Trusted ANSM-Aligned Pharmacovigilance Execution for EU & Global MAHs
Operating in France requires more than EU-level pharmacovigilance compliance. ANSM expectations around local safety oversight, SDEA management, LPPV accountability, and inspection readiness demand a pharmacovigilance partner with proven operational depth.
DDReg delivers end-to-end Pharmacovigilance Services in France, supporting pharmaceutical and biotech companies with ANSM-aligned drug safety operations, local QPPV/LPPV support, and inspection-ready PV systems. Our teams combine EU regulatory expertise with hands-on local execution, ensuring continuous compliance throughout the product lifecycle.
France Pharmacovigilance Regulatory Context
Pharmacovigilance activities in France are overseen by the French National Agency for Medicines and Health Products Safety (ANSM – Agence nationale de sécurité du médicament et des produits de santé).
France operates within the EU pharmacovigilance framework under EMA oversight, while applying additional national requirements defined by ANSM and the French Public Health Code. Marketing Authorisation Holders (MAHs) must ensure that EU-level pharmacovigilance systems are effectively implemented and locally overseen in France.
From a practical compliance perspective, companies operating in France must:
- Maintain continuous adverse event monitoring and reporting via EudraVigilance
- Ensure national pharmacovigilance oversight through a locally appointed reference person
- Align EU QPPV governance with France-specific operational controls
- Remain inspection-ready for ANSM audits and safety data requests
ANSM places strong emphasis on local accountability, SDEA clarity, and real-time access to safety data at national level.
In France, pharmacovigilance accountability follows a dual-layer model:
All MAHs must appoint a Qualified Person Responsible for Pharmacovigilance (QPPV) at the European level, as required under EU legislation. The EU QPPV retains ultimate responsibility for the pharmacovigilance system and compliance across the EU.
RPV – Personne de Référence en matière de Pharmacovigilance
In addition to the EU QPPV, French regulations require the appointment of a local pharmacovigilance reference person, known as the RPV.
- Must be a physician or pharmacist
- Must reside and practice in France
- Must have documented experience in pharmacovigilance
- Acts as ANSM’s national-level contact for pharmacovigilance matters
- Oversight of France-specific pharmacovigilance activities
- Ensuring compliance with both EU GVP and French national requirements
- Supporting ANSM inspections, audits, and safety follow-ups
- Coordinating safety data exchange between local operations and the EU QPPV
- Ensuring SDEA management and clear delegation of PV activities
DDReg provides Local QPPV service France, including RPV and local safety officer support, ensuring seamless integration between EU governance and French operational execution.
- ANSM Pharmacovigilance Guidelines
- EU Good Pharmacovigilance Practices (GVP Modules I–XVI)
- EMA EudraVigilance Reporting Requirements
- ICH Guidelines (E2A, E2B(R3), E2C, E2E)
- WHO Pharmacovigilance Guidance
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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
- Proven experience as a pharmacovigilance service provider France trusts
- Deep expertise across EU GVP, ANSM inspections, and national PV nuances
- Scalable pharmacovigilance outsourcing in France models
- Reliable support for MAHs, affiliates, and non-EU companies entering France
- Trusted by companies seeking pharmacovigilance consulting firms in France
Our Pharmacovigilance & Drug Safety Services in France
Why Choose DDReg as Your Pharmacovigilance Partner in France
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...
