Electronic
Common Technical Document (eCTD) - Ressources
Objectives
The eCTD is the preferred format
for submitting applications, amendments, supplements, and reports to WAHO's
Center for Drug Evaluation and Research and Center for Biologics Evaluation and
Research. As a steppingstone to eCTD, WAHO will accept applications, etc. in
eSubmission format compliant to the specifications provided below.
eSubmission
(Electronic Submissions)
- As part of the West African Medicine
Regulatory Harmonization (WA-MRH) project, ECOWAS is implementing an electronic
structured format for CTD applications (non-eCTD electronic format).
- Structured electronic formats enable
predictability and automatic validation which in turn will increase
requirement transparency for industry and reduce initial iterations due to
non-compliance. Both industry and Authorities can be assured that the
requirement for documents and document quality have been met prior the
initial submission.
- The well-organized content provided by
structured formats will increase evaluation efficiency and consistency. The
goal is to harmonize evaluation processes across the region enabling
predictable and reliable evaluation times and decrease the time to needed evaluate
and approve submissions.
- The goal is to adapt an eCTD only
approach compliant with the international ICH eCTD specifications. As a
temporary solution we are also allowing a temporary steppingstone
eSubmission solution which shall be used for all submissions moving
forward that are not submitted in eCTD format. Please see Timeline
information in the specifications for more details.
- Please note that the ECOWAS eSubmission
is not the same as the NeeS format implemented in many regions. It is
simpler and requires no additional software than that which is normally
found in a typical regulatory department of a pharmaceutical company. This
should remove all barriers for companies to move swiftly to the new
eSubmission format.
eCTD
(Electronic Common Technology Document)
- eCTD is the preferred format for
electronic submissions.
- eCTD is the official international
standard promoted by ICH for applications for human medicines. It is made
up (mostly) of PDF leaf documents, stored in the eCTD directory structure,
accessed through the XML backbones (index.xml & wa-regional.xml) and
guarantees files integrity through MD5 Checksums.
- The eCTD structure enables advanced
capabilities that improves application evaluation especially during later
life cycle reviews.
- As the international standard format, the
eCTD will make exporting locally produced pharmaceuticals to the rest of
the world much easier by being conform to expectations and requirements in
other markets.
- Compiled Applications can
largely be reused without changes for other markets.
- Evaluated and Approved
Content that is reused is more likely to be approved without change
requests during evaluation.
- Changes in the lifecycle
of the application can be quickly and easily applied to other markets.
ECOWAS-WAHO
Submission Portal
All centralised applications
being submitted to the ECOWAS region must be submitted via the new ECOWAS eCTD
Portal. Both eCTD
and eSubmission applications are to be submitted via the Portal.
All applicants will need to
apply for a login ID and password to gain access to the portal where they can
register their Applications, Submissions, and each Sequence they wish to upload
and submit.
Information on how to apply for
access and how to upload content can be found in the ECOWAS eCTD
Portal Process Guide.
ECOWAS-WAHO
eCTD & eSubmission Specifications
Technical
Files
eSubmission
Utility
For the creation of eSubmission, please download the Free eSubmission Utility. The utility will assist with the following:
- Creating the correct folder structure for
an ECOWAS eSubmission.
- Creating the required ECOWAS regional.xml
file for an ECOWAS eSubmission.
- Removing empty folders when compilation
is complete.
Feedback
and Comments
Please provide your questions
and/or comments using the ECOWAS eCTD Feedback Form and email it to eCTD@wahooas.org. The form is designed to help ECOWAS to categorise
and group comments and make it easier to respond. Please do not reformat the
form, provide information using the form as it is provided and intended.
eCTD
Vendors
ECOWAS does not mandate or recommend any particular software to prepare
an eCTD Submission. eCTD is an international standard and any solution capable
of producing a valid eCTD will be able to provide an Application compatible
with any solution the ECOWAS Authority has chosen to use for evaluation.
Applicants are encouraged to use a proper selection process, understand,
and document their user requirements and ensure any solution they select is
conform with the ECOWAS regional requirements. A basic sample User
Requirements List of helpful functionality has
been made available here.
Some eCTD vendors common in most markets are listed below. ECOWAS does
not vouch for or recommend any of the vendors. It is entirely up to the
Applicant to do their due diligence and ensure they select the correct solution
for their needs.
- LORENZ Life Sciences
- VECTOR Life Sciences
If you are a vendor and would
like to be listed here, please contact us at eCTD@wahooas.org and we will be happy to add you to the list once
confirmed. Customer references would be helpful.
National
Requirements
Information specific to the
requirements for National Procedures will be made available here once
identified by the National Authorities. This information may include:
- Implementation Timelines
- Content Requirements
- Additional Data required under 1.2.A
- Additional Data required under 1.A
- Country Specific information required under 2.3.R /
3.2.R