Regulatory Intelligence
The intelligence dashboard aggregates regulatory signals from monitored agency websites, guideline updates, competitive intelligence, and industry databases. Signals are classified by impact level and automatically linked to affected products and applications.
Recent Regulatory Signals
| ID | Signal | Agency | Type | Impact | Products Affected | Date |
|---|---|---|---|---|---|---|
| SIG-001 | FDA draft guidance on Real-World Evidence for drug approvals | FDA | Guidance | High | 3 | 2025-05-15 |
| SIG-002 | EMA updated SmPC template section 5.1 requirements | EMA | Template Update | Medium | 12 | 2025-04-22 |
| SIG-003 | PMDA new electronic submission requirements for biologics | PMDA | Regulatory Change | High | 5 | 2025-03-18 |
| SIG-004 | ICH Q13 implementation deadline approaching — continuous manufacturing | ICH | Deadline | Medium | 2 | 2025-02-28 |
| SIG-005 | NMPA new data localisation requirements for clinical data | NMPA | Regulatory Change | Critical | 4 | 2025-01-10 |
| SIG-006 | MHRA post-Brexit labeling requirement finalized | MHRA | Labeling | High | 8 | 2024-12-15 |
AI Agent Recent Activity
| Run ID | Agent | Output Summary | Confidence | Review Required | Date |
|---|---|---|---|---|---|
| RUN-001 | Regulatory Gap Analyser | Analysis complete. Found 12 relevant precedents. Confidence: 71%. Critical gap i… | 71% | Yes | 2024-04-02 |
| RUN-002 | SmPC Drafter | Analysis complete. Found 10 relevant precedents. Confidence: 71%. Critical gap i… | 71% | Yes | 2024-01-03 |
| RUN-003 | Precedent Search | Analysis complete. Found 9 relevant precedents. Confidence: 77%. No critical gap… | 77% | No | 2024-08-12 |
| RUN-004 | Variation Classifier | Analysis complete. Found 6 relevant precedents. Confidence: 95%. No critical gap… | 95% | No | 2024-01-31 |
| RUN-005 | Query Summariser | Analysis complete. Found 10 relevant precedents. Confidence: 93%. No critical ga… | 93% | No | 2024-04-30 |
| RUN-006 | Clinical Data Extractor | Analysis complete. Found 2 relevant precedents. Confidence: 64%. No critical gap… | 64% | Yes | 2024-05-20 |
| RUN-007 | Guideline Tracker | Analysis complete. Found 11 relevant precedents. Confidence: 66%. No critical ga… | 66% | Yes | 2024-04-11 |
| RUN-008 | Risk Minimisation Advisor | Analysis complete. Found 7 relevant precedents. Confidence: 94%. Critical gap id… | 94% | No | 2024-02-24 |
| RUN-009 | Label Harmoniser | Analysis complete. Found 7 relevant precedents. Confidence: 79%. Critical gap id… | 79% | No | 2024-04-03 |
| RUN-010 | Inspection Pack Assembler | Analysis complete. Found 1 relevant precedents. Confidence: 80%. No critical gap… | 80% | No | 2024-07-08 |