Starting January 1st, 2026, PSURs will become mandatory for many active substances, making it essential for Marketing Authorisation Holders to be well-prepared. To ensure proper planning for the submission of these mandatory PSURs, it’s important to anticipate regulatory requirements and timelines well in advance.
Periodic Safety Update Reports (PSURs) are evaluations of the risk-benefit balance of a medicinal product at defined time points during the post-authorisation phase.
The objective:
Comprehensive, concise and critical analysis of the risk/benefit balance of the medicinal product taking into account new or emerging information in the context of cumulative information on risks and benefits
The scope includes evaluation of safety in real medical practice including:
- Use in unauthorized indications
- Gaps in knowledge for specific safety issues or populations, (e.g. use in paediatric population or in pregnant women).
- Urgent safety information should be reported through the appropriate mechanism. A PSUR is NOT intended, in the first instance, for notification of significant new safety or efficacy information .
- It is acknowledged that the review of the data in the PSUR may lead to new safety issues being identified
Unless otherwise specified by competent authorities, the MAH shall prepare a SINGLE PSUR for all its medicinal products containing the same active substance with information covering:
- all the authorised indications
- route of administration
- dosage forms and dosing regiments
Irrespective of whether authorised under different names and through separate procedures.
At Asphalion, we apply a fully digital methodology across all our processes — and PSURs are no exception. We leverage advanced digital tools to streamline and optimize the entire PSUR workflow, reducing human error and increasing efficiency. Backed by extensive expertise in PSUR preparation and submission, we ensure high-quality, compliant outcomes that meet evolving regulatory standards.
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