Korea should establish clear concepts and guidelines of regulatory science to catch up with the global biotech market quickly, an expert said.
The Ministry of Science and ICT hosted the 2021 Bio Future Forum on Thursday, which was organized by the Korea Research Institute of Bioscience and Biotechnology (KRIBB), the National Research Foundation of Korea, and the National Biotech Policy Research Center.
At the event, Kim Heoung-yeol, head of the KRIBB’s National Biotech Policy Research Center, said it was important to introduce concepts of regulatory science from the early stage of R&D.
Regulatory science is a new field of scientific research that evaluates the safety and effectiveness of a specific study by weighing the benefits and harms it could generate in the future.
It acts as a bridge to deliver information about various tech products to consumers.
Advanced nations such as the U.S. and the U.K. recognized the importance of regulatory science more than a decade ago and established strategies to utilize it.
Korea, in contrast, belatedly set up a national R&D investment strategy in biotech and health under the Ministry of Science and ICT in 2019.
The Ministry of Food and Drug Safety’s strategy for advancing regulatory science also came out only recently.
Experts said that regulatory science has a relatively short history in Korea and is making progress too slowly.
Kim admitted that Korea has just started to make policies to nurture regulatory science.
Still, the scope of regulatory science is too limited to the process between clinical trials and product approval only in Korea, he noted.
“We should build a foundation for regulatory science so that we can anticipate the time when the technology will be commercialized from the initial stage of R&D,” he said.
Kim went on to say that it is time to reorganize systems and strategies to prepare for the transition to a platform-based digital biotechnology era.
Just as the government helped companies develop and commercialize vaccines to fight the Covid-19 pandemic, he said that it should provide flexible regulations and systems for biotech firms for new drug development and innovation.
“Just like the case where a Covid-19 vaccine came out within a year, the key concept of regulatory innovation is to make an environment where companies can pursue innovation without breaking regulations,” Kim said. “In the biotech industry, the difficulty of entering a market can vary depending on regulatory barriers, and the scope and speed of the market entry also vary. So, regulatory issues are matters of a national strategy.”
Kim suggested that companies have their regulatory management division and view that complying with regulations can accelerate innovation and become more competitive against rivals.
Regulatory authorities should also collect data on how authorized products are used by consumers and patients in the market and use them to improve regulatory guidelines, he said.