Food and Drug Safety Ministry wins top policy award

The Food and Drug Safety Ministry said Wednesday it had won the Korean Policy Society's Best Policy Award for its K-Bio and Health Regulatory Support System for Global Expansion policy at the society's 2026 summer conference.

The award recognized a regulatory-service framework that puts public safety first while supporting innovation and growth in the bio-health industry, the ministry said.

One part of the program established a 240-day medical-product approval review system, down from 420 days for new drugs. The ministry attributed the shorter process to parallel reviews, rolling submissions and additional review staff. It also introduced pre-application face-to-face meetings and checklists for companies preparing approval materials.

The global biopharmaceutical contract development and manufacturing market is forecast to reach $43.9 billion in 2029 from $19.7 billion in 2023, the ministry said. Regulatory support for the sector was enshrined in a December 2025 law that created certification systems for specialist contract manufacturers and domestic raw materials. An exporter registration system allows manufacturers to enter overseas markets without a pharmaceutical manufacturing license.

The program included the world's first Digital Medical Products Act and approved South Korea's first generative AI medical device in April.