OBJECTIVE:

• To define the procedure for establishing, reviewing, approving, and maintaining Safety Data Exchange Agreements (SDEA) with all partners involved in safety-related activities.
• To ensure compliance with World Health Organization (WHO) and European Union Good Pharmacovigilance Practices (EU-GVP) requirements.
• To clearly define safety responsibilities between the company and external partners for the exchange, reporting, and management of safety information.

SCOPE:

• This SOP applies to all contracts requiring safety data exchange, including:
  • • Distributors
    • Contract Manufacturing Organizations (CMO)
    • Contract Research Organizations (CRO)
    • Marketing partners
    • Co-marketing / co-promotion partners
    • Importers and exporters
• This SOP applies to the Qualified Person for Pharmacovigilance (QPPV), Regulatory Affairs (RA), Quality Assurance (QA), Pharmacovigilance (PV) team, and Legal Department.

RESPONSIBILITIES:

Qualified Person for Pharmacovigilance (QPPV):

• Ensure all applicable partners have a valid SDEA.
• Review SDEA content for regulatory completeness.
• Approve SDEA from a safety and compliance perspective.
• Ensure safety responsibilities and timelines are aligned with regulatory obligations.

Pharmacovigilance (PV) Department:

• Draft SDEA in collaboration with Legal and RA.
• Maintain a master list of all active SDEAs.
• Ensure partners understand AE reporting timelines and formats.
• Periodically review SDEA compliance.

Regulatory Affairs (RA):

• Provide country-specific regulatory reporting requirements.
• Ensure alignment of SDEA commitments with registration obligations.

Quality Assurance (QA):

• Ensure SDEA documents follow document control requirements.
• Verify SDEA requirements during vendor qualification and audits.

Legal Department:

• Review and finalize legal clauses.
• Ensure contractual enforceability of responsibilities.

DEFINATIONS:

• Safety Data Exchange Agreement (SDEA): A written agreement defining pharmacovigilance responsibilities between the company and a partner.
•  Qualified Person for Pharmacovigilance (QPPV): Person responsible for overall PV system oversight.
•  Individual Case Safety Report (ICSR): A report of an individual patient’s adverse event.
•  Periodic Safety Update Report (PSUR): A regular report summarizing product safety.
•  Periodic Benefit–Risk Evaluation Report (PBRER): A benefit–risk evaluation of the product.

PROCEDURE:

Identification of Partners Requiring an SDEA:

• PV identifies partners involved in any activity that may generate, receive, or transmit safety information.
• Partners requiring SDEA include:
  • Distributors
  • CROs (for clinical and bioequivalence studies)
  • CMOs (contract manufacturing organizations)
  • Marketing authorization holders (MAH)
  • Importers / Exporters
  • Co-marketing partners
• No commercial activity shall start without a signed SDEA.

 Preparation of SDEA:

• PV drafts SDEA using the approved company template.
• SDEA must define:
  • Safety responsibilities of each party
  • Reporting timelines for serious and non-serious cases
  • Safety communication process
  • Exchange format (email, database, secure system)
  • Responsibilities for PSUR/PBRER, RMP, signal management
  • Responsibilities for safety database management
  • Audit and inspection support
  • Partner training responsibilities
•  RA provides country-specific reporting timelines to include in the SDEA.
• Legal reviews the agreement for compliance.
• QPPV reviews and approves safety-related clauses.

 Key Safety Responsibilities to be Included in SDEA:

• Adverse Event (AE) / ICSR Handling
• Partner must report serious ICSRs within 24 hours.
• Partner must report non-serious ICSRs within 48–72 hours.
• AE forms and minimum information requirements must be defined.
• Literature Screening.
• Responsibilities for global and local literature screening must be defined.
• Periodic Safety Update Report (PSUR) / PBRER
• Clarify which party prepares and submits PSUR/PBRER.
• Partner must share sales volume and exposure data within defined timelines.
• Risk Management Plan (RMP)
• Specify who prepares RMP and monitors risk minimization activities.
• Signal Detection & Emerging Safety Issues.
• Either party must notify the other of potential safety signals immediately.
• Signal validation and assessment responsibilities must be defined.
• Quality Complaints Linked to Safety.
• Product Quality Complaint cases with AE must be routed to PV within 24 hours.
• Recalls & Safety Communications.
• Responsibilities for Dear Healthcare Professional Letters (DHCPL) must be defined.
• Partner must support safety alerts and recall investigations.

Review and Approval Process:

• PV drafts the SDEA and shall forward for RA and Legal reviews.
• The reviewed SDEA approves by QPPV and Head PV.

Training on SDEA Responsibilities:

• PV shall train internal stakeholders on new or revised SDEAs.
• Training records shall be maintained as per Training SOP.

 SDEA Implementation and Compliance Monitoring:

• PV shall monitor partner compliance through:
  • • AE reporting timeliness
    • PSUR/PBRER data submission timeliness
    • SDEA audit reports
    • Partner performance review
• Repeated non-compliance shall be escalated to QPPV and QA.
• CAPA shall be initiated for significant non-compliance.

SDEA Review and Renewal:

• SDEA must be reviewed at least every two years, or earlier if:
• • • Regulatory requirements change
    • Partner responsibilities change
    • New safety processes are introduced
• Updated versions must follow the same approval process.

 Archiving & Retention:

• All signed SDEAs shall be archived for five years after revision.

Training:

• All PV, RA, QA and relevant commercial personnel must be trained on this SOP.
• Refresher training shall follow the Training SOP.

 Deviations:

• Deviations from this SOP shall be handled through the Deviation and CAPA SOP.
• QPPV must be informed of PV-related deviations.

SDEA Numbering Pattern:

• SDEA Numbering shall contain, SDEA – XXX – YYY – ZZ, Where:
  • • SDEA = Safety Data Exchange Agreement
    • XXX = Manufacturer
    • YYY = Distributor
    • ZZ = Version

REFERENCES:

• WHO Technical Report Series (TRS) – PV guidance
•  EU Good Pharmacovigilance Practices (GVP)
•  Company QMS SOPs (Document Control, Training, Audit, Risk Management, Deviation & CAPA) 

RECORDS:

REVISION HISTORY.