Navigating regulatory pathways for access to innovative medicines in Tunisia.

Abstract

Background: Recent years have witnessed a surge in the launch of breakthrough therapies, offering new hope to patients with severe or life-threatening conditions. However, access to these innovative medicines (IM) is often hindered by complex regulatory frameworks. This study aims to explore the regulatory environment shaping access to IM in Tunisia.

Methods: A retrospective observational study was conducted using national data from January 2005 to December 2022, including all marketing authorization (MA) applications for human medicines. IM were defined according to the U.S. Food and Drug Administration (FDA) criteria. Data were extracted from the SIAMED® software managed by the Directorate of Pharmacy and Medicine (DPM).

Results: A total of 8,377 MA applications were submitted, of which 424 (corresponding to 76 molecules) were classified as innovative. Oncology, including hematologic cancers, accounted for 83% of IM submissions. The average MA processing time was 1,169 days for IM (range: 38-3624) versus 650 days for non-innovative medicines (NIM). While 80% of IM were imported, 59% of NIM were locally manufactured. The number of IM applications increased twentyfold, from 34 in 2005-2010 to 300 in 2016-2022. MA approvals rose from 15 (2005-2010) to 74 (2016-2022). Between 2015 and 2021, IM accounted for approximately 10% of the national pharmaceutical budget. Additionally, 26 IMs were included in access program contracts, primarily for cancer, rheumatology, and multiple sclerosis.

Conclusion: This study highlights the evolving regulatory landscape for IM in Tunisia. The growing number of applications signals a shift toward improved access, but further regulatory reforms are needed to accelerate patient access to innovation.