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Registration of drugs in Iran

Iran is a large pharmaceutical market in regional terms having a large and fast-growing population of more than 70 million and wide public healthcare coverage. Although Iran has low per capita pharmaceutical consumption (around US$34.7 in 2008 and 40.0 US$ in 2009) compared to other countries in the region, the large size of its population and its under-developed market coupled with the growing aging population will continue to encourage the development of its pharmaceutical market. Basic healthcare reaches about 90% of the rural population and almost the entire urban population. Self-medication is common among the population, creating a sizable OTC drug market.
In 2009, the market topped US$2.8bn showing an increase of almost 20% compared to 2008. In 2013, The market is expected to reach US$4.5bn in value. The government funds about 48% of health expenditure while the private sector and out-of-pocket spending – account for a majority of healthcare costs, private health insurance meets only 2.6% of total expenditure. All Iranians are eligible for community-based preventive public health and limited curative health services which is funded entirely by the national government.

Iran has a national drugs list, the Iran Drug List (IDL), which is drafted by the Iran Drug Selection Committee. All prescription and OTC drugs marketed in Iran (with molecule, salt, dosage form and strength specified) must be listed in IDL prior to availability for prescription. A limited volume of unregistered drugs are allowed to be imported through Emergency Pharmaceutical Centers (EPCs) which are dispensed at the responsibility of the prescribing physician. All manufacturing, distribution and imports of medicines are supervised by the General Pharmaceuticals Bureau and require initial approval from the Ministry of Health. For imported products, a local agent is required to register a product in Iran. If the imported drug is already included in the Iran Drug List (IDL), the import is subjected to submission of required documents along with the DMF/CTD (eCTD in future) and the approval of the MOH’s QC laboratories. For drugs not listed on IDL, the manufacturer or importer/local agent has to follow the process of registering the drug in IDL.