PVC Periodic Safety Update Reports 2 — Questions and Answers
Question 1: What is the International Birth Date (IBD) of a medicinal product used in PSUR scheduling?
- The date the product received its first marketing authorization anywhere in the world (Correct answer)
- The date the product was first manufactured
- The date the product entered clinical trials
- The date the product was approved in the US market
Correct answer: The date the product received its first marketing authorization anywhere in the world
The IBD is the date of first marketing authorization for a medicinal product anywhere in the world, which anchors the PSUR submission schedule.
Question 2: In ICH E2C(R2), what does the 'data lock point' (DLP) refer to in a PSUR?
- The date after which no new safety data is included in the current PSUR (Correct answer)
- The date the PSUR is submitted to regulatory authorities
- The date clinical trials for the product were locked
- The date the MAH finalizes the benefit-risk conclusion
Correct answer: The date after which no new safety data is included in the current PSUR
The data lock point is the cut-off date for including safety data in a PSUR; data received after this date is excluded from the current report.
Question 3: Which section of the PSUR specifically addresses the benefit-risk evaluation of the product?
- Integrated Benefit-Risk Analysis for Approved Indications (Correct answer)
- Patient Exposure Section
- Summary Tabulations of Adverse Events
- Signal and Risk Evaluation
Correct answer: Integrated Benefit-Risk Analysis for Approved Indications
ICH E2C(R2) designates a dedicated Integrated Benefit-Risk Analysis section where the MAH evaluates the overall benefit-risk balance for approved indications.
Question 4: Under the EU pharmacovigilance legislation (Regulation 726/2004), what is the standard PSUR submission frequency for a product in the first two years post-authorization?
- Every 6 months (Correct answer)
- Annually
- Every 3 months
- Every 2 years
Correct answer: Every 6 months
EU legislation requires PSURs every 6 months for the first 2 years following initial marketing authorization.
Question 5: What is a PSUR Single Assessment (PSUSA) in the European context?
- A single EU-coordinated assessment of PSURs for products containing the same active substance (Correct answer)
- A simplified PSUR for generics
- A PSUR submitted by a single MAH for multiple products
- An accelerated review of urgent safety PSURs
Correct answer: A single EU-coordinated assessment of PSURs for products containing the same active substance
PSUSA is a procedure where EMA coordinates a single harmonized assessment of PSURs for all EU-authorized products sharing the same active substance.
Question 6: Which of the following best describes the role of the 'Reference Safety Information' (RSI) in a PSUR?
- It serves as the benchmark for classifying adverse events as listed or unlisted (Correct answer)
- It lists all serious adverse events received during the reporting period
- It summarizes findings from clinical trials conducted during the period
- It defines the benefit-risk thresholds set by regulators
Correct answer: It serves as the benchmark for classifying adverse events as listed or unlisted
The RSI, typically the Company Core Data Sheet (CCDS) or Company Core Safety Information (CCSI), is the reference document used to determine whether adverse events are listed (expected) or unlisted (unexpected).
Question 7: When a new significant safety signal is identified during a PSUR reporting interval, what is the MAH typically required to do beyond the PSUR?
- Submit an expedited safety report or urgent safety restriction if warranted (Correct answer)
- Wait and include only in the next scheduled PSUR
- Conduct a new clinical trial before reporting
- Notify the WHO but not the local regulatory authority
Correct answer: Submit an expedited safety report or urgent safety restriction if warranted
Significant safety signals that pose an immediate risk require expedited reporting or urgent safety restrictions independently of the PSUR schedule.
PVC Periodic Safety Update Reports 2
What is the International Birth Date (IBD) of a medicinal product used in PSUR scheduling?