MFDS Revises Clinical Trial Guidelines for Digital Therapeutics, Aiming to Shorten Preparation Time

The Ministry of Food and Drug Safety (MFDS) has revised guidelines for preparing clinical trial protocols for digital therapeutics targeting seven indications, including nicotine use disorder.

The National Institute of Food and Drug Safety Evaluation said on the 10th that it pursued the revision to provide practical review criteria reflecting clinical trial protocol review cases since the Digital Medical Products Act took effect, as well as the latest international trends.

The seven indications are nicotine use disorder, alcohol use disorder, panic disorder, depressive disorder, eating disorders, attention-deficit/hyperactivity disorder (ADHD) and mild cognitive impairment.

The MFDS expects the revision to reduce development setbacks and shorten the time companies need to prepare for clinical trials.

Key revisions include incorporating the latest review criteria, such as scientifically grounded efficacy endpoints and the setting of a minimum clinically important difference (MCID); adding examples of multicenter trials and follow-up periods to strengthen clinical trial reliability; and updating items and terminology to reflect revisions to the Digital Medical Products Act and its subordinate regulations.

MCID refers to the minimum change that patients can perceive as an actual improvement in their condition, beyond a simple change in statistical values.

The MFDS said it expects the revision to improve companies’ understanding of the latest review criteria and contribute to more complete clinical trial designs. It added that it plans to continue developing guidelines that reflect feedback from the field to support the rapid market entry of digital therapeutics and foster an environment for their safe use.

More information is available under Laws and Data on the MFDS website (www.mfds.go.kr).