Key bills related to biotech industry globalization remain pending in the National Assembly. Experts point out there should be no more procrastination.
The bills include those on advanced biopharmaceuticals and in vitro diagnostic devices. The National Assembly failed to pass the bills last year. This month, unproductive public hearings and discussions were repeated.
The bill on advanced biopharmaceuticals is the one the industry is looking forward to most. Tabled in August last year, the bill is for large-scale deregulation. According to the bill, for example, biotech companies submitting data on an ongoing basis can go through Food and Drug Safety Ministry screenings even without final clinical trial data. In addition, more competitive new drugs can be examined ahead of general biopharmaceuticals and new drugs indispensable for patients can be conditionally approved even before clinical trial completion.
The bill on in vitro diagnostic devices was tabled last year, too. South Korean President Moon Jae-in promised in July last year that there would be deregulation for the devices, yet the bill is still pending.
In-vitro diagnostics perform tests on samples such as blood, body fluids and tissue, which means they entail much less side effects than drugs. Nonetheless, these devices require Food and Drug Safety Ministry approvals and the New Health Technology Assessment for literature-centered safety assessment at the same time.