Korea’s Biopharma Policies Put To Test Amid Political Turmoil

Discontinuity Concerns Raised

A short-lived but shocking attempt to declare martial law by South Korea's president has thrown the country into political turmoil which could disrupt foreign biopharma investment and key policy initiatives.

Political Turmoil
Political Stability, Policy, Regulatory Environment Crucial For Global Pharmas (Shutterstock)

The year-end festive mood in South Korea ended abruptly on the night of 3 December with a shocking but short-lived martial law declaration by President Suk Yeul Yoon, citing “anti-state” acts by opposition political parties.

More from Asia

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.

Trump Tariffs: Indian Pharma Dodges Bullet, But Sword May Remain

 
• By 

Trump announced a 26% reciprocal tariff on India, but a country-agnostic exemption of pharmaceuticals implies that the interests of Indian firms are protected for now. What is Indian pharma’s business exposure and what is domestic industry saying?

Japan Pushes Generic Industry Reforms Via New Govt Fund

 
• By 

Amid ongoing generic drug supply problems, Japan's government is to set up a new fund to support corporate investments geared towards manufacturing and consolidation.

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.

More from Pathways & Standards

US FDA Staffing Uncertainty Could Impact Upcoming User Fee Negotiations

 

FDA staffing cuts are making negotiation preparations more difficult, but also could mean the result is a smaller user fee renewal package.

EMA Considers Whether Intrathecal Zolgensma Deserves Fast Tracking

 

Novartis is planning to file EU and US marketing applications for an intrathecal formulation of its spinal muscular atrophy gene therapy, Zolgensma, in H1 2025.

Surrogate Endpoint ‘Reasonably Likely’ Decision Process An ‘Uncertain Standard,’ Industry Says

 
• By 

The FDA’s accelerated approval draft guidance has left stakeholders seeking clarification of the process for determining a surrogate marker or intermediate clinical endpoint is reasonably likely to confirm clinical benefit.