On 8 and 9 April 2025, Dr Rogerio Gaspar, Director of Regulation and Prequalification at the World Health Organization (WHO) headquarters, led a high-level mission to the Islamic Republic of Iran to support the strengthening of Iran’s national regulatory system for medical products. The 2-day visit focused on:

• providing updates on WHO’s Global Benchmarking Tool (GBT) for medicines and vaccines and the WHO Listed Authorities (WLA) framework, including a preview of the upcoming GBT+ medical devices;
• the expansion of WHO’s Prequalification Programme to include medical devices, ensuring greater internal alignment and efficiency in WHO’s access strategy; and
• understanding Iran’s current regulatory landscape and exploring collaborative pathways for capacity-building, in alignment with WHO's transitional WLA initiative, to help Iran progress toward Maturity Level 3 (ML3) and WLA recognition by 2027.

Discussions were opened with Dr Mahdi Pirsalehi, Deputy Minister and President of the Food and Drug Administration (FDA) of the Ministry of Health and Medical Education (MoHME). During the first day of his mission, Dr Gaspar met with senior Iranian health officials including MoHME’s Director General of International Affairs, the Director General for Pharmaceutical and Biological Inspection and Supervision at the FDA, the Director General of the Food and Drug Control Reference Laboratories (FDCRL) and other high-ranking figures. He also visited FDCRL facilities.