Title: eSubmissions via EMA Gateway and Web Client
1eSubmissions via EMA Gateway and Web Client
2The Gateway
- What is the Gateway?
- Gateway Options
- Key features of Web Client Gateway (AS2/AS3)
- Overview of Gateway Set-up
- Registration
- Using the Web Client
- Filenaming Conventions required to submit via
Gateway/Web Client
3What is the Gateway?
- An Agency-wide solution and central transmission
point for accepting secure electronic regulatory
submissions over the Internet. The EMA
eSubmission Gateway is a conduit, or "a route",
along which submissions travel to reach their
final destination. It does not open or review
submissions it automatically routes them to the
relevant EMA Office.
eCTD Compliance check
EMA Gateway (receives submission sends MDN to
sponsor)
4eSubmissions Gateway Options
- EMA Gateway Web Client
- Free option
- Uses applet
- EMA is using European Review System (EURS) to
validate the eCTD Submissions - Gateway to Gateway (AS2)
- Applicability Statement 2 (AS2) and AS3
Gateway-to- Gateway - Requires an AS2 AS3 compliant gateway software
- EMA is using a product called Axway Synchrony
Gateway Interchange (version 5.x) EURS to
validate the eCTD submissions.
5EMA Gateway Web Client Facts
- EMA does not charge for the use of this solution.
- ONE Web Client account is allowed per applicant.
A second account may be requested though please
do provide a justification to ectd_at_ema.europa.eu - Web Client uses Hypertext Transfer Protocol
Secure (HTTPS) to ensure secure delivery of
submissions over internet. - Consultancy companies can register and send on
behalf of Various Applicants. - From 1st March 2014 use of Gateway/Web Client is
mandatory for all eCTD submissions to EMA in
context of Centralised Procedure.
6Feature comparison of Web Client and Gateway
25 GB
7Electronic Submissions Gateway Process What to
do in order to use the gateway
- Determine the preferred route, i.e. AS2/GW or
GW/Web Client - To use the Gateway Web Client you need to ensure
that online registration has been completed and
account(s) have been activated. - Understand and consult guidance documents on the
eSubmission website http//esubmission.ema.europa.
eu/ - File naming convention described in the guidance
document is followed correctly when uploading zip
files.
8Overview of Gateway Set-up
Apply for Online Registration (Test PROD
simultaneously)
- Testing is strongly recommended for Web Client
users even though it is stated Optional when
registering online.
9Web Client Registration - 1
10Web Client Registration - 2
11Web Client Registration - 3
12Web Client Registration - 4
13Using The Web Client
- Logon with the credentials supplied in
communication from the registration team - Start Submitting!
Always select the send documents more than 10MB
option to use Large file applet, Note that
receipts (MDN) are sent only when you use this
option, and this link will appear only with
correct Java Version JRE 1.5.0_05
14Technical Validation Issues
- eCTD Technical Validation identifies and rates
the severity of the errors (P/F checks from the
eCTD criteria) encountered in a typical eCTD
submission, results are indicated in Final
Acknowledgement message as SUCCESS or FAILURE. - eCTD validation criteria valid at present is
available here http//esubmission.ema.europa.eu/e
umodule1/index.htm - Duplicate Submission
- Typo in the product number(HC000xxx), or a
procedure number for PSURs in Single assessment(8
digit EURDID). - If an already existing sequence (in EMA database)
has been modified and sent to the agency as
replacement ! - Incorrect Submission structure (4 digit folder
not at the root of submission package) - Incorrect submission Type
15Acknowledgement Example
16Key Points during the Web Client Transmission - 1
- There are two automated messages sent during the
transmission - Always use the Large File Applet for All
transmissions via the Web Client. - You need to run version Java version JRE 1.5.0_05
http//www.oracle.com/technetwork/java/javasebusin
ess/downloads/java-archive-downloads-javase5-41941
0.htmljdk-1.5.0_05-oth-JPR - The Receipt is sent once the submission has been
successfully received by the EMA Gateway Web
Client. It is a simple text file with reception
timestamp and is merely a receipt - this does not
indicate a successful technical validation. To
note Receipt is sent only when using the Large
File applet. - The final Acknowledgement is an xml file sent
after the system has completed the technical
validation of the submission. It contains the
result of the validation (SUCCESS or FAILURE). In
case of a failure, a detailed description of the
error is included in it.
17Key Points during the Web Client Transmission - 2
- Dependent on the submission size and web client
gateway queue, both automated messages can take
up to 24 hours for the Acknowledgment delivery
back to the sender. - Where applicable, for multiple submissions,
please trigger Web Client transmission belonging
to same product/dossier in sequential order. - e.g. If you need to send 0033, 0035, 0036 for
same product please send them in that order and
allow some gap between those transmissions.
Failure in following this may result in Negative
technical validation. - All submissions should be archived as a zip file.
The compressed application file must comply with
the ZIP open format.
18Key Points during Web Client Transmission - 3
- Senders Inbox view showing Acknowledgement and
Receipt
19Filenaming Conventions for Gateway - 1
- Effective from 1st March 2014 please use
following File Name Convention for submissions
Example ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_va
r-typeII_0020.zip
20Filename to be used for ASMF
- ESUBPXYZ_ESUBPROD_EMEA-ASMF-xx123_Activesubstance_
asmf_00xx.zip - ASMF holders who have on-going ASMF eCTD
life-cycle (one or multiple) related to Centrally
Authorised Product(s) are strongly advised to
apply for the EMEA/ASMF/xxxxx number to ensure
smooth integration with the eSubmission Gateway. - You can request to apply new ASMF procedure
number at the following link http//esubmission.e
ma.europa.eu/eASMF/index.htm
21I am a supplier of active substance for 4
Centrally Authorised Products, how should I
proceed ?
- Apply for EMEA/ASMF number -request form
- Once you received a number, submit one new eCTD
sequence explaining in the cover letter which
current CAP_ASMF you choose to carry on the
life-cycle of, i.e. CAP A is at sq0003, CAP B is
at seq0006, CAP C is at seq0004, you would inform
us that you want to follow the life-cycle of CAP
B and therefore you are sending seq 0007. - After this submission you only have to maintain
this life-cycle and it will cover all products
(the others will be archived)
22General ASMF submission rules
- Consult ASMF guidance documentation available at
http//esubmission.ema.europa.eu/eASMF/index.htm - Always submit Annexes 2 and 3 in Module 1 of the
eCTD sequence, but ensure that when submitting to
EMA the relevant EMEA/ASMF/xxxxx numbers are
quoted. - Never submit two parts (Restricted and Open
part)within the same sequence
23Filenaming Convention for Plasma Master Files
(PMF)
24How to Avoid Problems - 1
- Correct Routing IDs should be used for
respective environments and reflected correctly
in the Submissions filename e.g.
ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_initial-maa_
0020.zip - Incorrect folder structure used in Zipped file
sent to EMA. Always ensure that Sequence
Number(0xxx) folder is at the root, as reflected
below
25How to Avoid Problems - 2
- Submissions should be compressed before
transmission as a zip file. The compressed
application file must comply with the ZIP open
format. - Duplicate submissions
- Gateway/Web Client only processes the first
submission not the duplicate. - If the first submission was in error, contact
eCTD support team at ectd_at_ema.europa.eu - Bad characters in the file names (NO Spaces!)
only underscore is allowed to separate the
filenames. No other special characters are
allowed. - Do not send duplicate submissions using both CD
or DVD and Web Client. - Use correct Java version (JRE 1.5.0_05) when
using Web Client.
26Why should you bother?
- These errors require us to manually process your
gateway submission - Manually processed submissions delay access to
your material - Sometimes these issues result in us rejecting
your submission
27Contact Information Useful links
- Registration Link https//esubregistration.ema.eur
opa.eu/registration - Registration Documentation (contact info, forms,
guidance documents) http//esubmission.emea.europ
a.eu/esubmission.html - Technical issues during the Gateway / Web Client
set-up gatewaysupport_at_ema.europa.eu - for Technical validation issues (e.g. Failure
Acknowledgements) ectd_at_ema.europa.eu - TIGes Guidance on eCTD NeeS http//esubmission.
ema.europa.eu/tiges/tigesdocuments.html
28 -
- Thank You for your
interest! -
- Questions?