eSubmissions via EMA Gateway and Web Client - PowerPoint PPT Presentation

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eSubmissions via EMA Gateway and Web Client

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PowerPoint Presentation Author: Singh Jaspreet ... eSubmissions Gateway Options EMA Gateway Web Client Facts Feature comparison of Web Client and Gateway ... – PowerPoint PPT presentation

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Title: eSubmissions via EMA Gateway and Web Client


1
eSubmissions via EMA Gateway and Web Client


2
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

3
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)
4
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.

5
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 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.

6
Feature comparison of Web Client and Gateway

25 GB
7
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.

8
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.

9
Web Client Registration - 1
10
Web Client Registration - 2
11
Web Client Registration - 3

12
Web Client Registration - 4

13
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
14
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/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

15
Acknowledgement Example
16
Key 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.

17
Key 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.

18
Key Points during Web Client Transmission - 3
  • Senders Inbox view showing Acknowledgement and
    Receipt

19
Filenaming 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
20
Filename 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

21
I 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)

22
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

23
Filenaming Convention for Plasma Master Files
(PMF)
24
How to Avoid Problems - 1
  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
  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

25
How 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.

26
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

27
Contact 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?
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