What is a Periodic Safety Update Report?

A Periodic Safety Update Report (PSUR) is a pharmacovigilance document designed to assess a medicinal product’s risk-benefit ratio after its authorization. The main objective of a PSUR is to provide a comprehensive and critical analysis of the safety and efficacy data of the approved pharmaceutical product taking into account new or emerging safety information in the context of cumulative information on risk and benefits. This report is important in ensuring the ongoing performance and safety of pharmaceutical products. Regulatory agencies such as the European Medicines Agency (EMA) and United Kingdom Medicines & Healthcare products Regulatory Agency (UK MHRA) require marketing authorization holders (MAHs) to submit PSURs for their approved products.

What is the format, content, and submission schedule of a PSUR?

The format and content of a PSUR is outlined in Regulation (EU) No. 520/2012 and Guideline on Good Pharmacovigilance Practices (GVP) Module VII- Periodic Safety Update Report. This is also based on the required format and content for Periodic Benefit Risk Evaluation Report (PBRER) that is outlined in the ICH E2C(R2) guideline.

An MAH must prepare a single PSUR for all its products that have the same active substance, and include information on the product’s authorized indications, administration route, dosage forms & dosing regiments. A PSUR must be prepared and submitted in eCTD format and as a new eCTD sequence for products that have previously had their documents submitted in the eCTD format. A MAH must also consider the impact that this information and presented evaluation will have on the product’s marketing authorization status. Based on the risk-benefit analysis & safety data evaluation, MAHs can draw conclusions for changes to the product information of the products that the PSUR covers.

The PSUR submission schedule is structured where reports are required at certain intervals after the permit is issued. MAHs must initially submit PSURs every six months for the first two years after marketing authorization, then annually for the following two years and every three years thereafter.

Challenges in preparing and submitting a PSUR

There are several challenges that MAHs face when preparing and submitting a PSUR to competent authorities. Firstly, there is vast amount of information available from various and diverse sources (ie., clinical trials, post market surveillance, medical/scientific literature) which requires analysis. Gatheritng such comprehensive and accurate safety data from these sources can be challenging for MAHs. Secondly, it is imperative that MAHs submit the PSURs as per the regulatory agency timelines in order to maintain compliance. Coordinating between various stakeholders involved in the PSUR development process (i.e., clinical, safety, and regulatory affairs teams) should be done efficiently to ensure timely submission of PSURs that have the necessary information. MAHs also experience trouble when it comes to harmonizing data formats and standards for PSUR submission in multiple countries. Indeed, the differences in reporting criteria and even terminology across different countries requires PSUR adaptation to ensure compliance.

DDReg’s Capabilities

As part of its pharmacovigilance services portfolio, DDReg has supported its customers for the development and submission of various aggregate reports including PSURs. The dedicated medical safety writing team brings their experience and capabilities to help author PSURs and incorporate safety information from various sources. The team compiles the information in the required format, publishes in eCTD format, and submits to competent authorities. Additionally, the team tracks PSURs in respective trackers to manage and maintain PSURs. The team is also adept in handling queries raised by the regulatory agencies, if any.

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