Actualizaciones regulatorias

Korea Korus was ordered to halt production of its export‑only recombinant human erythropoietin product for one month after failing to conduct required post‑marketing safety studies.

The Korea Pharmaceutical & Bio Association will hold a seminar on Sep 30 to discuss 2026 accounting issues and response strategies for pharma‑bio firms, featuring Samjeong KPMG executives.

A grade‑5 NHIS staff accessed family and others’ personal data 62 times between Dec 2020 and Nov 2023; a three‑month suspension was imposed in May 2024.

The Korean Ministry of Food and Drug Safety inspected the pilot K‑NASS system, aiming to detect misuse and illegal distribution of medical narcotics more rapidly.

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

The Korean Pharmacy Information Center will host a seminar on October 22 for pharmaceutical registration staff, covering practical registration procedures and common review cases.

The Gangseo‑gu Pharmacy Association has asked Seoul Metro for an official response and document disclosure regarding the bidding and sub‑lease approval process for pharmacy space in Balsan Station’s Medical Zone.

Health Canada alerts that counterfeit laser hair removal devices marketed as “Soprano” are being sold to clinics in Canada, posing health risks and violating regulations.

Analysis shows 82% of the Ministry’s 177 websites and apps are accessibility certified, leaving 18% uncertified as of August 2026.

The association will hold a mandatory 8‑hour pharmacist training on Sep 19 at Gangdong Kyung Hee University Hospital for pharmacists who have not met the annual requirement.

Yuyu Pharmaceutical re‑shipped four voluntarily recalled items, including Tanamin tablets, before official recall closure, prompting the MFDS to impose a 15‑day manufacturing halt. The action was due to procedural lapses, not product safety.

MHRA published a series of Field Safety Notices covering devices such as Acu‑Loc 2, bedside monitors, orthopaedic cements and a peripheral artery stent‑graft between 31 Aug and 4 Sep 2026.