Korea food and drug ministry sets one-stop review for drug-device combinations

South Korea's food and drug safety ministry said Friday it has published review procedures for digital combination drugs, products that pair a medicine with a digital medical or health-support device, and will apply them from Oct. 30.

The framework creates a one-stop integrated review in which drug, biopharmaceutical and medical device reviewers form a joint team, conducting independent assessments of each component alongside a combined review of the product as a whole, the ministry said. The Korea Institute of Food and Drug Safety Evaluation, the ministry's review arm, issued the procedures.

The ministry said the procedures respond to a rise in domestic development interest in digital combination drugs and to a need raised in the field for a review system that treats devices and medicines together, as products combining AI- and software-equipped digital medical or health-support devices with medicines, including biopharmaceuticals, have appeared. The procedures reflect opinions gathered at a public report on the ministry's 2026 food and drug safety tasks held in July, the ministry said.

The procedures set out how joint review teams are formed and run, define four categories of digital combination drugs, and tell companies what documents to submit when applying for product approval. Under the Digital Medical Products Act, a digital combination drug is a medicine physically and functionally combined with a digital medical device or a digital medical and health-support device; products whose main function is the device itself are excluded.

The ministry said it will form and operate joint review teams promptly when applications for digital combination drug approval are filed, and that it expects the integrated review to bring products to market sooner.

"Through the one-stop integrated review system for digital combination drugs, we will support the entry of our products into new markets and help them secure a lead in those markets," said Kang Seok-yeon, head of the Korea Institute of Food and Drug Safety Evaluation. He said the institute will keep issuing guidance, including a guideline on designing clinical trials for digital combination drugs, within the year.