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...[more]

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...[more]

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...[more]

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...[more]

BE: Update of the national eSubmission Guideline and corresponding NeeS checker

The Belgian Federal Agency for Medicines and Health Products (FAGG) has released an updated version 2.11 of the national eSubmission Guideline applicable for electronic...[more]

CMDh releases updated Best Practice Guide for the use of eCTD in MRP/DCP

The Co-ordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released an updated revision 3 of the "Best Practice Guide on the Use of the...[more]

Updated national eSubmission guidance for Spain released

The Spanish Medicines Agency AEMPS (Agencia Española de Medicamentos y Productos Sanitarios) has releases and updated version 2.1 of their national eSubmission guidance...[more]