Periodic Safety Update Report (PSUR) MCQs With Answer

Periodic Safety Update Report (PSUR) MCQs With Answer is a focused practice set designed for B.Pharm students to deepen understanding of pharmacovigilance, regulatory safety reporting, and post-marketing surveillance. This resource covers PSUR objectives, reporting timelines, data sources, adverse drug reaction analysis, risk-benefit assessment, and global guidance such as ICH principles and national regulatory requirements. Through clear explanations and targeted questions, students will reinforce concepts like signal detection, observed-versus-expected analyses, case aggregation, cumulative safety evaluation, and measures for risk minimization. Ideal for exam preparation and practical learning in pharmaceutical industry settings, the MCQs build competence in drafting, reviewing, and interpreting PSURs. Now let’s test your knowledge with 30 MCQs on this topic.

Q1. What is a Periodic Safety Update Report (PSUR)?

• A periodic report summarizing safety information and risk–benefit evaluation of a marketed medicinal product
• A daily log of manufacturing deviations
• A clinical trial protocol amendment document
• An initial marketing authorization application

Correct Answer: A periodic report summarizing safety information and risk–benefit evaluation of a marketed medicinal product

Q2. What is the primary objective of a PSUR?

• To present cumulative safety data and evaluate the product’s benefit–risk profile
• To report preclinical toxicology only
• To replace batch release testing
• To register a new clinical investigator

Correct Answer: To present cumulative safety data and evaluate the product’s benefit–risk profile

Q3. Which ICH guideline introduced the Periodic Benefit–Risk Evaluation Report (PBRER) as an evolution of the PSUR?

• ICH E2C(R2)
• ICH Q1A
• ICH M3
• ICH E6(R2)

Correct Answer: ICH E2C(R2)

Q4. For an established marketed product, what is the commonly expected reporting frequency for PSURs in many regions?

• Annually
• Every month
• Every five years
• Only once at approval

Correct Answer: Annually

Q5. Which of the following are typical data sources included in a PSUR?

• Spontaneous adverse event reports, clinical trial data, scientific literature, and marketing experience
• Only manufacturing batch records
• Only preclinical animal study reports
• Only investigator names and addresses

Correct Answer: Spontaneous adverse event reports, clinical trial data, scientific literature, and marketing experience

Q6. Compared with earlier PSURs, the PBRER places increased emphasis on which element?

• Structured benefit–risk evaluation and narrative contextualization
• Only listing individual case safety reports
• Manufacturing process optimization
• Laboratory stability data

Correct Answer: Structured benefit–risk evaluation and narrative contextualization

Q7. Who is typically responsible for preparing and submitting the PSUR to regulatory authorities?

• Marketing Authorization Holder (MAH)
• Clinical trial volunteer
• Contract manufacturing site operator
• Hospital pharmacy chief

Correct Answer: Marketing Authorization Holder (MAH)

Q8. PSURs are primarily generated during which phase of a medicinal product lifecycle?

• Post-marketing (after product approval)
• Preclinical development only
• During Phase I single-center trials only
• During dossier compilation for clinical trial authorization only

Correct Answer: Post-marketing (after product approval)

Q9. One important purpose of PSURs is signal detection. Which activity supports this purpose?

• Trend analysis of aggregated adverse event data
• Only performing dissolution testing
• Counting marketing samples without analysis
• Filing patent renewals

Correct Answer: Trend analysis of aggregated adverse event data

Q10. How does a PSUR normally present individual case safety reports (ICSRs)?

• As aggregated summaries and analyses rather than full individual narratives for every case
• By publishing every full narrative verbatim
• By excluding any mention of ICSRs
• By including only investigator names without details

Correct Answer: As aggregated summaries and analyses rather than full individual narratives for every case

Q11. In which section of a PSUR would you expect to find the overall benefit–risk conclusion and recommendations?

• Summary and conclusions (including benefit–risk assessment)
• Manufacturing appendix
• Stability study data table
• Investigator CVs

Correct Answer: Summary and conclusions (including benefit–risk assessment)

Q12. Which international body developed the original E2C guideline on PSURs?

• International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)
• World Health Organization (WHO) Pharmacopoeia Commission
• European Court of Justice
• United Nations Office for Drugs and Crime

Correct Answer: International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH)

Q13. What does the reporting period of a PSUR commonly represent?

• The cumulative safety data since the last report or since marketing authorization, defined by a data lock point
• Only the last two weeks of spontaneous reports
• Manufacturing dates for the product batch
• Only clinical trial data before authorization

Correct Answer: The cumulative safety data since the last report or since marketing authorization, defined by a data lock point

Q14. How does a PSUR differ from a Development Safety Update Report (DSUR)?

• PSURs focus on post-marketing safety; DSURs focus on safety during clinical development
• PSURs are only for preclinical studies; DSURs are for marketing
• PSURs and DSURs are identical in scope and timing
• DSURs are submitted only after product discontinuation

Correct Answer: PSURs focus on post-marketing safety; DSURs focus on safety during clinical development

Q15. Which statistical or analytic approach is commonly used in PSURs to evaluate trends in adverse events?

• Observed-versus-expected (O/E) analysis and trend analysis
• Only Kaplan–Meier survival curves for manufacturing
• Infrared spectroscopy quantitation
• Randomized block design for batch testing

Correct Answer: Observed-versus-expected (O/E) analysis and trend analysis

Q16. Can a PSUR recommend risk minimization measures for a medicinal product?

• Yes, PSURs often recommend additional risk minimization actions if needed
• No, PSURs cannot make any recommendations
• PSURs only recommend manufacturing changes
• PSURs only focus on marketing strategies

Correct Answer: Yes, PSURs often recommend additional risk minimization actions if needed

Q17. Who typically reviews PSURs submitted by the MAH?

• Regulatory authorities and internal pharmacovigilance teams at the MAH
• Only hospital ethics committees
• Only contract manufacturers’ quality assurance
• Independent community pharmacists without regulatory role

Correct Answer: Regulatory authorities and internal pharmacovigilance teams at the MAH

Q18. Which section of a PSUR typically provides details on the product’s worldwide marketing authorization status?

• Worldwide marketing and regulatory status section
• Analytical methods validation appendix
• Nonclinical pharmacology chapter
• Investigator credential summary

Correct Answer: Worldwide marketing and regulatory status section

Q19. A PSUR may trigger regulatory action. Which of the following is a possible regulatory outcome after PSUR review?

• Label change, restriction of use, additional warnings, or further studies
• Cancellation of unrelated patents only
• Immediate closure of all pharmacies in a region
• Transfer of manufacturing to a new unrelated product line

Correct Answer: Label change, restriction of use, additional warnings, or further studies

Q20. Which of the following items is NOT normally part of a PSUR?

• Detailed batch manufacturing process parameters unrelated to safety
• Aggregate adverse event summaries
• Literature review on safety findings
• Benefit–risk assessment and conclusions

Correct Answer: Detailed batch manufacturing process parameters unrelated to safety

Q21. How does a PBRER differ conceptually from the traditional PSUR?

• PBRER integrates explicit benefit evaluation with the safety review, offering a more comprehensive benefit–risk analysis
• PBRER excludes benefit considerations entirely
• PBRER is only a manufacturing quality report
• PBRER is a marketing plan disguised as a safety report

Correct Answer: PBRER integrates explicit benefit evaluation with the safety review, offering a more comprehensive benefit–risk analysis

Q22. Which activity is essential when preparing the literature section of a PSUR?

• Conducting a systematic search and critical appraisal of published safety-relevant literature
• Only translating the product label into one language
• Excluding all non-English papers without justification
• Listing only promotional articles

Correct Answer: Conducting a systematic search and critical appraisal of published safety-relevant literature

Q23. Under ICH E2C(R2), what is the recommended timeframe between the data lock point and submission of a PBRER/PSUR?

• Approximately 70 days
• 7 days
• One year
• 24 hours

Correct Answer: Approximately 70 days

Q24. Which of the following actions would NOT typically result directly from PSUR review?

• Changing the molecular structure of the drug substance
• Updating the product label to include new adverse reactions
• Requesting post-authorization safety studies (PASS)
• Issuing contraindications or warnings

Correct Answer: Changing the molecular structure of the drug substance

Q25. Which pharmacovigilance database is commonly used in the European Union for collecting adverse reaction reports referenced in PSURs?

• EudraVigilance
• FAERS only
• WHO Essential Medicines List
• PubChem

Correct Answer: EudraVigilance

Q26. Should a PSUR include considerations for special populations such as pregnant women, pediatric or elderly patients?

• Yes, PSURs should address safety information and exposure in special populations
• No, special populations are never discussed in PSURs
• Only pediatric data are permitted, others are excluded
• Only preclinical pregnancy data are allowed

Correct Answer: Yes, PSURs should address safety information and exposure in special populations

Q27. Which of the following best describes the role of literature surveillance in PSUR preparation?

• Identify new safety signals, contextualize spontaneous reports, and update cumulative evidence
• Serve only as a marketing bibliography
• Exclude case reports from peer-reviewed journals
• Replace the need for spontaneous reporting systems

Correct Answer: Identify new safety signals, contextualize spontaneous reports, and update cumulative evidence

Q28. How does cumulative review in PSURs help detect rare adverse drug reactions?

• By aggregating data over time and across sources to reveal low-frequency events
• By hiding rare events to prioritize common ones
• By focusing only on manufacturing quality control
• By limiting analysis to a single clinical trial

Correct Answer: By aggregating data over time and across sources to reveal low-frequency events

Q29. Which statement about PSUR applicability is correct?

• PSURs are generally required for all marketed medicinal products, including generics, biologics, and new chemical entities
• PSURs are only required for orphan drugs
• PSURs apply only to veterinary products
• PSURs are optional for all products

Correct Answer: PSURs are generally required for all marketed medicinal products, including generics, biologics, and new chemical entities

Q30. Who is the term used in European pharmacovigilance to describe the person responsible for the overall pharmacovigilance system of the MAH?

• Qualified Person for Pharmacovigilance (QPPV)
• Chief Financial Officer (CFO)
• Head of Manufacturing
• Clinical Research Coordinator (CRC)

Correct Answer: Qualified Person for Pharmacovigilance (QPPV)

Download