Major regulatory improvement tasks pushed by the Ministry of Food and Drug Safety (MFDS), such as simplifying clinical approval of artificial intelligence (AI)-based diagnostic software, are being deliberated by the National Assembly, drawing the industry’s attention.
Following the selection of the Top 100 Food and Drug Regulatory Innovation Tasks last year, MFDS declared “Regulatory Innovation 2.0” this year and has been continuously announcing the results of its regulatory improvement drive.
Among them, three major regulatory innovation tasks are pending in the National Assembly; establishing a new legal system for digital medical products, excluding the approval of clinical trial plans by the Minister of Food and Drug Safety if there is a small risk of affecting the safety of clinical trial subjects; and establishing grounds for displaying e-labels on containers and packaging of specialty drugs and providing electronic forms of attachments.
In the case of the Digital Medical Products Act, it is pending at the Subcommittee on Bills of the Health and Welfare Committee.
Reflecting the trend of combining medical devices and the latest IT technologies, the main content is to define digital medical products by dividing them into digital medical devices, digital convergence drugs, and digital health support devices (wellness products). The amendment bill includes support measures, including preferential health insurance benefits.
A bill to amend the Medical Device Act is also pending at the Health-Welfare Committee's subcommittee. The main thrust of the bill is to exclude clinical trial plans from approval by the head of MFDS if there is little risk of affecting the safety of clinical trial subjects. Currently, this applies only to cases such as observing the effects of marketed medical devices.
If the amendment is passed, the approval process for clinical trials involving vital signs collection using digital technologies, such as diagnostic auxiliary software, and medical devices used in primary hospitals, including blood glucose meters, will be simplified. These will likely reduce the time required for product development.
An amendment to the Pharmaceutical Affairs Act to introduce e-labels for specialty drugs is pending before the plenary session of the Legislation-Judiciary Committee.
The e-label is a system that provides information on efficacy, effectiveness, dosage, and precautions in electronic form by inserting QR codes on containers and packaging of specialized drugs. When a QR code is scanned with a mobile device, it connects to the website of the drug manufacturer. The MFDS expects it to allow applicants to check the latest drug information conveniently using mobile devices and reduce the inefficiency of changing the attached documents each time.
Starting with Pfizer's Torisel Inj. (temsirolimus) in April, all 27 items of injectable drugs for direct administration in medical institutions under the pilot project are being shipped with e-labels. Ten companies are participating in the pilot project. They are Dong-A ST, Boryung (formerly Boryung Pharmaceutical), Boryung Biopharma, Imaging Solution Korea, Ildong Pharmaceutical, Chong Kun Dang Pharmaceutical, GE Healthcare Korea, AstraZeneca Korea, Pfizer Korea, and Hanmi Pharm.
MFDS is determined to fulfill all of its regulatory innovation tasks by getting approvals for these bills from the National Assembly as soon as possible.
"We hope these bills will pass the Assembly at the Legislation-Judiciary Committee’s plenary session and are actively working on this," Vice Minister of Food and Drug Safety Kim Yoo-mi told reporters.