10 April 2025, Tehran, Islamic Republic of Iran – 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.
“We are here because the Islamic Republic of Iran has expressed a clear interest in improving its regulatory system, and WHO is committed to building this capacity together,” said Dr Gaspar. “Our joint efforts aim to ensure the safety, quality and efficacy of medical products, not just for Iran but for regional and global public health.”
WHO Representative in Iran Dr Jaffar Hussain underlined the country’s existing strengths and its potential as a leader in pharmaceuticals, biologics and medical devices, saying: “Iran has already demonstrated strong capacity in producing medicines and vaccines. Our objective is to support Iran reach ML3, a milestone that will enable the country to export its products more widely and contribute to global health security.”
Dr Gaspar and Dr Hussain reaffirmed WHO’s commitment to equity, innovation and international collaboration in health systems development, stressing that regulatory strengthening is essential not only for national resilience but also to ensure access to quality-assured medical products worldwide.
A significant step towards enhancing Iran’s regulatory system and ensuring better health outcomes for its population, the visit sets the stage for robust cooperation in regulatory system strengthening with the goal of achieving universal health coverage.
The mission also included meetings with the Iran Blood Transfusion Organization, Pasteur Institute, Razi Vaccine and Serum Research Institute and regulatory experts.