eCTD wird Pflicht – 4 tips for a smooth transition. 10.05.2016

Since June 2003, approval officers have been able to submit approval documents to European authorities in paper form (CTD) as well as electronically (eCTD). This option will soon no longer be available. Electronic submission in eCTD format has been mandatory for new registration applications in the decentralised procedure since July 2015. From 01.01.2017, it will also be mandatory to submit new applications for approval in the MRP procedure in eCTD format. From 2018, the eCTD obligation will then apply to all processes in CP, DCP, MRP and national procedures. The eCTD format is becoming the standard throughout Europe. It is high time for authorisation holders to switch to the eCTD format.

Tip 1: Integrate into project planning at an early stage

The change to the eCTD format can be made in any product life cycle, whether at the time of new approval or later with a variation (notification of change) or a renewal. In addition to the acquisition and integration of the corresponding eCTD software, the additional time required for document transfer to the eCTD, the adaptation of internal company processes and the necessary employee training must also be taken into account. It is important that once the data has been transmitted in eCTD format, everything else must also be submitted via eCTD.

Tip 2: Adapting work processes

In the meantime, many pharmaceutical companies have largely converted their approval processes to electronic processes. The documents are no longer submitted via the laborious process of creating several hundred folders and sending them by post, but on CD/DVD or on the computer via the CESP portal (Common European Submission Platform).

For the eCTD submission, the registration documents are prepared as an eCTD sequence using special software. When purchasing software, you should choose one that meets the needs of your company. This question will be difficult to answer if you have no experience with the new format. In this case it makes sense to use an eCTD-experienced service provider. The purchase costs for the software as well as the maintenance costs and training requirements are thus eliminated.

The structure of the eCTD is based on the CTD structure. The individual files are equally stored as Word or PDF documents in a predefined folder structure. The naming of the individual documents and folders as well as the formatting rules are precisely specified in the eCTD specification. Finally, the eCTD software generates an XML file for each sequence, which serves as a table of contents. In this way, users can access the relevant information in seconds. We recommend that you always create an eCTD baseline when converting to the eCTD format, despite the high workload. This is the only way to create a solid basis for effective life cycle management in which the marketing authorisation officer can quickly call up the current consolidated version of the dossier at any time with a click. In cooperation with an experienced service company, it is possible to integrate a baseline into the eCTD software in a relatively short time. The service provider creates the complete baseline and finally transfers it back to the company.

Tip 3: Integrate external support

There are enormous costs to purchase and integrate the eCTD software. Admissions staff need separate training to be able to use the new system properly. Small and medium-sized pharmaceutical companies in particular have start-up difficulties because they simply have difficulty in assessing the actual extent of the changeover to eCTD. On the other hand, eCTD-experienced service providers know exactly when a changeover makes sense and in what steps to take. They also have the necessary software systems and know-how to make the approval documents eCTD-compliant. This begins with the correct data preparation up to the professional creation of the eCTD dossier based on the applicable eCTD specifications. The current regulations for electronic submission in accordance with the EMA’s eSubmission Roadmap must always be taken into account.

Tip 4: Submit new applications via eCTD

The time for the Europe-wide eCTD obligation is approaching. We recommend that you create the next new applications in eCTD format if possible. Acting with foresight is more promising than reacting at short notice.

B.A. Sonja Friedsam

Marketing Project Manager

pharmadocs GmbH & Co. KG

eCTD wird Pflicht – 4 Tipps für eine reibungslose Umstellung.pdf