2021 Volume 11 Issue 3 Pages 173-179
The aim of the study was to explore the characteristics of supplemental new drug application (s-NDA) and market expansion re-pricing (MErP). For 433 new active substances to which marketing approval was granted from 2008 April to 2020 March, we collected review reports on the s-NDA through December 2020 from the website of the Pharmaceutical and Medical Devices Agency and reports of market expansion re-pricing from that of the Central Social Insurance Medical Council, Ministry of Health, Labour and Welfare. One-hundred and fifty-eight drugs (36.5%) of 433 drugs obtained sNDA approval. Of them, a total of 214 sNDA approval for extensions of indications (sNDA-i) were granted for 131 drugs. Fifty point and five percent (46 drugs) of anticancer drugs received sNDA-i approval, which was the most among therapeutic categories. A total number of sNDA-i approval per a drug was 0.87 for anticancer drugs, which was the most among therapeutic categories, too. As for the period from NDA to the first sNDA-i approval, the mean of 13.7±5.5 (mean±S. D., months) and the median of 11.0 months in gastrointestinal drugs were the shortest among therapeutic categories, followed by 23.5 months for biologics, 24.0 months for anticancer drugs and 24.5 months for the allergy drugs. Of 131 drugs with sNDA-i approval, a total of 27 MErP have been applied to 25 drugs. More MErP have been applied to central nervous system drugs, other drugs affecting metabolism, and anticancer drugs. A total number of sNDA-i approval per a drug was 2.2 for drugs with MErP and 1.5 for drugs without MErP.
