What regulatory intelligence is
The DIA Regulatory Intelligence Network Group defines regulatory intelligence (RI) as “the act of gathering and analyzing publicly available regulatory information.” The Johner Institute describes it as “a systematic process of collecting, analyzing, and disseminating information about regulatory requirements, policies, and guidelines.”
In practice RI answers three kinds of question:
- What is changing? New and revised laws, guidance, standards and enforcement trends.
- What does it mean for us? Impact on products, filings, processes and strategy.
- What have regulators accepted before? Precedents from approval packages, review documents, advisory committee materials, warning letters and published assessment reports, used to plan strategy.
The third question is what separates intelligence from monitoring. Monitoring tells you a guidance was published. Intelligence tells you how regulators have applied similar requirements and what that means for your next submission.
The three parts of a mature RI function
A 2024 PDA Letter article by RI leaders from Moderna, Eli Lilly and Pfizer proposes a broader definition with three components:
| Component | What it covers | Output |
|---|---|---|
| Regulatory surveillance | Monitor, capture, distribute for impact evaluation, track decisions | Change log, impact assessments, actions |
| Regulatory information | Structured knowledge, categorized by content type (guidances, Q&As, laws, position papers), impact and stage (draft, final, effective) | Searchable knowledge base |
| External engagement | Comments on drafts, industry association work, ICH and committee participation | Influence on future requirements |
The authors rank engagement by maturity. Individual comments are the least effective; company comments are common; industry association comments are the most effective because they provide a unified voice. The most mature practice is proactive engagement, such as ICH working groups and white papers.
Why RI matters more now
The volume and pace of change keep rising. The PDA authors counted 771 FDA guidances from 2018 to 2022 and an estimated 600 EMA guidelines in the same period. Since then:
- FDA’s CDER guidance agenda for 2026 includes planned guidance on AI and ML quality considerations in manufacturing, according to ECA.
- The EU reached a provisional agreement on major pharmaceutical reform in December 2025.
- The EU consulted on a revised GMP Annex 11 and a new Annex 22 on AI in 2025.
- FDA’s laboratory developed tests rule was vacated in court in March 2025 and rescinded in September 2025, showing that intelligence must cover litigation as well as publication.
Regulators are also using AI themselves. FDA launched its internal generative AI tool, Elsa, on June 2, 2025, for tasks including summarizing adverse events, comparing labels and prioritizing inspections, according to Morgan Lewis.
What regulatory intelligence software does
RI software has become a distinct category. Typical capabilities:
| Capability | What to look for |
|---|---|
| Source coverage | Which regulators, markets, languages and document types; how quickly new items appear |
| Alerts and filtering | Filters by product type, market and topic; few false alerts |
| Translation and summaries | Quality of machine translation and summaries; link back to the original |
| Precedent databases | Approval documents, review reports, warning letters, searchable by topic |
| Impact workflow | Ability to assign items to experts, record assessments and actions |
| Integration | Links to RIM, eQMS and change control |
| Audit trail | Who assessed what, when, with what decision |
The Johner Institute notes that service providers typically handle collection, first evaluation and filtering, while the company must handle decisions and implementation. Software follows the same split: it can deliver relevant information, but it cannot decide what your company must do.
Regulatory intelligence and AI
Most RI vendors now offer AI features. Where they help:
- Summaries of long documents, with links to the source text
- Classification of new items by topic, product type and market
- Translation of non-English guidance
- Comparison of draft and final versions, or of guidance across regions
- Mapping a new requirement to the parts of your own documents it affects
Where they need care:
- Summaries can be wrong or incomplete. Every summary must link to the source, and decisions should be made on the source.
- Relevance judgments can miss context. A tool may not know that a guidance on one dosage form affects your combination product.
- Hallucinated citations. Generative tools can invent references. Verify any citation before relying on it.
The joint EMA-FDA guiding principles for good AI practice in drug development, issued in January 2026, emphasize a defined context of use and a risk-based approach. For RI tools, that means stating clearly what the tool is used for (for example, “first-pass triage of regulator publications”) and keeping expert review for impact decisions.
Building or improving an RI function
- Define scope. Products, markets and topics in scope.
- List sources and owners. Who watches what, how often.
- Set a triage standard. What counts as relevant; how fast items are triaged.
- Standardize impact assessment. One template, linked to change control.
- Build the knowledge base. Categorize by type, impact and stage, as the PDA framework suggests.
- Decide on engagement. Which consultations you will comment on and through which associations.
- Choose tools last. Select software to support the process you defined, not the reverse.
Regulatory intelligence checklist
- Scope of products, markets and topics defined
- Sources and owners assigned
- Triage criteria and timelines set
- Impact assessments recorded and linked to actions
- Precedent research used in regulatory strategy
- Knowledge base categorized by type, impact and stage
- Engagement plan for consultations
- AI outputs verified against sources before decisions
Turn intelligence into evidence with AskDona
RI tools tell you what changed. The next question is where your own documents stand. AskDona reads a new guidance or regulation alongside your SOPs, specifications and submissions, and shows where you comply, where you conflict and what is missing, with links to the exact pages. Run a sample regulatory impact assessment on a guidance your team is assessing now. AskDona shows the evidence; your regulatory team decides.
FAQ
What is regulatory intelligence? The gathering and analysis of regulatory information to understand requirements, anticipate changes and inform strategy.
How is regulatory intelligence different from regulatory monitoring? Monitoring watches for changes. Intelligence also analyzes their meaning, uses precedent to inform strategy and engages with regulators on future requirements.
What does regulatory intelligence software do? It collects regulatory publications from many sources, filters and alerts on relevant items, and often supports impact assessment workflows and precedent searches.
Can AI do regulatory intelligence? AI can collect, classify, translate and summarize. Impact decisions and strategy still need experts, and AI outputs should always be checked against the source.
Who owns regulatory intelligence? Usually regulatory affairs, often with a dedicated RI team in larger companies, working with quality and subject matter experts.
References
All pages opened and checked by October 14, 2026.
| Source | Type | Used for |
|---|---|---|
| PDA Letter, A Comprehensive Review of Regulatory Intelligence and Its Framework (2024) | Professional association article | DIA definition; three-part framework; guidance volumes |
| Johner Institute, Regulatory Intelligence | Consultancy article | Definition; task division |
| ECA, FDA Guidance Plans for 2026 | Industry news | CDER agenda |
| Cooley, EU pharma reform: we have a deal | Law firm analysis | EU reform |
| EC consultation on Chapter 4, Annex 11 and Annex 22 | EU consultation page | Consultation |
| Clinical Lab Products, FDA withdraws final rule on LDTs | Trade news | LDT dates |
| Morgan Lewis, FDA’s AI-assisted review | Law firm analysis | Elsa |
| RAPS, EMA and FDA issue joint AI guiding principles | Professional society news | AI principles |