News Archiv

EU: PIM DES 2.8 beta relased by EMA

A new beta version of the PIM (Product Information Management) DES (Data Exchange Standard) v2.8 has been released by the EMA. The Beta release is provided to stakeholders for...[more]

EU: New eCTD implementation survey report Jul. - Dec. 2009 released by TIGes

The Telematics Implementation Group for Electronic Submissions (TIGes) has released the 5th version of the EU eCTD implementation survey report (see download link at the bottom of...[more]

EU: CMD(h) releases further updated Q&A-list for the submission of variations

The Coordination Group for Mutual Recognition and Decentralized Procedures - Human (CMD(h)) has released yet another updated version (revision 7) of the "Q/A-List For The...[more]

EU: TIGes releases Notice of Intent to update the European eCTD validation criteria

The EU TIGes (Telematic Implementation Group) Harmonisation Group has released a Notice of Intent to update the European validation criteria for eCTD and NeeS as the latest...[more]

EU: Further updates regarding PIM released by EMA

Only 1 day after the last PIM update (see our related News Article), the EMA has posted some more updates:

The "PIM Concepts" document which has been published...[more]

EU: Updates regarding PIM released by EMA

Update from 27-Aug-2010:

Further updates regarding PIM have been released by the EMA (see our corresponding News Article). Among them, a new version v2.2 of the "PIM...[more]

EU: Updated additional data requirements for MRP/DCP published by CMD(h)

The CMD(h) published an updated table (revision 5) for "Data requested for New Applications in the MRP/DCP which are not stated in the current EU legislation and/or in Volume...[more]