Korea’s Regulatory Innovation Steps Focus On Investment, New Technologies

Faster Approvals, Better Competitiveness Eyed

South Korean ministries release comprehensive broad steps under new government aimed at accelerating investment to deal with infectious diseases and supporting regulatory innovation, including speeding up processes, to match global standards, support new technologies and improve access.

Korea
Initiatives To Include Large-Scale Bio and Vaccine Fund This Year • Source: Shutterstock

South Korea has unveiled a set of regulatory innovation measures designed to foster the biopharma industry, particularly new vaccines and technologies, by boosting investment, speeding up processes, aligning with global standards and adopting systems appropriate for the latest technologies.

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.