In May 2024, the EMA completed a periodic safety update report single assessment (PSUSA) for loperamide, resulting in a maintenance decision, indicating no significant changes required in the product information. (ema.europa.eu)
In January 2025, the FDA updated import alerts to reinforce that all unauthorized e-cigarettes may be detained without physical examination. While this update does not directly pertain to loperamide, it reflects the FDA's ongoing efforts to regulate imported products rigorously.
In October 2024, the FDA and U.S. Customs and Border Protection announced the seizure of approximately three million units of misdeclared, unauthorized e-cigarette products. This action underscores the importance of accurate product declaration and compliance with FDA regulations for all imported pharmaceuticals, including loperamide.
In March 2022, the EMA published a list of nationally authorized medicinal products containing loperamide, providing transparency and guidance for manufacturers and healthcare professionals. (ema.europa.eu)
In March 2019, the EMA released scientific conclusions and grounds for variation, amendments to the product information, and a timetable for implementation for loperamide-containing products, reflecting ongoing pharmacovigilance efforts. (ema.europa.eu)
These developments highlight the dynamic regulatory environment surrounding loperamide and the necessity for manufacturers to stay informed and compliant with international standards to ensure continued market access.
