On February 5, 2018, the French National Security Agency for Medicines and Health Products (ANSM) updated their Good Pharmacovigilance Practices (FR-GVP) with the aim of bringing the French particularities in line with EU pharmacovigilance requirements (EU-GVP). Initially, the FR-GVP
So, what are the major modifications and how do you deal with these changes? Our before and after comparative analysis helps to clarify these questions by identifying the seven major changes.
1. A first time for the ANSM
Before, the FR-GVP would have been submitted by ANSM to the French government and validated by the French Minister for Solidarity and Health. However, with the aim of simplifying the procedure, the power of approval for such matters has been transferred to the General Director of ANSM, currently Dr. Dominique MARTIN, according to the Code of Public Health. This responsibility gives the ANSM a full control on the FR-GVP and this new version is the first one that has been published since this decision.
2. A new tool for reporting AEs
In line with the ANSM program of continuous improvement and modernization, a web portal for reporting adverse events (AEs) has been established in March 2017. This permits both patients and healthcare professionals to access the different reporting systems of AEs. Information collected through this online platform is automatically sent to the adequate regional pharmacovigilance center among the Centres Régionaux de Pharmacovigilance. In the new version of the FR-GVP, the chapter relating to the declaration of AEs describes this new tool as the preferable method to declare AEs. Furthermore, a chapter is specifically dedicated to the role of the patients in PV and explains the procedure to declare AEs through this new platform.
3. Description of EUQPPV & LPPV roles
The FR-GVP also details the role of the EU-QPPV (Qualified Person responsible for Pharmacovigilance in EU) and of the LPPV (Local Person for Pharmacovigilance). Indeed, pharmaceutical companies need an efficient PV system by appointing an EUQPPV, responsible for all related PV activities, and an LPPV, in charge of all PV activities on a national level.
Moreover, an EU-QPPV can also handle the position of LPPV if he/she:
- Is a medical doctor or a pharmacist
- Is located and executes his/her activities in France
- Has proven expertise in PV
4. Modifications of MAH and ‘’Exploitant’’ responsibilities
The ANSM published an FAQ in June 2018 which:
- Explains the differences between Exploitant and MAH, as the Exploitant is a local particularity. An
Exploitantis a company which commercializes the pharmaceutical product without necessarily being the MAH. An Exploitant can be responsible for PV activities but in this case, the respective roles between Exploitant and MAH must be defined.
- Clarifies the AEs declaration to the ANSM. There is no more obligation for Exploitant/MAH to report Medication Errors without AE to the “ANSM Medication Error Desk’’ or to submit reports of abuse or dependence to medicines containing psychoactive substances to the Dependence Evaluation and Information Center (CEIP).
5. Definition of the scope of audits
The new FR-GVP specifies that the Exploitant must monitor the PV system, its performance, and efficacy by conducting audits in accordance with GVP Guidelines.
The scope of the audit can vary according to the status of the Exploitant.
Indeed. if the Exploitant is also the MAH, the audit program should be based on PV audit procedures and cover at least:
- Internal PV procedures and their correlation with the regional PV system in place at HQ level
- Audits of affiliates where appropriate
- Audits of vendors providing PV-related services
- Audits of distributors, etc.
On the other hand, if the Exploitant is not the MAH (e.g a French affiliate), the scope of the audit concerns:
- PV procedures (internal and in the interface with MAH), reference can be made to audits performed by the MAH
- Contracted vendors
- PV partners (local contract)
If the audit is performed by the MAH, the Exploitant (responsible Pharmacist and LPPV) must get a copy of the audit report including CAPAs.
6. Harmonization with European-GVP
France contributes to the European Medicines Agency’s Eudravigilance database. Due to Eudravigilance new functionalities from November 22, 2017, new procedures for the exchange of electronic transmission of Individual Case Safety Reports (ICSRs) have also been implemented in the FR-GVP. The ANSM no longer sends ICSRs to pharmaceutical companies by regular post but uses Eudravigilance. For ICSRs from literature, pharmaceutical companies are no longer required to forward the corresponding articles to the ANSM since 10 July 2017.
7. Clarification on the PSMF
Like the MAH, the Exploitant must have an up-to-date copy of the Pharmacovigilance System Master File (PMSF). In addition to the global PSMF, a local PSMF is also required and should include:
- The identity, qualification and contact details of the LPPV/EUQPPV
- The organizational chart of the local PV services and the management system
- The description of the organization of the PV system and the management of PV related activities
- The list of current procedures concerning PV
- The description of all PV tools used in the company
- The list of all the contracts between the Exploitant and the MAH
- The description of PV training
- The description of the archiving process
From now on, the ANSM has stated that the FR-GVP will be updated on a regular basis to give clearer guidelines on the National level, ensure a better concordance with the EU Guidelines and improve communication with pharmaceuticals companies.
Blog by: Juliette Bayle