegal medicinal products have entered the legal supply chain. Moreover, it was recognized that there is a well established (GMP) control when it comes to manufacturing of medicinal products, but once the product has left the facility of the manufacturer, there is little control. Products have been transported and stored, but nearly no pharmaceutical manufacturer seems to be able to monitor the full supply chain. Products may be stored at the airport or in trucks but not always with the necessary controls in place.

大量案例已显示非法药品已进入了合法供应链。并且，大家也认识到现在当药品进入生产阶段，其会受到很好的GMP控制，而一旦离开了生产场所，则控制就很少了。药品被运输和存贮，但几乎没有药品生产商能够监控整个供应链。药品可能会被存贮在飞机场或在卡车里，而并不能总是受到必要的控制。

As one of the consequences from the Counterfeit Directive an European wide authorisation and monitoring system has been established. Member States are supposed to enter their information relating to the authorisations referred to article 77(4) in the Union Database (EudraGMDP). Each Wholesaler will need a Wholesale Distributor Auhorisation (WDA). Those facilities that have been audited will receive a GDP certificate. It is the intention that the publicly available information about WDAs and GDP certificates will enable the responsible persons to establish a legal supply chain for the products by choosing competent and trustworthy companies.

防伪指令的结果之一就是整个欧洲已建立了批准和监控系统。成员国被要求将其关于批准的信息输入欧盟GMDP数据库。每个批发商将需要一份批发销售许可证（WDA）。那些已被检查过的场所被收到一份GDP证书。将WDA和GDP证书信息公开的目的是使得责任人可以通过选择有资质的值得信任的公司，来建立其产品合法的供应链。

However, for the time being it is difficult to use the information in the European Database for the purpose of establishing a controlled supply chain. The data in EudraGMDP are currently incomplete and cause some discussions among the stakeholders who access the data. The following information is taken from EudraGMDP on 9 March 2015:

但是，到目前为止，还是很难使用这些欧洲数据库里的信息来建立受控的供应链。欧洲GMDP数据现在还不完整，在进入数据库的干系人中引发了许多讨论。以下信息是2015年3月9日在欧洲GMDP数据库中获得的：

Germany 141 WDAs
Belgium 141 WDAs
Denmark 199 WDAs
Portugal 199 WDAS
Spain 3 WDAs
France 5 WDAs
Sweden 233 WDAs
Netherlands 275 WDAs
Norway 152 WDAs
Malta 67 WDAs
Poland 704 WDAs
United Kingdom 2303 WDAs

德国 141份WDA

比利时141份WDA

丹麦199份WDA

葡萄牙199份WDA

西班牙3份WDA

法国5份WDA

瑞典233份WDA

荷兰275份WDA

挪威152份WDA

马尔它67份WDA

波兰704份WDA

英国2303份WDA

It seems to be unlikely that these figures represent the real situation. Still not all data have been entered into the database. This can lead to confusion among stakeholders who access this data. Wholesalers not listed in the database might have problems to convince their customers that they have the necessary authorisation for dealing with medicinal products. The numbers above cause a number of additional questions, e.g. "Why does the UK and Poland issue more WDAs than all other EU states ina total?" Or "Is it logical that Germany has less WDAs than Denmark and Portugal?"

这些数字貌似不太可能代表了真实的情形。看来并非所有的数据已被输入数据库。这可能会在进入数据库的干系人中引起混乱。未被列入数据库的批发商可能会面临困难，难以说服其客户实际其具备必须的许可证来处理药品。上述数据导致了很多另外的问题，例如“为什么 英国和波兰签发了比所有其它欧盟国家合起来都要多的WDA？”或“德国的WDA比丹麦和葡萄牙还要少，不太合逻辑哦？”

A closer look at the GDP certificates which have been entered into the database even cause more questions. Some figures below:
United Kingdom: 1560 GDP Certificates
Germany 3 GDP Certificates
Austria 383 GDP Certificates
Portugal 198 GDP Certificates
Poland 0 GDP Certificates

再看一下已输入数据库里的GDP证书情况，就会引起更多问题了。一些数据如下：

英国1560份GDP证书

德国3份GDP证书

奥地利383份GDP证书

葡萄牙198份GDP证书

波兰0份GDP证书

Does this mean that Portugal has audited all WDA holders, except for one? How many GDP Certificates might already exist in other countries but have not been entered into the EU Database?

这是不是说波兰已经审计了所有的WDA持有人，只有一个除外？在其它国家里有多少GDP已经存在但还没有输入欧盟数据库呢？

The above figures only represent a snapshot of the current status of EudraGMDP. But 2 years after the EU GDP Guide has been published some more work is needed to make sure that the objectives of the EU Directive will be met.

上述数据仅代表了现在欧盟GMDP数据的一个缩影。但是在EU GDP公布2年后，还有很多工作需要去做，以保证达到EU指令的目标。

Source: EudraGMDP