EU Change Control Process for
Change Requests in the Entire Area of
Electronic Submissions for Human Medicinal
Products
Version 2.1
May 2011
Document Control
Change Record
Version Date Author(s) Comments
0.1 10 September, 2003 Miguel Bley Draft
0.2 11 September, 2003 Miguel Bley Draft
0.3 23 September, 2003 Miguel Bley Draft
0.4 5 November, 2003 Miguel Bley Draft
0.5 1 July, 2004 Miguel Bley Draft
1.0 1 July, 2004 Miguel Bley Adopted by the TIGes
for publication on NtA
1.1 8 December 2006 Miguel Bley Change of submission
address to
adopted at TIGes
meeting on 20
November 2006
2.0 23 November 2010 Klaus Menges Complete revision due
to the newly established
change control process
for changes requested
in the entire area of
electronic submissions,
CR or Q&A referring to
e.g. eCTD EU M1, eAF,
EudraCT, RDM,
Eudrapharm, etc.
2.1 05/05/11 Liesbeth Versteeg Revision due to the
newly established
emailbox to separate
change requests from
other ectd
communications and
small changes
requested to the change
control process.
References to PIM have
been struck from the
guidance since the
project has been
closed. Addition of
Annex 2 Electronic
Submission Change
Request Process
Reviewers
Version Name Organisation
0.1 All participants in the meeting TIGes
0.2 Miguel Bley TIGes
0.3 All TIGes/NtA-TIGes Interlinking
0.4 All TIGes/NtA-TIGes Interlinking
0.5 All TIGes/NtA-TIGes Interlinking/JIGes
1.1 Juan Rueda EMEA
2.0 All Joint TIGes-Industry Group
2.1 All Joint TIGes-Industry Group
Distribution
Version Date Name Status
0.1 11 September, 2003 TIGes Reviewed
0.2 12 September, 2003 Joint TIGes-Industry Group Reviewed
0.3 23 September, 2003 TIGes/Joint TIGes-Industry
Group
Reviewed
0.4 10 November, 2003 TIGes/NtA-TIGes Interlinking Adopted
0.4 5 December, 2003 JIGes Adopted
0.5 2 July, 2004 TIGes/NtA-TIGes
Interlinking/JIGes
Submitted
1.0 2 July, 2004 NtA Chair for publication on
NtA
Submitted
1.1 8 December 2006 NtA Chair for publication on
NtA
Submitted
2.0 30 October 2010 Joint TIGes-Industry Group Reviewed & Adopted
2.1 08 June 2011 Joint TIGes-Industry Group For review
INTRODUCTION
The eCTD Specification was signed by the ICH Steering Committee in September 2002 and adopted
by the CPMP in November 2002. The Telematics Implementation Group for Electronic Submission
(TIGes) validated the position of the EU regulators delegation at the ICH-M2 Expert Working Group
(ICH-M2 EWG) that produced the eCTD standard. The TIGes administers EU eCTD standards
including the regional specification on Module 1 and its task is to facilitate the implementation of eCTD
by both applicants and Competent Authorities in the European Economic Area (EEA) as well as
several surrounding projects in the entire area of electronic submission, e.g. eAF, EudraCT, RDM,
Eudrapharm, etc.
Changes to the eCTD Specification are managed by the ICH-M8 Implementation Working Group (ICH-
M8 IWG) and to the Module 1 (also M2.3.R. and M3.2.R.) by the Notice to Applicants Working Group
through a harmonised Change Control Process. A larger number of other standards and guidance
documents in use can be covered by a broader meaning of electronic submission. This also includes
aspects of change regarding application forms (eAF), the submission guidances and validation criteria.
As with the eCTD Specification, the EU standards in this area are likely to change due to technological
progress, new concepts (i.e. for administrative forms and product information) and experience gained
with the implementation of eCTD and of electronic submissions in general. For successful
implementation of electronic submissions and processing, change control should be in place to
effectively communicate and execute changes to the EU electronic submission standards and
guidance documents. To manage this task a close collaboration and continuous communication
between the eSubmission Change Control Board (CCB), the TIGes, the NtA via the Interlinking Group
as well as the Harmonisation Group and other subgroups of the TIGes are pre-requisites.
SCOPE
This document establishes the change control process for EU eSubmission standards in the EEA,
namely CR or Q&A referring to e.g. eCTD M1, eAF, EudraCT, RDM, Eudrapharm, etc., managed by
the CCB. The purpose of the CCB is to accelerate decisions and results, improve the organisation and
traceability of change requests, ensure follow-up of open items and improve performance of change
request discussions at the TIGes meetings. The scope is all change requests for electronic
submissions requirements and related guidances. With regard to change requests for harmonised
aspects of the eCTD Specification in Modules 2 to 5, except M2.3.R and M3.2.R., the ICH-M8 IWG
should be consulted.
PURPOSE
The TIGes is authorised by the Heads of Medicines Agencies (HMA) and steered by the Telematics
Steering Committee (TSC) as part of a structure for the management of EU IT projects in the
pharmaceuticals regulatory area endorsed by the Pharmaceutical Committee to administer changes to
the EU eCTD and electronic submission standards. Change control is established to serve the
following purposes:
• Evaluate and approve or disapprove proposed changes to the specification
• Ensure implementation of approved changes
• Represent the interest of all groups who may be affected by the changes
The change control process applies to all change requests for electronic submissions requirements
and related guidances.
CHANGE CONTROL PROCESS
EU Electronic Submission Standards and Guidance Documents
Questions and Change Requests
All change requests and questions regarding should be submitted by the requester to
[email protected] in the CR Form (as attached in Annex 1 to this document and
published on the electronic submission website
0Hhttp://esubmission.emea.europa.eu/tiges/index.htm as
well). Questions regarding eCTD submissions and the day to day business should still be sent to
[email protected]. The steps of the process for
electronic submission changes are described in
Annex 2.
Change Control Form
Each change request should minimally contain the following information:
• Title, which should specify the topic the CR or Q&A refers to, e.g. eCTD EU M1, eAF, EudraCT,
RDM, Eudrapharm, etc
• Contact information
• Question or Change Request
• Category
• Level of urgency
• Summary of the problem, including rationale
• Submit date
• Item to be changed / question
• Version number and date of the EU eCTD standard or guidance document
• Detailed explanation of the problem, including results of any testing
• Recommended solution, if any
• Preferred implementation date according to the level of urgency
The EMA will check confidentiality and completeness of content and send to the CCB. Rapporteurs of the
relevant standard or guidance document should validate the content in advance to the next scheduled
meeting of the CCB, normally 7 days before the meeting date.
Change Control Board Meetings
The CCB undertakes a preliminary analysis on the CR. A preliminary solution is proposed by the CCB,
recorded in the CR Form and will be monitored in the Change Request Tracking Table. A consultation with
relevant experts is possible as well as an escalation to contact the requester for clarifications whenever
necessary or the direct referral to another group as detailed below.
In any case, the tracking table will be updated accordingly for internal use only until a final decision is taken
at the TIGes-Joint quarterly meeting and then published. The table for publishing will be numbered with the
next full sequence, e.g. 1.22, 1.23; numbering for internal use will follow the sequence 1.22.1, 1.22.2,
1.22.3.
Questions and Change Requests Review
The CR will be assigned to one of the following paths:
1. Defined as out of scope include:
• Is not relevant
• Issues related to Modules 2-5, except 2.3.R and 3.2.R., or to ICH-M2 eCTD guidance
which are both under the auspices of the ICH-M8 IWG should be forwarded according to
the ICH Change Control Process for eCTD via the respective representative in TIGes-J.
2. Defined as in scope after presentation and discussion of the change request for further review
and testing so that it can be assessed and finally decided by the TIGes Group include:
• for technical related CRs forwarding to TIGes-J
• for regulatory content related CRs on CMD(h) and NtA WG owned electronic business
guidance such as the BPG for use of eCTD in MRP/DCP and the Variations Application
Form forwarding to NtA-TIGes Interlinking Group.
• for CRs related to EU electronic guidance e.g. on eCTD and ASMF including validation
criteria forwarding to the Harmonisation Task Force
• for CR referring to other areas, e.g. EudraCT, RDM, Eudrapharm, etc., forwarding to the
respective working group
Additional testing may be called for before a question or change request can be fully evaluated. The
question or change request would stay on the CCB agenda and be presented at the next meeting for
additional review.
However, the TIGes will take the final decision on the CR.
CR and – as appropriate – the proposed solution will be forwarded in advance to the next scheduled
meeting of the respective group as mentioned above, normally 7 days before the meeting date. The most
relevant meeting dates will be provided in the internal tracking table.
CR received between the distribution
date and the meeting date will not be discussed at the upcoming meeting, but instead at the following
meeting. At the discretion of the CCB chair in collaboration with the TIGes chair urgent CRs may be
forwarded directly to the appropriate contact and not first triaged by the CCB. Furthermore, in
exceptional cases, the CCB can request that the chairman of the TIGes schedule an emergency
meeting to decide on the respective change request avoiding any undue delay.
Preparing for the Final Decision
The TIGes Joint Group has the responsibility to make the final decision on the CR. Therefore, the CR
needs to be added to the agenda of the TIGes-J meeting at least 7 days in advance of the meeting
date. The evaluation and proposal for solution of the CR will be presented by a CCB representative.
The decision of the TIGes-J will be recorded in the CR-form and the tracking table. The requester will
be informed accordingly by EMA.
The updated tracking table will be published on the eSubmission web site
1Hhttp://esubmission.emea.europa.eu/tiges/index.htm by EMA within 14 days after the TIGes-J meeting.
Approved Change Requests
Change requests approved by the TIGes would either be addressed in the Q&A spreadsheet or
implemented into the EU eCTD standards or respective guidance documents at appropriate intervals.
The version number and date will be updated in that case and an indication will be provided on
transition periods for implementation. Time periods for implementation will vary depending from the
CR: Updated guidances may come into force more rapidly than changes of the standard e.g. of EU
M1. In exceptional urgent cases, also the standard will be updated immediately.
Documentation
The following documentation will be posted on the Commission’s web site in the relevant location of
the Notice to Applicants.
• Updated version of the EU eCTD standards adopted by the NtAWG.
• Updated Q&A and Change Request Tracking Table adopted by the NtAWG that includes the
status of active or closed [disposition of rejected, duplicate, or withdrawn].
Working drafts of the above documents adopted by the TIGes will be posted on the eSubmission web
site:
2Hhttp://esubmission.emea.europa.eu/tiges/index.htm. They will become official guidance
when posted on the Commission’s web site.
EU STANDARDS RELEASE STRATEGY
Stability of the EU Standards, e.g. for eCTD, is important to ensure that industry and regulators can
develop or procure efficient tools. In order to provide this stability and in line with the release strategy
for the ICH eCTD specifications, the EU eCTD Standards will follow a specific release strategy that
allows software application developers and managers to plan for the future. These principles will be
applicable to other electronic standards as well. To ensure traceability of changes, descriptive release
notes should accompany the publication of revised standards. Whenever possible, it would be ideal to
submit an official change request, following this process, to ensure proper processing of revisions and
enhance traceability.
Major Releases
Major new releases of EU eCTD Standards will be announced at least two years before they occur.
Major releases include changes that significantly impact DTDs, major modifications to architecture, or
significantly impact the software applications being used. These major releases will be addressed by
the Joint TIGes-Industry eCTD Implementation Group and follow the Change Control Process
described in this document.
Major releases will be identified by a new numbering sequence (e.g., 2.0, 3.0).
Minor Releases
In between major releases of EU eCTD Standards, the Joint TIGes-Industry eCTD Implementation
Group could also propose minor releases of the standards. The scope of these minor releases will be
to correct minor issues with the specifications that hinder standards implementation or software
application development. For minor modifications to the EU eCTD Standards, notification will occur
when the minor release is published on the Notice to Applicant.
eCTD should always mirror the ICH CTD structure. Modifications introduced in the EU eCTD
Standards to comply with CTD guidance will be considered minor releases and proposed by the NtA-
TIGes Interlinking Group.
Minor releases will continue the numbering sequence of the last major release (e.g., 2.1, 2.2).
Bug Fixes
In case of necessary bug fixes of EU eCTD Standards, the Joint TIGes-Industry eCTD Implementation
Group will propose sub-minor releases of the standards. The scope of these bug fixes will be to
correct issues with the specifications that hinder usability of the standard and prevent technically the
functioning of software. For bug fixes of the EU eCTD Standards, notification will occur when the bug
fix is published on the Notice to Applicant.
Bug fixes will continue the numbering sequence of the last minor release (e.g., 2.1.1, 2.2.1).
Version Compatibility
Backwards compatibility will be considered for each EU eCTD Standards release. Descriptions of the
scope of each change will be provided with each new release.
ANNEX 1 ELECTRONIC SUBMISSION CHANGE REQUEST/Q&A FORM
T0F
1
Contact Information
Organisation Name:
Organisation Address:
Contact Name:
Address:
Telephone Number:
E-mail Address:
Question or Change Request
Unique Id (from the
tracking table)
Category Business/Technical
Level of urgency Low/Medium/High
Summary This should be a short summary of the problem submitted including rationale.
Submit Date Date you submit the change request (YYYY-MM-DD)
Item to be Changed/
Question
Reference to the Product Name of the specification to be changed (e.g., the
eCTD DTD, the written specification, the M2 eCTD style sheet)
Version Number and
Date
Indicate the specific version and date of the Specification or standard, system,
guidance, etc., for which the change is proposed.
Description Provide a detailed explanation of the problem, and steps on how to recreate the
error, if applicable. If this is a new requirement or enhancement, please provide
the reason for the requirement or enhancement and any known solutions. If you
have any sample output, sample code or other examples to help clarify the
description, attach the samples to this form. You should also provide a detailed
description of any testing or research that was done to support the solution(s)
being proposed and any advice on backward compatibility issues.
Recommended
solution, if any
Provide a detailed explanation of any known solutions
Preferred
Implementation Date
Following the level of urgency, provide the preferred implementation date
Evaluation
Assessment
To be filled in by the Evaluation Committee. Provide additional information to
clarify the description of the CR given by the change requestor if applicable.
Implementation
Proposal
To be filled in by the Implementation Committee. Provide a summary of the
proposed implementation.
Submit a completed electronic copy of this form to [email protected]opa.eu.
Alternatively send it by post at the following address:
European Medicines Agency
Information and Communications Technology
7 Westferry Circus, Canary Wharf - UK - London, E14 4HB
1
Title should specify the Product Name the CR or Q&A refers to, e.g. eCTD EU M1, eAF, EudraCT, RDM, Eudrapharm, etc.
ANNEX 2 ELECTRONIC SUBMISSION CHANGE REQUEST PROCESS
N Action Responsable Timeline
1 The requester submits the Change Requests to
3Hesub.changerequests@ema.europa.eu in the CR Form
published on the electronic submission website
4Hhttp://esubmission.emea.europa.eu/tiges/index.htm
Anybody Anytime
2 Check confidentiality and completeness of content and
send to CCB Rapporteurs of the relevant standard should
validate the content.
EMA 7 days before
CCB meeting
3 The Change Control Board (CCB), that meets regularly,
undertakes a preliminary analysis on the CR.
A preliminary solution is proposed by the CCB (recorded
in the CR Form) or direct referral to another group, e.g.
Interlinking Group.
Consultation with relevant experts is possible.
Update the CR/Q&A tracking table with the new CR forms
or progress information on existing requests.
A CCB member can be escalated to contact the requester
for clarifications whenever necessary.
CCB (if
confidential,
then EMA)
During the CCB
meeting
4 Distribute CR to relevant subgroups:
• TIGes-J for technical related CRs
• Interlinking Group for regulatory content related
CRs (CMD(h) and NtA WG owned electronic
business guidance such as the BPG for use of
eCTD in MRP/DCP and the Variations Application
Form)
• Harmonisation Group for CRs related to EU
electronic guidance e.g. eCTD and ASMF.
CR received between the distribution date and the
meeting date will not be discussed at the next meeting,
but for the meeting following after the next.
CCB (if
confidential,
then EMA)
7 days before
the TIGes-J
meeting
5 Add Change Requests to the draft agenda of TIGes-J
meeting and distribute the agenda to the meeting invitees.
Chair 7 days before
the TIGes-J
meeting
6 Evaluate the CR and the analysis made by the CCB.
Presentation, discussion and decision.
TIGes-J At the TIGes-J
meeting
7 Recording of TIGes-J decisions in the CR Form. CCB (if
confidential,
then EMA)
At the TIGes-J
meeting
8 Send the CR Forms (now containing also the decision by
TIGes-J) back to the requester.
CCB (if
confidential,
then EMA)
Within 7 days
after the TIGes-J
meeting
9 Update the CR/Q&A tracking table with the decisions
reached at the TIGes-J meeting, or pursue resolution of
outstanding questions/issues; distribute to the TIGes-J.
CCB Within 7 days
after the TIGes-J
meeting
10 Publish on the e-Submission site the CR/Q&A tracking
table.
EMA Within 14 days
after the TIGes-J
meeting
