The lifecycle compliance layer
Your renewal tracker, turned into continuous compliance.
Change #5 of 10 — RA / Portfolio
Your renewals are being abolished. Your obligations aren't.
Article 46 grants MAs for unlimited duration — no more 5-year renewals. The renewal gate that forced periodic review is gone, and continuous lifecycle obligations replace it. The risk isn't missing a renewal — it's missing what comes after.
Art. 46 — MA Validity
No renewal gateRenewal gate vs. indefinite validity
Valid indefinitely from grant
GrantYr 5Life of product
The portfolio impact
Removing the renewal doesn't remove the work
The 5-year renewal was a forcing function. Without it, that discipline must be built into continuous lifecycle management.
∞
Duration of new EU MAs under Art. 46 — unlimited validity from first grant
SourceArt. 46, EU Pharmaceutical Directive 2026
~30%
Estimated EU Rx portfolios with a renewal due within 3 years of 2028
SourceEMA product register analysis, 2024
Art.108
PSUR reporting survives abolition and intensifies — now the primary periodic checkpoint
SourceArt. 108, EU Pharmaceutical Directive 2026
What's actually changing
From periodic renewal to continuous compliance
Regulators haven't reduced scrutiny — they've embedded it into continuous obligations throughout the product lifecycle.
Workbench
+ New TaskQuick Tasks/MA validity — current vs new directive
We have 14 renewals due in the next 18 months. Renewals are being abolished. What do we actually need to do?
RegIntel12:39
138.00s268 sources89% confidence2 warnings
2 warnings
Here's the obligation delta for MA validity. 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
MA validity period
Current
First MA for 5 years. After renewal, unlimited — but only after completing the renewal process. Miss the deadline, MA lapses.
Renewal procedure
Current
Full renewal dossier at 5 years — updated safety, efficacy, quality, benefit-risk. Significant resource investment.
New directive
Renewal abolished. Replaced by PSURs, variations, and ongoing benefit-risk review. EMA retains power to suspend or revoke.[5]
Post-approval commitments
Current
Commitments tracked partially through renewal. Gaps common — some outstanding for years without enforcement.
New directive
Commitments must be explicitly tracked against defined schedules. EMA can impose conditions including MA suspension.[6]
⚠Dates reflect the political agreement text; final deadlines depend on entry into force and the transition period for each obligation.
Synthesised from 16 citations across 268 regulatory sources.
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Why this catches teams off-guard
The missing layer
Most teams manage renewal dates in spreadsheets. That system worked every 5 years — continuous compliance is a different discipline.
RE
Renewal date trackers
The current system
EN
Enterprise RIM (Veeva, OpenText)
The dossier system
How Regunaut solves it
Five steps. Renewals gone — nothing missed.
Each step maps the transition from renewal-based to continuous lifecycle management.
Ingests your renewal calendar and classifies: must-file (before mid-2028), auto-convert (after mid-2028), or flagged (outstanding commitments needing resolution).
- Three-way classification per product
- MA type detection: standard, conditional, exceptional
- Outstanding commitment cross-reference
- Urgency prioritisation by renewal date proximity
Industry evidence
Good news that hides a compliance trap
Teams will welcome removed renewal workload. The risk is interpreting this as 'less work' when scrutiny has been made continuous.
40%
Of post-approval commitments outstanding at first renewal were overdue — a gap the new framework closes
EMA Post-Approval Commitments Review, 2023
€2M
Average cost of a full MA renewal dossier for a CAP — freed up only if teams replan continuous compliance
EFPIA Regulatory Operations Benchmarking, 2024
3×
More EMA-initiated benefit-risk reviews in 2023 vs 2019 — EMA already operates continuous scrutiny
EMA Annual Report, 2023
“Companies that interpret renewal abolition as 'less work' will find EMA's continuous scrutiny far less forgiving than the renewal gate it replaces.”
Common questions
What teams are asking about MA validity changes
Turn your renewal list into a continuous compliance calendar
The renewal dates in your spreadsheet will become meaningless. The obligations behind them won't.
Audit your renewal portfolio
Categorised action report: which renewals must file, which convert, and what continuous obligations each product carries.
Audit renewal datesMap your lifecycle obligations
30-minute session reviewing commitments, PSUR schedule and conditional MA positions.
Book lifecycle review