規制動向

The FDA has recalled a product after discovering an adulterated active ingredient and insufficient manufacturing controls that caused content uniformity failures.

The FDA has recalled products after CGMP deviations revealed exposure to temperatures outside labeled storage conditions.

The MHRA has released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

MHRA warns that combining warfarin with tramadol can elevate INR, leading to severe bruising, bleeding and potentially fatal outcomes.

Topiramate is now contraindicated in pregnancy and in women of childbearing potential unless a Pregnancy Prevention Programme is followed, per MHRA review.

The PMDA and Japan's Ministry of Health, Labour and Welfare provide a webpage with drug risk information under review, noting possible translation inaccuracies and untranslated files.

The MHRA released a summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

MHRA advises against prescribing Epimax Ointment or Epimax Paraffin‑Free Ointment for facial use due to reports of eye injury.

The MHRA’s July 2024 update provides a concise summary of recent letters and notifications sent to healthcare professionals about medicines and medical devices.

The MHRA released a summary of letters and notifications sent to healthcare professionals in August 2024 regarding medicines and medical devices.

MHRA released a summary of recent letters and notifications to healthcare professionals concerning medicines and medical devices for September 2024.

MHRA safety review recommends blood pressure monitoring for patients on bromocriptine following a Yellow Card report.