Background Road traffic crashes and associated injuries and mortalities are one of the big public health challenges, especially in low/middle-income countries. Road safety lead agency (RSLA) is a vital factor in the sustainable prevention and promotes road safety. In the recent decades, various policy interventions have been conducted for road safety in Iran. This study aimed at exploring the challenges of RSLA from the perspectives of stakeholders at various levels.

Methods A qualitative study was conducted. In-depth interviews and document reviews were used for data collection. To conduct interviews, different stakeholders at various levels such as policy-makers, senior national authorities, researchers and faculty members were selected. Data collection was conducted between November 2019 and June 2020. Thematic content analysis approach was used for data analysis.

Results The experts’ perspectives were analysed and then categorised under five main themes including the role and position of the lead agency, the role and duties of the actors and players, translating policy into practice, intrasectoral and intersectoral cooperation and coordination and evidence production and application and a total of 22 subthemes were identified. The current structure of the RSLA is one of the main challenges emphasised by the research participants.

Conclusion To achieve significant improvements in road safety at the national level, a strong management system and leadership body is a critical issue. Organisational reform to establish an effective unique lead agency is proposed to cope with RSLA challenges.