FDA成立新委员会 专门监督药品独占期认定
美国食品药品管理局（FDA）药品审评部门10月16日表示，已成立一个专门委员会，负责监督和咨询该部门作出的药品独占期认定，以提高这类决定的清晰度和一致性。
据FDA介绍，药品审评与研究中心（CDER）独占期委员会将监督部分独占期认定，包括是否应授予独占期、应授予何种类型的独占期，以及授予的适当范围。委员会重点处理三类：活性成分从未获FDA批准的药品享有的5年新化学实体独占期；依赖申办方实施或资助的新临床研究获批的药品享有的3年新临床研究独占期；以及生物制品的独占期咨询。其他类型的独占期不在该委员会审查范围内。
FDA表示，独占期制度旨在奖励创新：新批准药品在低价仿制药竞争者进入市场之前，可获得一段市场保护期。该委员会还可评估CDER与独占期相关的政策和做法并提出建议，并保存独占期认定记录。（GSM 据路透社报道）
FDA Sets Up Board to Oversee Drug Exclusivity Determinations
The U.S. Food and Drug Administration's drug evaluation department said on October 16 that it has formed a board to oversee and advise on exclusivity determinations made by the department, aiming to improve clarity and consistency of those decisions.
According to the agency, the Center for Drug Evaluation and Research (CDER) exclusivity board will oversee certain exclusivity determinations, including whether and what type of exclusivity should be granted and the appropriate scope of grants. The board will focus on five-year new chemical entity exclusivity, granted to a drug whose active ingredient has never before been approved by the FDA; three-year new clinical study exclusivity for drugs whose approval relies on new clinical studies conducted or funded by the sponsor; and advice on exclusivity for biological products. It will not review other types of exclusivity.
The FDA said exclusivity rewards innovation by giving newly approved drugs a period of market protection before lower-cost generic competitors enter the market. The board may also evaluate and make recommendations regarding CDER's policies and practices relating to exclusivity, and maintain records of exclusivity determinations. (GSM, via Reuters)
发布：GSM·美国（发布链接）
图片来源：FDA白橡树园区64号楼外观 / Exterior of FDA Building 64 at the White Oak campus. Photo: FDA via Wikimedia Commons, Public domain.
GSM Global · 本篇英文版 English edition of this story
- 2026-10-17 00:55FDA设立药品独占期审查委员会 统管新药5年与新临床研究3年独占认定
- 2026-10-17 00:58FDA成立新委员会 专门监督药品独占期认定本篇
