CHEONGJU — Minister of SMEs and Startups Lee So-young visited the Global Innovation Regulation-Free Special Zone for Advanced Regenerative Biotechnology in Cheongju, North Chungcheong Province, where she heard from biotech ventures about their technology development and the obstacles they face. Lee pledged regulatory improvements in the pharmaceutical and biotech sector, along with joint support from related ministries to foster the industry as a new growth engine.
At a roundtable held at the zone on the 16th, Lee said the ministry has selected several areas in which it can resolve regulatory problems alongside other agencies, with pharmaceuticals and biotech among them, after setting up a dedicated unit and building expertise. "We will define the ministry's role in fostering advanced regenerative biotechnology and consult more actively with the agencies that oversee the relevant rules," she said.
The session was structured around questions from officials of the special zone and resident biotech ventures, with the minister responding. Attendees included Lee Bok-won, vice governor for economic affairs of North Chungcheong Province, Park Soon-ki, president of Chungbuk Technopark, Yoo Jong-man, chief executive of Organoid Sciences, Park Hyun-sook, chief executive of Cellbio, and Hwang Joon-sung, chief executive of Qpeak Bio.
The North Chungcheong zone runs for four years, from June 2024 through May 2028. Thirty-five institutions, including biotech ventures and hospitals, are taking part in clinical research on advanced regenerative medicine and overseas demonstration projects. Three regulatory exemptions apply within the zone, covering the operation of an in-house clinical research review committee, the operation of a safety management body, and the participation of outside personnel in cell processing facilities.
Lee also stressed that removing unnecessary rules matters as much as policies that support corporate growth. "There are various support programs, including research and development funding and loans, but I believe clearing away the regulations that block corporate growth is the better policy," she said. "The ministry will work to ensure that companies can test new technologies in the special zone and that the results feed into actual regulatory reform."
Participants called for broader support for commercializing animal-free testing methods based on advanced regenerative biotechnology and for expanding into overseas markets. "Support centered on small and medium-sized enterprises is needed so that animal-free testing methods can take hold," Yoo said. "We would also like to see voucher programs set up so that drug developers can make active use of these methods, along with a special zone in North Chungcheong to support commercialization of the related technology."
Animal-free testing methods assess the safety and efficacy of new drugs using human cells, artificial organs and computer simulations instead of laboratory animals. In South Korea, however, commercialization has been slow because replacing conventional animal testing in the drug approval process requires validation of reliability and other factors.
Participants also said gaps between national regulatory regimes in the biotech field need to be narrowed and cooperation with overseas drugmakers expanded. "Cell therapies are manufactured differently from conventional chemical drugs, so there are many points where they clash with the rules," Park said. "Regulations in Korea, Japan and Europe are similar yet different from one another, which makes it hard for smaller firms to respond on their own."
Hwang of Qpeak Bio suggested that fostering biotech ventures be approached as a matter of medical security. "Going through COVID-19 showed us how important it is to secure a country's own drug development capabilities," he said. "Please expand opportunities for joint research and development between Japan's global drugmakers and domestic biotech ventures, and strengthen programs that provide growth capital, based on technological capability, to companies that deliver actual results from such partnerships."
In response, Lee said the ministry has the strongest incentive of any agency to resolve the difficulties facing small and medium-sized enterprises, but acknowledged that its support has been limited because expertise in pharmaceuticals and biotech, as well as the authority to approve products, rests with other ministries. "We will soon set up dedicated units for four priority areas, including pharmaceuticals and biotech, and strengthen cooperation with the relevant agencies," she said.