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Glossary

Safety Data Exchange Agreement (SDEA)

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A Safety Data Exchange Agreement is a legal written contract which ensures that all safety data regarding a medicinal product makes its way quickly and reliably back to the marketing authorisation holder so that they may fulfil their legal obligations

Safety Data Exchange Agreement

SDEAs are written contracts developed between two or more parties working together, to define the responsibilities of each party with reference to each pharmacovigilance activity. A well-drafted agreement ensures regulatory compliance and prevents the duplication of pharmacovigilance activities by various partners.

Safety Data Exchange Agreement in the European Union

SDEAs can be requested for inspection both under FDA legislation and the EU drug safety regulations. Within the EU, the SDEA needs to include at a minimum, but not exclusively, name and contact details of the Qualified Person Responsible for Pharmacovigilance, each party responsibility with regard to literature surveillance, ICSR collection and submission to concerned authorities, , PSUR writing, and submission, RMP, Signal detection and management, response to requests from Competent Authorities handling the complaints, etc.

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