Iran's medicines and food regulator, part of the Ministry of Health. It keeps the country's official medicines list and approves new medicines, which a 2024 study found reached Iran years after the United States and Europe.
The Iran Food and Drug Administration, in Persian Sazman-e Ghaza va Daru, is the health ministry's food and medicines arm. Its own history page, read in Persian from an Internet Archive copy of 18 April 2021, says a pharmaceutical deputy ministry was formed in 1352 (1973 to 1974), a body called the Food and Drug Organization existed for one year from 1355, and the present organisation was formed in 1389 (2010 to 2011) with the approval of the Supreme Administrative Council. The same site lists offices for health technology assessment and economic studies, rational use of medicines, tariffs and pharmaceutical care standards, and pharmacovigilance, and publishes the country's official medicines list.
A 2024 study of new molecular entities from 2001 to 2021 found that 148 of the 710 approved by the US Food and Drug Administration had also been approved by the Iranian regulator, and that for cancer and immune medicines (ATC group L) the mean lag behind approval in the United States was 77.2 months, behind the European Medicines Agency 63.96 months and behind Japan's agency 57.93 months. Policies the regulator applied during the 2012 sanctions crisis included facilitating domestic manufacture and reducing the market share of imported medicines, according to a 2019 study based on interviews with experts and managers in the regulatory system. fda.gov.ir did not answer from here on 4 November 2026.
It is the only published measure OnCo found of how long new cancer medicines take to be approved in Iran, and it puts the delay in years rather than months.
Sanctions on Iran exempt medicines and food in principle, but these clinicians report that cancer patients still meet shortages, substitutions and delays, which is the practical context for Iran's push to make cancer medicines itself.
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