The portfolio intelligence layer
Every ERA gap across your portfolio, found and closed.
Change #2 of 10 — Environmental / RA
Your ERA was optional in 2005. It's mandatory in 2028.
Articles 22–24 and 47 make Environmental Risk Assessment compulsory for all medicines — including thousands of legacy products authorised before the 2006 ERA guideline existed. Four new hazard categories. No grandfathering. Most regulatory teams don't know which products are exposed.
Art. 22–24 — ERA
No grandfatheringNo more legacy exemption
Current — Directive 2001/83/EC38% of products
Exempt
ERA required
New directiveAll products
ERA required
’06Products authorised before the 2006 ERA guideline were never required to have one.
The new directive removes the exemption: every medicine needs a complete ERA — including thousands of legacy products that never had one.
The scale of the problem
ERA gaps in every legacy portfolio
For products authorised after 2006, ERAs exist but many were never challenged. For pre-2006 products, the requirement simply didn't exist.
~60%
Estimated proportion of marketed EU medicines with outdated, incomplete or no ERA documentation
SourceEMA ERA Review, 2023
4
New persistent-hazard categories: PMT, PBT, vPvB and vPvM — each requiring dedicated environmental studies
SourceArt. 22–24
Art.47
Explicit provision allowing refusal, restriction or revocation where ERA is inadequate
SourceEU Pharmaceutical Directive 2026
What's actually changing
From advisory to obligation
Environmental Risk Assessment was required in principle — but enforcement was weak, exemptions broad, and legacy products were never reassessed.
Workbench
+ New TaskQuick Tasks/ERA screening — current vs new directive
Our ERA dossiers were filed in 2006. We don't know which are still valid, which are missing, and which need updating before 2028.
RegIntel12:39
114.00s284 sources96% confidence2 warnings
2 warnings
Here's the obligation delta for ERA screening. 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
ERA status
Current
Required for new MAs since 2006. Pre-2006 products largely exempt. Exemptions where exposure considered negligible. Rarely enforced as refusal criterion.
Hazard categories
Current
Two categories: PBT and vPvB, driven by REACH criteria. No provision for mobile or water-persistent substances.
New directive
Four categories: PBT, vPvB, plus PMT and vPvM. PMT/vPvM substances in drinking water sources require dedicated assessment. Art. 51.1(f) may mandate Rx-only status.[5]
Legacy products (pre-2006)
Current
No retroactive obligation. Products authorised before the 2006 guideline were not required to submit ERA data.
New directive
No grandfathering. ERA must be provided at the next major regulatory action. Art. 24 gives EMA authority to request ERA for any existing product.[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 284 regulatory sources.
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Where teams get stuck
The missing layer
Resources exist for parts of the ERA problem. None give your team a portfolio-wide view or structured workflow to resolve it at scale.
EC
ECOTOX databases
The data source
CR
CROs and testing labs
The study generator
How Regunaut solves it
Five steps. Full ERA compliance.
Each step maps to a real phase of ERA remediation — from initial portfolio screen through maintaining compliance as the EMA Monograph programme evolves.
Ingests your product register and cross-references ERA documentation in your dossier archive. Outputs a structured gap list: complete, outdated, absent, and PMT/PBT/vPvM hazard matches.
- Product register import via spreadsheet or API
- ERA status classification: complete / outdated / absent
- Pre-2006 legacy product flagging by authorisation date
- Active substance cross-reference against hazard databases
Industry evidence
Regulators are already acting — are you?
The EMA Monograph programme is live. Member States with environmental inspection programmes are citing ERA gaps in assessment reports.
200+
Active substances in the EMA ERA Monograph programme — MAHs can reference shared data instead of repeating studies
EMA ERA Monograph programme, 2025
€15M
Maximum fine under new enforcement provisions for failure to meet environmental obligations
Art. 168
3
Member States — Germany, Sweden and the Netherlands — already citing ERA adequacy in product assessment reports
EFPIA Environmental Survey, 2024
“The new ERA provisions end the era of ERA as a compliance formality. For the first time, an inadequate environmental assessment is a statutory ground for MA refusal. Companies that haven't audited their legacy portfolio against the new PMT/PBT criteria are carrying regulatory risk they probably haven't quantified.”
Common questions
What teams are asking about ERA
Know exactly where your ERA gaps are — before a variation triggers them
Most teams find out about ERA gaps when they're already in a regulatory procedure. Regunaut surfaces them first, when you still have time to act.
Run a portfolio ERA screen
Upload your product register and get a gap analysis — ERA status per product, PMT/PBT exposure flags, and a prioritised action list.
Screen my portfolioBook an ERA strategy session
30-minute session to review your ERA position and map the right remediation sequence for your portfolio.
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