This concise guide helps B.Pharm students explore Differences between Indian and global pharmacovigilance systems MCQs With Answer. It explains key contrasts — Indian Pharmacovigilance Programme (PvPI), CDSCO roles, ADR reporting through ADR Monitoring Centres (AMCs) and national databases — versus global frameworks like FDA’s FAERS, EMA’s EudraVigilance, and WHO‑UMC’s VigiBase. Topics covered include causality assessment (WHO‑UMC, Naranjo), data standards (ICH E2B(R3), MedDRA), signal detection (disproportionality, PRR/ROR), periodic safety reporting (PBRER vs PSUR), risk management plans, active surveillance and MAH obligations. The language is practical and targeted for exam preparation and deeper understanding. Now let’s test your knowledge with 30 MCQs on this topic.
Q1. Which programme is the primary pharmacovigilance initiative in India?
- Pharmacovigilance Programme of India (PvPI)
- EudraVigilance
- FDA Adverse Event Reporting System (FAERS)
- WHO‑UMC VigiBase
Correct Answer: Pharmacovigilance Programme of India (PvPI)
Q2. Which regulatory authority oversees drug safety and approvals in India?
- Central Drugs Standard Control Organization (CDSCO)
- Food and Drug Administration (FDA, USA)
- European Medicines Agency (EMA)
- World Health Organization (WHO)
Correct Answer: Central Drugs Standard Control Organization (CDSCO)
Q3. Which system is the European safety database for adverse event reports?
- EudraVigilance
- FAERS
- VigiBase
- MedWatch
Correct Answer: EudraVigilance
Q4. Which database is managed by the US FDA for postmarketing safety reports?
- FAERS
- VigiBase
- EudraVigilance
- MedDRA
Correct Answer: FAERS
Q5. Which causality assessment method is recommended by WHO for global harmonization?
- WHO‑UMC causality assessment
- Naranjo algorithm only
- PRR method
- PBRER summary
Correct Answer: WHO‑UMC causality assessment
Q6. Which causality tool uses a structured questionnaire with a scoring system?
- Naranjo algorithm
- WHO‑UMC method
- PRR disproportionality
- PBRER format
Correct Answer: Naranjo algorithm
Q7. Which statistical approach is commonly used globally for signal detection in large safety databases?
- Proportional Reporting Ratio (PRR)
- Periodic Benefit‑Risk Evaluation Report (PBRER)
- Risk Management Plan (RMP)
- Summary of Product Characteristics (SmPC)
Correct Answer: Proportional Reporting Ratio (PRR)
Q8. Which report format has largely replaced the older PSUR for benefit–risk periodic reporting per ICH guidance?
- PBRER (Periodicity Benefit‑Risk Evaluation Report)
- PSUR
- DSUR
- CIOMS I report
Correct Answer: PBRER (Periodicity Benefit‑Risk Evaluation Report)
Q9. Which coding dictionary is widely used internationally and in India for adverse event classification?
- MedDRA
- WHO‑ART
- ICD‑10
- SNOMED CT
Correct Answer: MedDRA
Q10. What best describes spontaneous ADR reporting?
- Voluntary reporting of suspected adverse drug reactions by healthcare professionals or patients
- Mandatory clinical trial adverse event reporting only
- Routine periodic lab monitoring
- Pre‑market safety testing
Correct Answer: Voluntary reporting of suspected adverse drug reactions by healthcare professionals or patients
Q11. Which ICH standard defines the electronic ICSR messaging format required for international exchange?
- ICH E2B(R3)
- ICH E2C
- ICH E6
- ICH M4
Correct Answer: ICH E2B(R3)
Q12. Which organization maintains the global VigiBase database of individual case safety reports?
- WHO‑UMC (World Health Organization — Uppsala Monitoring Centre)
- FDA
- EMA
- CDSCO
Correct Answer: WHO‑UMC (World Health Organization — Uppsala Monitoring Centre)
Q13. Which active surveillance method is commonly used postmarketing to estimate incidence of ADRs in a defined group?
- Cohort event monitoring
- Spontaneous reporting
- Randomized controlled trial
- Case reports only
Correct Answer: Cohort event monitoring
Q14. The ‘black triangle’ symbol indicating intensive monitoring of new medicines is primarily used in which region?
- European Union (EU)
- India
- United States
- World Health Organization
Correct Answer: European Union (EU)
Q15. Which responsibility is a core obligation of a Marketing Authorization Holder (MAH) in pharmacovigilance?
- Establish and maintain a pharmacovigilance system to monitor product safety
- Set clinical trial protocols only
- Provide free samples to hospitals
- License new manufacturers
Correct Answer: Establish and maintain a pharmacovigilance system to monitor product safety
Q16. Which organization coordinates the network of ADR Monitoring Centres (AMCs) in India?
- Indian Pharmacopoeia Commission (IPC) under PvPI
- European Medicines Agency
- US FDA
- World Bank
Correct Answer: Indian Pharmacopoeia Commission (IPC) under PvPI
Q17. Which term describes an adverse reaction that is not consistent with applicable product information or label?
- Unexpected adverse reaction
- Serious adverse reaction
- Known adverse reaction
- Non‑adverse event
Correct Answer: Unexpected adverse reaction
Q18. Which of the following is NOT a core step in signal management?
- Marketing of the product as a first step
- Signal detection
- Signal validation and confirmation
- Prioritization and assessment
Correct Answer: Marketing of the product as a first step
Q19. Which document provides a planned set of pharmacovigilance activities and interventions for a medicine to identify, characterize and mitigate risks?
- Risk Management Plan (RMP)
- Periodic Safety Update Report (PSUR)
- Clinical Study Report (CSR)
- Prescription Insert
Correct Answer: Risk Management Plan (RMP)
Q20. REMS (Risk Evaluation and Mitigation Strategies) is a safety program specific to which regulatory region?
- United States (FDA)
- European Union (EMA)
- India (CDSCO)
- WHO globally
Correct Answer: United States (FDA)
Q21. Which of the following lists the standard WHO‑UMC causality categories?
- Certain, Probable/Likely, Possible, Unlikely
- Definite, Suspected, Confirmed, Rejected
- High, Medium, Low, None
- Serious, Non‑serious, Unexpected, Expected
Correct Answer: Certain, Probable/Likely, Possible, Unlikely
Q22. What is the primary purpose of a PBRER?
- Summarize cumulative benefit–risk information and new safety data over a defined period
- List manufacturing batch records
- Document clinical trial consent forms
- Set drug pricing strategy
Correct Answer: Summarize cumulative benefit–risk information and new safety data over a defined period
Q23. Which organization is responsible for pharmacovigilance inspections and regulatory enforcement in India?
- CDSCO (Central Drugs Standard Control Organization)
- WHO‑UMC
- Pharmacovigilance Programme of India only (PvPI)
- MedDRA maintenance center
Correct Answer: CDSCO (Central Drugs Standard Control Organization)
Q24. Which items are commonly classified as criteria for seriousness of an adverse event?
- Death, life‑threatening event, hospitalization, persistent disability
- Mild headache only, cosmetic concern, taste alteration, noncompliance
- Off‑label use, interaction, allergy, patient age
- Marketing status, patent life, cost, availability
Correct Answer: Death, life‑threatening event, hospitalization, persistent disability
Q25. Which stakeholders are encouraged to report ADRs under the Indian pharmacovigilance system?
- Healthcare professionals, patients, and marketing authorization holders
- Only pharmaceutical company CEOs
- Only clinical trial sponsors
- Only regulatory inspectors
Correct Answer: Healthcare professionals, patients, and marketing authorization holders
Q26. Which database or standard is primarily used to exchange coded adverse event data internationally?
- ICH E2B structured ICSR format
- Local hospital paper forms only
- Company internal spreadsheets without standardization
- Postal mail summaries
Correct Answer: ICH E2B structured ICSR format
Q27. Which quality management action documents problems and defines corrective and preventive steps in a PV system?
- CAPA (Corrective and Preventive Action)
- SUSAR reporting
- Case Report Form (CRF)
- Product Monograph update
Correct Answer: CAPA (Corrective and Preventive Action)
Q28. Which method is most appropriate for detecting rare adverse events at the population level after widespread use?
- Disproportionality analysis of large safety databases
- Small single‑center RCT
- Basic pharmacokinetic study
- Preclinical toxicology only
Correct Answer: Disproportionality analysis of large safety databases
Q29. In India, where do AMCs submit individual case safety reports for aggregation and analysis?
- To the central PvPI system coordinated by IPC and reported onward to national database
- Directly to EudraVigilance without national routing
- Only to local hospitals and not to any central system
- To international media outlets
Correct Answer: To the central PvPI system coordinated by IPC and reported onward to national database
Q30. Which pharmacovigilance approach is especially useful during public health immunization campaigns to actively monitor vaccine safety?
- Cohort event monitoring
- Spontaneous reporting only
- Randomized placebo‑controlled trial during campaign
- Retrospective literature review only
Correct Answer: Cohort event monitoring
