EMA Stakeholder Meeting on the Transferable Data Exclusivity Voucher for Priority Antimicrobials
October 30, 2026
Event Details
Organizer: European Medicines Agency (EMA)
Date: November 12, 2026
Location: Online (live broadcast)
The European Medicines Agency (EMA) is holding an online stakeholder meeting on the transferable data exclusivity voucher (TDEV) for priority antimicrobials on Thursday 12 November 2026, from 14:00 to 17:00 Amsterdam time (CET). The information session covers how the voucher will be put into practice under the new EU pharmaceutical legislation.
What the transferable data exclusivity voucher does
EMA presents the voucher as a way to support investment in new treatments for antimicrobial-resistant infections, which it calls a major global public health challenge. The agency’s event page shortens the name to TEV.
A voucher holder can extend the regulatory data protection of a centrally authorised medicinal product by 12 months. The holder does not have to spend it on the antimicrobial that earned it. The voucher can be applied to that priority antimicrobial or to another product, held either by the same marketing authorisation holder or by a different one.
Our report on the provisional deal on EU pharmaceutical reform places transferable exclusivity vouchers within the wider package, next to mandatory stewardship plans and stricter prescription rules. For the broader debate on rewarding antibiotic development, see our piece on pull incentives in pricing, procurement and reimbursement policy. Germany has taken its own route through reserve antibiotic designations, such as the G-BA decision on meropenem/vaborbactam.
What participants will learn
EMA says the session gives an overview of the voucher’s practical implementation. It lists four topics: eligibility criteria for a priority antimicrobial, the scientific assessment requirements, the conditions for requesting a voucher, and the main elements of the related guidance.
Live broadcast, invitation-only registration
The meeting will be broadcast live, but registration for virtual participation is by invitation only. EMA will publish a video recording after the event. Questions go to the agency’s contact point at [email protected].
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