eCTD Transition in Tunisia
eCTD Transition in Tunisia
eCTD Transition in Tunisia: One-Month Extension of Deadlines
A new ANMPS roadmap dated March 31, 2026 has been released regarding the implementation of the electronic Common Technical Document (eCTD) in Tunisia.
The updated roadmap maintains the previously announced requirements and transition steps, while introducing a one-month extension of the deadlines. In addition, greater flexibility has been granted regarding the submission methods, due to the delayed launch of the ANMPS electronic portal.
Updated Regulatory Timeline
Until May 1, 2026
Submissions including:
- New Marketing Authorization Applications (MAA)
- Renewals
- Variations
- Transfers
will continue under the current submission procedure, with prior appointment required.
From May 1, 2026
Electronic submissions (eCTD or e-submission) will become mandatory and can be performed through three channels:
- Submission via the ANMPS eCTD portal (for applicants with portal access)
- Submission through a secure file transfer platform
- Delivery of a physical medium (USB drive) to ANMPS, by appointment
From June 1, 2026
All regulatory submissions to ANMPS must be exclusively in eCTD format, without exception.
AREMA: Your Partner for a Smooth eCTD Transition
AREMA supports pharmaceutical companies throughout every stage of the eCTD transition process.
Through its partnership with EXTEDO, AREMA provides advanced regulatory technology solutions as well as a comprehensive eCTD outsourcing service, including:
- eCTD dossier publishing
- Technical validation of submissions
- Regulatory submission management
Our teams can manage your regulatory projects for Tunisia (ANMPS) as well as for GCC countries, helping you ensure compliance, efficiency, and adherence to regulatory timelines.
Contact us: info@arema-international.com