The French National Competent Authority, “Agence Nationale de Sécurité du Médicament et des Produits de Santé” (ANSM) aim to guide all stakeholders involved in the French pharmacovigilance system, including healthcare professionals, patients, ANSM, Regional Pharmacovigilance Centers (CRPVs), and pharmaceutical companies (Marketing Authorisation Holders and “expoitant”). They define the responsibilities of each stakeholder and provide a framework for ensuring effective pharmacovigilance activities. The latest version was published in May 2022.
In France, pharmacovigilance is central to ensure medicinal product safety. Its purpose is to monitor, assess, prevent, and manage the risks associated with adverse reactions to medicines throughout their entire lifecycle, both before and after marketing authorisation.
A French Framework Aligned with European Requirements
French Good Pharmacovigilance Practices must be interpreted in conjunction with the European Good Pharmacovigilance Practices (GVP) developed by the European Medicines Agency (EMA).
The May 2022 update reflects the strengthening of pharmacovigilance requirements at both national and European levels and incorporates regulatory changes resulting from the reform of France’s early access and compassionate use framework.
For pharmaceutical companies, compliance requires a dual approach:
- Adherence to European pharmacovigilance requirements;
- Consideration of French-specific obligations, particularly regarding local pharmacovigilance organization, the role of the French Pharmacovigilance Responsible Contact Person (RPV), and interactions with national authorities.
The Central Role of the MAH and exploitant
One chapter of the French GVP is dedicated to the responsibilities of the MAH and the exploitant, making it particularly relevant for pharmaceutical companies operating in France.
To further support implementation, ANSM published a dedicated FAQ, updated in January 2026, providing clarification on several operational aspects of pharmacovigilance system management in France.
Key points include:
- The appointment and responsibilities of the RPV;
- The RPV’s oversight on pharmacovigilance activities, including Periodic Safety Update Reports (PSURs), Risk Management Plans (RMPs), risk minimisation measures, computerised systems, and the European en local Pharmacovigilance System Master File (PSMF);
- Business continuity for pharmacovigilance activities;
- PV cases reporting and submission requirements;
- Signal management;
- Oversight of subcontracted activities;
- Additional guidance on quality management systems, including audits, archiving, business continuity plan, and control of computerised systems.
For pharmaceutical companies, these clarifications reinforce the importance of maintaining a well-documented, robust pharmacovigilance system that is effectively managed at the local level.
Adverse Event Reporting: A Shared Responsibility
The reporting of adverse events is the fundamental element of the pharmacovigilance system.
Healthcare professionals are required to report any suspected adverse reaction related to a medicinal product, regardless of the circumstances under which it occurred, including special situations without adverse events, for example: off-label use, misuse, abuse, overdose, medication errors, occupational exposure, etc.
Patients and healthcare professionals may also report suspected adverse reactions through the ANSM reporting portal. PV cases submitted through this platform are directed to the appropriate entities, including the CRPVs.
For MAHs and exploitant, this requires clear processes to:
- Identify PV cases from all relevant data sources;
- Ensure proper medical assessment and regulatory requirements;
- Meet regulatory submission timelines;
- Maintain the quality and traceability of collected information;
- Conduct appropriate follow-up when initial PV case information is incomplete.
Outsourcing Does Not Transfer Responsibility
Many pharmaceutical companies subcontracts some or all of their pharmacovigilance activities, including case processing, scientific literature monitoring, regulatory intelligence, safety report management and signal management. However, it does not transfer regulatory responsibility of the MAH or exploitant.
The MAH or exploitant retains ultimate responsibility and must maintain adequate oversight of service providers through written agreements and contracts, quality procedures, performance indicators, audits and periodic performance reviews.
Preparing for ANSM Inspections
Compliance with French GVP must be demonstrable at all times. Any pharmaceutical company subject to ANSM inspection should be able to present a complete, documented, and operational local pharmacovigilance system.
Inspection focus areas may include:
- Local pharmacovigilance organisation;
- Responsibilities and oversight of the RPV on PV activities;
- The pharmacovigilance quality system;
- Interfaces with partners and service providers;
- Pharmacovigilance case management;
- Local and global signal detection;
- PSURs and RMPs;
- Pharmacovigilance training;
- Computerised systems;
- Business continuity plans;
- Audits and CAPA management.
Successful inspection readiness relies on regular audits, mock inspections, structured document reviews and risk-based action plans.
The French GVP operate within continuously evolving European regulatory framework. For MAHs and exploitant, pharmacovigilance compliance should be fully integrated into the company’s overall governance strategy.
A robust pharmacovigilance system not only ensures regulatory compliance but also enhances product safety, improves the quality of safety data, facilitates inspection readiness, and ultimately contributes to the protection of patient health.
ATESSIA’s pharmacovigilance consultants support pharmaceutical companies in the assessment and optimisation of their pharmacovigilance systems. Our services include audits, training, gap assessments, ANSM inspection readiness, document reviews, process compliance remediation, support for RPVs and CAPA plan management.
Article written by Marion PETOT, Pharmacovigilance Consultant