What is a Safety Data Exchange Agreement (SDEA)?

A single MAH performs all pharmacovigilance activities internally using one controlled SOP A licensing partner markets a product while another organisation receives and processes adverse event reports A company updates its corporate branding without changing any safety process A regulator publishes a general pharmacovigilance guideline

Office occupancy, travel expenditure and sales revenue Case timeliness, completeness, duplicate rate, reconciliation performance and submission timeliness Number of contract pages and legal review hours Number of products in the company's commercial pipeline only

The QPPV personally performs every activity delegated to a vendor The QPPV uses SDEA terms and governance evidence to maintain visibility of distributed responsibilities and assess compliance risks The QPPV approves commercial pricing but has no role in vendor performance The QPPV can waive regulatory reporting timelines when an SDEA exists

A signed SDEA stored in the legal department A vendor invoice showing that case processing was purchased A timestamped case record linked to an assessment, transfer and regulatory submission acknowledgement An organisation chart without process details

It verifies that exchanged records correspond and that discrepancies are investigated and resolved It eliminates the need for individual case quality review It allows each party to use different case identifiers without comparison It replaces regulatory submission acknowledgements

Reviewing only whether a signed document exists Comparing SDEA requirements with SOPs, case records, reconciliations, governance outputs, audits and submission evidence Assessing the vendor only through its commercial reputation Reviewing contract formatting without examining execution

It contains extensive legal language but no operational records It is actively used, version-controlled, aligned with procedures and supported by evidence of performance and issue management It is kept confidential from all personnel performing safety work It avoids measurable obligations so that the parties retain flexibility

To transfer the MAH's legal pharmacovigilance responsibility to a service provider To define how safety responsibilities, information, timelines and controls operate between organisations To replace the pharmacovigilance system master file To serve only as a commercial contract governing product promotion

Changes may affect responsibilities, timelines, systems, SOPs, training, the PSMF and regulatory compliance Formal change control is needed only for changes to legal names Amendments are administrative and cannot affect pharmacovigilance operations Change control prevents the QPPV from reviewing vendor performance

A detailed escalation matrix specifying contacts, thresholds, responsibilities and timelines A general confidentiality clause with no operational contacts A product marketing plan A liability cap without any notification requirements