The French Agency (ANSM) has announced (1) the publication of a revised version of the French Good Pharmacovigilance Practices (GVP) (2). This comes in replacement of the version issued in February 2018 (3), which was supplemented by a set of Frequently Asked Questions (FAQs) published in June 2018 (4). These documents are only available in French and we are not aware of any plans to publish an English translation.
As explained in the ANSM announcement, the new version reflects the changes introduced in the French legislation regarding derogatory access to medicines, which relates to the new arrangements for early access and compassionate use instead of the former Temporary Use Recommendation/Authorisation (RTU & ATU).
It also clarifies the process and responsibilities for the reporting and processing of cases of Medication Errors with no Adverse Drug Reaction (ADR).
Like in the previous version, Healthcare Professionals are encouraged to report the occurrence and the potential risk of Medication Errors even in the absence of an ADR (see 2.8). Whereas these reports were directed to the ANSM until now, these now follow the same route as ADRs and are directed to the relevant Regional Pharmacovigilance Centre (CRPV).
More importantly, the sections describing the role of Patients (see 3.5) and CRPVs (see 5.4) have been revised to list all situations that qualify for reporting and contribute to Pharmacovigilance, including the reports of Medication Errors in the absence of ADR.
For the MAH/Exploitant, the 2018 version (3) caused some confusion as it specified that the MAH/Exploitant should submit all reports of Medication Error without an ADR to the ANSM (see 4.32.e in the 2018 version). The ANSM clarified in the FAQs published in June 2018 (4) that this was actually not an obligation (see Question 11) and this has been corrected in the 2022 version (see 4.34). Nevertheless, this information should be collected by the MAH/Exploitant and considered in the PSUR (see 4.25).
What else is New ?
We ran a side-by-side comparison of the 2018 and 2022 versions of the French GVPs and here is the list of the most significant changes we identified for the MAH/Exploitant:
Local Person Responsible for Pharmacovigilance (RPV)
The new version (2) clarifies which tools should be used for the notification of the details about the Local Person Responsible for Pharmacovigilance (RPV) and the EU QPPV (see 4.4). More importantly, it brings a new responsibility for the RPV, who must ensure that the Product Information reflects the most up-to-date Pharmacovigilance knowledge (see 4.8).
Pharmacovigilance System Master File (PSMF)
The requirements for the French PSMF have been revised and it is now expected that the list of contracts with Partners and Service Providers includes more detail regarding the distribution of responsibilities (see 4.12). It should also present information about the dates of the audits of these organisations over the past 5 years.
The paragraph 4.13.a has been reworded to state that the MAH/Exploitant should record and process “any information or enquiry related to exposure to a medicine”, which appears to refer to the management of Medical Enquiries by the Medical Information function.
It was a big surprise in 2018 when the French GVP removed the obligation for the MAH/Exploitant to assess causality using the French Imputability method, and the ANSM had to confirm that this was no longer a requirement (see Question 6) in the June 2018 FAQs (4). The 2022 version (2) clarifies that the MAH/Exploitant can use the causality assessment method of its own choice (see 4.13.c). Please note that the CRPVs are still expected to use the French Imputability method (see 5.16).
Regarding Case Follow-Up, it is now specified that consumer reports should be medically confirmed (see 4.13.f). The new version (2) brings the requirement to ensure the traceability of all exchanges with the reporter (see 4.13.h) and clarifies that only significant Follow-Up information should be submitted to EudraVigilance (see 4.14)
The new version of the French GVPs (2) reflects the clarifications brought by the FAQs published in June 2018 (4) regarding Signal Management (see Questions 8 and 9). It now clearly specifies that the Exploitant should have Signal Detection arrangements “at the national level” (see 4.20) and reflects the EU GVP requirements for the notification of “Emerging Safety Issues” to regulatory authorities (see 4.21).
A new article describes the obligation for the PSUR to include information on the effectiveness of Risk Minimisation Measures specified in the RMP (see 4.32).
The 2022 version (2) also brings expectations for Quality Control as part of the Pharmacovigilance Quality System. It specifies that Indicators should be in place to monitor the Pharmacovigilance System and that Non-Conformance or Deviations should be managed appropriately (see 4.46).
The dissemination by the MAH/Exploitant of Pharmacovigilance Information is now always subject to prior notification of the ANSM, who can change the content and/or the schedule (see 7.9). As a reminder, the previous version made it possible to notify the ANSM at the same time as the communication was disseminated in case of emergency.
Finally, the 2022 revision includes reference to the correct CNIL Document describing the arrangements for Personal Data Protection (see 4.53).
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