# Assessing drug lag in new drug approvals by the Iran Food and Drug Administration compared to the U.S. FDA, EMA, and PMDA: a 20-year analysis (2001-2021)

Source: https://onco.cc/key-papers/paper-ifda-drug-lag-alipour-medicine-2024/  
OnCo record `paper-ifda-drug-lag-alipour-medicine-2024` (Key paper). Data CC BY-NC 4.0, attribute "Data from OnCo (onco.cc)"; commercial use needs a licence.

## TL;DR

New medicines approved in the United States from 2001 to 2021 reached approval in Iran, when they did at all, more than five years later on average, and cancer medicines were no faster.

## Summary

The authors compared new molecular entities approved by the US Food and Drug Administration, the European Medicines Agency, Japan's Pharmaceuticals and Medical Devices Agency and the Iran Food and Drug Administration between 2001 and 2021, using the Iranian government's official medicines list and the agencies' own records, and measured absolute and relative drug lag by therapeutic area of the Anatomical Therapeutic Chemical classification.

## Fields

- Kind: Key paper
- Last checked: 2026-11-04
- Journal: Medicine
- Year: 2024
- DOI: 10.1097/MD.0000000000038142
- Authors: Alipour S, Nadimi Parashkouhi S, Mojahedian M, Abbasian H
- Findings: Of 710 medicines approved by the US agency, 410 were approved by the European agency, 344 by the Japanese agency and 148 by the Iranian regulator.; For the 148 approved by both, the mean relative lag behind the United States was 65.18 months (SD 61.56) and the maximum 237 months.; For antineoplastic and immunomodulating agents (ATC group L) the mean relative lag was 77.2 months against the US agency, 63.96 against the European agency and 57.93 against the Japanese agency.
- What it means: 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.
- Caveats: Approval dates were taken as the start of the year when only the year was known.; It measures registration, not when a medicine became available or reimbursed.; It covers only medicines approved by both the US agency and the Iranian regulator, and excludes vaccines, combinations and new versions of medicines already approved.

## Sources

- Medicine 2024: https://doi.org/10.1097/MD.0000000000038142
- PubMed: https://pubmed.ncbi.nlm.nih.gov/38905367/

## Connected records

- institutions: [Iran Food and Drug Administration (IFDA)](https://onco.cc/institutions/iran-fda/)
- bottlenecks: [Most of the world has almost no cancer care](https://onco.cc/bottlenecks/b-global-access/), [Regulatory divergence between regions](https://onco.cc/bottlenecks/b-regulatory-fragmentation/)

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