The National Agency for Medicines and Health Products Safety announced an update to the roadmap relating to the transition to the electronic Common Technical Document (eCTD), an internationally harmonized format that enables the preparation, organization, and electronic submission of medicinal product technical dossiers. This update notably provides for an exceptional extension of several deadlines granted to laboratories.
In a press release published on its Facebook page, the National Agency for Medicines and Health Products Safety indicated that this update is part of the monitoring of the implementation of the electronic format, the support of applicants for marketing authorization of medicines, and the compliance of dossiers with the technical requirements in force.
The Agency specified that this decision also follows difficulties encountered, according to its assessment, by certain laboratories during the transition to the electronic formats.
It thus announced, exceptionally, the extension until 31 December 2026 of the deadline for a new submission, under the new electronic format, of dossiers for new marketing authorization applications filed in 2025, whose examination has not yet begun and which did not benefit from prioritization during that same year.
For new dossiers filed during 2026, the deadline for new submission under the new electronic format has been extended until 31 March 2027.
The Agency, however, stressed that any dossier not resubmitted within the prescribed deadlines will lose the priority linked to its initial filing date. The effective submission date under the new electronic format will then be considered the dossier’s new reference date.
The National Agency for Medicines and Health Products Safety also indicated that it will, exceptionally, allow the continuation of the submission of renewal applications for marketing authorizations according to the electronic format currently in force, and this until 31 December 2026.
From 1 January 2027, renewal applications will be submitted exclusively in the electronic Common Technical Document format, with the obligation to first deposit the dossier’s reference base.
The Agency also indicated that the official opening date of the electronic portal dedicated to the new format will be announced later to marketing authorization applicants. The current submission modalities will remain unchanged until the portal opens.
Finally, guidance documents and practical recommendations concerning the preparation and submission of dossiers according to the new format will be made available to authorization applicants. The objective is to limit errors likely to lead to the rejection of filings or affect processing times.
