규제 업데이트

The Bundestag approved a reform that lifts the mandatory discount on original medicines from 7% to 15.5%, despite opposition from pharma groups.

Intensifying global drug development competition highlights the need for strong patents, timed disclosures and strategic workarounds as China’s fast‑follower biotech sector accelerates patient recruitment and cuts clinical costs.

The Korean Pharmaceutical Association marked the 300th day of its relay rally outside the Blue House, urging the government and parliament to overhaul the herbal pharmacist licensing system and fulfill promises on Korean medicine division.

FDA approved Lupin's ANDA209272 for metoprolol succinate extended‑release tablets in four strengths, all currently listed as discontinued.

The FDA has approved TOLSURA, an oral itraconazole 65 mg capsule from Mayne Pharma, under NDA208901 as a new formulation.

The FDA granted priority approval for SANOFI AVENTIS US's ORNIDYL injectable (Eflornithine Hydrochloride 200 mg/mL) under NDA019879, with orphan drug designation.

FDA granted approval for ANDA208181 covering oral tiagabine hydrochloride tablets (2 mg, 4 mg, 12 mg, 16 mg) submitted by Amneal Pharms Co.; all listed products are discontinued.

FDA approved several manufacturing and labeling submissions for Prilosec (omeprazole) products under NDA 019810, including priority reviews for 10 mg, 20 mg and 40 mg strengths.

Democratic Party urges the People Power Party to end boycott and resume full committee work, including health and welfare, amid growing pressure for parliamentary normalization.

Analysis of 283 OTC adverse cases reported over three months shows cold medicines, oral antihistamines and decongestants most frequently involved.

The FDA has approved application ANDA210272 for a buprenorphine transdermal patch, covering five dosage strengths and requiring a REMS program.

The FDA has approved ANDA209953 for generic Ranolazine extended‑release tablets (500 mg and 1 g) manufactured by Ascend Laboratories and sponsored by ALKEM LABS.