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)
t-op2-003-fr-000-guide_enregistrement_medicaments_humain_tunisie_juin- 2025.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.