"Regulation is an Ally of the Biohealth Industry"... No Industry Development Without Proper Regulation

Regulatory Science Center Hosts 'Regulatory Science Media Forum'
Kim Kang-rip "Regulations Should Be Tight but Reflect Corporate Characteristics"
Lim Jin-hwan "High-Intensity Regulations Ensure Quality Assurance"
Kang Sung-ji "Cutting-Edge Regulations Needed for DTx"

The general industrial sector calls for a "regulatory revolution," arguing that regulations are obstacles hindering industrial growth. However, the healthcare industry, including pharmaceuticals and bio sectors, shows the opposite trend. They demand strengthening regulations, such as requesting an increase in personnel at the regulatory agency, the Ministry of Food and Drug Safety (MFDS). This is due to the nature of the healthcare industry, where product launches are impossible without proper regulations, and low regulatory standards can actually degrade product quality.

On the 13th, the Korea Center for Regulatory Science held the "1st Regulatory Science Media Forum" to emphasize the importance of proper regulation. Established in 2022, the Regulatory Science Center serves as the control tower for training regulatory science experts at the MFDS. Additionally, it aims to support regulatory science research and policy, strengthen partnerships, enhance competitiveness, and revitalize the overall regulatory science ecosystem.

On the 13th, at Post Tower in Jung-gu, Seoul, Kim Kang-rip, Special Professor at Yonsei University (former Commissioner of the Ministry of Food and Drug Safety), is giving a lecture at the "1st Regulatory Science Media Forum."
[Photo by Lee Chun-hee]

Kim Kang-rip, a special professor at Yonsei University and former head of the MFDS, gave a lecture titled "The Role of Regulatory Science in Illuminating the Future Biohealth Industry." He stated that the biohealth industry inevitably grows alongside regulation and that only when regulatory science advances can the industry expand. He defined regulatory science as "an enabler rather than a gatekeeper." Professor Kim explained, "Unlike other industries, the bio and healthcare industries are inherently regulated. Because they deal with human life and health, products cannot enter the market nor services be launched without passing regulations."

Professor Kim pointed out that deregulation could actually hinder industrial development. He said, "Regulations should be business-friendly, but this does not mean lax regulations that protect corporate profits. Instead, they should maintain international-level rigor while reflecting corporate characteristics and helping to resolve issues," highlighting the proper direction for regulation.

On the 13th, Lim Jin-hwan, CEO of AimMed, is giving a lecture at the '1st Regulatory Science Media Forum' held at Post Tower in Jung-gu, Seoul.
[Photo by Lee Chun-hee]

Jinhwan Lim, CEO of AimMed, which developed Somzz, the "first domestic digital therapeutic device (DTx)" for insomnia, emphasized, "Somzz could be developed thanks to the government's efforts related to regulatory science." Lim explained, "With the proactive and open attitude of the MFDS and related government agencies, and support for regulatory innovation, we quickly obtained approval for the country's first DTx and were able to make the first prescription last January." Since the first prescription on January 9, the number of prescriptions for Somzz has continued to increase.

Lim cited the establishment of the MFDS Digital Health Regulatory Support Division as a representative support case. In 2021, the MFDS created this dedicated department overseeing DTx and AI medical devices. Lim said, "Regulation and support are like a spear and shield. The MFDS helped a lot with approvals through the new department and also established the Innovative Medical Device Integrated Review System." He added, "High regulatory standards are not a problem. On the contrary, surpassing these standards is recognized for efficacy and acts as a barrier preventing other companies from entering," explaining that high-intensity regulation can guarantee quality.

However, Lim emphasized the need to speed up the regulatory process. He noted, "Corporate time flows differently from regulatory time. Since corporate time is limited, there is an unfriendly aspect regarding time."

On the 13th, Kang Sung-ji, CEO of Welt, is giving a lecture at the "1st Regulatory Science Media Forum" held at Post Tower in Jung-gu, Seoul.
[Photo by Lee Chun-hee]

Following this, Seongji Kang, CEO of Welt, which developed the insomnia DTx SleepCure, called for regulatory authorities to keep pace with the rapidly advancing technologies such as AI. He said, "AI should be managed by AI," suggesting that if necessary, hybrid committees including neutral AI could be created within various regulatory committees. He also pointed out that since DTx has the characteristic of being 'digital,' appropriate regulations are needed to address various updates, errors, and other issues that may arise.

Kang explained, "DTx requires efforts to collect only real patient data and can effectively conduct real-time clinical trials by continuously managing patients after prescription. However, if regulations do not accommodate these aspects, such tasks cannot be performed."

This content was produced with the assistance of AI translation services.