規制動向

Lawmakers, including MP Baek Hye-ryeon, announced proposals to amend the Public Official Election Act and Election Commission Act to address recent voting paper shortages and election management issues.

The Gyeonggi‑do Pharmaceutical Association sub‑chapter chairpersons council strongly opposes the Ministry of Health’s proposal to increase convenience‑store OTC safety medicines from 13 to 20 items, calling it a hasty policy that threatens public safety.

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 Pharmacy Information Center announced an extension of the PM+20 conversion deadline after partner companies and member pharmacies reported capacity constraints and a surge in requests during the July‑August vacation period.

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.

Lawyer Seo Young-seok (Democratic Party) introduced a bill to amend the Local Tax Basic Act, allowing AI and intelligent IT for proactive tax delinquency management in Korea.

Solubiomix received FDA approval for ANDA 076329 for a prescription topical lotion containing 0.1% amcinonide.

The FDA has approved the ANDA for REVONTO, a 20 mg/vial injectable dantrolene sodium product from USWM, LLC, for prescription use.

FDA has approved ANDA078670 submitted by Aiping Pharm Inc for prescription pioglitazone hydrochloride tablets in 15 mg, 30 mg, and 45 mg strengths.

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.

Epic Pharma LLC filed ANDA078975 for a discontinued topical ciclopirox 8% solution; FDA records show the original submission was approved on 2010-02-17.

The FDA approved an ANDA for alclometasone dipropionate 0.05% topical ointment submitted by Fougéra Pharms. Original approval was granted in July 2005 with a labeling supplement in August 2015.