So, in 2026 what changes can be expected to impact the EU-PSMF and is the UK impacted by these?
Firstly, let’s consider the updates to the EU-PSMF following regulation 2025/1466.
1. Only major or critical deviations must be documented
Routine or minor deviations no longer need to be captured in the PSMF.
Only deviations that materially affect compliance or patient safety must be recorded until resolved.
2. More explicit detail on PV activities and organisational structure
The updated wording clarifies the list of PV activities that must be described (e.g., ICSR collection, signal detection, RMP preparation and maintenance, safety variations, PASS management).
3. Clearer expectations for third‑party oversight
Contracts with service providers must explicitly define roles, responsibilities, data exchange, and audit rights.
This strengthens the link between the PSMF and the MAH’s oversight model.
4. Risk‑based internal audits across the entire PV system
MAHs must demonstrate a risk‑based audit strategy covering internal teams and third parties.
The PSMF must reflect this approach.
Often with changes of this magnitude it is important to consider why these changes are happening.
Some of the rationale for these changes are:
1. A decade of real‑world experience
The original EU Pharmacovigilance 520/2012 regulation has been in place since 2012. Regulators have seen what works, what creates unnecessary burden, and where clarity was lacking.
2. Reducing administrative load
Documenting every minor deviation in the PSMF created noise rather than insight. The new approach focuses on issues that genuinely affect compliance or patient safety.
3. Improving consistency and transparency
The updated descriptions of PV activities and third‑party oversight aim to reduce variability between MAHs and ensure regulators can quickly understand how a system operates.
4. Supporting international harmonisation
The EU is aligning more closely with global expectations (e.g., ICH, FDA PV system descriptions), making cross‑regional compliance easier for global companies.
5. Reflecting technological and scientific advances
Signal detection, data management, and RMP processes have evolved significantly since 2012. The regulation now acknowledges these modern practices.
So, what does this means in practice?
The EU PSMF becomes leaner, more strategic, and more risk‑focused.
MAHs must still maintain robust oversight, but the emphasis shifts from paperwork to true system performance.
Audits, contracts, and governance structures will need updating to reflect the new clarity and expectations.
How does this affect the UK?
The UK has its own pharmacovigilance framework post‑Brexit. MHRA guidance confirms that MAHs for UK‑authorised products must maintain a UK PSMF located in the UK and notify its details to the MHRA.
The UK broadly follows EU GVP but with formally published exceptions and modifications, most recently updated in February 2025 to reflect the Windsor Framework. At the time of the latest guidance, the UK had not automatically adopted the new EU Implementing Regulation 2025/1466. This means:
In Great Britain, PSMF expectations continue to be based on the earlier EU model, as adapted in UK guidance, rather than the new EU simplifications on deviations.
The MHRA has separately streamlined how changes to the PV system are notified, focusing on keeping system information up to date without unnecessary variation submissions.
Companies should therefore not assume that EU PSMF changes are mirrored in GB requirements.
And what about Northern Ireland?
Under the Windsor Framework, Northern Ireland remains aligned with EU GVP. UK guidance and specialist commentaries confirm that NI follows EU pharmacovigilance rules, while GB follows UK legislation.
In practical terms:
NI expects an EU‑compliant PSMF, including the new approach to deviations and explicit third‑party oversight once 2025/1466 applies.
GB expects a UK PSMF, following UK GVP as modified by MHRA.
MAHs with products in both territories must therefore manage dual compliance.
How can PharmaGuard help you?
PharmaGuard have developed a range of fixed price PV micro services such as Essential PV training, PV system gap analysis, PV vendor oversight auditing and UK monthly NCP service amongst others. One of the services is PSMF health check where we will assess the status of your PSMF.
So, don’t delay, get compliant today. Reach out to us to discuss how we can support you in more detail.