What Are Pharmacovigilance Agreements - and When Are They Required?

Pharmacovigilance (PV) agreements - also referred to as Safety Data Exchange Agreements (SDEAs), Drug Safety Agreements (DSAs), or PV contracts - are legally binding documents that define the delegation of drug safety responsibilities between marketing authorisation holders (MAHs) and third parties.

According to EU GVP Module I, a written PV agreement is mandatory whenever pharmacovigilance activities are shared or outsourced, including:

• Partnerships between MAHs and distributors

• Outsourcing PV tasks to CROs or PV service providers

• Licensing, co-marketing, or co-development agreements

• Commercial contracts involving authorised medicinal products

Health authorities such as EMA, MHRA, and FDA expect clear contractual arrangements to ensure GVP compliance and to avoid findings during PV inspections.

PV Agreements & Contract Management

A robust pharmacovigilance agreement defines how each party fulfills its regulatory duties. Key elements include among others:

• Roles & Responsibilities: Defined obligations for ICSR handling, literature screening, signal management, PSURs, PSMF updates, RMP and (a)RMMs, and authority communication.

• Timelines & Reporting Requirements: Agreed deadlines for exchanging individual case safety reports and aggregate submissions.

• Safety Data Reconciliation: Processes to ensure consistent and aligned safety data across all involved parties.

• Quality Assurance & Inspection Preparedness: Audit rights, CAPA responsibilities, and documentation requirements to ensure inspection readiness.

• Data Privacy & Legal Compliance: GDPR-compliant clauses for the safe handling of personal data within pharmacovigilance systems.

• Legal Robustness: Legally sound language to prevent gaps in compliance and mitigate contractual risks.

What Should a GVP-Compliant PV Agreement Include?

Ensure EU GVP Compliance & Legal Security