The Danish Medicines Agency (DKMA) has restructured the information regarding submission format for paper applications and electronic drug applications in eCTD / NeeS format. In...[more]
The Telematic Implementation Group for electronic submission and ICH Implementation (TIGes) has updated the clarification document on the draft eCTD validation criteria 3.1 that...[more]
The U.S. Food and Drug Administration (FDA) has released an updated version 1.6 of the "Study Data Specifications" used for submitting animal and human study datasets in...[more]
A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes. The new version number is presumably 1.26 and has the official ...[more]
The Telematic Implementation Group for electronic submission and ICH Implementation(TIGes) has published additional clarification on the draft eCTD validation criteria 3.1 as...[more]
The European Medicines Agency has released new status reports regarding the European eSubmission Gateway and the electronic Application Form (eAF) projects. Both status reports...[more]
The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has announced in the CMDh meeting report from May 2011 that the deadline for using the...[more]
