MFDS Forum Highlights Korea’s Shift To Regulatory Science Approach

Regulation Lag, Expertise Among Issues

At a recent forum organized by South Korea’s drug ministry, participants discussed why a regulatory science-based approach is needed, what issues in this area are being faced by the country and which directions it should be headed.

regulatory science
Korea Gears Up For New Regulatory Science Innovation Law • Source: Shutterstock

With the increasing introduction of new innovative medical products including digital therapeutics amid intensifying competition among countries to rapidly secure new technologies, South Korea is feeling the urgent need to shift its focus more to a regulatory science-based approach.

More from South Korea

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

 
• By 

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 

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.

2024 Korea Regulatory Highlights And What’s In Store For This Year

 
• By 

The Pink Sheet looks at what major policies and regulations South Korean authorities prioritized in 2024 and what may be in store for this year.

What Will It Take For Korea To Become A Trial Hot Spot?

 
• By 

Speedier approval of clinical trials, flexibility towards new technologies, faster access to new drugs and lingering regulatory barriers to decentralized trials are among the challenges South Korea is facing in becoming a global trial hot spot.

More from Asia

Japan Expands Priority R&D List For Regular Vaccinations

 
• By 

Japan adds four new pediatric vaccines, including for MMRV and norovirus, to a list of priority vaccines eligible for assistance in regulatory processing.

Elevar/Hengrui’s Second US CRL A Bad Omen For Multiregional Trials In Asia-Dominant Cancers?

 

While CMC glitches linger over a US NDA for Elevar/Hengrui’s novel liver cancer combination following a second complete response letter, the separate issue of underrepresentation of US patients in multiregional trials is looming large after new FDA draft guidance last year.

China Signals Commercial Insurance, Biotech And Foreign-Owned Hospitals As Policy Priorities

 
• By 

The main 2025 policy priorities for China's government as outlined in an annual report will include the strengthening of commercial insurance for innovative drugs and opening up cell and gene therapy and the hospital sector to foreign investment.