PVC Periodic Safety Update Reports 3 — Questions and Answers
Question 1: Under ICH E2C(R2), which of the following is NOT a required section of the PSUR?
- Post-market clinical trial protocols (Correct answer)
- Executive Summary
- Overview of Signal and Risk Evaluation
- Patient Exposure
Correct answer: Post-market clinical trial protocols
The PSUR does not require inclusion of post-market clinical trial protocols; it focuses on safety data summaries, signal evaluations, and benefit-risk analysis.
Question 2: How is cumulative patient exposure typically expressed in a PSUR?
- As patient-years, units sold, or prescriptions dispensed with appropriate caveats (Correct answer)
- Only as the total number of adverse event reports received
- Exclusively as number of clinical trial participants
- As a percentage of the target population diagnosed with the condition
Correct answer: As patient-years, units sold, or prescriptions dispensed with appropriate caveats
Cumulative exposure is commonly expressed as patient-years, units sold, or prescriptions dispensed, with acknowledged limitations of each method.
Question 3: What is the purpose of the 'Summary Tabulations' section in a PSUR?
- To present cumulative and interval counts of adverse events by system organ class (Correct answer)
- To list all individual case safety reports verbatim
- To describe the manufacturing process changes during the period
- To provide a narrative of each serious adverse event
Correct answer: To present cumulative and interval counts of adverse events by system organ class
Summary tabulations aggregate adverse event counts by system organ class for both the reporting interval and cumulatively, enabling trend analysis.
Question 4: In the PSUR, the 'Interval' data refers to which time period?
- The data collected only within the current reporting period (Correct answer)
- All data since the product's first authorization
- Data from the last 5 years only
- Data from ongoing clinical trials exclusively
Correct answer: The data collected only within the current reporting period
Interval data covers only the safety information collected during the specific reporting period covered by the current PSUR.
Question 5: Which regulatory agency uses the term 'Periodic Benefit-Risk Evaluation Report' (PBRER) interchangeably with PSUR?
- EMA (European Medicines Agency) (Correct answer)
- FDA (US Food and Drug Administration)
- PMDA (Japan)
- Health Canada
Correct answer: EMA (European Medicines Agency)
The EU/EMA adopted the ICH E2C(R2) format calling it the PBRER, emphasizing the integrated benefit-risk evaluation component.
Question 6: When a product has multiple strengths and formulations, how are PSURs typically structured?
- A single PSUR covering all strengths and formulations under one active substance (Correct answer)
- A separate PSUR for each individual strength
- PSURs only for the highest-selling strength
- Separate PSURs for each route of administration
Correct answer: A single PSUR covering all strengths and formulations under one active substance
ICH E2C(R2) recommends a single PSUR for all formulations, strengths, and indications of a product containing the same active substance.
Question 7: What is the significance of a 'lack of efficacy' report in the context of PSURs for certain product types?
- It is particularly important for vaccines and anti-infectives where treatment failure may indicate a safety concern (Correct answer)
- It is never included in PSURs as efficacy is not a safety issue
- It only applies to orphan drugs
- It replaces the adverse event tabulation section
Correct answer: It is particularly important for vaccines and anti-infectives where treatment failure may indicate a safety concern
For vaccines and anti-infectives, lack of efficacy can be a critical safety signal (e.g., failure to protect against infection), and must be reported and analyzed in PSURs.
PVC Periodic Safety Update Reports 3
Under ICH E2C(R2), which of the following is NOT a required section of the PSUR?