SOPREFERENCE OUTLINE

Safety Data Exchange Agreement (SDEA)

Agreement defining how two organisations sharing a product exchange safety information: each party’s own obligations recorded first, the awareness definition and exchange clock with the receiving party’s remaining time made explicit, scope, periodic-report and signal responsibilities, reconciliation, and termination handling. Maps to ICH E2D(R1).

What a template is not

A template is a document baseline to adapt inside your own quality system. SPEQ does not approve, validate, or take responsibility for what you issue from it, and using one is not evidence of compliance.

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REGULATIONS MAPPED
ICH E2D(R1)
DOCUMENT TYPE
SOP
LAST UPDATED
August 2026
PURPOSE

Sets out how two organisations sharing a product will exchange safety information. It exists because reporting obligations are not divisible: both parties may hold obligations to different authorities for the same case, and each depends on the other for the information needed to meet them. Setting the exchange window equal to the reporting window is the defect that guarantees a late report.

What's Inside

✓Parties, products, territories and the review date, so the agreement cannot quietly outlive its scope
✓Each party’s own obligations recorded before any exchange is defined, in their own right
✓Awareness definition and the exchange clock, showing the receiving party’s remaining time explicitly
✓Calendar convention fixed: calendar or business days, and how holidays in each territory count
✓Scope of exchange covering special situations, literature findings, signals and requests received from authorities
✓Responsibility for periodic reports, signal management and RMP maintenance, named party by party
✓Reconciliation cadence, audit rights, change control, and how safety obligations survive termination of the agreement

How to Use It

1Record each party’s own obligations first; an agreement drafted without this step defines an exchange satisfying neither party’s actual duty.
2Never set the exchange window equal to the reporting window — show the receiving party’s remaining clock in the table instead.
3Fix the calendar convention explicitly: calendar or business days, and how weekends and public holidays in each territory are handled.
4Name the party responsible for each periodic report and signal activity; shared responsibility with no named owner is none.
5Set a reconciliation cadence and a route for resolving discrepancies, because reconciliation that finds gaps but fixes nothing is theatre.
6Write the termination clause deliberately; safety obligations for a case do not end when the commercial relationship does.
DOCUMENT CONTENTS

The full section structure of this template — every section and sub-section, so you can use it as a baseline for your own site document.

—Document Control
› Document Information› Approval Signatures› Revision History› Distribution List
1Parties, Products and Territory
2Each Party’s Own Obligations
3Awareness and the Exchange Clock
4Scope of Exchange
5Periodic Reports, Signals and Reconciliation
6Audit, Change and Termination
REGULATORY CONTEXT

ICH E2D(R1) defines post-approval safety data management and the awareness concept from which the reporting clock runs, and EU GVP Module VI governs the collection and submission of individual case safety reports for EU-authorised products. Neither instrument allocates work between two commercial partners: the exchange windows, the calendar convention, the named owners and the reconciliation cadence are what the parties agree, and are the terms a finding is written against. The agreement structure is SPEQ’s practitioner synthesis.

MAPPED STANDARDS
ICH E2D(R1)
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