EMA将启动eCTD电子提交试运行

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EMA将于2012年1月9日启动eCTD电子提交，邀请制药企业注册加入位于3个月的试运行工作。

http://www.ema.europa.eu/ema/index.jsp?curl=pages/news_and_events/news/2011/11/news_detail_001393.jsp&mid=WC0b01ac058004d5c1

23/11/2011

European Medicines Agency invites registrations for eSubmission GatewayThe European Medicines Agency is inviting pharmaceutical companies to register to take part in a three-month pilot of its eSubmission Gateway, beginning on 9 January 2012.
The eSubmission Gateway is a new electronic submission channel that applicants will be able to use to submit applications for centralised marketing authorisations for human medicines in the Electronic Common Technical Document (eCTD) format. This includes new applications, supplementary information, variations and renewals of marketing authorisation.
The Gateway will use a secure business-to-business transfer process to allow companies to send electronic applications to the Agency. This is expected to improve the speed and efficiency of the application process.
The pilot will be open to a limited number of applicants. Depending on its results, the Agency will consider extending use of the Gateway to all applicants.
The Agency is also working towards a web-based submission client for low-transmission volumes, which may be more suitable for small and medium-sized companies. It will announce plans for this client in the first quarter of 2012.
Companies interested in taking part in the pilot will need to have access to the Electronic Standards for the Transfer of Regulatory Information (ESTRI) Gateway.
Full details of how to register are available on the eSubmission Gateway web page.