What is Aggregate Reporting

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Aggregate Reporting in Pharmacovigilance: A Critical Compliance Requirement

A legal and ethical duty of pharmaceutical companies is safety monitoring of their products during the lifecycle; the drug development and post-marketing. As Individual Case Safety Reports (ICSRs) only involve recording individual adverse events, the focus is received on a bigger picture with aggregate reporting. It is an essential element of pharmacovigilance that could assist health authorities in the evaluation of the benefit-risk profile of a product over the longer term.

At Masuu Global we offer professional assistance with drafting, reviewing and filing regulatory compliant aggregate safety reports as per the global standards of pharmacovigilance.

What is Aggregate Reporting?

Aggregate reporting means that there should be periodical assessment and analysis of the total safety data of several sources during a specified term. These extensive safety reports enable regulators and manufacturers to be aware of new safety trends and conduct a re-review of the product risks and act where necessary.

In contrast with ICSRs being reported as discrete events, aggregate reports indicate an overview of all available safety data in a summarized and structured manner, such as:

  • Spontaneous reports
  • Literature cases
  • Clinical trials
  • Observational studies
  • Market experience

Types of Aggregate Safety Reports

There are various classifications of aggregated reports depending on the regulatory area, product phase, and marketing stage. Examples can be common:

    1. PBRER (Periodic Benefit Risk Evaluation Report)
      2. A mandatory procedure in Europe and the rest of the ICH countries evaluates the benefit-risk ratio of the products on the basis of post-marketing data.
    1. Periodic Safety Update Report (PSUR)
      2. Like the PBRER, which is mandatory in most nations in the world, and is frequently enacted in the first years following the grant.
    1. Development Safety Update Report (DSUR)
      2. Presented to Food and Drug Administration yearly of products which are in the clinical stage to evaluate the safety during the trials.
    1. AddCO (Supplement to Overview of Clinical Situation)
      2. Occasionally it is requested with submission of regulatory reviews as a means of giving cumulative safety data.
    1. PADER (Periodic Adverse Drug Experience Report)
      2. The manufacturers present these reports periodically to the U.S. FDA describing adverse drug reactions that occur subsequent to the approval or marketing of a drug.

Regulatory Requirements

Most regions require aggregate reporting and this is based on the guidelines that include:
      • ICH E2E (Pharmacovigilance Planning)
      • PBRERsICH E2C (R2)
      • DSURs ICH E2F
      • Module VII GVP (EU Good Pharmacovigilance Practices)
      • 21 CFR 314.80(c)(2) of (PADERs)

Timelines and formats are subject to regulatory authority (e.g. EMA, FDA, PMDA, TGA) and failure to meet certain deadlines or deliver a report can result in regulatory action or delay to market access.

Difficulties of Aggregate Reporting

Development of compliant and significant aggregate reporting entails:

      • Obtaining and analyzing bulk globally reported safety data
      • Composing comprehensive safety assessment and risk benefit discussions
      • Liaising with clinical teams, regulatory and safety teams
      • Compliance upon the labeling and signal management
      • Abiding by tough deadlines of submissions

How Masuu Global Assists in Aggregate Reporting

Masuu Global can provide complete solutions to aggregate reporting, such as:

      • Periodic report planning and scheduling of the project
      • The formulation and analysis of safety data
      • PSURs, PBRERs, DSURs medical writing
      • Lifecycle Management and Regulatory submission
      • Audit- prepared documentation, quality review

Regardless of whether you have a global portfolio or you are getting ready to launch a first product, our professionals can guarantee timely and compliant submission to new regulations that appear globally.

Aggregate reporting is the staple of pharmacovigilance and an essential part of ensuring regulatory compliance and patient safety. It converts unrefined safety data into action-able knowledge that informs benefit-risk decision-making.

Masuu Global is the trusted partner to help you develop accurate and high-quality safety reports to have confidence, compliance, and care with your product in its entire lifecycle.

Get in touch with us now to enhance your pharmacovigilance strategy by engaging in aggregate reporting services through experts.

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