Safety Data Exchange Agreement (SDEA)

A Safety Data Exchange Agreement (SDEA) is a legal written contractual agreement between two or more parties that ensures that all necessary information on the safety of medicine reaches the marketing authorization holder (MAH) quickly and safely so that he can fulfil his legal obligations on time. It defines each party’s responsibilities in pharmacovigilance activities, and it prevents the duplication of activities between different partners. Marketing authorization holders should sign these agreements with partners to be in full regulatory compliance.

In many cases, MAHs do not have sufficient internal resources (specialists or subsidiaries) to handle PV activities in all countries where they operate or have their product licences. In the event of an internal shortage of resources, there is a risk that the legal obligations relating to the medicinal product’s safety will not be fulfilled in a timely and proper manner. It is worth remembering once again that ultimately only the MAH is responsible for complying with the legal pharmacovigilance obligations. In such cases, the MAH may contract potential partners, e.g. distributors or service providers, to share pharmacovigilance activities and to fully implement and sign the DSEA.

The most common Safety Data Exchange Agreement (SDEA) signatories are:

• MAH and Distributors;
• MAH and Licensing partners (in-licensing / out-licensing);
• MAH and Manufacturers;
• MAH and batch release site;
• MAH and Service Providers;
• MAH and Local Qualified Person for Pharmacovigilance (LQPPV).

Preparation, review, and approval of the Safety Data Exchange Agreement (SDEA)

In order to prepare a Safety Data Exchange Agreement (SDEA), all aspects of proper and reliable cooperation in the view of pharmacovigilance obligations between the responsible parties should be considered and documented. The following points should be included in the SDEA:

• Terminology and language for communication;
• Products to be covered;
• Countries to be covered;
• Distribution of responsibilities for pharmacovigilance activities;
• Information on a pharmacovigilance management system;
• Exchange of safety data- timelines, format, and responsibilities;
• Safety databases;
• Reconciliation method and frequency;
• Handling of safety-related recalls;
• Data privacy and confidentiality clauses;
• Business continuity plans;
• Termination clauses;
• SDEA revision details – when and how;
• Responsibilities during regulatory inspections for PV;
• Auditing;
• Contact details such as phone no, email ID for communication of safety information.

In agreements of this type, the types of SDEA and the distribution of activities depend on the needs of each company. Depending on the MAH requirements, SDEA may be asked to assign responsibilities for EU-QPPV, PSUR writing, reporting and answering questions to regulators, local literature screening, signal detection, etc. However, it is worth noting that even if only certain pharmacovigilance activities, such as the monitoring of adverse reactions and the preparation of individual case safety reports are delegated to another party, the SDEA must still be comprehensive enough to indicate all pharmacovigilance obligations and which party is responsible for which activity.

The stakeholders must be aware that all SDEAs must be part of their management system and every one of them must comply with the company’s internal SOPs. This is an important aspect because these arrangements are evaluated and verified during pharmacovigilance audits and inspections. Deficiencies in SDEA are identified as one of the main reasons for non-compliance in pharmacovigilance audits and inspections. To prevent this, it is necessary to properly monitor the safety data that is being exchanged, as well as to properly manage all SDEAs with the business partners the MAH has.

Measures to support the control of SDEA partners

In order to ensure the proper function of pharmacovigilance and the fulfilment of obligations documented in SDEA, the MAH should assure some form of quality oversight of its partners. This can be done in a form of:

• Audits;
• Teleconferences;
• Remote audits;
• Routine face-to-face or virtual meetings;
• Conclusion.

Safety data exchange agreements (SDEAs) play a vital role in pharmacovigilance systems in all areas of data collection, safety, evaluation, and reporting. It ensures full regulatory compliance and helps to fulfil pharmacovigilance obligations by preventing the duplication of pharmacovigilance activities by various partners.

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