WE.SPEED.
The Health Authority (HA) of Moldova has introduced a 10-day fast-track review timeline for all phases (I-III) of clinical trials, with the regular review set at 21 working days.
As an EU-candidate country, Moldova conducts autonomous reviews of clinical trials outside the EU system (absence of application via CTIS). Consequently, every clinical trial is submitted simultaneously to the Moldova HA and the Central Ethics Committee (CEC).
The Central Ethics Committee provides three review options: a 5-day expedited review, a 10-day expedited review, and a standard 21-day review. The review process within each HA and CEC begins upon payment acknowledgment related to the selected timeline option.
With a rich history of 15 years of collaborating with Moldova's regulatory authorities in early-phase clinical research, ARENSIA applauds Moldova's strategic positioning as a hub for innovative drug development.
This initiative is establishing Moldova among the fastest countries worldwide to initiate clinical trials, to grant Moldova patients early access to cutting-edge therapies in the drug development process.
04.03.2024