Objectives: To describe the characteristics of originator drugs granted marketing authorization in Vietnam and to evaluate drug lag compared with reference regulatory agencies.
Methods: A cross-sectional descriptive study was conducted using secondary data from the list of originator drugs issued by the Ministry of Health between June 2022 and June 2025. Data were collected from the National Drug Database and publicly available sources from the U.S. Food and Drug Administration (FDA), European Medicines Agency (EMA), and Pharmaceuticals and Medical Devices Agency (PMDA). Drug lag was defined as the time interval between the date of approval by each reference regulatory agency and the date of the first registration number issued in Vietnam.
Results: A total of 658 marketing authorizations for originator drugs were identified, of which 80.7% were covered by health insurance and 59.9% were orally administered. Of these, 544 were approved by the FDA, 282 by the EMA, and 378 by the PMDA. The mean drug lag compared with the FDA was 188.78 ± 125.01 months, with a median of 172.5 (4.3 – 744) months, only 9.1% approved within five years of FDA approval. The mean drug lag compared with the EMA and PMDA was 121.19 ± 65.97 months and 118.75 ± 84.68 months, respectively. The median drug price was 63,200 VND (IQR: 15,941–668,710 VND). Several high-cost biologics and oncology drugs showed drug lag exceeding 200 months.
Conclusion: This study provides evidence on the characteristics and drug lag of originator drugs in Vietnam, contributing to a better understanding of the current status of access to originator drugs in the country and serving as a reference for future studies on factors associated with drug lag.