Regulatorische Updates

At CPHI Korea 2026, committee member Seo Kyung‑won urged Korea to abandon fragmented ministries and redesign its regulatory and investment ecosystem to become a global bio‑health leader.

Medsun Pharma Korea's oxurumoju, SK Biopharm's Excofri, and Korean Janssen's Spravato nasal spray have begun price negotiations for health‑insurance reimbursement, with potential listing after October.

Il Dong Pharmaceutical Group, with the Korea Fair Trade Mediation Agency, delivered practical fair‑trade law training to all staff on May 8, aiming to strengthen self‑compliance culture and compliance management.

Health Canada has issued a retail recall of JAMP Temozolomide 140 mg capsules (lot RLTS0225A) because the active ingredient temozolomide is out of specification.

On July 10, 2026, the Korean Ministry of Health and Welfare announced the director‑level transfer of Kim Hyun-sook to the role of Population and Child Policy Officer.

South Korea's Ministry of Health and Welfare announced a public hearing on the proposed Digital Healthcare and Health Information Utilization Support Act, inviting experts and the public to discuss key issues.

The National Assembly held a plenary session on the 18th, approving 32 items such as an investigation into ballot shortages, a special‑education law amendment, and expanded benefits for Korean War veterans' families.

The Korea Pharmaceutical Safety Management Agency announced a 0.018% basic burden rate for the 2026 drug adverse reaction compensation fund, applicable to the Jan and July assessments.

A domestically developed human skin model combined with MFDS technology is now part of OECD TG 498, signaling international standardization of Korea’s animal‑free testing methods.

Fierce Pharma’s 2026 regulatory tracker logs progress of in‑market products, noting geographic expansions and new indications, even when not full stories.

The FDA’s ANDA088071 filing shows that DEXAIR ophthalmic ointment, containing 0.05% dexamethasone sodium phosphate, is marked discontinued by sponsor PharmaFair.

Unicycive is optimistic its third‑party manufacturing facility can meet FDA standards to support an approval, CEO Shalabh Gupta, M.D., said.