欧盟立法者于2025年12月11日批准了新的毒品规则,通过扩大保护、订货定价、强化非专利药品和短缺保障,促进创新和准入。 EU lawmakers approved new drug rules on Dec. 11, 2025, boosting innovation and access with extended protections, subscription pricing, and stronger generics and shortage safeguards.

欧盟立法者已商定对药品条例进行重大改革,制定新规则,以平衡创新和患者获得治疗的机会。 EU lawmakers have agreed on a major overhaul of pharmaceutical regulations, setting new rules to balance innovation and patient access. 药物将获得长达11年的综合数据和市场保护,满足未得到满足的医疗需要或稀有疾病。 Drugs will get up to 11 years of combined data and market protection, with extensions for unmet medical needs or rare diseases. 订阅模式与销售收入脱钩,各国可以要求供应,对不遵守者予以惩罚。 A subscription model decouples revenue from sales, and countries can demand supply with penalties for non-compliance. 改革包括更快的EMA处理、数字病人传单以及强制性预防短缺计划。 The reform includes faster EMA processing, digital patient leaflets, and mandatory shortage prevention plans. 它还为优先抗菌剂引入可转让凭单,并通过更明确的专利豁免加强非专利药品的获取。 It also introduces transferable vouchers for priority antimicrobials and strengthens generics access through clearer patent exemptions. 2025年12月11日最后敲定的这项交易旨在提高欧洲的药物竞争力和健康保障。 The deal, finalized December 11, 2025, aims to boost Europe’s drug competitiveness and health security.