OBJECTIVES: The drug approval process ensures the safety and efficacy of medications before they are made available to the public. U.S. Food and Drug Administration (FDA) approval process differs of other countries. This analysis aims to compare the drug approval differences between the FDA , USA and TITCK, Turkiye.

METHODS: The analysis was conducted using information obtained from the FDA's official site and the List of Licensed Products published by the Turkish Pharmaceutical and Medical Device Agency (TITCK). The descriptive analysis for the study were conducted through the Microsoft Office Excel program.

RESULTS: Over the past years, a total of 188 medicines were approved by the FDA. It was found that 32.45% of FDA-approved medicines are licensed in Turkiye by TITCK. When the licensed medicines analysed by the ATC classification; the percentage of approval for each category differed. 36% for A, 36% for B, 50% for C, 17% for D, 33% for H, 18% for J, 49% for L, 43% for M, 24% for N, 67% for R, 25% for S, 0% for P, G and V. The average duration for FDA-approved medicines to obtain licensing in Turkey was determined to be 20.9 months. The minimum duration for licensing is 5 months, while the maximum duration extends to 41 months.

CONCLUSIONS: According to the analysis, it takes more than a year for a newly FDA-approved drug to become licensed by TITCK and significant proportion of these medicines don’t obtain licensing at all.