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KRSC Aims To Raise Korea’s Regulatory Science Game

Cooperation To Build Bridges And Expertise

 
• By Jung Won Shin

The head of the Korea Regulatory Science Center talks exclusively to the Pink Sheet about why regulatory science is crucial, the country's efforts to improve in the area and the center's strategic bridging role.

In-Sook Park, Director General, Korea Regulatory Science Center
KRSC Aims To Bridge Industry And Government In Regulatory Science (Korea Regulatory Science Center)

The global biopharma industry is rapidly adopting the use of artificial intelligence (AI), digital transformation and innovative clinical trial designs as efficiency has become a key word in new drug development, given the massive investment and time involved.

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More from South Korea

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.

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

 
• By Jung Won Shin

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.

More from Agency Leadership

Companies Advised To Assess Potential Impacts Of Landmark Global Pandemic Treaty

 
• By Neena Brizmohun

Mechanisms in the draft treaty that the more than 190 member states of the World Health Organization have finally agreed to are expected to “materially affect companies,” particularly those that develop, manufacture or distribute pandemic-related health care products.

FDA Leadership Shuffle Continues: Lowell Zeta Returns As OPDP, OGD Leaders Depart

 
• By Sue Sutter and Derrick Gingery

Lowell Zeta, a senior counselor at the FDA from 2020 to 2021, returns as deputy commissioner for strategic initiatives. The agency also names a new acting CIO and acting CVM director, but OGD's Ted Sherwood and OPDP's Catherine Gray retired.

US FDA’s Makary Floats Vague ‘Plausible Mechanism’ Approval Pathway For Rare Diseases

 
• By Sarah Karlin-Smith

Ascertaining the novelty and benefits of Makary’s new drug approval idea – along with what it would take to implement it – requires more clarity on the types of studies he envisions being used to grant and confirm “plausible mechanism’ approvals.