Safety Data Exchange Agreements (SDEAs) and Pharmacovigilance Agreements (PVAs) – An Overview

A Safety Data Exchange Agreement (SDEA) or Pharmacovigilance Agreement (PVA) is a legal written contract which ensures that all safety data, PV tasks and responsibilities are detailed between two or more parties.

Such contractual agreements may be set-up between license partners or service providers during the development or the post marketing phase.

They are aimed to ensure compliance with the legal requirements and to have appropriate and reliable safety data available to ensure patient safety.

Guidance from the EU Good Pharmacovigilance Practices (GVP) Legislation

Where the marketing authorisation holder has set up contractual arrangements with a person or an organisation, explicit procedures and detailed agreements should exist between the marketing authorisation holder and the person/organisation to ensure that the marketing authorisation holder can comply with the submission of valid Individual Case Safety Reports (ICSRs) within the appropriate time frames. These procedures should specify the processes for the exchange of safety information, including the timelines and responsibilities for the regulatory submission of valid ICSRs. They should be organised in order to avoid the submission of duplicate ICSRs to the competent authorities.

GVP Module VI.B.7.

Where contractual arrangements are made with a person/organisation to perform literature searches and/or submit valid ICSRs, detailed agreements should exist to ensure that the marketing authorisation holder can comply with its regulatory submission obligations.

SDEA 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 (QPPV), 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 safety requests from Competent Authorities.

Situations requiring PV contracts

Licensing situations:

• (Co-)Development
• (Co-)Marketing,
• Logistic distributor/supplier performing PV activities on behalf of MAH
• (Co-)Promotion
• Clinical trial supply
• Pure Supplier, wholesaler, logistic distributor, manufacturer
• Purchase, Divesture

PV contractual services:

• delegation of PV resp. of MAH, QPPV, local resp. pers. For PV
• services linked to PV e.g. call centres, sales reps, RA, QA
• named patient use (NPU), compassionate use
• marked research program (MRP), patient support program (PSP)
• Investigator Initiated Trials/Studies (IIT/IIS)
• Post-Authorisation Studies (e.g. PASS, NIS)

Elements of an effective SDEA, include but not limited to

• Relationship between the SDEA parties
• Product(s) and Territory(ies) covered in the SDEA
• Language (and/or translation included)
• Local Qualified Person for Pharmacovigilance (LQPPV)
• Pharmacovigilance System Master File (PSMF)
• SOP, Training, CAPA & deviation management
• Global and local literature handling
• Regulatory Intelligence
• Timelines and mechanism of safety data exchange (e.g., Individual Case Safety Report, Medical Information enquiry)
• Mechanism and responsibilities of preparing and maintaining Periodic Safety Update Reports (PSURs)/Periodic Benefit-Risk Evaluation Reports (PBRER), Risk Management Plans (RMPs), Signal Management activities
• Reconciliation process
• Global Safety Database
• Reference Safety information
• Safety requests from Authorities
• Data Privacy and Business Continuity Plan
• Audit & Inspection terms
• SDEA Termination clause

Principal elements for management of an SDEA/PVA

A process needs to be established to receive the contractual details and agreed rights between the parties prior to drafting any SDEA/PVA. Good communication and continuous interaction between PV and functions initiating or reviewing contracts is key for this. Such functions maybe located in Business Development for licensing agreements, Medical Affairs for PSP, IIT, PASS, NIS, clinical operations for clinical trial supply, Medical Information for call centre or sales reps agreements, procurement for vendor agreements. Many pharmaceutical companies have a policy that their legal department or attorney needs to review all agreements, so it maybe helpful to train such a function to always reach out to PV for relevant contracts to have an expert reviewing those contracts to determine if it requires a PVA/SDEA.

Based on the licensing situation or the contracted PV service certain elements for an effective SDEA/PVA shall be described in such a document. The SDEA/PVA template and checklists may help to create such a comprehensive document. Make sure that all aspects and all stakeholders are included to provide content to the specific situation.

A negotiation and escalation process are helpful to get the drafted SDEA/PVA finalised and signed. Important stakeholders (e.g. the QPPV) and decision makers shall be involved, as well.

Once the SDEA/PVA is finalised a robust implementation process is key to ensure that everyone concerned is following the arrangements and the PSMF is updated accordingly.

Finally, an oversight tool, which could be simply a Pharmacovigilance System Master File Annex, an excel table or a contract database can help the set-up, implementation and maintenance of SDEAs/PVAs.

Final Thoughts About SDEAs

In the complex landscape of drug development and marketing, SDEAs and PVAs play a crucial role in ensuring that safety data is accurately managed and regulatory requirements are met. These agreements provide a structured approach to pharmacovigilance, outlining clear responsibilities and processes for all parties involved. By adhering to the guidelines and best practices discussed, pharmaceutical companies can enhance their compliance, improve patient safety, and streamline their pharmacovigilance operations.

Effective management of SDEAs and PVAs requires thorough planning, robust communication, and continuous oversight. Leveraging templates, checklists, and experienced personnel can significantly aid in the creation, negotiation, and implementation of these agreements. Ultimately, a well-executed SDEA/PVA not only protects patients but also supports the integrity and reputation of the pharmaceutical company.

Get Help with Your SDEAs and PVAs

If you need assistance with setting up or managing SDEAs or PVAs, contact ProPharma for expert guidance and support. Our team of experienced professionals is here to help ensure your compliance with regulatory requirements and safeguard patient safety.

Authors

Thomas Chatzopoulos

Vice President, QPPV Office

Tariq Khan

Senior Consultant Pharmacovigilance, Alliance Management