欧盟市场原料药生产概览

julia朱玉姣

Overview about API manufacturing for the European market

欧盟市场原料药生产概览

EudraGMDP provides some interesting information about the API manufacturing sites as well as about importers, distributors of APIs to be used as starting material in Medicinal Products for human use in Europe. Although the database is still not complete (not all competent authorities in Europe have established a system to make sure that all registration data will be entered into EudraGMDP in a timely manner) the current information is already very interesting.

欧洲药事GMDP数据库提供了一些关于原料药生产场所的有意思的信息，以及用作人药用起始物料的原料药在欧洲的进口商、分销商的信息。尽管数据还不完整（并不是所有欧洲国家药监局都建立了体系来保证及时将所有登记数据输入欧洲药事GMDP数据库），现在的信息已经很有意思了。

Currently (as per 19 March 2015) the database counts 3.275 API manufacturing sites, importers or distributors located outside Europe. On the other side 936 API manufacturing sites, importers or distributors are located in EEA countries (EU Member states plus Norway, Liechtenstein and Iceland). According to the database India counts for 1.473 companies and China for 1102 companies. The USA only counts for 198 and Switzerland for 71 companies. Within the EEA the United Kingdom counts 138 countries while Italy counts for 71and Spain for 192. Still work is needed to put all information into the database as France does not have a single entry and Germany only 3.

现在数据库中，欧盟境外有3275个原料药生产场所，进口商或分销商，另一方面936个原料药生产场所、进口商或分销商是在EEA国家（欧盟成员国加上挪威、冰岛和列支敦士克）。根据数据库里的数据，印度有1473个公司，中国有1102个公司，美国只有198个公司，瑞士有71个公司。在EEA境内，英国有138个公司，意大利有71个，西班牙有192个。应该还有很多信息没有输入数据库，因为法国显示一个数据都没有，德国只有3个。

But the database is a good source to find some basic information about API manufacturers, importers and distributors. Each company registration file is available and allows to check the date of issue of the registration and the products concerned. However, it must be stated that a registration does not mean that an inspection took place. A registration will be granted also without a prior inspection at the company.

但数据库是一个发现原料药生产商、进口商和分销商基本信息的好地方。在这里可以找到每个公司的注册文件，可以查看签发注册的日期，相关产品名称。但是，必须要说明的是注册并不代表已经经过了现场检查。没有对公司进行检查前也可以颁发注册的。

Source: API Registration in EudraGMDP

yanzhengren

谢谢分享。

Whats

谢谢分享。

孙艳红

印度有1473个公司，中国有1102个公司，原料出口大国

syhorchid

了解一下

新鲜的空气

了解一下
谢谢分享

土豆王

感谢分享，了解一下。