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EMA updates XEVPRM FAQ

The European Medicines Agency has released an updated version of the XEVPRM FAQ, document EMA/945380/2011. The new version, dated 21 June 2012 has no version number and includes...[more]

EMA releases further updated XEVMPD controlled vocabularies for Substances and Organisations

The European Medicines Agency (EMA) has released further updated versions of the following XEVMPD controlled vocabularies:

Organisations (WC500123647), version 4.0Substances...[more]

EMA issues new version of the Post-authorization procedural advice for users of the Centralized Procedure

The European Medicines Agency (EMA or the Agency) has released a further update of their "Post-authorization procedural advice for users of the centralized procedure",...[more]

EMA launches XEVMPD e-learning course to support Article 57(2) compliance and further updates XEVMPD controlled vocabularies

The European Medicines Agency (EMA) has launched the long-awaited XEVMPD e-learning course to support compliance of Marketing Authorisation Holders (MAHs) with Art. 57 (2) of...[more]

EU eCTD Change Request/Q&A tracking table updated by TIGes

The Telematics Implementation Group - electronic submissions (TIGes) has released an updated version of the EU eCTD Change Request/Q&A Tracking Table.  Compared to the...[more]

EMA releases version 3 of the Controlled Vocabulary for XEVMPD Substances

The European Medicines Agency (EMA) has released a further update of their controlled vocabulary containing the list of substances published in XEVMPD.

In this new version 3, 213...[more]

New XEVMPD controlled vocabularies published by EMA

The European Medicines Agency (EMA) has published new versions 2.0 of some of the controlled vocabularies required to comply with the requirements on submission of...[more]