Regulatorische Updates

A new notification service lets medical institutions receive real‑time SMS or KakaoTalk alerts on recalled or near‑expiry hazardous drugs distributed to pharmacies, enhancing safety at the compounding stage.

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.

The association named the implementation of ward‑dedicated pharmacists and activation of specialist pharmacist roles as key initiatives for the second half of the year, emphasizing their importance for preventing medication‑related safety incidents.

The Korea Research-based Pharmaceutical Industry Association (KRPIA) praised the MFDS for completing its first joint drug assessment with overseas regulators through EMA’s OPEN program, conducted simultaneously in Europe and Korea.

An online Zoom discussion on June 25 will examine the government's plan to include hair‑loss treatments in national health insurance and related coverage principles.

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.

Industry groups argue that applying the serial‑number reporting system used for prescription drugs to over‑the‑counter medicines would enable electronic tracking of batch numbers and expiry dates, improving returns efficiency and distribution transparency.

The ‘YakOlryeo’ platform offers up to 8% purchase benefits to pharmacies, prompting industry criticism that it exploits regulatory gaps and creates unfair competition.

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.

FDA approved Hikma's ANDA 079217 for oral Dronabinol capsules (2.5 mg, 5 mg, 10 mg); all listed products are currently marked discontinued.

FDA has approved ANDA078898 for Zydus Pharm's oral galantamine hydrobromide tablets (4 mg, 8 mg, 12 mg) with standard labeling submissions.

The FDA approved application ANDA080531 for a 5 mg oral prednisolone tablet marketed by Chartwell RX, LLC, with multiple manufacturing and labeling supplements authorized.