24 June 2013

Health Canada to Use US FDA’s Electronic Submission Gateway (ESG) for eCTD Submissions

Very soon Pharmaceutical organization able to submit/transfer their eCTD Submissions to Health Canada through the US Food and Drug Administration’s gateway. Health Canada is collaborating with its U.S. regulatory counterparts to reduce regulatory burden for health products, and to move closer to an automated environment for the exchange, review and management of information supporting the health product review process.
One initiative in this collaboration is the U.S. Food and Drug Administration’s (FDA) – Health Canada Common Electronic Submission Gateway project, will enable industry to submit health product submissions online for approval to Health Canada, in the same way they do in the U.S.
Michael Fauntleroy, Program Manager of FDA’s Electronic Submissions Gateway, noted during a presentation for the GDUFA Conference in Silver Spring, MD on 13th June 2013 that the FDA and Health Canada are in negotiations for FDA to act as a service provider to Health Canada to facilitate electronic submissions via the ESG. Mr. Fauntleroy hoped that the production environment would be available this fall.
Find link to a summary of the plan and goals from a Canadian government website.

20 June 2013

EMA – Revised Implementation Guide for EU Module 1, eCTD/NeeS validation Criteria

EMA publishes revised Implementation Guide for EU Module 1 Specification (v2.0), EU eCTD Validation Criteria (v5.0) and EU NeeS Validation Criteria (v4.0)

You find further information and a link to the Implementation Guide on EMA’s esubmission webpage at


For more information on the EU Module 1 v2.0 follow the link below


05 June 2013

The eCTD Summit: Automated Review Increases Vulnerability to Rejection

As evidenced by the FDAs impending mandate that drug and life science companies switch from paper to eCTD format, the Agency is serious about transitioning to electronic submissions.

The FDA is on the verge of instituting a change that will fully automate the process for those in the industry already submitting in eCTD. This is all part of the refinement underway to prepare for the overwhelming amount of electronic submissions expected as the mandate takes effect.
With the human element gone from the process, there is no flexibility, no margin for error.

The Agency recently updated to eCTD Validation Criteria Version 2.2, giving them the capability to accept or reject a submission on technical merit without the possibility of human intervention.
Currently, a submission is loaded onto the Agency server and run through validation software. Error reports are then generated, and subsequently reviewed for legitimacy by a member of the FDA team.

For more information


CH eCTD Module 1 specification 1.2 released by Swissmedic

Swissmedic has released the new version 1.2 of the Swiss Module 1 eCTD specification. The full set of documents released in this context comprises

Implementation schedule:
The eCTD specification 1.2 will be implemented on July 01, 2013 and can be used by applicants from that point onwards. The current version 1.1 will still be valid during a transition period until December 31, 2013 . From January 01, 2014 the usage of the new CH Module 1 specification 1.2 will be mandatory for eCTD submissions to Swissmedic. Note that eCTDs that have switched to the new version 1.2 during the transition period cannot be switched back to version 1.1.

Guidance for Industry:
The Guidance version 1.4 contains only very limited modifications compared to the last version. The change introduced considers the alignment of the new eCTD validation criteria for Switzerland with the existing EU eCTD validation criteria (see below). Details are obtainable from the "track change" version.

Also the Q&A have been modified in a rather moderate fashion. Some Q&A have been updated due to the alignment of the Swiss eCTD validation criteria with the current EU eCTD validation criteria (3-3-2, 5-4 updated, 5-12 deleted). New dedicated eCTD subsections for some forms have been introduced in section 1.2.2. Corresponding Q&As 3-3-5, 3-3-6, and 6-9 have been updated accordingly.

A major update of the eCTD Module 1 specification 1.2 concerns the Swiss Administrative Metadata in Module 1 ("envelope"). Among the changes, the envelope element "application" is now repeatable. The corresponding Q&A 5-5 has been updated. See "track change" version of the Q&A for details.

eCTD Validation Criteria:
The new Swiss eCTD Module 1 validation criteria have been aligned with the current EU eCTD Module 1 validation criteria. As a major consequence the previous classification of "A", "B", and "C" validation errors has been changed to "Pass/Fail" criteria (P/F) and "Best Practice Guidance" (BPG) criteria. Details can be obtained from the release notes.

Swiss eCTD Module 1 specification 1.2:

Numerous changes have been introduced, the key changes are:

  • File formats: .docx Word 2007 file formats are allowed now; the requirement for additional MS Word formatted files for Module 2 documents have been removed.
  • Table 1 detailing the possible switch to a subfolder "common" for a Module 1 with a 2nd galenic form branch for certain documents and the corresponding allowed life cycle operation attributes have been updated completely.
  • Clarification regarding country codes for United Kingdom ("uk" allowed), Greece ("el" allowed) and EU Centralized ("ema" or "emea" allowed) has been introduced
  • An additional row including the "Directory" name has been introduced on file level in Table 4 detailing the directory / file structure for a Swiss Module 1. Previously this information was covered by the "File" information.
  • Additional directory / file names have been specified for some forms. This resulted in new subsections -
  • Appendix 2 with the "Envelope Element Description" has been largely updated
For More information


EMA: Implementation guide for EU Module 1 Specification, version 2.0 released

The Implementation guide for EU Module 1 Specification, version 2.0 and EU eCTD Validation Criteria, version 5.0 and EU NeeS Validation Criteria, version 4.0 has been published by the EU Telematics Implementation Group - electronic submissions (TIGes).

According to this implementation guide the new EU Validation Criteria for eCTD and NeeS will come into force on 01 September 2013 and will be used for the technical validation for all incoming electronic submissions by National Regulatory Agencies and the EMA. As a consequence, the corresponding earlier versions of the EU Validation Criteria will be withdrawn on 31 August 2013.

Regarding the new EU Module 1 that has been published in 01 March 2013 a transition period for will be established:

  1. Starting from 01 July 2013 applicants can submit either eCTDs compliant with EU Module v. 1.4.1 (applying eCTD validation criteria 4.1) or EU Module v. 2.0 (applying eCTD validation criteria 5.0)
  2. From 01 September 2013 only eCTDs compliant with EU Module 1 v. 2.0 will be accepted.

For NeeS submission the timelines and transitional arrangements are applicable likewise. For NeeS, EU validation criteria 4.0 must be used from 01 September 2013 on.

Guidance on how to submit information relevant to Croatia:

If there is a need to provide information relevant to Croatia prior to 01 September 2013 and EU Module 1 v. 2.0 cannot be used, it is acceptable to submit the corresponding information for Croatia in the "<sequence>-workingdocuments" folder accompanying the eCTD. A respective subfolder "hr" should be used. A corresponding note should be included in the cover letter. This approach is also applicable for Centralized Procedures.
For More Information

23 August 2012

Meeting of Czech and Slovak colleagues have been devoted to the problem eCTD

Representatives of the Czech State Institute for Drug Control (SIDC) visited Slovakia in order to learn more about the electronic processing of documents related to the registration of medicines for human use. Documentation in eCTD format is to be submitted Slovak state constitution by June 2012.

The meeting of the two parties was held on 08.21.2012. Bratislava headquarters of the State Institute for Drug Control visited five representatives SIDC. The aim of the meeting was to inform the Czech colleagues with data processing systems in Slovakia.

To find more information please use the below mentioned weblink