Your Trusted Local Partner for Israel Pharmacovigilance Services
Operating in Israel requires more than global pharmacovigilance compliance. The Israeli Ministry of Health (MOH) places strong emphasis on local safety oversight, timely reporting, and clear pharmacovigilance accountability. Marketing Authorization Holders (MAHs) must appoint a local QPPV to ensure continuous compliance with MOH requirements, including inspections and safety data management.
DDReg delivers end-to-end Pharmacovigilance Services in Israel, supporting pharmaceutical, biotech, and medical device companies with MOH-aligned drug safety operations, local QPPV services, and inspection-ready PV systems. Our teams combine local regulatory expertise with global pharmacovigilance standards, ensuring seamless integration between Israel-specific requirements and international PV governance.
Israel Pharmacovigilance Regulatory Context
Pharmacovigilance in Israel is overseen by the Pharmacovigilance and Drug Information Department under the Ministry of Health (MOH).
MAHs are obligated to ensure all pharmacovigilance activities are compliant with Israeli law, including prompt reporting of new safety information and local oversight by a licensed QPPV. Israel’s PV framework is supported by international standards, aligning with ICH GVP principles and WHO pharmacovigilance guidance, while enforcing additional national requirements.
Key practical requirements for MAHs in Israel include:
- Continuous monitoring, assessment, and reporting of adverse events
- Appointment of a local QPPV (Qualified Person Responsible for Pharmacovigilance)
- Timely reporting of safety information under Pharmacists’ Regulations (Preparations) 1986 for drugs
- Compliance with Medical Device Law (2012) Part C – Article 11 for medical devices
- Inspection readiness and authority engagement for MOH audits
Local Pharmacovigilance Oversight in Israel
QPPV / LCPPV Requirements
All MAHs must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) who is:
- A licensed pharmacist in Israel
- An employee of the local company or local MAH entity
- Experienced with minimum two years in pharmacovigilance
The local QPPV holds responsibility for all PV activities in Israel, ensuring alignment with both MOH requirements and international standards.
- Oversight of all Israel-specific pharmacovigilance operations
- Prompt reporting of new safety information to the MOH
- Management of safety data for both pharmaceutical and medical device products
- Preparation for MOH inspections, audits, and safety follow-ups
- Coordination of safety data exchange between global PV systems and local operations
DDReg provides LQPPV / local QPPV services in Israel, ensuring smooth integration between global PV governance and local operational requirements.
- Pharmacists’ Regulations (Preparations) 1986 – mandates MAHs to report any new drug safety information promptly via the appointed pharmacist.
- Medical Device Law (2012) Part C – Article 11 – requires medical device companies to report new safety information to the MOH.
- ICH Guidelines (E2A, E2B(R3), E2C, E2E) – global PV standards aligned with MOH expectations.
- WHO Pharmacovigilance Guidance – recommended practices for signal detection, reporting, and risk management.
Our Pharmacovigilance & Drug Safety Services in Israel
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Individual Case Safety Report (ICSR) Management
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Aggregate Safety & Periodic Reporting
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Signal Detection & Risk Management
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PV System Setup, Maintenance & Audit Support
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QPPV and Local Pharmacovigilance Support
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Local Literature Monitoring & Surveillance
Why Choose DDReg for Pharmacovigilance in Israel?
- Proven expertise delivering pharmacovigilance services in Israel
- Strong knowledge of MOH regulations, QPPV requirements, and inspection expectations
- Scalable drug safety outsourcing in Israel solutions
- Seamless integration with global QPPV governance
- Trusted partner for MAHs, affiliates, and non-Israeli companies entering the market
Our Pharmacovigilance (PV) Services Expertise
ICSR Case Processing and Submission
Our advanced Individual Case Safety Report (ICSR) Pharmacovigilance Services are dedicated to ensuring patient safety through precise case handling....
Literature Monitoring
DDReg’s Literature Monitoring Services offer advanced pharmacovigilance literature screening for drug safety. We help Marketing...
Risk Management
Our expert risk management solutions ensure patient safety by proactively addressing potential hazards in pharmaceutical...
Audit and Compliance
Our specialized services ensure that pharmacovigilance systems across the drug development pipeline meet strict regulatory...
Pharmacovigilance Signal Management Services
DDReg’s specialized pharmacovigilance services ensure that potential adverse events are identified and addressed promptly...
QPPV Services
DDReg’s expert team provides comprehensive QPPV services designed to strengthen your pharmacovigilance system. We ensure that...
