EMA 将召开抗菌药物可转让数据独占券（TEV）利益相关方会议
Stakeholder Meeting on the transferable data exclusivity voucher (TDEV) for priority antimicrobials, Online, Broadcast, from 12 November 2026, 14:00 (CET) to 12 November 2026, 17:00 (CET)
EMA 将于 2026 年 11 月 12 日在线直播抗菌药物可转让数据独占券（TEV）利益相关方会议，介绍该券的实际实施方式。TEV 可将集中授权药品的监管数据保护延长 12 个月，持有人可用于符合条件的优先抗菌药物或同一/不同上市许可持有人的其他产品。会议将覆盖优先抗菌药物的资格标准、科学评估要求及申请条件，仅限受邀线上参会，会后发布录像。
Date
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Thursday, 12 November 2026 , 14:00 - 17:00 Amsterdam time (CET)
Location
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Online
Live broadcast
Event summary
A transferable data exclusivity voucher (TEV) supports investment in new treatments for antimicrobial-resistant infections, a major global public health challenge.
A TEV allows its holder to extend the regulatory data protection of a centrally authorised medicinal product by 12 months. The voucher may be used for the priority antimicrobial that qualifies for the incentive or for another product held by the same or a different marketing authorisation holder.
What participants learn
This meeting provides an overview of the practical implementation of the TEV, including:
- Eligibility criteria for a priority antimicrobial
- Scientific assessment requirements
- Conditions for requesting a voucher
- Key elements of the related guidance
Registration
The meeting will be broadcast live. Registration for virtual participation by invitation only.
A video recording will be published after the event.
来源：EMA What's New · ema.europa.eu