New draft version of technical EU eCTD/NeeS validation criteria released for consultation

The Telematics Implementation Group for electronic submissions (TIGes) has released new draft versions for public consultation of the EU technical validation criteria for eCTD...[more]

EMA informs stakeholders about reduced data requirements for XEVMPD

The European Medicines Agency informed stakeholders from the pharmaceutical industry about the proposed way forward to progress with the implementation of Article 57(2) of...[more]

CMDh releases new version of the cover template for new applications submitted through MRP/DCP

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMDh) has released revision 3 of the cover letter template that should be used by applicants...[more]

UK MHRA details technical validation process for eCTDs

The Medicines and Healthcare products Regulatory Agency (MHRA) in the UK has released some information regarding the technical validation of electronic Marketing Authorisation...[more]

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...[more]

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...[more]

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,...[more]