SDEA Essentials for PV Leaders

How to design SDEAs that ensure compliant, audit-ready safety exchange.

Map responsibilities, data, and timelines clearly

A strong Safety Data Exchange Agreement (SDEA) begins with absolute clarity on who does what, when, and how evidence will be generated. Treat the SDEA as an operating manual, not just a legal contract. Start by defining the full scope of safety information to be exchanged across pre‑ and post‑authorization contexts—spontaneous reports, solicited programs, clinical study cases, literature, partner complaints, medical inquiries with safety content, and follow‑ups. For each source, specify minimum required data, acceptable formats, serialization expectations (if applicable), and the transfer mechanisms.

Document when a report is considered valid, how duplicates are handled, and how data privacy constraints are honored. Next, map roles and responsibilities in a RACI that covers intake, triage, medical review, coding, case quality checks, ICSR submission, acknowledgments (ACK/NAK) handling, periodic reporting, signal inputs, and responses to authority questions. Make the Qualified Person Responsible for Pharmacovigilance (QPPV) and 24/7 contact details explicit, along with alternates and escalation paths. Where outsourcing is involved, remember that the marketing authorisation holder (MAH) remains accountable: the UK regulator has emphasized that agreements must be specific and enforceable, with robust oversight by the MAH; see guidance from the MHRA Inspectorate at MHRA PV agreement guidance. Timelines must be unambiguous. Define triage and data‑entry service levels, medical review turnaround, and submission windows for E2B(R3) ICSRs by seriousness and region, as well as literature screening frequency and periodic report calendars.

Reference authoritative sources directly in the SDEA or its appendices so expectations are traceable—for UK specifics on procedures and submissions, see the government’s overview at GOV.UK PV procedures. Include change control provisions that require impact assessments, versioned redlines, and training before new obligations go live. Finally, align on data standards and dictionaries up front: MedDRA version, product dictionary governance, seriousness criteria, causality approaches, and narrative expectations. Define partner identifiers and case number conventions to simplify reconciliations. The more explicit your SDEA, the fewer disputes and the faster your day‑to‑day work will move.

Operationalize routing, quality, and oversight at scale

Translating a well‑written SDEA into daily reliability depends on engineered workflows. Separate business processing from transport: your intake, triage, coding, medical review, QC, and periodic report compilation should function consistently whether cases arrive via gateway, secure file, or portal. Build layered validation around every exchange: syntactic checks (required fields, XML schema validity), semantic checks (business rules such as seriousness alignment and plausible dates), and regional conformance (headers, terminology, destination‑specific fields).

Acknowledge and track every transmission with correlation IDs so partners can reconcile submissions and acknowledgments quickly. Define routing logic so the right authority or partner receives the right message at the right time—by product licence, region, case type, and seriousness. Specify re‑submission behavior after transient failures and ensure replay‑safe mechanics to avoid duplicates. For cases originating in clinical trials or post‑marketing programs, harmonize intake templates and minimum data requirements so that quality thresholds are consistent, regardless of channel. Embed literature surveillance responsibilities and frequency, with explicit rules for what triggers case creation. Quality must be measurable. Standardize case quality checklists (narrative completeness, chronology consistency, seriousness criteria linkage, MedDRA coding concordance) and make them auditable.

Define reconciliation cadences for partner‑to‑partner case counts and statuses, and publish dashboards that highlight backlogs, late tasks, and first‑pass acceptance rates. Keep authoritative references close: for evolving UK PV expectations, monitor updates such as those following the Windsor Framework at MHRA Windsor Framework PV. When your operational design mirrors the SDEA with clear evidence and controls, partner friction drops and regulatory confidence rises.

Prove compliance with evidence, metrics, and governance

Inspection‑ready SDEAs produce evidence as a by‑product of daily work. Maintain an auditable chain of custody for every exchanged item: who sent what, to whom, when, via which channel, with which validations, under which MedDRA version—and what ACK/NAK or error was returned. Keep role‑based dashboards for QPPV, safety physicians, PV operations, QA, and system owners so each function sees its obligations and risks in real time. Track KPIs that matter: on‑time submission by case type and region, first‑pass acceptance rate, reconciliation variances, literature detection‑to‑case cycle time, and backlog aging.

Operationalize governance with a cross‑functional change board that owns SDEA updates, dictionary upgrades, routing changes, and validation packs—each with documented impact assessments and rollback plans. Train teams using scenario‑based playbooks (e.g., duplicate case merges across partners, late seriousness upgrades, follow‑up re‑routing) and record adherence. Anchor your SDEA and SOPs in authoritative references so reviewers can verify alignment quickly: for UK procedures see GOV.UK PV procedures, and for oversight expectations when outsourcing PV tasks, review the MHRA Inspectorate’s guidance at MHRA PV agreements guidance.

When SDEAs are explicit, version‑controlled, and operationalized with measurable controls, compliance becomes predictable and partner collaboration improves—protecting patients and accelerating safe access to therapies.