RA Team
eCTD is of great interest nowadays for the pharmaceutical industries, as the EMA disposed mandatory use of eCTD format for all submissions before 2019.

The final countdown: Transition from paper/NeeS to eCTD format submission for all regulatory activities

eCTD is of great interest nowadays for the pharmaceutical industries, as the EMA disposed mandatory use of eCTD format for all submissions before 2019.

For centralised procedures eCTD format is already a „must-have” since 1st January 2010, when NeeS format was no longer accepted for CP submissions. New MAA in DCP and MRP took the same path as CP and since July 2015 respectively January 2017, eCTD format was fully adopted as the starting point for new applications.

The ultimate goal is that eCTD to be the only e-submission type used in the European regulatory environment. We are just a few steps away from this challenge if we consider that the deadline for implementing the mandatory use of eCTD for all regulatory activities (variations, renewals, PSURs, ASMFs etc.) in MRP/ DCP procedures is 1st January 2018 – that is only 3 months away!

National procedures will also have to comply with these requirements thus paper/NeeS submissions for new MAA in NP will automatically be rejected after by 1st July 2018, while for the rest of regulatory activities in NP starting from 1st January 2019 eCTD will be is the only acceptable electronic format. NCAs are already aware of the important changes following conversion to eCTD, as a proof that approximately half of the NPs were submitted in eCTD format in EU untill beginning of 2017 (1).

If your previous submissions have been filed on paper or non-eCTD, you have the opportunity to switch to eCTD at the beginning of any phase in the life cycle of a product (renewal, variation, extension etc.), keeping in mind that all pending regulatory activities have to be closed. It is important to know that once transition to eCTD have been successfully made, further applications will be submitted only in the upgraded eCTD format (2) .

Generally, a baseline submission is not mandatory, but it is highly recommended to use it. A baseline is actually a re-submission of previously submitted files and is created at the start of an eCTD lifecycle for an existing dossier. Sequence 0000 will be associated with the baseline submission and next regulatory activity will be sequence 0001. Ideally, high quality electronic source documents should be included in the baseline, however, good quality scanned images would also be acceptable, preferably using Optical Character Recognition (OCR) to convert scanned images to editable text (3).

From our own research conducted in 14 EU member states, during the summer of 2017, only four of them consider that the baseline submission is mandatory. In addition to that, the creation of baselines will always require that human and financial resources  are allocated for such activities, without generating any clear gain. Therefore, companies, especially those with a high number of dossiers to convert into eCTD,  will think twice before covering such costs. However, here is something to think about before making a decision in this sense: having a baseline submitted enables the agencies to assess your future applications faster, as they won't have to dig out previous paper or NeeS file. Their assessment will also be more accurate, since the risk of asking for information they already received in the past, but can't find it quickly as it is in a different format, considerably diminishes in such cases.

Managing changes is an essential part of regulatory and experts have to keep abreast new legislation and requirements in this field, keeping track of all changes. This can be overwhelming sometimes. Clients can always rely on us for perfoming the necessary investigations for them to better draft their strategies.

BrexitCP submissions EMA MAH MRP/DCP Regulatory Affairs eCTD

All Articles

18 Sep 2017

The final countdown: Transition from paper/NeeS to eCTD format submission for all regulatory activities

eCTD is of great interest nowadays for the pharmaceutical industries, as the EMA disposed mandatory use of eCTD format for all submissions before 2019.

Tags: eCTD,Regulatory Affairs,MRP/DCP,CP submissions

04 Jul 2017

Marketing Authorisation Holders, the impact of the UK’s decision to invoke Article 50 of the Treaty on European Union. How could this affect MAH’s products currently registered in the UK and EU?

Tags: EMA, MAH, Brexit