法规动态

The FDA lists APRESAZIDE oral capsules (hydralazine HCl 25 mg / hydrochlorothiazide 25 mg) as discontinued, with a series of approved original and supplemental submissions from 1976 to 1998.

WHO regrets the United States' notification of withdrawal, saying it makes both the US and the world less safe and will be discussed at upcoming meetings.

Eli Lilly gave hospitals a June 8 deadline to submit 340B data, warning loss of discounts; hospital groups call the move unlawful.

The FDA record for NDA018082 lists DEPAKENE syrup as discontinued, with a Federal Register note that safety was not a factor, and details multiple labeling submissions from 1981 to 2016.

FDA’s ANDA083639 lists five ENDEP oral amitriptyline tablets (10‑100 mg) from Roche, all marked discontinued.

FDA records show B. Braun’s Dextrose 60% injectable products (NDA 017995) have been discontinued, with submission history dating back to 1978.

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

The August 2026 MHRA safety roundup highlights a ResMed ventilator PCBA leak risk, a Dräger anaesthesia workstation piston failure, and updated guidance on Belzer organ‑preservation solutions.

The EMA’s Committee for Medicinal Products for Human Use (CHMP) recommended twelve new medicines for approval and issued several positive, negative and withdrawal decisions on other products.

The European Medicines Agency has appointed a new Head of Stakeholders and a new Head of Veterinary, highlighting Ivo Claassen’s role since 2018 in the veterinary medicines network.

Pharmacies in Korea are dealing with inventory chaos as BioKill spray insecticide sales are halted and a full return is required, while other brands lack clear recall plans.

A Suwon district court dismissed a pharmacist’s counterclaim and ordered the return of a 600 billion‑won deposit and handover of the pharmacy in a dispute over a lease tied to 30% of dispensing fees.