Good Pharmacovigilance Practices – FAQ 2026
This situation is common. An “exploitant”, which is a subsidiary of a foreign parent company, asks the parent company to comply with a local pharmacovigilance requirement that is not set out in European legislation or that goes beyond the provisions of European regulations: access to PSURs (periodic safety update reports that analyze pharmacovigilance data for a medicine after it has been placed on the market in order to reassess its benefit-risk profile), visibility regarding a contract affecting the subsidiary, detection of local signals, access to validation reports for computerised systems…
In response, the parent company asks the expected question: ‘Which legislation provides for this?’. It is precisely on this point that the FAQ (frequently asked questions) published by the ANSM on 9 January 2026 provides clearer written guidance. It does not introduce any new obligations. Instead, it sets out in writing the expectations already identified during inspections and in the June 2022 guidelines on good pharmacovigilance practices. This FAQ was eagerly awaited, as the last version dated from 2018 but was linked to the previous version of the French guidelines on good pharmacovigilance practice.
For a French subsidiary, the benefits are immediate. What was previously merely a record of a discrepancy or a verbal reminder now becomes a dated, published and legally binding document. The BPPV FAQ 2026 does not introduce any new requirements. It provides the Chief Pharmaceutical Officer and th elocal qualified person responsible for Pharmacovigilance (local QPPV) of the exploitant site with a reference document to draw upon.
What the FAQ on good pharmacovigilance practices actually sets out
The 2026 FAQ on Good Pharmacovigilance Practices does not replace the 2022 BPPV, the European GVP (Good Pharmacovigilance Practices) or the Public Health Code. It clarifies Chapter 4 of the Good Pharmacovigilance Practices, which deals with the role of the marketing authorisation holder and the exploitant. Its scope is therefore primarily practical: it sets out in black and white requirements that already existed within the French pharmacovigilance system, but which were sometimes difficult to enforce within an international group.
In this regard, it sets out several key points. The ANSM states that the local QPPV must be appointed as soon as possible after Marketing Authorisation has been granted and, at the latest, before the medicinal product is placed on the market; that they must reside and practice in France; and that their employer must ensure they possess the necessary knowledge of pharmacovigilance at national level. The FAQ also states that the local QPPV must be able to access the European PSMF if the local PSMF refers to it, and that it may obtain it on request in order to understand the overall structure of the pharmacovigilance system.
The same reasoning applies to safety reports, local signal detection, data flow, updates to the SPC (Summary of Product Characteristics), the RMP (Risk Management Plan) or labelling, and, more broadly, to pharmacovigilance activities entrusted to the parent company, the Marketing Authorisation Holder or service providers. The benefit of this is that it transforms expected practices into a written reference that can be used by the exploitant.
Aurélia Bidant, co-founder of Alhena Consult, sums it up clearly: “These clarifications do not introduce any real changes, but they do reinforce the role of the exploitant and the local QPPV. For a subsidiary, this is more a matter of operational support than a major legal change.”
Why the FAQ redefines the relationship between subsidiaries and parent companies
Within an international pharmaceutical group, the parent company almost always requires an explicit regulatory basis to justify a local requirement. This approach is legitimate: it seeks to harmonise practices, contracts, systems and processes across the group. In this context, the French subsidiary regularly found itself in difficulty. Whenever it requested access to certain reports, transparency regarding subcontracting, or support in identifying local issues, the only evidence it could provide to support its case were the discrepancies identified during inspections by the ANSM.
An inspection report does not carry the same weight in discussions with a parent company as a formal document, dated and published by the regulatory authority. It is precisely this gap that the FAQ fills. It does not create a new obligation, but it finally provides the subsidiary with a written text on which to rely when justifying French requirements that are not always shared by other countries.
As Aurélia Bidant points out, the problem was clearly identified: prior to January 2026, certain expectations existed in the practice of inspections, but these were not set out in a formal document. Without written guidance, parent companies were reluctant to adapt their organisational structures or documentation. The FAQ therefore changes the nature of the exchange: the subsidiary no longer relies solely on inspection feedback; it can now cite a legally binding document from the ANSM.
Access to safety reports: a practical example
Access to safety reports is a prime example of the practical value of the FAQ. In some international groups, PSURs are prepared and submitted at group level. The French subsidiary therefore has only partial, or even no, insight into their content, conclusions or the follow-up measures envisaged. Yet it remains responsible in France for the safety of the medicines it markets. It is precisely this disconnect that the FAQ helps to address.
The local QPPV cannot properly fulfil its obligations if it is unaware of the findings of the periodic reports, the issues identified, or the measures that may result from them within its territory.
As Aurélia Bidant points out, this problem still exists in some laboratories: pharmacovigilance reports are managed at head office level, even though the local subsidiary should be able to access them and be aware of their findings. The FAQ provides practical guidance on this matter.
It enables the Chief Pharmaceutical Officer and the local QPPV to formalize their request to the parent company on the basis of a written document from the ANSM, rather than solely on the basis of expected usage or a previous inspection.
In practice, this strengthens the subsidiary’s ability to gain access to PSURs, their conclusions and, more broadly, the safety data required for the local monitoring of products marketed in France.
How to use the FAQ in your internal discussions
The first step is to use the FAQ as a reference document. If the parent company does not work in French, it must be translated accurately, attached to written requests and incorporated into the local quality system. This formalisation already provides practical support for internal decision-making.
The second stage involves document structuring. The FAQ is intended to be incorporated as a reference document into applicable procedures, relevant contracts and communications with the Marketing Authorisation Holder, the exploitant’s parent company or service providers responsible for certain activities. The principles set out in the policy must also be reflected in the local PSMF, in particular through the description of responsibilities, access to security data and the interfaces between the subsidiary and the group entities. It may also be cited in discussions concerning critical computerised systems and the management of computerised systems – in terms of governance, validation and maintenance of a validated state – where such systems support pharmacovigilance activities.
The third step is about building relationships. The aim is not to use the FAQs as a means of opposing the parent company, but as a tool for clarification and alignment. The approach must remain collaborative. The subsidiary must explain what the ANSM expects from an exploitant in France, from the local QPPV and from a pharmacovigilance system managed at local level.
See also: Pharmacovigilance: the new 2025 European requirements for quality systems
Conclusion
FAQ 2026 on good pharmacovigilance practices does not introduce any new regulatory requirements. It formalizes expectations already identified during inspections and provides French subsidiaries with a written document to support their requests to the parent company, the Marketing Authorisation Holder or the group’s head office. For the Chief Pharmaceutical Officer and the local QPPV, it provides a practical tool for ensuring access to the information needed to manage drug safety at a local level.
Do you find yourself having to advocate for French requirements with your parent company? Contact our team for pharmacovigilance support tailored to your situation.
