eCTD News

Registration procedure for EudraVigilance updated 16.05.2013
The following updates regarding the Registration with EudraVigilance have been announced by the European Medicines Agency: Virtual affiliate Registration: New instructions...[more]
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Swissmedic releases updated version of Art 13 TPA guidance and checklist formal control 12.04.2013
The Swiss Drug Regulatory Agency Swissmedic has released an revised version 3.0 of the "Administrative Ordinance Instructions: Authorisation of medicinal products...[more]
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ectdexperts 12.04.2013, 17:38
Swissmedic releases updated version of Art 13 TPA guidance and checklist formal control http://t.co/mParqinUS5
ectdexperts 27.02.2013, 19:09
@kathie_clark #eCTD 4.0 I really hope you are right. Personally I become more and more skeptic.
ectdexperts 14.02.2013, 12:17
@RAPSorg: Electronic CTD Document Updates to Now Allow Information about Medical Devices, #FDA Says - #Regulatory Focus http://t.co/Y ...
ectdexperts 14.02.2013, 12:07
@kathie_clark: Health Canada announces extension of deadline for using the old Canadian Module 1 DTD Version 1.0 to 30-Sep-2013 #eCTD ...
ectdexperts 14.02.2013, 12:06
@kathie_clark: FDA: public comment period for new #eCTD guidance closes March 4, 2013 http://t.co/1ouvDPfC