Despite earlier recommendations to the contrary, as of 1 January 2018 all types of EU mutual recognition procedure (“MRP”) submissions should be made in electronic Common Technical Document format (“eCTD format”).

Background information

eCTD format is the principal electronic submission format required by the European Medicines Agency (“EMA”) in the centralised market authorisation procedure since 2010.

The Heads of Medicines Agency (“HMA”) and the EMA introduced mandatory eCTD format for MRP submissions for medicinal products for human use in February 2017 in the EU eSubmission Roadmap 2.0. The goal of the eSubmission Roadmap is to guarantee effective electronic submission pathways for medicinal products for human and veterinary use within the European Medicines Regulatory Network.

According to the Harmonised Technical Guidance for eCTD Submissions in the EU, the use of eCTD format was not required for the regulatory procedures initiated in a non-eCTD format. Until recently, only new applications for marketing authorisation within MRP had to be thus submitted in this format.

New guidance

A new Q & A document published on 4 January 2018 by the HMA states that from 1 January 2018 all MRP submissions should be made in eCTD format. This format is, therefore, required not only for new MAAs submissions, but also for submissions regarding on-going regulatory activities, such as follow up submissions for variations, responses or renewals, even if this means a format shift of the dossier. This requirement clearly contradicts prior guidance providing that the format change should preferably be done at the start of a regulatory activity.

The newly issued document clarifies how to change to eCTD format in submissions concerning on-going regulatory procedures. A new version of eCTD validation criteria will come into force from 1 September 2018.