Starting October 1, 2016, Version 3.0 of the European Union Module 1 electronic Common Technical
Document (eCTD) Specification, released by the European Medicines Agency (EMA)
will become mandatory.
The guidance document specifies Module 1 of the
eCTD and implements several changes from Version 2.0, including:
●
additional submission
types;
●
a new submission
unit to further specify regulatory activities;
●
a Universal
Unique Identifier (UUID) attribute to support automation;
●
and various changes to standard terminologies and
values.
Committed to staying ahead of the curve, RPI has updated all eCTD tools to support
these new technical requirements.