Our regulatory staff's tireless efforts to prepare our first Marketing Authorisation Application (MAA) were rewarded this month by the acknowledgement of its timely and successful validation. RPI now has full capability to directly submit all eCTD submissions related to the authorisation and maintenance of medicinal products in Europe via EMA’s eSubmission Gateway. The use of the Gateway has significantly improved the EMA’s efficiency in handling the receipt of submissions, making them quickly available within the European Review System.
Find out more about how RPI can support your EMA submissions.
Sunday, August 21, 2016
EMA Publishes Final Version of eCTD Module 1 Specification
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.
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