Preparing your experience...

Capability Domain

Regulatory Intelligence

Navigate ICH guidelines, FDA guidance documents, EMA EPARs, and global regulatory requirements. Find the exact section you need without wading through hundreds of pages of regulatory text.

How It Works

Regulatory intelligence answers: what does the guidance say, and how does it apply to this situation? NexVigilant indexes the authoritative sources — ICH, FDA, EMA, CIOMS — and extracts the specific provisions relevant to your question.

ICH Guideline Hierarchy

The International Council for Harmonisation (ICH) guidelines are organized into four topic areas. Each letter represents a domain; the number represents the specific guideline within that domain.

E — Efficacy

E2A (expedited reporting), E2B (ICSR format), E2E (pharmacovigilance planning), E6 (GCP)

S — Safety

S1 (carcinogenicity), S2 (genotoxicity), S7 (pharmacology studies), S9 (oncology)

Q — Quality

Q8 (pharmaceutical development), Q9 (quality risk management), Q10 (pharmaceutical QS)

M — Multidisciplinary

M1 (MedDRA), M4 (CTD structure), M7 (mutagenic impurities), M8 (eCTD)

Key Pharmacovigilance Guidelines

Guideline	Topic	Key Requirement
E2A	Expedited Reporting	7-day for fatal/life-threatening, 15-day for serious unexpected ICSRs
E2B(R3)	ICSR Data Elements	ICH ICSR format, 195 data elements, HL7 FHIR-aligned
E2C(R2)	PBRER	Periodic Benefit-Risk Evaluation Report structure and content
E2D	Post-Approval Reporting	Definitions, case processing, minimum dataset requirements
E2E	PV Planning	Risk characterization, pharmacoepidemiological studies, RMP planning
E2F	DSUR	Development Safety Update Report — annual aggregate for trials

FDA Guidance Documents

FDA guidance documents provide FDA's current thinking on regulatory topics. They are organized by product type, therapeutic area, and regulatory activity. NexVigilant enables full-text search across FDA guidance with semantic query support.

Safety Reporting

IND safety, postmarket surveillance, MedWatch 3500A

REMS

Risk Evaluation and Mitigation Strategies design and assessment

Labeling

Prescribing information, boxed warning criteria (21 CFR 201.57)

Pharmacoepidemiology

RWD studies, BEST framework, Sentinel System use

Drug-Drug Interactions

In vitro/in vivo studies, labeling recommendations

Benefit-Risk

Structured approach for NDA/BLA review and approval decisions

EMA EPARs and CIOMS Forms

European Public Assessment Reports (EPARs) document EMA's scientific conclusions for approved medicines, including benefit-risk assessment summaries and PRAC recommendations. CIOMS (Council for International Organizations of Medical Sciences) forms provide the international standard for individual case safety reporting.

EMA EPAR

—Scientific discussion and benefit-risk rationale
—PRAC signal assessments
—Risk Management Plan summaries
—Post-authorisation safety studies

CIOMS Forms

—CIOMS I — Individual case safety report
—CIOMS II — Periodic safety update (forerunner to PBRER)
—CIOMS VI — Signal management
—CIOMS VIII — signal detection methods

Tools & Data Sources

ICH Guideline Search

Full-text search across E2A, E2B, E2C, E2D, E2E, E2F, PBRER structure, DSUR content requirements

Regulatory Primitives

Structured extraction of deadlines, definitions, and requirements from FDA, EMA, and PMDA sources

4 Authoritative Sources

ICH.org guidelines, FDA.gov guidance library, EMA EPAR database, CIOMS reports — all indexed live

Data Sources

ICH.orgFDA.govEMA.europa.euCIOMS

Search regulatory guidance instantly

Connect your AI agent to mcp.nexvigilant.com and query ICH, FDA, and EMA sources in a single natural-language call.

Connect via MCP Back to Library