eCTD Editor - News

9/9/2016USA Module - version 2.3. validation criteria 3.3

eCTD Editor is supporting M1 module also for USA region now. Check the specification.

9/1/2016EU Module - version 3.0.1

eCTD Editor has been update to support 3.0.0. version. It is distrubuted to all our customers for free.

8/1/2016EU Module - version 3.0.0

eCTD Editor has been update to support 3.0.0. version. It is distrubuted to all our customers for free.

12/15/2015Happy 13

We are celebrating. We have 13 customers now. Check our list of customers.

9/1/2013EU Modul 1 version 2.0

New version EU Modul 1 - 2.0 download here. It has been implemented.

7/10/2012Validation criteria 4.1

Validation criteria version 4.1 can be downloaded here. It has been implemented!

10/20/2011website ectd-editor.com launched

eCTD Editor is online. Now you can create an eCTD submission in a much more simple way and at much cheaper price than before. In the eCTD Starter edition you can do so through our website.

9/3/2011SÚKL – Meeting with the Association members

e-Submission in the process of registering LP in SÚKL submission: In 2011 the Office starts a public contract concerning the eCTD project. Find our more here.

8/1/2011EU – New validation criteria - version 3.1

EMA informs all pharmaceutical companies that as of today a new version of validation criteria for assessing the technical (formal) accuracy of eCTD requests has entered into force. Read more here.

6/10/2011ŠÚKL - submission test

Slovak ŠÚKL reviews the results of testing 37 submissions in the eCTD format that have been received so far. Find out more here.

1/13/2011ŠÚKL – The Office plans gradual transition to the eCTD format

Slovak ŠÚKL plans a gradual transition to receiving and processing submissions and documentation for registration purposes exclusively in the eCTD format in 2011. Find out more here.

7/1/2010EU – as of this day only version 1.4 is valid for the M1 module.

EMA informs all pharmaceutical companies that as of today it will not accept eCTD submissions in older versions 1.3 and lower version of the M1 module. Find out more here.

10/1/2008SÚKL - REG-84

Decree No. 228/2008 Coll. on Marketing Authorisation of Medicinal Products in Section 3, para. 1 stipulates the following: „All applications and other documentation submitted to the Office (in case of human preparations) or to the Veterinary Office (in case of veterinary preparations) have to be filed in the electronic form... Find out more here.