101 Medical Products Approved Last Month, Including Digital Therapeutic for Emotional Disorders

Ministry of Food and Drug Safety Approves
101 Medical Products in June
Including 30 Pharmaceuticals and 68 Medical Devices

The Ministry of Food and Drug Safety announced on July 14 that it approved 101 medical products last month. By category, this includes 30 pharmaceuticals, 3 quasi-drugs, and 68 medical devices.

This figure is 20 fewer than the 121 products approved in May, representing 81.5% of the monthly average for last year (124 products) and 86.3% of the monthly average for the first half of this year (117 products).

Last month, the Ministry approved two orphan drugs for the treatment of non-small cell lung cancer and solid tumors: 'Oktairo Capsule 40mg (Repotrectinib)' and 'Oktairo Capsule 160mg'.

Additionally, the Ministry granted the first domestic approval for a digital medical device, the emotional disorder treatment software 'Bluekare-T', designed to improve depressive symptoms in patients with depressive disorders.

The Ministry stated that it will continue to promptly approve safe and effective products to expand treatment opportunities for patients, regularly provide updates on medical product approvals, and actively enhance the transparency and reliability of the medical product approval and review process.