OBJECTIVES: The purpose of the present study was to evaluate the time elapsed between Health Technology Assessment (HTA) application to completion of the clinical evaluation of new medicinal products (including orphans) in Greece, from July 2018 (establishment of the Greek HTA Committee) until April 2022.

METHODS: Data were collected from the Greek HTA Committee’s database and other publicly available sources for medicinal products containing new active substances (including orphans). Median time intervals were computed in calendar days for the overall HTA clinical evaluation process.

RESULTS: The number of HTA clinical recommendations for new active substances (including orphans) increased from 4, between July 2018 and July 2020 (HTA Committee first operation period), to 87 during the second operation period (July 2020 up to April 2022). In July 2020, 45 products were under clinical assessment, while, in April 2022, the backlog was reduced to 27 products. During the HTA Committee’s first and second operation periods, the median times (25^th-75^th percentile) from HTA application to HTA clinical recommendation for new active substances (including orphans) were 200 (58-231) and 127 (84-178) days, respectively.

CONCLUSIONS: Since its establishment, a significant improvement in the performance of the HTA process has been observed by decreasing the backlog of medicinal products as well as the time of HTA assessment. Further actions may be needed to optimize the HTA process at the national level.