Tunisia – New Version of the Human Medicines Registration Guide Published – June 2025

On June 4th, 2025, the National Agency for Medicines and Health Products (ANMPS) officially published the updated version of the Human Medicines Registration Guide in Tunisia.

Download the guide:

• Human Medicines Registration Guide – June 2025 (PDF)

http://www.dpm.tn/images/pdf/t-op2-003-fr-000-guide_enregistrement_medicaments_humain_tunisie_juin-%202025.pdf

This revised document provides essential clarifications on the registration process, while integrating the latest international standards and regulatory best practices. Key highlights include:

• Clearer structure of the dossier submission process.
• Better defined and more transparent processing timelines.
• Introduction of electronic formats for certain steps.
• Focus on the quality of the pharmaceutical dossier and compliance with international standards (ICH, WHO, EMA...).

This update marks a significant step toward enhanced regulatory efficiency, benefiting industry stakeholders, healthcare professionals, and ultimately, patients.

Draft 'Reliance' Registration Guide Released for Public Comment:

In addition, on June 4th, 2025, the ANMPS released the draft version of the Human Medicines Registration Guide via the Regulatory Reliance Procedure for public review and comment.

View the draft:

• Reliance Registration Guide – June 2025 (PDF)

http://www.dpm.tn/images/pdf/guide_enreg_med_proc_reliance-juin%202025.pdf

This initiative reflects the ANMPS ongoing commitment to regulatory modernization and mutual recognition with reference agencies.