The Ministry of Food and Drug Safety has published the guidelines for winning regulatory approval for digital therapeutics.
Digital therapeutics refers to medical software programs that prevent, manage, or treat a disease based on scientific and clinical evidence for the treatment mechanism.
Digital therapeutics can be used not only for mental and nervous system diseases such as drug addiction and depression but for various illnesses, including asthma and diabetes. Compared to conventional drugs, it takes less time and cost to develop digital therapeutics because it does not require pre-clinical trials.
According to the Korea Evaluation Institute of Industrial Technology, it costs about 10 billion won ($8.4 million) to 20 billion won to develop a digital therapy, much less than the average development cost of conventional drug development, 3 trillion won. Besides, it takes about only four to five years to develop a digital therapeutic, compared to 15 years for conventional new drug development.
No local digital therapy has won approval so far. However, the food and drug safety ministry granted a clinical trial of virtual reality (VR)-based digital therapeutics for improving visual disorder caused by brain injury in June last year.
As part of the government’s Digital New Deal initiative, the ministry’s guidelines aim to help medical device makers research and develop digital therapeutics, the ministry said.
The guidelines include the definition and product scope of digital therapeutics, criteria and product examples, technical document writing, and attachments.
The ministry also published the guidelines for getting a review for innovative medical devices in multiple stages and those for major changes in innovative medical device software.
The ministry provided the two guidelines to support swift approval reviews on innovative medical devices including digital therapeutics, with the enforcement of the Medical Device Industry Growth and Innovative Medical Device Support Act on May 1.
“The publication of the guidelines is expected to help speed up the commercialization of digital therapeutics, which will be the key technology in this non-contact era,” a ministry official said.
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