Dr. Sameh Ben Tekhyat is a licensed pharmacist from the Faculty of Pharmacy of Monastir University and holds a Master’s Degree in Quality Management for the Health Sector. She began her career as a Quality Assurance Officer in a local pharmaceutical company before joining the Directorate of Pharmacy and Medicines (DPM) at the Tunisian Ministry of Health.

Since December 2022, she has served as Deputy Director in charge of pharmaceutical industries, where she leads key national regulatory initiatives. She is the regulatory lead of the ANMPS eCTD project, the project manager for the updated drug registration guidance released in June 2025, and the project coordinator for the operationalisation of the National Agency for Medicines and Health Products.

Dr. Sameh has played a pivotal role in shaping Tunisia’s pharmaceutical regulatory framework. She led the bioequivalence guidance released in 2017, and contributed to the biosimilars guideline (2018), in addition to other national regulatory documents. Since 2017, she has also served as Coordinator of the National Biosimilar Committee.