The stewardship layer
Build your ASP once — kept compliant and reportable for life.
Change #3 of 10 — RA / Medical Affairs
AMR is now your regulatory problem, not just your brand problem.
Articles 17, 51 and 69 make Antimicrobial Stewardship Plans mandatory at MA application for all systemic antimicrobials. All systemic antibiotics, antifungals, antivirals and antiparasitics become Rx-only. An AMR card must appear in every patient leaflet.
Art. 17 / 51 / 69 — Stewardship
Now mandatoryAntimicrobial MA dossier obligations
MA dossier readiness0/4 sections
The scale of the obligation
Not a comms exercise — a regulatory deliverable
An ASP is a structured dossier document regulators will review, challenge and require you to update annually.
100%
Of systemic antimicrobials reclassified Rx-only under Art. 51, regardless of current OTC status
SourceArt. 51, EU Pharmaceutical Directive 2026
1.27M
Deaths attributable to AMR in Europe annually — the public health driver behind mandatory stewardship
SourceLancet/ECDC AMR surveillance, 2022
Art.69
Requires annual ASP progress report to EMA and ECDC — stewardship becomes ongoing reporting
SourceArt. 69, EU Pharmaceutical Directive 2026
What's actually changing
From voluntary commitments to dossier obligations
Stewardship has been voluntary for two decades. The directive ends the voluntary era.
Workbench
+ New TaskQuick Tasks/Antimicrobial stewardship — current vs new directive
We have six oral antibiotics on the market. None has a formal stewardship plan. Where do we start?
RegIntel12:39
151.00s241 sources95% confidence2 warnings
2 warnings
Here's the obligation delta for Antimicrobial stewardship. The new EU Pharmaceutical Directive replaces Directive 2001/83/EC[1][2] — below is what changes, row by row.
Current vs. new directive4 rows
Change area
Current — 2001/83/EC
New directive — from ~mid-2028
Stewardship plan
Current
No formal ASP in MA dossier. Industry initiatives are voluntary with no regulatory review.
Prescription status
Current
Generally Rx-only by default but OTC possible in some Member States for specific products.
New directive
All systemic antibiotics, antifungals, antivirals and antiparasitics mandatorily Rx-only across all EU Member States.[5]
Patient leaflet content
Current
Standard PIL structure. No specific AMR messaging required.
New directive
Mandatory AMR card in every PIL — standardised content on resistance, course completion, and misuse risks.[6]
⚠Dates reflect the political agreement text; final deadlines depend on entry into force and the transition period for each obligation.
Synthesised from 15 citations across 241 regulatory sources.
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Why existing approaches don't solve this
The missing layer
Stewardship content exists in medical affairs documents and AMR roadmaps — none structured for a regulatory dossier or maintained as a living document.
ME
Medical affairs / AMR teams
The content owners
RA
RA document management
The storage layer
How Regunaut solves it
Five steps. Your ASP ready for submission.
Each step maps ASP compliance — from drafting your first plan through annual progress reporting.
Guided authoring for each required section: appropriate use measures, surveillance commitments, HCP education, and Reserve-category enhanced access controls.
- Section-by-section authoring aligned to Art. 17 / Art. 69
- Product-type templates by antimicrobial class
- Measures library reusable across portfolio
- Completeness scoring against EMA criteria
Industry evidence
Regulators have waited two decades
AMR stewardship pledges since the 2016 UN Declaration are now enforceable regulatory obligations.
10M
Annual deaths projected from AMR by 2050 if current trends continue
O'Neill Review on AMR, 2016
27
EU Member States where systemic antimicrobial OTC rules currently vary — all harmonised to Rx-only
ECDC Antimicrobial Consumption Report, 2024
£1B+
Industry investment through AMR Action Fund — stewardship provisions protect that commercial window
AMR Action Fund Annual Report, 2025
“For the first time, a company's stewardship measures will be assessed by EMA, reported annually to ECDC, and can form the basis of MA conditions.”
Common questions
What teams are asking about ASP requirements
Get your ASP built and linked to your MA
An ASP written at the last minute, disconnected from your dossier and PIL, won't survive EMA assessment.
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Structured to EMA/ECDC guidance, linked to your product record, ready for dossier inclusion.
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Map ASP obligations, Rx reclassification exposure and annual reporting requirements.
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