eCTD News

EMA releases version 3 of the Controlled Vocabulary for XEVMPD Substances 08.05.2012
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...[mehr]
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New XEVMPD controlled vocabularies published by EMA 30.04.2012
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...[mehr]
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EMA informs stakeholders about reduced data requirements for XEVMPD 01.02.2012
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...[mehr]
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ectdexperts 14.05.2012, 14:50
Irish Medicines Board updates Guide to electronic submissions http://t.co/arCEwGrR #eCTD
ectdexperts 14.05.2012, 11:08
#FDA Guidelines for requesting waiver to current supported clinical study data standard versions http://t.co/PpB5ScL3
ectdexperts 08.05.2012, 10:17
EMA launches also two-week survey to gather information to the future development of their eSubmission website http://t.co/66yijfvh
ectdexperts 08.05.2012, 10:15
EMA launches two-week survey to gather feedback on use of the EudraVigilance website http://t.co/qnh2sXZJ
ectdexperts 30.04.2012, 12:02
EMA requires VNeeS submissions to be 100% compliant to guideline by June 01, 2012 http://t.co/UlxDauoD
ectdexperts 30.04.2012, 11:56
Health Canada terminates Non-eCTD Hyprid Pilot phase by end of March 2013 http://t.co/DzhTvJXj #eCTD
ectdexperts 30.04.2012, 11:31
New XEVMPD controlled vocabularies published by EMA http://t.co/o4THC0qw #XEVMPD; #EVMPD
ectdexperts 05.04.2012, 18:42
The #EVMPD workshops in Dublin and Munich have been a great success - join us in Amsterdam! http://t.co/B35UiInt
ectdexperts 05.04.2012, 18:40
EU CMDh updates guidance documents for the submission of variations http://t.co/i7bQaH7d
ectdexperts 05.04.2012, 18:39
Health Canada releases Draft for consultation: Preparation of Drug Regulatory Activities in eCTD http://t.co/hkn5GAYv