Ensuring the ongoing safety and efficacy of medicinal products is a cornerstone of pharmacovigilance. In the United Kingdom, the Medicines and Healthcare products Regulatory Agency (MHRA) mandates the submission of Periodic Safety Update Reports (PSURs) for all approved medicinal products. These reports provide a structured evaluation of a product's risk-benefit balance throughout its lifecycle, incorporating new safety information and assessing its impact on the product's overall profile.
The MHRA has released updated version, "Guidance: Periodic Safety Update Reports (PSURs) for Medicinal Products", on 1st April 2025, providing detailed instructions on how to submit a periodic safety update report report (PSUR) or periodic benefit risk evaluation report (PBRER).
A PSUR is a periodic assessment of the risk-benefit balance of a medicinal product that you must submit for all approved medicinal products in the UK. This requirement applies regardless of whether the product is currently marketed. The PSUR should analyze the product's safety, efficacy, and effectiveness throughout its lifecycle, focusing primarily on safety but also including any new limitations or alternative treatment information.
It's crucial to promptly notify the MHRA of any significant new safety or efficacy information, separate from routine PSUR submissions. Notifications of signals should be sent to signalmanagement@mhra.gov.uk.
When to Submit Your PSUR
Upon receiving a UK Marketing Authorisation (MA), you typically need to submit your PSUR:
Every 6 months until the product is placed on the market.
Every 6 months for the first 2 years after the product is placed on the market.
Annually for the subsequent 2 years.
The European reference date (EURD) list determines the exact submission date related to the active substance in your product, overriding the standard cycle. Check the EURD list for specific deadlines. The MHRA may also request a PSUR when necessary. EU versions of the PSUR are acceptable, but include a specific annex for UK-specific information or requests.
If the submission date for your active substance isn't on the EURD list, follow the standard PSUR cycle.
Data lock points (DLPs): The Data Lock Point (DLP) is a specific date used in safety reports for medicines. It marks the last day that data can be included in the report. Any safety or effectiveness information about the medicine collected up to this date will be analyzed and summarized in the report. After the DLP, no new data will be added until the next reporting period.
Your submission date is based on your data lock point (DLP), which is the cutoff point for report preparation:
70 days after your DLP if your PSUR covers a period of 12 months or less.
90 days after your DLP if your PSUR covers a period of 12 months or more.
You can use modules from the development safety update report (DSUR) and risk management plan in the PSUR to minimize duplication and improve efficiency.
How to Prepare Your PSUR
Preparing a PSUR requires meticulous attention to detail and adherence to established guidelines. The report should be compiled in accordance with the International Council for Harmonisation (ICH) E2C(R2) guidelines, which provide a harmonized structure for PSURs globally. Key components to include in your PSUR are:
Cumulative safety information: A comprehensive overview of all safety data collected since the last report, including adverse reactions and new safety signals.
Evaluation of the risk-benefit balance: An assessment determining whether the benefits of the medicinal product continue to outweigh its risks.
Summary of relevant new information: Incorporation of data from studies, literature, and other sources that may influence the product's safety profile.
While the MHRA accepts PSURs prepared for EU submissions, it's imperative to include any UK-specific information or data requested by UK authorities in a dedicated annex. This ensures that the MHRA has all pertinent information to assess the product's safety within the UK context.
How to Submit Your PSUR
Submit PSURs through the PSUR portal using MHRA Submissions, accessible via a company administrator in your organization. Certain medicinal products may be exempt from routine PSUR submission requirements. These exemptions are typically outlined in the Human Medicines Regulations 2012, as amended.
Fees (Link)
A fee of £979 is payable for the assessment of PSURs for actives/combinations listed on the EURD or future UKRD. A reduced fee of £490 applies for each PSUR involving multiple Marketing Authorisation Holders. The MHRA will publish the outcome of PSUR assessment procedures, and no further fee is required for amending product information as a result of the assessment; updates will be made via a Type IA variation.
By adhering to the MHRA's guidelines on the timing, preparation, and submission of PSURs, Marketing Authorisation Holders contribute significantly to public health and patient safety.
🔗 Reference Link: LINK
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