eCTD (Electronic Common Technical Document), is a standard format and interface for electronic delivery of documentation submitted to Medicines Agency for the purposes of registration of medicines or variations. eCTD structure is based on CTD format (Common Technical Document).
The intensive preparations are underway for the implementation of electronic filing and processing applications (eCTD) in practice. Launch of this process is by the end of 2011. For the success of the eCTD project is inavitable that applicants are familiar with the requirements to fill an application and its identification.
Up to 10th June 2011, 37 applications submitted to SIDC in eCTD format have been tested. Only 3 (~8%) applications fully meet the validation criteria of eCTD version 3.1.
For More Information Please click here: SIDC(Slovakian Agency) Ongoing eSubmissions Issues
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