News Archiv

We have moved our offices!

Facing our 5th Anniversary in July this year, we are happy to inform you that we have relocated our offices into a neighboring building of the "Center of Innovation and...[more]

Spanish Medicines Agency updates national electronic submission guidance

The Spanish Medicines Agency "Agencia Española de Medicamentos y Productos Sanitarios (AEMPS)" has released an updated version 2.2 of their national electronic...[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]

Swissmedic releases version 1.4 of their national "Q&A of Swissmedic eCTD Implementation"

The Swiss national drug regulatory agency Swissmedic has released an updated version of their "Questions & Answers of Swissmedic eCTD Implementation". The Q&A...[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]