1. Pink Sheet
  2. >>Geography
  3. >>Asia
  4. >>South Korea

AIRIS 2024: Global Cooperation A Challenge For Regulation Of AI Products

Certainty And Clarity Key Issues For Industry

 
• By Jung Won Shin

During the first international symposium on the use of AI in medical products, co-hosted by US and Korean regulators, global experts discussed issues and challenges related to effective development and regulation. Cooperation, flexibility and the need for a "human-centric" approach emerged as key themes in the fast-moving field.

AIRIS 2024
Regulators Should Pursue Alignment Of Expectations, Harmonized, Consensus Standards • Source: Jung Won Shin

Cutting-edge digital technologies, such as generative artificial intelligence (AI), are rapidly becoming embedded into people's daily lives, while in the health and medical field AI technology is increasingly being actively applied to the development of new drugs and medical devices.

To keep pace with industry developments, South Korea’s Ministry of Food and Drug Safety (MFDS) says it is aiming to create a regulatory environment that will enable the rapid growth of such new applications. After formulating guidelines for AI-based medical devices several years ago, the ministry approved the first digital therapeutic in the country, for insomnia, last year

At present, about 60 digital therapeutics targeting various indications, including depression, are under development in Korea

More from South Korea

DIA Korea: Medical Turmoil, Global Factors Blunt Korea’s Trial Edge

 
• By Jung Won Shin

DIA Korea hears how multiple domestic and global factors are affecting the environment for clinical trials in South Korea, and what actions may be taken to address this.

US Tariff Impact On Korea Dissected As Country Gears For Presidential Election

 
• By Jung Won Shin

Analysts expect a limited impact on South Korean pharma from US tariffs, even if imposed at a later date. Meanwhile, the early June domestic presidential election is set to determine the direction of policies in the sector.

Korea To Revise ‘Innovative Company’ Criteria Amid Calls From Foreign Industry

 
• By Jung Won Shin

South Korea announces planned revisions to a government scheme to designate "innovative" biopharma companies amid allegations of "discrimination" against foreign firms.

Korea ‘Guide’ Program To Speed Select Innovative Products To Market

 
• By Jung Won Shin

In an ongoing effort to accelerate the commercialization of select innovative drugs and medical devices, Korea’s MFDS is launching a new program for certain products that will receive regular regulatory consultations until they reach the approval stage.

More from Asia

Japan Looks To Build Domestic Capacity In New Modalities

 
• By Lisa Takagi

Japan's trade ministry is providing new support to build domestic capacity for new modalities including cell and gene therapies, as part of wider efforts to support the national bioventure ecosystem.

Pipeline To Product – What Is Driving Cell And Gene Therapy Progress In India?

 
• By Vibha Ravi

US-based Colossal Labs has claimed to bring back the dire wolf from extinction. While the science is not as dramatic in India yet, cell and gene therapies are making progress as treatments for cancer and other diseases. Pink Sheet takes a look at what is driving CGT success and growth.

Japan Identifies Drugs ‘In Urgent Need’ Of Development

 
• By Lisa Takagi

Artesunate for malaria, TB drug pretomanid and omadacycline for pneumonia and skin infections are among the drugs identified by Japanese regulatory authorities in urgent need of domestic development.