eCTD News

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]

CA: Update from Health Canada regarding scope of submissions being accepted in eCTD format and acceptance of electronic-only submissions

Health Canada has released an update regarding the scope of submissions currently accepted in eCTD format. Furthermore selected submission types will be accepted in eCTD-only...[more]

Updated information regarding RPS R2 DSTU and RPS R3 available from HL7

Health Level 7 international has released new information regarding the development of the Regulated Product Submissions (RPS) standard.

The new information includes:

A new...[more]

DE: New version of the eValidator available from BfArM

The German Federal Institute of Drugs and Medical Devices (BfArM) has released a new version of the eSubmission validation software "eValidator" (by Lorenz,...[more]

EU: Best Practice Guide for the submission and processing of variations in MRP updated by CMD(h)

The CMD(h) - Coordination Group for Mutual Recognition and Decentralized Procedures - Human has relased an updated revision 9 of the "Best Practice Guides for the Submission...[more]