Regulatorische Updates

A relay protest in front of Seoul’s Blue House entered its 359th day, with officials urging the government and parliament to clarify and reform the licensing system for pharmacists and herbal pharmacists.

GC Green Cross secured MFDS IND approval for its mRNA COVID‑19 vaccine candidate GC4006A and will begin a Phase 2 study in Korea targeting adults 19‑85, aiming for domestic self‑sufficiency by 2028.

The Korean Pharmacists' Association staged its 357th consecutive relay protest in front of the Blue House, urging the government and National Assembly to clarify licensing scopes and resolve role conflicts between pharmacists and han‑yak (traditional medicine) pharmacists.

The Seongdong-gu Pharmaceutical Association resolved to actively oppose the expansion of drug delivery services and convenience‑store drug sales, sharing recent pharmacy complaint cases.

The first regular Health and Welfare Committee meeting showed sharp partisan clashes, focusing on the MFDS’s responsibility linked to the Justice Minister nominee.

Following earlier network‑pharmacy and name‑restriction laws, a new bill targeting external capital in pharmacies entered discussion, aiming to limit operators to one outlet and ban terms like “warehouse.”

Lee Yoon-hak, appointed head of drug price negotiations at Korea’s Health Insurance Review & Assessment Service, vows to boost essential medicine access, foster new‑drug development and ensure rational post‑pricing management.

The Korean MFDS announced a meeting on Oct 10 to guide herbal medicine makers on the new standard decoction definition effective Sep 2024 and share change‑approval procedures.

South Korea's MFDS has detailed new review criteria and updated guidelines for digital therapeutic device trials covering seven mental‑health and substance‑use disorders.

A Korean lawmaker urged the government to lift caps on IVF and IUI coverage under national health insurance, citing patient cost barriers and the need for case‑by‑case care.

Rising GLP‑1 obesity drug prescriptions in Korea prompt calls for enhanced misuse prevention and clinical appropriateness checks.

The Korean Pharmacy Association for Health Society urges a shift to a public, non‑profit telemedicine platform ahead of the December 24 medical law amendment.