Examples
Worked examples
- Is an instance
A US biotech out-licenses ex-US rights to a Phase III asset to a European pharmaceutical company. The license agreement requires the parties to execute an SDEA before first patient dosing under the licensee's territory, specifying that serious adverse event and suspected unexpected serious adverse reaction (SUSAR) reports must pass from whichever party's investigator site detects the event to the other party within a set number of calendar days -- shorter than the underlying regulatory expedited-reporting clock -- so each party has time to complete its own submission to its own regulators.
- Is an instance
Two companies co-market the same approved product under different brand names in different countries. Their SDEA designates one party's global safety database as the single master repository of record, sets the schedule for the other party to transmit newly received cases into it, and defines how the parties jointly prepare and reconcile the Periodic Safety Update Report (PSUR) so both parties' submissions to their respective health authorities are based on the same underlying case set.
Counter-examples
Looks similar, but isn't
- Not an instance
A single sponsor running its own multi-site clinical trial does not need an SDEA. Adverse event flow between its own trial sites and its own safety department is governed by the sponsor's pharmacovigilance SOPs and the trial protocol -- there is no second legal entity with independent reporting obligations to contract with.
- Not an instance
An SDEA is not a Material Transfer Agreement (MTA). An MTA governs the transfer of physical or biological materials (e.g. cell lines, reagents, patient samples) and associated IP/use terms between institutions; it does not address adverse-event data exchange, and a research collaboration that only involves shipping materials -- with no shared marketing authorization or overlapping safety-reporting obligation -- has no reason to have an SDEA in place.
- Not an instance
An SDEA is also distinct from a plain pharmacovigilance reporting obligation to a regulator. Reporting AEs/SAEs to FDA, EMA, or another health authority is a one-way regulatory duty that exists regardless of any contract; an SDEA is the separate, negotiated instrument that governs how two or more commercial partners share that safety information with each other so each can meet its own version of that duty.
Editorial commentary
What a Safety Data Exchange Agreement covers
A Safety Data Exchange Agreement (SDEA), sometimes called a Pharmacovigilance Agreement (PVA), is a written contract executed between two or more parties that share rights to the same medicinal product — most commonly co-development partners, in-licensor/out-licensor pairs, co-marketing partners, or distributors — and therefore each carry independent pharmacovigilance obligations to their own regulators for the same product. The SDEA is the operational document that makes those parallel obligations workable: it specifies who does what, on what timeline, and how the parties confirm nothing was missed.
Why it exists
Once a product is developed, marketed, or distributed by more than one legal entity, an adverse event reported to one party’s safety department is a case the other party also needs, on its own regulatory clock, in order to meet its own expedited and periodic reporting duties. Without a formal agreement, there is no defined mechanism for that handoff, no agreed timeline tighter than the regulatory deadline to allow for downstream processing, and no reconciliation step to catch gaps. SDEAs are typically drafted with reference to the ICH E2 series (E2A definitions and standards for expedited reporting, E2B for the electronic ICSR format, E2D for post-approval safety data management) and, for EU-facing obligations, to the European Medicines Agency’s Good Pharmacovigilance Practices (GVP) modules.
What a typical SDEA specifies
- Division of pharmacovigilance responsibilities — which party performs case intake, medical review, causality assessment, literature surveillance, and signal detection for which markets.
- Data exchange format and timelines — how individual case safety reports (ICSRs) and aggregate reports (e.g. Periodic Safety Update Reports, PSURs) move between the parties, usually on a schedule shorter than the underlying regulatory deadline to leave time for the receiving party’s own submission.
- Reconciliation procedures — a periodic process (often quarterly) where both parties compare case logs to confirm no report was received by one side and not passed to the other.
- Named contacts and roles — including, where EU obligations apply, each party’s Qualified Person Responsible for Pharmacovigilance (QPPV).
- Scope — whether the agreement is bipartite (two parties) or tripartite (three, for example when a contract research organization or specialty distributor also holds independent reporting duties).
How an SDEA differs from adjacent agreements
An SDEA is not a Material Transfer Agreement (MTA). An MTA governs the transfer of physical or biological materials and the IP/use terms attached to them; see CASRAI’s MTA process guide for that separate mechanism. An SDEA is also not the same as the underlying regulatory obligation to report adverse events to a health authority in the first place — that duty exists independent of any contract; the SDEA is the negotiated instrument that lets two or more commercial partners coordinate how they each meet that duty for a shared product. For the mechanics of AE, SAE, and SUSAR reporting itself, see CASRAI’s guide to pharmacovigilance in clinical research.
Who negotiates and holds an SDEA
SDEAs are typically negotiated alongside (and referenced by) the underlying commercial agreement — a licensing deal, co-development agreement, co-marketing arrangement, or distribution agreement — and are usually required to be in place and operational before the first patient is dosed or the product is marketed under the arrangement, precisely because safety-reporting obligations begin at that point. Research administrators and technology transfer offices negotiating a licensing or co-development deal involving a medicinal product should expect the SDEA to be a required companion document, not an afterthought.
Machine-readable encodings
Use in your systems
<role vocab="credit"
vocab-identifier="https://casrai.org/dictionary/"
vocab-term="Safety Data Exchange Agreement (SDEA)"
vocab-term-identifier="https://casrai.org/dictionary/term/safety-data-exchange-agreement-sdea" />{
"@context": "https://schema.org",
"@type": "DefinedTerm",
"@id": "https://casrai.org/dictionary/term/safety-data-exchange-agreement-sdea",
"name": "Safety Data Exchange Agreement (SDEA)",
"identifier": "https://casrai.org/dictionary/term/safety-data-exchange-agreement-sdea",
"description": "A Safety Data Exchange Agreement (SDEA) is a written contract between two or more legally distinct parties who share development, marketing, licensing, distribution, or co-promotion rights to the same medicinal product, defining how each party will exchange safety information -- adverse event and adverse drug reaction reports, product complaints with a safety component, literature findings, and aggregate safety reports -- so that each party can independently meet its own national and regional pharmacovigilance reporting obligations. An agreement qualifies as an SDEA (rather than some other contract) when it specifies, at minimum: which party holds which pharmacovigilance responsibilities (case intake, medical review, causality assessment, expedited and periodic reporting, literature surveillance, signal detection); the format and timelines for exchanging individual case safety reports (ICSRs) and aggregate reports such as PSURs between the parties, typically set tighter than the underlying regulatory deadlines to leave room for each party's own downstream submission; reconciliation procedures to confirm no cases were missed on either side; and named contacts, including each party's Qualified Person Responsible for Pharmacovigilance (QPPV) where EU obligations apply. SDEAs are prepared with reference to ICH E2A/E2B/E2D definitions and reporting standards and, in the EU, to the EMA's Good Pharmacovigilance Practices (GVP) modules; they can be bipartite (two parties) or tripartite (three, e.g. when a contract research organization or specialty distributor is also party to the arrangement).",
"inDefinedTermSet": "https://casrai.org/dictionary/domain/clinical-research#set",
"url": "https://casrai.org/dictionary/term/safety-data-exchange-agreement-sdea",
"sameAs": [],
"license": "https://creativecommons.org/licenses/by/4.0/",
"publisher": {
"@id": "https://casrai.org/#organization"
},
"dateModified": "2026-08-09T02:27:33",
"inLanguage": "en"
}
