Preparation of PSURs according to the requirements of GVP Module VII

The preparation of Periodic Safety Update Reports (PSURs) is an essential component of pharmacovigilance and plays a central role in the continuous assessment of the benefit-risk profile of a medicinal product.

The “Guideline on Good Pharmacovigilance Practices (GVP) Module VII” provides a comprehensive framework for the preparation, submission and evaluation of PSURs.

PSUR format

The format of the PSUR is strictly regulated and consists of several defined sections summarizing the global collection of safety data for a medicinal product over a specified period of time. This includes information on the benefit-risk balance, data on new or changed risks and an assessment of the impact of this information on the product information material, such as SmPC, package leaflet/information for use and educational material approved by the authorities.

EURD list

The EURD list (European Union Reference Dates list) is a central element for the planning of PSUR submissions. It specifies the marketing authorizations for which PSURs must be submitted and defines the frequency of PSUR submissions for certain medicinal products or active substances.
Generics, well-established use (WEU) marketing authorizations, registered homeopathic and traditional herbal medicinal products, as well as standard marketing authorizations are generally exempted from the PSUR obligation.
The list also contains the respective data lock point (DLP) and submission date.
Harmonizing the submission dates for medicinal products with the same active substances allows the simultaneous assessment of these medicinal products by the Pharmacovigilance Risk Assessment Committee (PRAC). The regular and systematic submission of PSURs contributes to the consistent monitoring of drug safety.
The EURD list is regularly updated to reflect new scientific findings and regulatory requirements.

PSUR Single Assessment (PSUSA)

The PSUR single assessment (PSUSA) is a procedure in which the simultaneous assessment of PSURs for medicinal products with the same active substance is carried out centrally. This procedure is intended to avoid inconsistencies in the assessment between the Member States and enable a harmonized risk assessment at EU level. This will ensure that the same safety standards are applied to all medicinal products with the same active substance.
The centralized assessment also enables faster decision-making, which is particularly beneficial when identifying risks and implementing risk minimization measures.

PSUR requirements from national authorities

National authorities can request a PSUR at any time for purely national approvals, e.g., in the event of risk concerns or as part of approval extensions. The assessment is then carried out by the requesting authority.

PSUR submission via the PSUR Repository

The submission of PSURs in the EU is done electronically via the PSUR Repository in a specific electronic format (eCTD - electronic Common Technical Document), as a structured and standardized presentation of the data is required.
The PSUR Repository is a central electronic platform managed by the European Medicines Agency (EMA). All PSURs are submitted via the repository and stored there. It enables national competent authorities and other authorized institutions to access the reports to facilitate the assessment and monitoring of drug safety.
It is crucial that PSURs are submitted on time by the deadlines specified in the EURD list. Once submitted, the assessment is carried out by the Pharmacovigilance Risk Assessment Committee (PRAC), or the national competent authority.

Conclusion

The preparation and submission of PSURs in accordance with the requirements of GVP Module VII is a complex but essential process for ensuring drug safety. It requires careful planning and knowledge of the regulatory requirements.
The standardized format, compliance with the deadlines of the EURD list, participation in PSUSA procedures and use of the PSUR repository allow the central and uniform evaluation of medicinal products with the same active substance.
Marketing authorization holders and authorities thus jointly contribute to monitoring the safety of medicinal products and implementing measures to minimize risks, thereby continuously ensuring the protection of public health.