Dossier submission in eCTD format

What is eCTD?
It is a standard for structured electronic submissions aimed to facilitate the submission itself and to increase the trace ability of the life cycle of a specific medicinal product. Its main advantage is the Life Cycle Management (LCM), which is achieved through the use of an XML backbone for navigating through the content and tagging data as well as tracking changes, and represents the master document containing all metadata of an individual submission. The XML instance and .pdf versions of documents form a complete eCTD, which consists of a total of five sections, i.e. five modules:

• Module 1 (administrative data and product information)
• Module 2 (clinical and non-clinical overviews)
• Module 3 (quality)
• Module 4 (non-clinical study reports)
• Module 5 (clinical study reports).

Transition to eCTD format
In view of the obligation set to enter into force in January 2020, there is an emerging need to change the format of previously approved product documentation, which is submitted as a baseline sequence.

The baseline sequence is not mandatory when transitioning to the eCTD format but is desirable because it facilitates the monitoring of a medicinal product’s life cycle and of the regulatory requirements. This also enables the Agency to review previously approved documents more efficiently and easily. It can be sent in two ways: either as part of a new regulatory activity, whereby the baseline sequence and the sequence of the new regulatory activity are attached, or as a baseline sequence together with a written application. Regardless of the method of submission of the baseline sequence, a consolidated version of the previously submitted product documentation is delivered to the Agency, the backbone of which is Module 3 along with other modules that have been updated accordingly.

A complete transition to eCTD submission significantly facilitates the tracking of a medicinal product’s life cycle and any variations that have occurred over time as well as its storage.

Our team has the expertise required for providing successful support and assistance in eCTD compilation: we offer full project management service, including formatting, editing, preparation as well as extensive and knowledgeable communication with competent authorities.