Ang OMUFA — OTC Monograph User Fee Act — ay nagkabisa noong 2020 at nagdala ng pinakamalawak na reporma sa OTC drug regulation sa loob ng maraming dekada. Kasama ang mga dayuhang manufacturer tulad ng mga nasa Pilipinas na nagbebenta ng OTC products sa US, lahat ay kailangang magbayad ng taunang mandatory na bayad.
Sino sa Pilipinas ang Naapektuhan
Ang mga OTC monograph drug tulad ng pain relievers, antacids, cold medicines, at sunscreens ay saklaw. Ang mga pasilidad na nagbebenta ng mga produktong ito sa US ay napapailalim sa OMUFA fee.
Nag-aalok ang FDABridge ng Drug Registration at US Agent Services
Pinamamahalaan ng FDABridge ang drug facility registration, drug listing, at US Agent appointment. Bisitahin ang fdabridge.com/drug.
ต้องการความช่วยเหลือในขั้นตอนถัดไป?
ต้องการความช่วยเหลือในการเลือกบริการหรือไม่?
เปรียบเทียบตัวเลือกหลักและเลือกขั้นตอนที่เหมาะกับผลิตภัณฑ์ของคุณ