Regulatory Updates

Korea’s MFDS is drafting a change order for mycophenolate and albendazole drug labels, incorporating safety findings from the US FDA and EU EMA, and has opened a public comment period.

South Korea’s MFDS is considering deleting the pediatric indication for the dioctahedralsmektate antidiarrheal after safety data were deemed insufficient, following proactive applications by manufacturers.

The Korean Ministry of Food and Drug Safety has prepared a draft amendment order for Opicapone oral drugs, revising the adverse‑reaction warnings and opening a public comment period.

MFDS amended the Regulatory Science Innovation Act rules, clarifying its head's authority over R&D project selection and updating agency titles, effective immediately.

New bills aim to tighten OTC drug sales to minors and require pharmacies to keep sales records, sparking debate over added burdens on pharmacies.

The MHRA's ninth MedSafety Week runs 4‑10 November 2024, encouraging public reporting of medication safety issues.

A brief overview of letters and notifications sent to UK healthcare professionals about medicines and medical devices in March 2024.

The Seoul Pharmacists Association held an advanced MFDS drug safety use instructor training on the 21st, with 120 participants from 24 local branches, to improve curriculum understanding and teaching skills.

MHRA reminds prescribers that montelukast can cause neuropsychiatric reactions, including sleep disorders, in patients of all ages.

The MHRA released a summary of letters and notifications sent to healthcare professionals in April 2024 regarding medicines, medical devices, and two new Device Safety Information pages.

MHRA notes topical steroids are effective but carry serious risks, especially with long‑term high‑potency use, and will update labelling soon.

The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.