Submission Platforms in EU and Further Changes

In this article, we will talk about the EMA eSubmission gateway, CESP (Common European Submission Platform), and the future of both platforms, CESSP (Common European Single Submission Portal).

The European Medicines Agency (EMA) and the 32 national competent authorities in Europe are almost at the finishing line of the race to complete the switch to eCTD submissions. If you used to send your application via CD/DVD and got into the trap of having it lost by the post office or not receiving confirmation from the agency about receiving your submission, this will no longer be an issue as the agencies have platforms to accept the submissions.

In this article, we will talk about the EMA eSubmission gateway, CESP (Common European Submission Platform), and the future of both platforms, CESSP (Common European Single Submission Portal).

EMA eSubmission gateway or Web client for centralized procedures

For MAAs (Marketing Authorisation Applications) planned via the centralized procedure in the EU, you need to send your submission via EMA eSubmission gateway or Web client, represented in Figure 1. Since March 2014 for human medicines and January 2017 for Veterinary medicines, the EMA no longer accepts CDs/ DVDs or submissions via Eudralink.

The use of XML delivery files is mandatory, for which the relevant delivery files are available. In cases where delivery files are unavailable – for example, for ancillary medicinal substances in medical devices, use of file naming conventions is allowed. In the references below, you can find the links for creating your XML delivery files as well the file naming convention in those exceptional cases.

Figure 1: How the EMA eSubmission gateway looks like

The submission is sent on a . ZIP file together with the generated XML delivery file, and you will instantly receive delivery confirmation after your upload on the eSubmission Gateway.

CESP: The Common European Submission Platform

For National procedures, Mutual Recognition Procedures, and Decentralised Procedures, you can use CESP.

CESP is an online delivery system capable of accepting information from stakeholders through one portal and distributing it to one or more agencies (human and veterinary). It accepts multiple submission standards, such as NeeS, VNeeS, and eCTD, with a simple notification system.

On the CESP website, we can also check the ‘Contacts’ list for receiving submissions via the CESP portal for human and/or veterinary submission, the dossier types accepted by this agency, and a point of contact at the agency; for requesting more information about CESP.

The difference compared to the EMA eSubmission gateway is that there are no file naming conventions for sending your . ZIP file.

EXTEDO can also help you in building your CESP, and eSubmission gateway accounts for you to submit your dossiers in Europe electronically, whether we are talking about a mutual recognition procedure, a decentralized or centralized procedure, and even some Nationals procedures.

The future of eSubmission gateway and CESP: The CESSP

The most current EU eSubmission Roadmap version 2.0, shown in Figure 2. describes the concept of a Single Submission Portal, which will be created by integrating the current CESP and the EMA eSubmission Gateway. The EU Telematics Management Board has agreed that this single portal shall be built using the current CESP portal. This future system is currently referred to as the Common European Single Submission Portal (CESSP).

Figure 2: Timelines extract from eSubmission Roadmap version 2.0

The electronic Application Form (eAF) is mandatory to be used for all applications submitted after January 2016, with forms for different submission types available on the eSubmission website.

CESSP is also envisaged to integrate the current content of the multiple eAFs. The application content (further on referred to as the application datasets) will be integrated into this new web-based solution with a stepwise approach, which has started already with Phase 1.

CESSP Phase 1 will deliver integrated human and veterinary Marketing Authorisation Application datasets for new marketing authorization and extension applications. The first version of the system is currently available for use. EXTEDO had the opportunity to join this User Acceptance Testing group and share our thoughts and comments on our first impressions.

This Single Submission Portal is expected to become mandatory by 2020. Until this point, it is recommended that we use the CESP, as discussed earlier in this article.

References:

http://esubmission.ema.europa.eu/tiges/docs/eSubmission%20Roadmap%20final%20v2.0.pdf

http://www.ema.europa.eu/docs/en_GB/document_library/Regulatory_and_procedural_guideline/2009/11/WC500014483.pdf

http://esubmission.ema.europa.eu/gateway/Gateway%20user%20guide%20xml%20delivery%20files.pdf

http://esubmission.ema.europa.eu/gateway/Annex1%20-%20A%20guide%20to%20the%20filenaming%20convention%20for%20eSubmission.pdf