法规动态

The MHRA has withdrawn the licence indication for post‑operative pain from all prolonged‑release opioids, citing heightened risk of persistent use and opioid‑induced respiratory complications.

MHRA warns that fezolinetant can cause drug‑induced liver injury and advises liver function monitoring before and during treatment.

The FDA has issued a recall for bottles labeled with an incorrect expiry date of 11/2016; the correct date should be 09/2016.

The FDA has issued a recall for sterile injectable drugs after detecting glass particulate contamination in the active pharmaceutical ingredient.

The FDA has issued a recall for products manufactured with a contaminated excipient that was previously recalled by the supplier, citing CGMP deviations.

Four years after a FDA rejection, Spero Therapeutics and GSK have moved their oral UTI drug Utebzi closer to approval.

Amid medical sector backlash, the Ministry of Health and Welfare reiterates its plan to implement separate payments for specimen testing and pursue spending efficiency measures.

A medical law amendment introduced by lawmaker Lee Hoon-gi aims to prohibit telemedicine intermediaries from selling drugs and conducting promotional activities, ensuring neutrality in drug distribution.

The FDA approved ANDA076320 for a prescription topical cream containing 2.5% lidocaine and 2.5% prilocaine, manufactured by Encube Ethicals.

FDA granted tentative approval to Hikma Pharm's ANDA078658 for three oral rosiglitazone maleate tablet strengths (2 mg, 4 mg, 8 mg).

The FDA has approved Dr. Reddy's Laboratories' DESLORATADINE oral disintegrating tablets in 2.5 mg and 5 mg strengths under ANDA 078367.

The MHRA reminds healthcare professionals and patients that overusing short‑acting β2‑agonists can trigger severe asthma attacks and increase mortality, even with maintenance therapy.