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.

Regulatory innovation is already a key part of the government's broader steps to accelerate investment and grow the biopharma sector,...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Pink Sheet for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required

More from South Korea

New Era Begins In Korea: Policy Predictions For Biopharma

 
• By 

As South Korea's new president immediately gets to work on setting initial policies, essential drug supplies, R&D incentives and AI-driven digital healthcare are among the key topics in focus.

Korean Pharma Industry Proposes Policies As Election Nears

 
• By 

As South Korea gears up for a snap presidential election, its biopharma industry proposes key desired policies to candidates, most of whom have not laid out detailed plans of their own for the sector.

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

 
• By 

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 

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.

More from Asia

Australia Looks To Modernize Human Tissue Laws, Improving Access For Researchers

 

Australia is reviewing its human tissue laws for the first time in almost 50 years, and is hoping to reduce barriers to access for scientific researchers, for instance by addressing issues with access to cell lines for developing drugs.

China NMPA Lays Out Regulatory Priorities At DIA

 
• By 

At this year’s DIA China meeting, the national regulator updated its policy focus areas for this year, including clinical trial data protection and pilot projects to shorten IND approval times.

Japan Price Cuts For Epkinly and Lunsumio Following CEA

 
• By 

Japan is cutting more drug reimbursement prices following cost effectiveness analysis and is applying the methodology to a new group of products including Wegovy and Leqembi.