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Update: FDA releases new minor version of PDF specifications

Update to News from Jan 04, 2012: Meanwhile, FDA has released a new minor version 3.1 of the PDF specification (see original News below). The minor update includes clarification...[mehr]

EMA updates template for eCTD cover letters in the Centralized Procedure

The European Medicines Agency (EMA) has published a new version of their template for administrative information to be presented in eCTD cover letters within the EU Centralized...[mehr]

Saudi SFDA publishes roadmap to eCTD, GCC releases Module 1 specification

The Saudi Food & Drug Authority (SFDA) published some further information regarding their road map towards electronic submission implementation:

Starting from December 20,...[mehr]

EU eCTD Module 1 specification version 1.4.1 released

The final version 1.4.1 of the EU eCTD Module 1 specification have been released by EMA. The new version which has the version date "November 2011" incorporates the...[mehr]

FDA releases new version of their eCTD validation criteria and updates transmission specification

The U.S. Food and Drug Administration (FDA) has released a new version of their eCTD validation criteria. The new version 2.1 is dated 12/20/2011 and contains significant changes...[mehr]

Updates regarding EU Change Request Tracking table and Change Control Processes

A new version of the EU Telematics EU eCTD Change Request/Q&A Tracking Table has been released by TIGes. The new version 1.28 of the Tracking Table contains changes from the...[mehr]

French Afssaps issues new version of their national Notice to Applicants

The French Drug Regulatory Agency Afssaps has released an updated version of their national "NOTICE TO APPLICANTS FOR MARKETING AUTHORISATIONS FOR MEDICINAL PRODUCTS FOR...[mehr]