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eCTD news

Be informed of the upcoming critical regulatory changes on the next two months in Europe and FDA.

Be informed of the upcoming critical regulatory changes on the next two months in Europe and FDA.
June 12, 2015

FDA new module 1 accepted from 15th June
2015 in eCTD format

 

From 15thJune 2015, FDA will accept submissions using the new M1
Specifications in eCTD format
.

 

For the
moment the use of this new module 1 is not mandatory, however it will be
necessary in order to use the new implementations like (among many others):

  • Submission of DSURs of INDs
    (Section 1.13.15 – Development safety update report (DSUR))
  • Submission of Promotional
    Labeling and Advertising Materials for Human Prescription Drugs
    (eCTD
    format accepted for submissions to the OPDP with the 2253 formfrom 15th June 2015)

 

If you are an user of eCTDmanager from Extedo, new FDA module 1 is already
incorporated
since version SP10, and your ongoing FDA dossier can be updated in a very simple way

Once the module 1 for FDA has been upgraded in your dossier, the sequence has to be
validated with the new FDA-eCTD validation criteria (v3.3) and the dossier
lifecycle must continue with this new module 1
.

Please contact us if you require further clarifications or support on
this topic, or if your software version is not up-to-date.

For more information, please refer to the following link

 

 

eCTD mandatory for Initial Decentralised
Applications from 1st July 2015

 

From 1st July 2015, new market
authorisation applications
for decentralised procedures must be
submitted in electronic common technical document (eCTD) format. This means
that any new DCP application in NeeS format will be rejected.

 

eAF mandatory on Centralised Procedures from 1stJuly 2015

 

From 1st July 2015 the eAF will become mandatoryfor the applications for the Centralised Procedure.

This means that for new applications, variations and renewals, the eAF must be used.

For more information, please refer to the following link

 

Opening of the forms might take some time, as data for the EUTCT pick-lists is downloaded.

If the pick-lists do not work, you probably have a firewall restriction to open the
EUTCT lists, please contact your IT for further information.

 

eRA 2015 eRegulatory Affairs Conference (01-02 July 2015, Munich, DE): “Next Generation of Regulatory information Management”

We are sponsoring the conferencein which about 25 high-level experts from the industry and regulatory authorities will share their experiences and knowledge with you.

They will highlight topics around:

  • Latest Innovations and Trends in eSubmissions
  • Latest Innovations and Trends in Drug Safety
  • Next Generation Planning & Tracking and Registration Management
  • Working in a Cloud
  • New Regulations – Localisation, Globalisation and Harmonisation
  • Technology and Innovations

In 2015 there will be extended time for the EXTEDO User Group Meetings
(for eCTDmanager, EURS, PcVmanager and MPDmanager customers) and there
will be optional training courses on the days before the conference.

For more information visit the event page and contact us for a special promotional code for an additional 10%
discount
at info@asphalion.com

 

Please contact us at info@asphalion.com  if you require further clarifications or support on these topics.

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