Korea’s drug regulator is moving on two fronts to speed approvals and cut red tape for the medical sector. On July 31, the Ministry of Food and Drug Safety (MFDS) said that it would streamline the process for converting orphan drugs into new drugs by waiving repetitive steps like pre-application and kickoff meetings when a product has already been vetted under orphan-drug status. The change follows May’s “Medical Product Approval and Review Innovation Plan,” which set a 240-day target for new drug reviews. The MFDS also clarified how it documents and communicates results from pre-application meetings. Through these measures, the MFDS aims to give companies clearer visibility into the review process.
Three days earlier on July 28, the MFDS revised its rules for digital medical devices to address long-standing complaints that clinical trial exemption standards were too vague. After reviewing roughly 1,000 past approval cases, the agency set clearer criteria for which products need clinical trial data versus performance verification data alone. Software that maps procedure paths or builds treatment plans from imaging can now rely on performance data. However, AI tools that diagnose disease or analyze test results are still required to provide clinical data.
The digital device rules also extend a real-world use waiver for advanced AI products, including generative and multimodal AI, from one year up to three years, and broaden a good-management-system waiver beyond Class 2 devices.