Transcript What is the Gateway? - eSubmission

eSubmissions via EMA Gateway and
Web Client
An agency of the European Union
The 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
What 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)
eSubmissions 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.
EMA 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
[email protected]
•
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.
Feature comparison of Web Client and Gateway
25 GB
Electronic 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.
Overview 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.
Web Client Registration - 1
Web Client Registration - 2
Web Client Registration - 3
Web Client Registration - 4
Using The Web Client
1.
Logon with the credentials supplied in communication from the registration team
2.
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
Technical 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/eumodule1/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
Acknowledgement Example
Key Points during the Web Client Transmission 1
There are two automated messages sent during the transmission:
1.
Always use the “Large File Applet” for All transmissions via the Web Client.
2.
You need to run version Java version JRE 1.5.0_05
http://www.oracle.com/technetwork/java/javasebusiness/downloads/java-archivedownloads-javase5-419410.html#jdk-1.5.0_05-oth-JPR
3.
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”.
4.
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.
Key Points during the Web Client Transmission - 2
5. 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.
6. 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.
7. All submissions should be archived as a zip file. The compressed application
file must comply with the ZIP open format.
Key Points during Web Client Transmission - 3
Sender’s Inbox view showing Acknowledgement and Receipt:
Filenaming Conventions for Gateway - 1
Effective from 1st March 2014; please use following File Name
Convention for submissions
Example:
ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_var-typeII_0020.zip
13/04/2015
Filename to be used for ASMF
• ESUBPXYZ_ESUBPROD_EMEA-ASMFxx123_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.ema.europa.eu/eASMF/index.htm
I am a supplier of ‘active substance’ for 4 Centrally
Authorised Products, how should I proceed ?
1.
Apply for EMEA/ASMF number -request form
2.
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.
3.
After this submission you only have to maintain this life-cycle
and it will cover all products (the others will be archived)
General 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
Filenaming Convention for Plasma Master Files
(PMF)
Plasma Master File (PMF):
1.
The following filenaming convention, should to be used (see e.g. below):
Sender's
Routing ID
Receiver's
Routing ID
PMF Holder
Ref. Number
PMF holder
or Product
name
(Abbreviate if
the name is
longer than
30
characters)
Submission
Type
Sequence
Number
ESUBPXYZ
EUBPROD
HPMFxxxxxx-xx
“holdername”
pmf
00xx
e.g. ESUBPXYZ_ESUBPROD_HPMF000003-04_Baxter_pmf_0002.zip
Please note that above change (to the “submission type” value) should be implemented
only at the gateway filename level, and eCTD envelope values should remain as per the
eCTD specification).
How to Avoid Problems - 1
1. Correct Routing ID’s should be used for respective
environments and reflected correctly in the Submission’s
filename – e.g.
ESUBPXYZ_ESUBPROD_HC000999_Wonderpill_initial-maa_0020.zip
2. Incorrect folder structure used in Zipped file sent to EMA.
Always ensure that Sequence Number(0xxx) folder is at the
root, as reflected below:
How to Avoid Problems - 2
5. Submissions should be compressed before transmission as a zip file.
The compressed application file must comply with the ZIP open
format.
6. 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 [email protected]
7. Bad characters in the file names (NO Spaces!) – only underscore is
allowed to separate the filenames. No other special characters are
allowed.
8. Do not send duplicate submissions using both CD or DVD and Web
Client.
9. Use correct Java version (JRE 1.5.0_05) when using Web Client.
Why 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
Contact Information & Useful links
Registration Link https://esubregistration.ema.europa.eu/registration
Registration Documentation (contact info, forms, guidance documents):
http://esubmission.emea.europa.eu/esubmission.html
Technical issues during the Gateway / Web Client set-up:
[email protected]
for Technical validation issues (e.g. ‘Failure’ Acknowledgements):
[email protected]
TIGes Guidance on eCTD & NeeS:
http://esubmission.ema.europa.eu/tiges/tigesdocuments.html
Thank You for your interest!
Questions?