美國新法要求改善處方藥標籤說明
New U.S. law requires better labeling on prescription drugs
一項名為「CLEAR LABELS法案」的新法案已在美國參議院提出。
A new piece of legislation called the "[CLEAR LABELS Act|noun]" has been introduced in the U.S.
該法案旨在透過要求處方藥標籤明確列出最終藥物及其「原料藥」(APIs)的「原產國」來提高透明度。
Senate.
該法案的支持者對安全性感到擔憂,並指出一些研究將海外製造的學名藥與較高的不良反應率連結起來。
Currently, many labels only show the final distributor, making it difficult for patients and doctors to trace where a drug was actually produced.
雖然「FDA」(美國食品藥物管理局)支持提高供應鏈透明度,但一些產業團體擔心這可能會為製造商帶來高昂的成本和物流負擔。
Proponents of the bill are concerned about safety, noting that some research links overseas-manufactured generic drugs to higher rates of adverse effects.
支持者希望這種增加的透明度將有助於確保為所有美國人提供一個更安全、更負責任的製藥市場。
Unlike current regulations, which focus on safety instructions and dosage, this act specifically targets "[geopolitical and manufacturing source|noun]" information.
